U.S. patent application number 13/827541 was filed with the patent office on 2013-10-24 for intra-oral light therapy apparatuses and methods for their use.
The applicant listed for this patent is BIOLUX RESEARCH LTD.. Invention is credited to Peter Brawn, Ryan Bredin, Paul Mathews, Timothy G. Shaughnessy, Kevin Strange.
Application Number | 20130280671 13/827541 |
Document ID | / |
Family ID | 49380429 |
Filed Date | 2013-10-24 |
United States Patent
Application |
20130280671 |
Kind Code |
A1 |
Brawn; Peter ; et
al. |
October 24, 2013 |
INTRA-ORAL LIGHT THERAPY APPARATUSES AND METHODS FOR THEIR USE
Abstract
In some embodiments, an apparatus comprises a housing, an
emitter, and an electronic circuit. The housing is configured to
fit within a patient's mouth. The emitter is at least partially
encased within the housing. The emitter is configured to emit an
effective amount of light to the alveolar soft tissue when the
housing is disposed within the mouth. The electronic circuit is
operatively coupled to the emitter. The electronic circuit is
configured to control the emitter when the housing is disposed
within the mouth and the apparatus is in use during orthodontic
treatment. The apparatus and its use for regulating tooth movement
or maintaining or improving oral tissue health are disclosed
herein.
Inventors: |
Brawn; Peter; (Vancouver,
CA) ; Bredin; Ryan; (Breton, CA) ;
Shaughnessy; Timothy G.; (Marietta, GA) ; Strange;
Kevin; (Victoria, CA) ; Mathews; Paul;
(Langley, WA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BIOLUX RESEARCH LTD. |
Vancouver |
|
CA |
|
|
Family ID: |
49380429 |
Appl. No.: |
13/827541 |
Filed: |
March 14, 2013 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
61635684 |
Apr 19, 2012 |
|
|
|
61659168 |
Jun 13, 2012 |
|
|
|
61745374 |
Dec 21, 2012 |
|
|
|
Current U.S.
Class: |
433/24 ; 433/215;
433/29 |
Current CPC
Class: |
A61N 5/0603 20130101;
A61N 5/0613 20130101; A61N 2005/063 20130101; A61N 2005/0659
20130101; A61N 2005/0606 20130101; A61N 2005/0652 20130101; A61C
7/00 20130101 |
Class at
Publication: |
433/24 ; 433/29;
433/215 |
International
Class: |
A61N 5/06 20060101
A61N005/06; A61C 7/00 20060101 A61C007/00 |
Claims
1. An apparatus, comprising: a housing configured to fit within a
patient's mouth; an emitter at least partially encased within the
housing, the emitter configured to emit an effective amount of a
light to the alveolar soft tissue when the housing is disposed
within the mouth; and an electronic circuit operatively coupled to
the emitter, the electronic circuit configured to control the
emitter when the housing is disposed within the mouth and the
apparatus is in use during orthodontic treatment.
2. The apparatus of claim 1, wherein the electronic circuit is
configured to control at least one of an operational state of the
emitter, a wavelength of the light emitted from the emitter, an
intensity of the light emitted from the emitter, a frequency of the
light emitted from the emitter, or a duration of light emission
from the emitter.
3. The apparatus of claim 1, wherein the emitter includes at least
one light emitting diode.
4. The apparatus of claim 1, wherein the effective amount of light
has a wavelength from about 600 nm to about 1200 nm.
5. The apparatus of claim 1, wherein the light is monochromatic
light.
6. The apparatus of claim 1, wherein the housing is configured to
wrap over at least a portion of the teeth of the patient.
7. The apparatus of claim 1, wherein the apparatus is configured to
produce a force on at least a portion of the patient's gums when
the housing is disposed within the mouth.
8. The apparatus of claim 1, further comprising: a reflective
material coupled to the housing and configured to direct the light
emitted from the emitter to the alveolar soft tissue.
9. The apparatus of claim 1, wherein the emitter is a first
emitter, the alveolar soft tissue having a first region, the
apparatus further comprising: a second emitter at least partially
encased within the housing, the second emitter configured to emit
an effective amount of light to a second region of the alveolar
soft tissue when the housing is disposed within the mouth, the
second emitter operatively coupled to the electronic circuit such
that the electronic circuit controls the second emitter when the
housing is disposed within the mouth and the apparatus is in use
during orthodontic treatment.
10. The apparatus of claim 1, wherein the housing is a first
housing having at least a portion configured to contact a maxillary
alveolar soft tissue of the mouth, the apparatus further
comprising: a second housing configured to fit within the patient's
mouth, at least a portion of the second housing configured to
contact a mandibular alveolar soft tissue of the mouth when the
second housing is disposed within the mouth, the second housing
coupled to an electronic circuit and configured to at least
partially encase an emitter operatively coupled to the electronic
circuit, the emitter of the second housing configured to emit an
effective amount of light to a region of the mandibular alveolar
soft tissue when the second housing is disposed within the mouth,
the electronic circuit of the second housing configured to control
the emitter of the second housing when the second housing is
disposed within the mouth and the apparatus is in use during
orthodontic treatment.
11. The apparatus of claim 1, wherein the housing is an intra-oral
housing, further comprising: an external housing extended from a
front of the intra-oral housing and configured to be disposed
exterior to the patient's mouth when the intra-oral cavity is
within the patient's mouth, a power source and at least a portion
of the electronic circuit disposed within the external housing.
12. The apparatus of claim 1, wherein the housing includes at least
one shape retaining member, the shape retaining member being biased
towards one of an open configuration or a closed configuration.
13. The apparatus of claim 1, wherein the electronic circuit is
configured for wireless communication with an external electronic
device.
14. A method for regulating tooth movement, comprising:
administering to a patient in need thereof an effective amount of
light from the emitter of the apparatus of claim 1.
15. The method of claim 14, further comprising: exerting a force on
one or more teeth of the patient, the force being exerted at least
one of before, during, or after the light is administered.
16. The method of claim 15, wherein the force is exerted by at
least one of the apparatus or an orthodontic appliance.
17. The method of claim 14, wherein at least a portion of the
emitter of the apparatus contacts the alveolar soft tissue when the
light is administered.
18. A method for maintaining or improving oral tissue health,
comprising: administering to a patient in need thereof an effective
amount of light from the emitter of the apparatus of claim 1.
19. The method of claim 18, further comprising: exerting a force on
one or more teeth of the patient, the force being exerted at least
one of before, during, or after the light is administered.
20. The method of claim 18, wherein the maintaining or improving
tissue health includes reducing, preventing or minimizing
tooth-root resorption.
21. The method of claim 18, wherein the maintaining or improving
tissue health comprises reducing bone resorption or inflammatory
dentin resorption or cementum resorption of the tooth root or
periodontium.
22. The method of claim 18, wherein the maintaining or improving
tissue health comprises preventing or minimizing inflammation of
tissue surrounding one or more teeth upon which the force is or was
exerted.
23. The method of claim 14, further comprising: administering an
effective amount of vitamin D to the patient, the vitamin D being
administered at least one of before, during, or after the light is
administered.
24. The method of claim 23, wherein the effective amount of vitamin
D is from about 2000 IU per day to about 12000 IU per day.
25. The method of claim 23, wherein the effective amount of vitamin
D increases the vitamin D blood serum level of the patient.
26. The method of claim 23, wherein the effective amount of vitamin
D is administered one of orally, transdermally, via injection or
via insolation.
27. The method of claim 14, further comprising: allowing a
functional appliance to exert a force on one or more teeth of the
patient, the force being exerted by the functional appliance at
least one of before, during, or after the light is
administered.
28. The method of claim 15, further comprising: administering an
effective amount of vitamin D to the patient, the vitamin D being
administered at least one of before, during, or after the force is
exerted.
29. The method of claim 15, further comprising: allowing a
functional appliance to exert a force on one or more teeth of the
patient, the force being exerted by the functional appliance at
least one of before, during, or after the force is exerted.
30. The method of claim 18, further comprising: administering an
effective amount of vitamin D to the patient, the vitamin D being
administered at least one of before, during, or after the light is
administered.
31. The method of claim 18, further comprising: allowing a
functional appliance to exert a force on one or more teeth of the
patient, the force being exerted by the functional appliance at
least one of before, during, or after the light is
administered.
32. The method of claim 15, wherein the force is a heavy force.
33. The method of claim 19, wherein the force is a heavy force.
34. The apparatus of claim 1, wherein the alveolar soft tissue is
alveolar mucosa.
35. The method of claim 14, wherein the alveolar soft tissue is
alveolar mucosa.
36. The method of claim 18, wherein the alveolar soft tissue is
alveolar mucosa.
37. A method for orthodontic treatment, comprising administering to
a patient who wears an orthodontic appliance or is in need of
orthodontic treatment an effective amount of light from the emitter
of the apparatus of claim 1.
38. The method of claim 37, wherein the patient wears an
orthodontic appliance that exerts a force on one or more teeth of
the patient.
39. The method of claim 37, wherein the light is administered
during the alignment phase of orthodontic treatment.
40. The method of claim 39, wherein the light is administered
during only the alignment phase of orthodontic treatment.
41. The method of claim 37, wherein the alveolar soft tissue is
alveolar mucosa.
42. The method of claim 38, wherein the force is effective for
regulating tooth movement, maintaining oral tissue health or
improving oral tissue health.
43. The method of claim 38, wherein the force is a heavy force.
44. The method of claim 37, wherein the patient wears the same or a
different orthodontic appliance that exerts a second force on one
or more teeth of the patient during the retention phase of
orthodontic treatment.
45. The method of claim 44, wherein the second force is a heavy
force.
46. The method of claim 37, wherein the patient wears an
orthodontic appliance and is in need of orthodontic treatment.
47. The method of claim 37, wherein the orthodontic treatment
comprises tooth movement.
48. The method of claim 47, wherein tooth movement is tooth
alignment.
49. The method of claim 48, wherein tooth alignment is measured
using Little's Irregularity Index (LII).
50. The method of claim 47, wherein the rate of tooth movement
exceeds that of tooth movement caused by orthodontic treatment with
an orthodontic appliance, but not with light therapy.
51. The method of claim 38, wherein the orthodontic appliance
comprises a round wire.
52. The method of claim 44, wherein the same or different
orthodontic appliance comprises a square wire.
53. An apparatus, comprising: a housing configured to fit within a
patient's mouth; an emitter optically coupled to the housing, the
emitter configured to emit an effective amount of a light to the
alveolar soft tissue when the housing is disposed within the mouth;
and an electronic circuit operatively coupled to the emitter, the
electronic circuit configured to control the emitter when the
housing is disposed within the mouth and the apparatus is in use
during orthodontic treatment.
54. The apparatus of claim 53, wherein the electronic circuit is
configured to control at least one of an operational state of the
emitter, a wavelength of the light emitted from the emitter, an
intensity of the light emitted from the emitter, a frequency of the
light emitted from the emitter, or a duration of light emission
from the emitter.
55. The apparatus of claim 53, wherein the emitter includes at
least one light emitting diode.
56. The apparatus of claim 53, wherein the effective amount of
light has a wavelength from about 600 nm to about 1200 nm.
57. The apparatus of claim 53, wherein the light is monochromatic
light.
58. The apparatus of claim 53, wherein the housing is configured to
wrap over at least a portion of the teeth of the patient.
59. The apparatus of claim 53, wherein the apparatus is configured
to produce a force on at least a portion of the patient's gums when
the housing is disposed within the mouth.
60. The apparatus of claim 53, further comprising: a reflective
material coupled to the housing and configured to direct the light
emitted from the emitter to the alveolar soft tissue.
61. The apparatus of claim 53, wherein the emitter is a first
emitter, the alveolar soft tissue having a first region, the
apparatus further comprising: a second emitter optically coupled to
the housing, the second emitter configured to emit an effective
amount of light to a second region of the alveolar soft tissue when
the housing is disposed within the mouth, the second emitter
operatively coupled to the electronic circuit such that the
electronic circuit controls the second emitter when the housing is
disposed within the mouth and the apparatus is in use during
orthodontic treatment.
62. The apparatus of claim 53, wherein the housing is a first
housing having at least a portion configured to contact a maxillary
alveolar soft tissue of the mouth, the apparatus further
comprising: a second housing configured to fit within the patient's
mouth, at least a portion of the second housing configured to
contact a mandibular alveolar soft tissue of the mouth when the
second housing is disposed within the mouth, the second housing
coupled to an electronic circuit and configured to be optically
coupled to an emitter operatively coupled to the electronic
circuit, the emitter of the second housing configured to emit an
effective amount of light to a region of the mandibular alveolar
soft tissue when the second housing is disposed within the mouth,
the electronic circuit of the second housing configured to control
the emitter of the second housing when the second housing is
disposed within the mouth and the apparatus is in use during
orthodontic treatment.
63. The apparatus of claim 53, wherein the housing is an intra-oral
housing, further comprising: an external housing extended from a
front of the intra-oral housing and configured to be disposed
exterior to the patient's mouth when the intra-oral cavity is
within the patient's mouth, a power source and at least a portion
of the electronic circuit disposed within the external housing.
64. The apparatus of claim 53, wherein the housing includes at
least one shape retaining member, the shape retaining member being
biased towards one of an open configuration or a closed
configuration.
65. The apparatus of claim 53, wherein the electronic circuit is
configured for wireless communication with an external electronic
device.
66. A method for regulating tooth movement, comprising:
administering to a patient in need thereof an effective amount of
light from the emitter of the apparatus of claim 53.
67. The method of claim 66, further comprising: exerting a force on
one or more teeth of the patient, the force being exerted at least
one of before, during, or after the light is administered.
68. The method of claim 67, wherein the force is exerted by at
least one of the apparatus or an orthodontic appliance.
69. The method of claim 66, wherein at least one of a portion of
the emitter of the apparatus or a portion of an optical fiber
coupled to the emitter of the apparatus contacts the alveolar soft
tissue when the light is administered.
70. A method for maintaining or improving oral tissue health,
comprising: administering to a patient in need thereof an effective
amount of light from the emitter of the apparatus of claim 53.
71. The method of claim 70, further comprising: exerting a force on
one or more teeth of the patient, the force being exerted at least
one of before, during, or after the light is administered.
72. The method of claim 70, wherein the maintaining or improving
tissue health includes reducing, preventing or minimizing
tooth-root resorption.
73. The method of claim 70, wherein the maintaining or improving
tissue health comprises reducing bone resorption or inflammatory
dentin resorption or cementum resorption of the tooth root or
periodontium.
74. The method of claim 70, wherein the maintaining or improving
tissue health comprises preventing or minimizing inflammation of
tissue surrounding one or more teeth upon which the force is or was
exerted.
75. The method of claim 66, further comprising: administering an
effective amount of vitamin D to the patient, the vitamin D being
administered at least one of before, during, or after the light is
administered.
76. The method of claim 75, wherein the effective amount of vitamin
D is from about 2000 IU per day to about 12000 IU per day.
77. The method of claim 75, wherein the effective amount of vitamin
D increases the vitamin D blood serum level of the patient.
78. The method of claim 75, wherein the effective amount of vitamin
D is administered one of orally, transdermally, via injection or
via insolation.
79. The method of claim 66, further comprising: allowing a
functional appliance to exert a force on one or more teeth of the
patient, the force being exerted by the functional appliance at
least one of before, during, or after the light is
administered.
80. The method of claim 67, further comprising: administering an
effective amount of vitamin D to the patient, the vitamin D being
administered at least one of before, during, or after the force is
exerted.
81. The method of claim 67, further comprising: allowing a
functional appliance to exert a force on one or more teeth of the
patient, the force being exerted by the functional appliance at
least one of before, during, or after the force is exerted.
82. The method of claim 70, further comprising: administering an
effective amount of vitamin D to the patient, the vitamin D being
administered at least one of before, during, or after the light is
administered.
83. The method of claim 70, further comprising: allowing a
functional appliance to exert a force on one or more teeth of the
patient, the force being exerted by the functional appliance at
least one of before, during, or after the light is
administered.
84. The method of claim 67, wherein the force is a heavy force.
85. The method of claim 71, wherein the force is a heavy force.
86. The apparatus of claim 53, wherein the alveolar soft tissue is
alveolar mucosa.
87. The method of claim 66, wherein the alveolar soft tissue is
alveolar mucosa.
88. The method of claim 70, wherein the alveolar soft tissue is
alveolar mucosa.
89. A method for orthodontic treatment, comprising administering to
a patient who wears an orthodontic appliance or is in need of
orthodontic treatment an effective amount of light from the emitter
of the apparatus of claim 53.
90. The method of claim 89, wherein the patient wears an
orthodontic appliance that exerts a force on one or more teeth of
the patient.
91. The method of claim 89, wherein the light is administered
during the alignment phase of orthodontic treatment.
92. The method of claim 91, wherein the light is administered
during only the alignment phase of orthodontic treatment.
93. The method of claim 89, wherein the alveolar soft tissue is
alveolar mucosa.
94. The method of claim 90, wherein the force is effective for
regulating tooth movement, maintaining oral tissue health or
improving oral tissue health.
95. The method of claim 90, wherein the force is a heavy force.
96. The method of claim 89, wherein the patient wears the same or a
different orthodontic appliance that exerts a second force on one
or more teeth of the patient during the retention phase of
orthodontic treatment.
97. The method of claim 96, wherein the second force is a heavy
force.
98. The method of claim 89, wherein the patient wears an
orthodontic appliance and is in need of orthodontic treatment.
99. The method of claim 89, wherein the orthodontic treatment
comprises tooth movement.
100. The method of claim 99, wherein tooth movement is tooth
alignment.
101. The method of claim 100, wherein tooth alignment is measured
using Little's Irregularity Index (LII).
102. The method of claim 99, wherein the rate of tooth movement
exceeds that of tooth movement caused by orthodontic treatment with
an orthodontic appliance, but not with light therapy.
103. The method of claim 90, wherein the orthodontic appliance
comprises a round wire.
104. The method of claim 96, wherein the same or different
orthodontic appliance comprises a square wire.
105. The apparatus of claim 53, wherein the emitter is external to
the patient's mouth.
106. The apparatus of claim 53, wherein the emitter is separate and
apart from the housing.
107. The apparatus of claim 59, further comprising a wire that
exerts the force.
108. The apparatus of claim 7, further comprising a wire that
exerts the force.
109. The apparatus of claim 1, wherein at least a portion of the
housing is configured to contact alveolar soft tissue of the mouth
when the housing is disposed within the mouth.
110. The apparatus of claim 53, wherein at least a portion of the
housing is configured to contact alveolar soft tissue of the mouth
when the housing is disposed within the mouth.
111. A system for administering light therapy to alveolar soft
tissue of a patient, comprising: a first portion configured to be
disposed within a patient's mouth, a first emitter coupled to the
first portion and configured to emit an effective amount of a light
at a first wavelength to the alveolar soft tissue when the first
portion is disposed within the mouth, and an electronic circuit
operatively coupled to the first emitter, the electronic circuit
configured to control the first emitter when the first portion is
disposed within the mouth and the apparatus is in use during a
first stage of an orthodontic treatment, the first stage beginning
at a time T.sub.0, the first; and a second portion different from
the first portion and configured to be disposed within the
patient's mouth, a second emitter coupled to the second portion and
configured to emit an effective amount of a light at a second
wavelength, different than the first wavelength, to the alveolar
soft tissue when the second portion is disposed within the mouth,
and an electronic circuit operatively coupled to the second
emitter, the electronic circuit configured to control the second
emitter when the second portion is disposed within the mouth and
the apparatus is in use during a second stage of the orthodontic
treatment, the second stage subsequent to the first stage and
beginning at a time T.sub.>0.
112. The method of claim 14, wherein at least a portion of the
apparatus is configured to contact the patient's alveolar soft
tissue.
113. The method of claim 18, wherein at least a portion of the
apparatus is configured to contact the patient's alveolar soft
tissue.
114. The method of claim 37, wherein at least a portion of the
apparatus is configured to contact the patient's alveolar soft
tissue.
115. The method of claim 66, wherein at least a portion of the
apparatus is configured to contact the patient's alveolar soft
tissue.
116. The method of claim 89, wherein at least a portion of the
apparatus is configured to contact the patient's alveolar soft
tissue.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application Ser. No. 61/635,684, filed on Apr. 19, 2012, U.S.
Provisional Application Ser. No. 61/659,168, filed on Jun. 13,
2012, and U.S. Provisional Application Ser. No. 61/745,374, filed
on Dec. 21, 2012, each of which is incorporated by reference herein
in its entirety.
BACKGROUND
[0002] The invention relates generally to intra-oral light therapy
apparatuses and methods for using the same, including methods for
regulating orthodontic tooth movement.
[0003] Orthodontics involves the movement of teeth through bone. By
applying pressure to a tooth, bone can be broken down at a leading
edge of the tooth to facilitate tooth movement. New bone is then
created at a trailing edge of the tooth. Bone is resorbed in (e.g.,
broken down) in areas of pressure between a tooth root and
periodontium, and bone is deposited (created) in areas of tension
between a tooth root and periodontium. Pressure can cause
resorption and tension can cause deposition regardless of where
they occur along a tooth root surface. Movement of teeth through
bone is slow based on the speed of the remodeling process while
teeth are undergoing conventional orthodontic treatment, thereby
necessitating treatments of long duration in order to achieve the
desired tooth position. Tooth movement in adults is slower than
tooth movement in adolescents. Long-term orthodontic treatment can
have an increased risk of root resorption, gingival inflammation
and dental caries. Moreover, movement of teeth through bone can be
uneven, as teeth might "tip" due to the force applied, i.e., the
crown of the tooth can move in the desired direction more quickly
than the root of the tooth, resulting in tipped movement of the
tooth. When teeth move "bodily" through the bone, i.e., in a more
or less perpendicular orientation relative to the bone, the teeth
move without tipped movement or with only a low degree of tipped
movement.
[0004] Methods for increasing the rate of tooth movement without
damage to the tooth and periodontium have been sought. For example,
acceleration of tooth movement can be achieved by the local
injection of prostaglandin, the active form of vitamin D3, and
osteocalcin around the alveolar socket. These substances might
increase the rate of tooth movement, but might also cause side
effects such as local pain and discomfort for a patient during the
process of injection. An alternative strategy for increasing the
rate of tooth movement is to improve bone regeneration. For
example, light therapy has been found to be effective in the
treatment of bone disorders and the biostimulation of bone and soft
tissue, and can be effective in accelerating alveolar bone
regeneration. Light can stimulate a variety of biological
activities in cells and tissues that are compromised in function,
for example, by stimulating cytochrome C oxidase or nitric oxide
synthase.
[0005] Phototherapy or light therapy treatment is typically
administered by a dentist, orthodontist, physician or therapist who
directs light from a hand-held light emitting apparatus at an
affected area. Light emitting apparatuses can be difficult to
position consistently over the affected area. Additionally, light
therapy typically involves repeated treatments over at least
several days, which would require patients undergoing light therapy
to make multiple visits to a practitioner's office or clinic in
order to complete a therapy regimen. Such repeated visits can be
time consuming or expensive.
[0006] Furthermore, in a recent study, more than 65% of the
subjects in North America were shown to be deficient vitamin D
serum levels. In these vitamin D-deficient subjects, bone
metabolism and remodeling can be adversely affected.
[0007] A need exists for methods and apparatuses that are useful
for increasing the velocity (or rate) or improving the quality of
tooth movement through bone in response to orthodontic treatment,
to decrease treatment times for patients without undesirable side
effects or pain. There is also a need for methods and apparatuses
that can be used to achieve a desired mode or quality of movement
of teeth through the bone, e.g., bodily movement of teeth through
bone, using intra-orally administered light therapy that permits
tooth movement to be modulated at a desired specific location or
locations within a patient's mouth without undue difficulty.
SUMMARY OF THE INVENTION
[0008] The invention provides apparatuses, comprising: [0009] a
housing configured to fit within a patient's mouth; [0010] an
emitter at least partially encased within the housing, the emitter
configured to emit an effective amount of a light to a region
associated with the alveolar soft tissue when the housing is
disposed within the mouth; and [0011] an electronic circuit
operatively coupled to the emitter, the electronic circuit
configured to control the emitter when the housing is disposed
within the mouth and the apparatus is in use during orthodontic
treatment.
[0012] The apparatus is useful for regulating tooth movement or for
maintaining or improving oral tissue health.
[0013] The invention further provides methods for regulating tooth
movement, maintaining oral tissue health or improving oral tissue
health, comprising:
[0014] administering to a patient in need thereof an effective
amount of light from the emitter of the apparatus, wherein at least
a portion of the apparatus is configured to contact the patient's
alveolar soft tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIGS. 1 and 2 are perspective views of intra-oral
light-therapy apparatuses according to an embodiment of the
invention.
[0016] FIG. 3A is a sectional view of the apparatus of FIG. 1,
taken along line X-X.
[0017] FIG. 3B is a side view of a portion of an intra-oral
light-therapy apparatus according to an embodiment of the
invention.
[0018] FIGS. 4-8 are schematic diagrams of intra-oral light-therapy
apparatuses according to an embodiment of the invention.
[0019] FIG. 9 is a schematic diagram of an intra-oral light-therapy
apparatus according to an embodiment of the invention.
[0020] FIG. 10 is a sectional view of a portion of the apparatus of
FIG. 9.
[0021] FIG. 11 is a top perspective view of a portion of the
apparatus of FIG. 9.
[0022] FIG. 12 is a sectional view of a portion of the apparatus of
FIG. 9.
[0023] FIG. 13 is a schematic diagram of an intra-oral
light-therapy apparatus according to an embodiment of the
invention.
[0024] FIG. 14 is a side view of the apparatus of FIG. 13.
[0025] FIG. 15 is a side view of the apparatus of FIG. 13 and a
charging station.
[0026] FIGS. 16 and 17 are schematic diagrams of intra-oral
light-therapy apparatuses according to an embodiment of the
invention.
[0027] FIG. 18A is a top view of a portion of an intra-oral
light-therapy apparatus according to an embodiment of the
invention.
[0028] FIG. 18B is a front view of a portion of an intra-oral
light-therapy apparatus according to an embodiment of the
invention.
[0029] FIG. 19 is a top view of a portion of an intra-oral
light-therapy apparatus according to an embodiment of the
invention.
[0030] FIG. 20 is a perspective view of an intra-oral light-therapy
apparatus according to an embodiment of the invention.
[0031] FIG. 21 is a sectional view of the apparatus of FIG. 20
taken along line A-A.
[0032] FIG. 22 is a bottom view of the apparatus of FIG. 20.
[0033] FIG. 23 is a side view of an intra-oral light-therapy
apparatus according to an embodiment of the invention in use within
an oral cavity.
[0034] FIGS. 24 and 25 are side and front views, respectively, of
portions of intra-oral light-therapy apparatuses according to
embodiments of the invention.
[0035] FIG. 26 is perspective view of an intra-oral light-therapy
apparatus according to an embodiment of the invention.
[0036] FIGS. 27-29 are top views of intra-oral light-therapy
apparatuses according to embodiments of the invention.
[0037] FIGS. 30-33 are perspective views of an intra-oral
light-therapy apparatus according to an embodiment of the
invention.
[0038] FIGS. 34 and 35 are top and rear views, respectively, of the
apparatus of FIGS. 30-33 in a powered (i.e., "on") operational
state.
[0039] FIG. 36 is a perspective view of the apparatus of FIGS. 34
and 35 coupled to an electronic device.
[0040] FIG. 37 is an image of the apparatus of FIGS. 30-36 disposed
in the oral cavity of and in use by a patient.
[0041] FIG. 38 is an image of an intra-oral light-therapy apparatus
according to an embodiment of the invention disposed in the oral
cavity of and in use by a patient.
[0042] FIG. 39 is an image of an upper arch of a patient prior to
light therapy treatment using the intra-oral light-therapy
apparatus of FIG. 38.
[0043] FIG. 40 is an image of the patient's upper arch of FIG. 39
after light therapy treatment using the intra-oral light-therapy
apparatus of FIG. 38.
[0044] FIG. 41 is an image of the upper arch of a patient prior to
light therapy treatment using the intra-oral light-therapy
apparatus of FIG. 38.
[0045] FIG. 42 is an image of the patient's upper arch of FIG. 41
after light therapy treatment using the intra-oral light-therapy
apparatus of FIG. 38.
[0046] FIG. 43 is a rear view of an intra-oral apparatus according
to an embodiment of the invention.
[0047] FIG. 44 is a front view of the intra-oral apparatus of FIG.
43.
[0048] FIGS. 45 and 46 are side and top views of an intra-oral
apparatus according to an embodiment of the invention.
[0049] FIG. 47 is a perspective view of a portion of the intra-oral
apparatus of FIG. 45.
[0050] FIGS. 48A and 48B are bottom-rear and top-rear perspective
views of a portion of the intra-oral apparatus of FIG. 45.
[0051] FIGS. 49 and 50 are perspective and front views of the
intra-oral apparatus of FIG. 45 and an external station according
to an embodiment of the invention.
[0052] FIG. 51 is a front view of the external station of FIG.
49.
[0053] FIG. 52 is a schematic illustration of a portion of the
intra-oral apparatus of FIG. 45.
[0054] FIG. 53 is a top view of an intra-oral apparatus according
to an embodiment of the invention.
[0055] FIG. 54 is a side view of a portion of an intra-oral
apparatus according to an embodiment of the invention.
[0056] FIGS. 55 and 56 are end and perspective views of the
intra-oral apparatus of FIG. 54.
[0057] FIG. 57 is a schematic illustration of a system including
the intra-oral apparatus of FIG. 54 according to an embodiment of
the invention.
[0058] FIG. 58 is a schematic illustration of an intra-oral
apparatus according to an embodiment of the invention.
DETAILED DESCRIPTION
[0059] The term "about" as used herein in connection with a
referenced numeric indication means the referenced numeric
indication plus or minus up to 10% of that referenced numeric
indication. For example, the language "about 50" units covers the
range of 45 units to 55 units.
[0060] The verb "surround" as used herein means to be within about
one (1) centimeter of a target object. For example, oral tissue
that surrounds a tooth is within about 1 cm of the tooth. In some
embodiments, the methods disclosed herein are useful for preventing
or minimizing inflammation that is within about 1 cm of a
tooth.
[0061] The term "patient" as used herein refers to any living
subject that can receive medical, including orthodontic, treatment.
A patient can be, for example, a mammal such as a human. The
patient can be an adult patient or a child patient. In some
embodiments, the patient can be a living subject that receives
light treatment, e.g., light administered to the patient
intra-orally using an intra-oral apparatus described herein.
[0062] The term "root area" as used herein refers to a portion of a
patient's anatomy that includes the anatomic length and width of a
tooth root, as well as at least a portion of peripheral tissue that
facilitates attachment of the tooth to the alveolar bone within
which the tooth sits. The peripheral tissue can include the
periodontal ligament and the boney socket in which the periodontal
ligament is disposed and which surround the tooth. The root area
can include tissue extending from the gum line to a depth of about
10 mm to about 22 mm, depending on the type of tooth. The root area
can also include an area within a particular distance (e.g., within
about 0.1 cm to about 3 cm) of the root area of each tooth, unless
the context clearly indicates otherwise. The dimensions of a root
area can vary depending on the particular subject tooth. References
to the root area herein can include at least a portion of the root
area or the entirety of the root area, unless the context clearly
indicates otherwise.
[0063] Intra-Oral Light Treatment Apparatuses
[0064] Some embodiments described herein relate to exposing the
alveolar soft tissue, e.g., the alveolar mucosa, to light (e.g.,
having an intensity from about 10 to about 200 mW/cm.sup.2).
Administering the light can modify the rate of tooth movement,
increase the rate of healing, or provide one or more other
orthodontic benefits. For example, administering light to an
extraction site can increase the rate of healing and slow the
movement of a tooth into the site. Some embodiments described
herein include an intra-oral light-therapy apparatus configured to
administer light to one or more portions of the patient's alveolar
soft tissue. Such an apparatus can be used prior to, during or
subsequent to orthodontic treatment and/or prior to, during or
subsequent to oral surgery. In some embodiments, as disclosed
herein, an apparatus can be used to administer light to a patient
for 1 minute to 60 minutes per day. In other embodiments, the
apparatus can contact a patient's oral mucosa for minutes, hours,
day, weeks, months, or years, and one or more of the apparatus's
emitters can irradiate light during at least some time during that
period.
[0065] In some embodiments, an apparatus is configured to conform
to the alveolar soft tissue of any human patient; in other
embodiments, an apparatus can be configured to conform to the
alveolar soft tissue of a specific human patient. For example, the
apparatus can be configured to conform to any human patient's, or
to a specific human patient's, particular dental geometry, for
example, using information obtained from CT scans (e.g., cone beam
CT scans), models of the patient's jaw, intra-oral digital scanned
models, and/or photographs of the patient's jaw. More specifically,
the placement of LEDs within an apparatus to be positioned within
the patient's mouth can be custom designed, using CAD/CAM design
applications, for example, based on information obtained from one
or more of the foregoing methods. In other embodiments, a
standardized apparatus can be selected from a set of apparatuses
configured to conform generally to human patients' oral anatomical
features. In some such embodiments, the standardized apparatus can
be adjusted to conform to a specific human patient's features.
[0066] In some embodiments, the apparatus is configured to
administer light therapy based on a customized dosage, e.g., a
dosage that is customized for a particular patient. Younger
patients may have less dense bone than older patients. Density of
the patient's bone can be measured, for example, using computed
tomography (CT), in one embodiment, cone beam CT, prior to light
therapy administration. In some embodiments, the patient's bone
density can be measured by irradiating the patient's teeth and
measuring the amount of light that penetrates the teeth (e.g.,
using an apparatus similar to or such as that illustrated and
described with respect to FIG. 18A.) Once the patient's bone
density is determined, an optimal dosage of light can be determined
for achieving the desired tooth movement.
[0067] In some embodiments, the apparatus can include a bite pad to
improve patient comfort when the apparatus is in contact with the
patient's alveolar soft tissue and/or for positioning of the
apparatus in a patient's mouth.
[0068] In some embodiments, the apparatus can be used in
conjunction with an appliance that exerts a force on the patient's
teeth and/or on muscular tissue such as buccal and lanial cheeks,
tongue, etc. In some embodiments, the apparatus of the invention is
used in conjunction with more than one appliance that exerts a
force on the patient. Exerting one or more forces to the gum region
and intra-orally administering light to a patient's alveolar soft
tissue can increase the rate of tooth movement, increase the rate
of healing of oral tissue and provide other orthodontic benefits.
In some embodiments, one or more of the forces exerted is a heavy
force. In some embodiments, one or more of the appliances exerting
a force is a functional appliance. Heavy forces and functional
appliances are disclosed herein.
[0069] In other embodiments, the apparatus can be used in
conjunction with an orthodontic appliance.
[0070] In some embodiments, the apparatus can be used in
conjunction with an appliance or other suitable conveyance that is
configured to deliver vitamin D to the patient. Vitamin D treatment
raises the vitamin D blood serum levels of the patient and, when
combined with intra-oral light treatment, can increase the rate of
tooth movement, increase the rate of healing of oral tissue and
provide other orthodontic benefits. Vitamin D treatment is
disclosed herein.
[0071] In some embodiments, the apparatus of this invention can be
used in conjunction with one or more appliances that exert a force
on the patient's oral tissue, such as a patient's tooth, or with an
appliance (or other suitable conveyance) that is configured to
deliver vitamin D to the patient. In this manner, the patient
receives light treatment and vitamin D treatment and also has
forces exerted, for example, on one or more teeth.
[0072] FIGS. 1 and 2 are schematic diagrams of intra-oral
light-therapy apparatuses of the invention. As shown in FIG. 1, the
apparatus includes panels 1, 2, 3, 4, 5, and 6. Panels 1, 2, and 3
are configured to be disposed near the root area of one or more
teeth of the upper jaw. In some embodiments, panels 1, 2, and 3 can
be configured to be disposed adjacent to the upper buccal alveolar
soft tissue. For example, in one embodiment, the panels 1, 2, and 3
are in contact with the upper buccal alveolar soft tissue; whereas,
in other embodiments, the panels 1, 2, and 3 are not in contact
with the upper buccal alveolar soft tissue but are within a certain
distance (e.g., within 0.1 cm to 3 cm) of the upper buccal alveolar
soft tissue. The alveolar soft tissue can include, for example, the
alveolar mucosa. In other embodiments, panels 1, 2, and 3 can be
configured to be disposed adjacent to the upper lingual alveolar
soft tissue. For example, in one embodiment, the panels 1, 2, and 3
are in contact with the upper lingual alveolar soft tissue;
whereas, in other embodiments, the panels 1, 2, and 3 are not in
contact with the upper lingual alveolar soft tissue but are within
a certain distance (e.g., within 0.1 cm to 3 cm) of the upper
lingual alveolar soft tissue. Similarly stated, in some
embodiments, panels 1, 2, and/or 3 can be configured to be disposed
posterior to the maxillary root area, while in other embodiments,
panels 1, 2, and/or 3 can be configured to be disposed anterior to
the maxillary root area. Similarly, panels 4, 5, and/or 6 can be
configured to be disposed adjacent to anterior and/or posterior
mandibular root area.
[0073] In other embodiments, the panels (or other portions of the
apparatus) can be disposed at any of the various regions or areas
described herein. For example, although in some embodiments, the
panels are described herein as being in contact with or within a
certain distance (e.g., within 0.1 cm to 3 cm) of the upper buccal
or lingual alveolar soft tissue, in other embodiments, the panels
are configured to be in contact with and/or within a certain
distance (e.g., within 0.1 cm to 3 cm) of the lower buccal or
lingual alveolar soft tissue. In still other embodiments, an
apparatus can include a plurality of panels of which at least a
first portion are configured to be in contact with or within a
certain distance (e.g., within 0.1 cm to 3 cm) of the upper buccal
or lingual alveolar soft tissue, and of which at least a second
portion is configured to be in contact with or within a certain
distance (e.g., within 0.1 cm to 3 cm) of the lower buccal or
lingual alveolar soft tissue when the first portion is in contact
with or within the certain distance of the upper alveolar soft
tissue.
[0074] In some embodiments, an apparatus is configured to be
disposed only adjacent to the maxillary or mandibular root area.
For example, in one embodiment, the apparatus is in contact with
the maxillary or mandibular root area; whereas, in other
embodiments, the apparatus is not in contact with the maxillary or
mandibular root area but is within a certain distance (e.g., within
0.1 cm to 3 cm) of the maxillary or mandibular root area. Similarly
stated, although FIG. 1 depicts an apparatus including an upper
portion and a lower portion, in other embodiments, the apparatus
has only an upper portion or only a lower portion. Although the
apparatus is shown with six panels, in other embodiments, the
apparatus can have one or more panels. For example, a single panel
can be configured to cover at least a portion of the maxillary
and/or mandibular root area or the entirety. In other embodiments,
one or more panels can be disposed adjacent to the root area of
each tooth. For example, in one embodiment, one or more panels are
in contact with the root area of each tooth; whereas, in other
embodiments, one or more panels are not in contact with the root
area of each tooth but are within a certain distance (e.g., within
0.1 cm to 3 cm) of the root area of each tooth.
[0075] Although in some embodiments the panels described herein
cover at least some of the anatomical dimensions (e.g., length) of
most tooth roots, variation in soft tissue and boney architecture
of individual patients may prevent the panel from covering the
apical extent of some tooth roots. In such cases, apical portions
of the teeth may receive lower energy density. In some embodiments,
however, the panels include an embedded LED array that is
configured to direct light in the direction of such apical
portion(s) or is configured to otherwise increase the intensity in
the apical portions of the panels.
[0076] In some embodiments, such as the embodiment depicted in FIG.
2, the apparatus is configured to wrap over the teeth, such that a
first portion of the apparatus is disposed adjacent to the anterior
root area and a second portion of the apparatus is disposed
adjacent to the posterior root area. In such embodiments, the
apparatus is relieved over the anatomical crowns in order to
provide freedom of tooth movement when the apparatus is in
operation. For example, in one embodiment, the first portion of the
apparatus is in contact with the anterior root area and/or the
second portion of the apparatus is in contact with the posterior
root area; whereas, in other embodiments, the first portion of the
apparatus is not in contact with the anterior root area and/or the
second portion of the apparatus is not in contact with the
posterior root area but the first portion and/or the second portion
of the apparatus is/are within a certain distance (e.g., within 0.1
cm to 3 cm) of the anterior root area or posterior root area,
respectively.
[0077] FIG. 3A depicts a cross section of the apparatus of FIG. 1
taken along line X-X. The apparatus 10 can include one or more
wires 12, a reflective backing 20, a circuit 30, and one or more
emitters 32, encased in the panel 40. In some embodiments, the one
or more emitters 32 can be partially encased within the panel 40
such that at least a portion of the one or more emitters 32 are
exposed and can contact, for example, the alveolar soft tissue of
the patient when the apparatus is in the patient's mouth. The panel
40 can be constructed of a clear, flexible, and/or soft polymer,
such as a silicone. In other embodiments, the panel 40 can be a
rigid plastic, such as an acrylic. The panel 40 can be shaped to
cover a specific region of the patient's mouth when the apparatus
is worn by the patient. For example, the panel 40 can have a width
and a length effective to cover at least four of the patient's
tooth roots. A portion of the panel 42 can have a rounded and/or
teardrop shape to provide for patient comfort and to allow the
apparatus to adapt to the flange area. The portion of the panel 42
can have any shape that does not include sharp or acute edges as
such edges would irritate or be uncomfortable in the depth of the
vestibule of the patient's mouth.
[0078] In some embodiments, the panel 40 is at least partially
encased in the apparatus, which can have a shape similar to a mouth
guard or to a clear dental aligner and can be constructed of any
material suitable for use in the mouth. In this manner, the
components encased in the panel 40 are also at least partially
encased in the apparatus. In some embodiments, the panel 40 is
fully encased in the apparatus. The panel 40 and components encased
therein can be fluidically sealed within the apparatus so that
saliva or another fluid cannot contact the panel 40. Sealing the
panel 40 in this manner can provide safety benefits, extend the
life of the intra-oral apparatus, and/or require less maintenance.
For example, if the panel 40 is not fluidically sealed within the
apparatus, then the apparatus may require frequent maintenance to
clean fluids and other buildup from the panel 40.
[0079] The emitters 32 can be any suitable device that is operable
to emit light. The emitters 32 can be, for example, light emitting
diodes (LEDs). In some embodiments, the emitters 32 are optical
fibers (or portions thereof) that emit light. In some embodiments,
the emitters 32 are devices that are connected to and receive light
input from one or more optical fibers. The panel 40 can include any
combination of the LED and optical fiber emitters disclosed herein.
In some embodiments, the emitters 32 can emit monochromatic light
having a wavelength of about 620 nm. In other embodiments, the
emitters 32 can emit monochromatic light having a wavelength of
about 850 nm. In yet other embodiments, the emitters 32 can be
configured to emit a light having a wavelength ranging from about
600 nm to about 1200 nm, emit light at more than one wavelength,
progress through a range of wavelengths, and/or emit a broad
spectrum light or any suitable wavelength or wavelengths. The
emitters 32 can be configured to emit light having any wavelength
or characteristic described herein. Such wavelengths and
characteristics of light are described in more detail herein.
[0080] The emitters 32 can be positioned and arranged within the
panel 40 in any suitable manner. The emitters 32 can be arranged,
for example, so that they cover and irradiate light to a specific
region of the mouth when the apparatus is worn by the patient. In
one example, each emitter 32 is positioned over and irradiates
light to a different tooth root. In another example, the emitters
32 are grouped together into sets so that one set of emitters is
positioned over and irradiates light to a first region of the
patient's mouth (e.g., a tooth root) while another set of emitters
is positioned over and irradiates light to a second, different
region of the patient's mouth (e.g., another tooth root). In this
manner, the apparatus and the emitters 32 within each corresponding
panel 40 can be customized for a specific patient so that
particular needs of the orthodontic treatment are met. As noted
herein, the panels, and thus the emitters 32, can be in contact
with or within a certain distance of the alveolar soft tissue or
tooth root. A light dose emitted by the emitters 32 can be more
effective for regulating tooth movement the closer the emitters 32
are to the alveolar soft tissue or tooth root, due to a loss of
energy that can occur over a distance between the emitters 32 and
the tissue or root. In some embodiments, however, the power density
of light emitted by emitters 32 can be maximized by positioning the
emitters 32 in contact with and/or within the certain distance of
the tissue or root, as described herein.
[0081] In some embodiments, as shown in FIG. 3B, a light emitting
array 1001 has a first portion 1002 and a second portion 1003. The
first portion 1002 of the light emitting array 1001 is configured
to include a greater density of light emitters than a density of
light emitters in the second portion 1003. In some embodiments, the
first portion 1002 of the light emitting array 1001 includes a
tighter weave on a portion of a light mat. The first portion 1002
of the light emitting array 1001 (or light mat) can be disposed at
an apical portion of the array. The increased power density at the
apex resulting from the tighter weave of the light mat permits a
shorter extension to a flange as the increased power at least
partially compensates for a shorter extension.
[0082] Referring again to FIG. 3A, the circuit 30 can be, for
example, a flexible circuit. In some embodiments, the circuit 30
includes a controller (not shown) operable to control the operation
of one or more emitters 32. In other embodiments, the circuit 30
can be coupled to a controller, such as an intra-oral or extra-oral
controller. In some embodiments, the controller can independently
control each of the one or more emitters 32. For example, using the
circuit 30, the controller can collectively and/or individually
control the on/off state, the intensity, the frequency, the pulse,
the duty factor, and/or any other suitable parameter of the one or
more emitters 32. Any one of these parameters can be changed while
the apparatus is in use. By powering on one or more of the emitters
32, the controller enables the one or more emitters 32 to emit
light and thereby accelerate bone remodeling and/or tooth movement.
By powering off one or more of the emitters 32, the controller
minimizes the movement of the teeth in the area, as bone remodeling
will not have been accelerated by the light. In some embodiments,
one or more emitters 32 within panel 40 can be on while one or more
other emitters 32 within panel 40 are off. In some embodiments,
when the apparatus is in use, one or more emitters 32 can start in
the on state and then, at some later time, switch to the off state.
By increasing or decreasing the intensity of the light, the
controller can increase or decrease the dosage of light to the
patient. A dosage of light is based on intensity and time so, in
some instances, increasing the intensity of the light allows a
decrease in the amount of time that the light needs to be
administered to the patient. As a practical matter, there is a
biological threshold of both minimum time and intensity in order to
produce a therapeutic result. The controller can operate the
emitters 32 at or above this threshold. In some embodiments, the
intensity of light emitted from one or more emitters 32 within the
panel 40 can be increased while the intensity of light emitted from
one or more other emitters 32 within the panel 40 is decreased.
This increase and decrease can occur, for example, while the
apparatus is in use.
[0083] The controller can control the frequency and duty factor so
that higher peak intensities can be achieved. High peak intensities
can be useful in thicker tissues and/or when dosages of light need
to be administered at greater depths. In some embodiments, a first
emitter within the panel 40 can be disposed adjacent to and
targeting a bone region that is deeper beneath the alveolar soft
tissue than the bone region that a second emitter within the panel
40 is targeting. In these embodiments, the controller can program
or control the first emitter so that it emits light having a higher
peak intensity than the second emitter. Controlling the duty factor
can also protect the emitters from overheating. For example, the
controller can operate one or more emitters 32 at a 25% duty factor
and at a frequency of 100 Hz such that the emitters 32 are ON for
1/400th of a second and then OFF for 3/400ths of a second. The OFF
time would allow the emitters 32 to cool down, thereby avoiding any
potential performance degradation associated with higher
temperatures.
[0084] As disclosed herein, the controller can individually and
selectively control the various light emission characteristics of
each emitter 32 within the panel 40 and, as a result, each emitter
32 can operate independently of the other emitters 32 within the
panel 40. Specifically, each emitter 32 within the panel 40 can
emit light having different characteristics, if needed. The panel
40, therefore, can irradiate light at more than one wavelength or
otherwise irradiate light having multiple different
characteristics. In other embodiments, the controller can
collectively control the various light emission characteristics of
the emitters 32 within the panel 40. In some instances, all of the
emitters 32 within the panel 40 are controlled so that they emit
light having the same characteristics. These emitters 32, however,
can be operated and controlled independently of emitters within
other panels of the apparatus. For example, the emitters 32 can
emit light having a wavelength of 850 nm while the emitters within
another panel (e.g., panel 3 shown in FIG. 1) emit light having a
wavelength of 650 nm. Emitted light characteristics, therefore, can
vary from panel to panel within the apparatus. In other instances,
the emitters 32 within the panel 40 can form groups and the
emitters within each group are collectively controlled. For
example, the panel 40 can include two groups of emitters 32: the
first group of emitters can emit light at a first wavelength and
the second group of emitters can emit light at a second, different
wavelength. The panel 40, and the emitters 32 therein, can be
customized for a specific patient so that an effective amount or
dosage of light is administered to the patient and specific regions
within the mouth are targeted. This customization can be useful
when, for example, one region of the mouth undergoes a different
light treatment than another region of the mouth.
[0085] In some embodiments, the apparatus can include an internal
power source, such as a battery (not shown). In other embodiments,
the apparatus can include a port, such that the circuit 30 can be
coupled to an external power source.
[0086] In some embodiments, the circuit 30 can include one or more
sensors (not shown) to detect the temperature of the apparatus, the
patient's alveolar soft tissue and/or the patient's root area. For
example, a thermistor or similar temperature measuring device can
be placed in the circuitry 30 to monitor the temperature of the
emitters 32 (e.g., an LED array) and panel 40 as well as measure
the temperature inside the patient's mouth. This information can
serve as a method of obtaining temperature-related information as
well as monitoring patient compliance. When the circuits are placed
in the mouth (i.e., circuit 30 and the circuits from the remaining
panels of the apparatus) and when the apparatus emits light, the
temperature of the emitters will rise from pre-treatment ambient
temperature closer to normal body temperature. By monitoring the
change in temperature, the controller can monitor the period of
time that the emitters 32 are in the mouth, based on the period of
time the temperature is elevated and close to body temperature.
Alternatively, as discussed in more detail with reference to FIGS.
18A-18C, a photodetector can be placed in the circuit 30 and/or
with the emitters 32 to measure the reflectance of light from the
alveolar soft tissue. This configuration can serve as a method of
monitoring patient compliance and also serve as a failsafe
mechanism to ensure that the emitters 32 do not operate unless the
apparatus is within the mouth of the patient.
[0087] The reflective backing 20 can be a metallic foil or other
suitable reflective material operable to cause the light emitted by
the emitters 20 to be directed in a desired direction, in one
embodiment, substantially one direction, e.g., within about 1 to
about 10 degrees of a specific direction. For example, the
reflective backing 20 can define the back of the apparatus, such
that the light is directed towards the alveolar soft tissue or root
area of the patient (e.g., the region beneath the alveolar soft
tissue that includes bone and roots).
[0088] The wires 12 can be super-elastic wires operable to cause
the apparatus to conform to the alveolar soft tissue and/or
gingiva. In some embodiments, the wires 12 can produce a relatively
large orthodontic and/or orthopedic force, such as a force operable
to urge one or more teeth to move. The force can be, for example,
from about 10 to about 1000 grams of force. In some embodiments,
the force is a heavy force. In other embodiments, the apparatus can
be a portion of and/or be coupled to a separate intra-oral
apparatus, such as orthodontic braces, retainers and/or any other
suitable functional appliance. In some such embodiments, the
separate intra-oral apparatus can produce a force in conjunction
with or in lieu of the wires 12 producing a force.
[0089] FIGS. 4-6 are schematic diagrams of an apparatus of the
invention. As shown in FIG. 4, in some embodiments, one or more
emitters 132 can be disposed over the roots of one or more teeth
160. In other embodiments, as shown in FIG. 5, one or more emitters
232 can be disposed between the roots of one or more teeth 260. In
such embodiments, a mask can be applied to the apparatus and/or the
root area of each tooth 260 to prevent the root area of the teeth
260 from being exposed to the light. As is disclosed herein, the
mask blocks the light irradiated from the one or more emitters 132
so that little or none of the light reaches the area covered by the
mask. The mask can be a tooth mask. The mask can be opaque and/or
reflective. In some embodiments, the mask includes an adhesive
surface so that the mask can be placed and adhered to an outer
surface of the apparatus at a location where light is desired to be
blocked. In some embodiments, the mask is in the form of a sticker.
The adhesive surface of the mask can contact and/or cover one or
more panels (or a portion thereof). In some embodiments, the
opposing outer surface of the mask (or a portion thereof) can
contact the alveolar soft tissue (e.g., the alveolar mucosa) when
the mask is adhered to the apparatus and the apparatus is in the
patient's mouth. In some embodiments, more than one mask can be
applied to the apparatus and/or the root area of each tooth 260 to
prevent the root area of the teeth 260 from being exposed to the
light. In some such embodiments, more than one type of mask can be
applied. For example, both an opaque mask and a reflective mask can
be applied to the apparatus.
[0090] In other embodiments, as shown in FIG. 6, one or more
emitters 332 can be operable to illuminate the maxillary suture,
for example, the midline of the maxillary suture. In some
embodiments, the one or more emitters 332 emit light directed
towards the maxillary suture before, during, and/or after an
orthopedic force is exerted on the maxillary suture. The orthopedic
force can be exerted by an orthodontic appliance, such as, for
example, a Rapid Maxillary Expansion (RME) appliance. A RME
appliance can exert orthopedic forces on the patient's molars to
open up and expand the maxillary suture for skeletal expansion of
the upper jaw (as opposed to an orthodontic expansion where only
the teeth move). Light therapy can be used in these embodiments to
accelerate the rate at which the maxillary bone grows and the gaps
caused by the skeletal expansion are filled. In some embodiments,
the present methods are useful for accelerating the fill of bone
and/or decreasing the potential for relapse or narrowing of the
maxillary arch after orthodontic appliance removal. In some
embodiments, the one or more emitters 332 emit light directed
towards the midline of the palate such that boney regeneration is
simulated through light therapy. In some embodiments, the apparatus
shown in FIG. 6 is customized to fit around the RME appliance or
other like fixed orthodontic expander. In some embodiments, the
apparatus shown in FIG. 6 includes the one or more emitter 332 that
illuminate the maxillary suture as well as one or more other
emitters that illuminate the alveolar soft tissue.
[0091] The emitters 132, 232 and/or 332 can operate in a manner
similar to the emitters 32 described herein with respect to FIG.
3A.
[0092] FIG. 7 is a schematic diagram of an apparatus, according to
an embodiment. The apparatus includes four panels 401, 402, 403,
404, a light source 410, one or more optical fiber cables 420, and
a controller 430. The panels 401, 402, 403, and/or 404 can be
configured to be disposed adjacent to the root area of the upper
and/or lower jaw. For example, in one embodiment, the panels 401,
402, 403, and/or 404 are in contact with the root area of the upper
and/or lower jaw; whereas, in other embodiments, the panels 401,
402, 403, and/or 404 are not in contact with the root area of the
upper and/or lower jaw but are within a certain distance (e.g.,
within 0.1 cm to 3 cm) of the root area of the upper and/or lower
jaw. Such configurations can eliminate the need to place
electronics in the oral cavity.
[0093] The light source 410 can be operable to emit light. For
example, in some embodiments, the light source 410 can output
monochromatic light. For example, the light source 410 can be a
laser, an LED, and/or any other suitable light source. The light
source 410 can be configured to emit a light having a wavelength
ranging from about 600 nm to about 1200 nm, emit light output at
more than one wavelength, progress through a range of wavelengths,
and/or emit a broad spectrum light output or any suitable
wavelength or wavelengths. The light source 410 can output light
with any wavelength or characteristic described herein.
[0094] The light can be conveyed from the light source 410 to the
controller 430 via one or more optical fibers 420. The controller
430 can be, for example, an optical switch. The controller 430 can
be operable to selectively transmit light from the light source 410
to the panels 401, 402, 403, and/or 404 via one or more optical
fibers 420. For example, the controller 430 can collectively and/or
individually control the on/off state, the intensity, the
frequency, the pulse, the duty factor, and/or any other suitable
parameters of the light that is delivered to the panels 401, 402,
403, and/or 404. The controller 430 can operate similar to the
controller described herein with respect to FIG. 3A.
[0095] In some embodiments, more than one optical fiber 420 can be
directed to each panel. The optical fiber can terminate adjacent to
(e.g., within 0.1 cm to 3 cm) or at the root area, similar to the
apparatuses shown and described with reference to FIGS. 4 and 5.
Thus, each optical fiber can direct light from the light source 410
to the root area. By providing more than one fiber 420, light from
the source 410 can be directed and/or controlled to illuminate a
specific portion of the root area. In this way, the controller 430
can selectively apply light to the root area of one or more teeth,
similar to the emitters 32, 132 and/or 232 as shown and described
herein with reference to FIGS. 3, 4 and 5.
[0096] FIG. 8 is a schematic diagram of an apparatus, according to
an embodiment. The apparatus includes two panels 501, 502, a light
source 510, an optical fiber ribbon 520, and a controller 530. The
panels 501 and 502 can be configured to be disposed adjacent to the
root area of the upper jaw as well as the root area of the lower
jaw. As is disclosed herein, the panels 501 and 502, for example,
can first be disposed adjacent to the root area of the upper jaw;
then, after orthodontic treatment of the upper jaw is complete, the
panels 501 and 502 can be removed from the upper jaw and placed on
the lower jaw such that they are disposed adjacent to the root area
of the lower jaw. In one embodiment, the panels 501, 502 are in
contact with the root area of the upper and/or lower jaw; whereas,
in other embodiments, the panels 501, 502 are not in contact with
the root area of the upper and/or lower jaw but are within a
certain distance (e.g., within 0.1 cm to 3 cm) of the root area of
the upper and/or lower jaw. Such configurations can eliminate the
need to place electronics in the oral cavity.
[0097] The panels 501, 502 can define an upper portion 542. The
cross-section of the upper portion 542 can be rounded and/or
teardrop shaped (similar to the portion of the panel 42 illustrated
and described with respect to FIG. 3A) to provide for patient
comfort and to allow the apparatus to adapt to the flange area of
the upper and lower jaw. For example, as is disclosed herein, the
apparatus can be worn on the upper jaw so that the upper portion
542 of the panels 501, 502 adapt to the upper flange area; then,
the apparatus can be removed from the upper jaw, flipped upside
down, and then installed on the lower jaw such that the upper
portion 542 is now disposed in the lower flange area. In this
manner, the upper portion 542 of the panels 501, 502 is configured
to fit and adapt to both the upper and lower flange area of the
patient's mouth. In some embodiments, the panels 501, 502 can also
define a lower portion 541 that has a rounded and/or teardrop
shaped cross-section so that, for example, the apparatus can be
removed from the upper jaw and installed on the lower jaw without
having to flip the apparatus. Here, the lower portion 541, as
opposed to the upper portion 542, is disposed and configured to fit
in the lower flange area.
[0098] The portions 541, 542 of the panels 501, 502 can have any
shape that does not include sharp or acute edges as such edges
would irritate or be uncomfortable in the depth of the vestibule of
the patient's mouth. In some embodiments, the portions 541 and/or
542 have a shape or cross-sectional shape that disperses forces and
minimizes pressure points which would cause discomfort for the
patient. In some embodiments, the portions 541 and/or 542 have a
thicker cross-section than the remaining portions of the panels
501, 502. In this manner, the portions 541 and/or 542 can deflect
the delicate mucosal soft tissue and allow full extension of the
flanges with little or no discomfort to the patient. More
specifically, the portions 541 and/or 542 can deflect buccal tissue
away from the alveolus.
[0099] The light source 510 can be operable to emit light in the
same manner as the light source 410 in reference to FIG. 7. The
light can be conveyed from the light source 510 to the controller
530 via the optical fiber ribbon 520. The controller 530 can be
operable to selectively transmit light from the light source 510 to
the panels 501 and/or 502 via the optical fiber ribbon 520 in the
same manner as the controller 430 in reference to FIG. 7. For
example, the controller 530 can collectively and/or individually
control the on/off state, the intensity, the frequency, the pulse,
the duty factor, and/or any other suitable parameters of the light
that is delivered to the panels 501 and/or 502.
[0100] The optical fiber ribbon 520 can be coupled to the
apparatus, as shown in FIG. 8, such that one or more optical fibers
of the ribbon 520 are electrically connected and/or directed to
each panel 501, 502. For example, one or more of the optical fibers
in the ribbon 520 can terminate adjacent to (e.g., within 0.1 cm to
3 cm) or at the root area, similar to the apparatuses shown and
described with reference to FIGS. 4 and 5. Thus, each optical fiber
of the ribbon 520 can direct light from the light source 510 to the
root area in the same manner as the optical fibers 420 in reference
to FIG. 7. The optical fibers of the ribbon 520 can be configured
to optically couple the panels 501, 502 together. The optical fiber
ribbon 520 can have one or more optical fibers for example, in one
or more bundles, therein. For example, the ribbon 520 can have
anywhere from 1 fiber to 500 fibers for each panel 501, 502
depending on the specific light emission technology or pattern used
for the treatment. The optical fiber ribbon 520 can have any
suitable shape and/or size such that the ribbon can comfortably
extend from the apparatus to outside the patient's mouth. The
ribbon 520 can, for example, have a width of about 0.5 cm to about
1.0 cm. Although the apparatus of FIG. 8 is illustrated and
described as having a single ribbon that electrically couples to
both panels 501 and 502, in other embodiments, the apparatus
includes more than one ribbon. For example, in one embodiment, the
apparatus includes two ribbons. In some embodiments, one ribbon can
be electrically connected to the panel 501 and the other ribbon can
be separately electrically connected to the panel 502. In some
embodiments, the ribbon 520 is a woven fiber-optic fabric. More
specifically, the ribbon 520 in this embodiment can be comprised of
one or more optical fibers that are woven into a fabric. In some
embodiments, light from the woven fiber optic fabric is emitted at
about 90 degrees or is emitted perpendicular to the plane of the
fabric. An example of a woven fiber optic fabric that can be used
with the apparatus of FIG. 8 is LightMat.RTM., which is
commercially available from Lumitex, Inc.
(http://www.lumitex.com/).
[0101] As disclosed herein, the apparatus in FIG. 8 can be
installed on either the upper or lower jaw. In some embodiments,
the apparatus in FIG. 8 is installed during orthodontic treatment.
For example, at the outset of the treatment, the apparatus can be
installed on the upper jaw such that the upper portion 542 of the
apparatus is disposed in the upper flange area. Then, at a later
time during the treatment, the patient can remove the apparatus
from the upper jaw and install the apparatus on the lower jaw for
the remainder of the treatment. In one embodiment, the apparatus
can be installed on the lower jaw such that the lower portion 541
of the apparatus is disposed within the lower flange area. In this
embodiment, the apparatus remains right-side up. In another
embodiment, however, the apparatus can be installed on the lower
jaw such that the upper portion 542 of the apparatus is disposed
within the lower flange area. In other words, after the patient
removes the apparatus from his or her upper jaw, he or she rotates
the apparatus 180 degrees so that it is upside down and then
installs the apparatus on the lower jaw. The upper portion 542, in
this embodiment, fits both the upper and lower flange area.
[0102] In some embodiments, the apparatus includes an electronic
device, such as a position sensor, that can determine the position
or orientation of the apparatus relative to the patient's mouth.
More specifically, in embodiments where the apparatus is turned
upside down (e.g., rotated 180 degrees) for installment on the
lower jaw, the apparatus can include an electronic device that
determines the apparatus's position or orientation in a patient's
oral cavity during an orthodontic treatment. For example, the
sensor can determine whether the apparatus is being worn on the
upper jaw or on the lower jaw. Such an electronic device can be
useful in monitoring compliance during orthodontic treatment. In
some embodiments, the electronic device can be one or more
switches, sensors, and/or the like.
[0103] Any of the apparatus illustrated and described herein with
reference to FIGS. 1-8 can have any number of panels, which can
operate and function in any manner described herein. Although not
necessarily illustrated, in some embodiments, the panels can be
coupled together and/or encapsulated within one or more units. For
example, the panels 403 and 404 in FIG. 7 can be coupled together
and/or encapsulated in a single unit, similar to a mouth guard that
fits the upper teeth. The panels 401 and 402 can likewise be
coupled together and/or encapsulated within a single unit, similar
to a mouth guard that fits the lower teeth. Example of mouth guards
including light emitting panels are shown in FIGS. 30-37 and FIGS.
43-50. It should be noted that although the mouth guard is shown in
FIG. 37 positioned with respect to the upper teeth of the patient,
the mouth guard is also configured to be positioned with respect to
the lower teeth of the patient. In another example, the panels 403
and 404 can be coupled together such at least a portion of the
panel 403 overlaps a portion of the panel 404. The panel 403 in
this example can emit light at the same wavelength as or at a
wavelength different from the panel 404. Furthermore, power output
and light treatment intensity can be increased by the layering or
overlapping of one or more panels.
[0104] In some embodiments, any of the intra-oral apparatuses
described herein can include a handheld controller that houses one
or more of a microprocessor, menu-driven software and an LCD
screen. The controller can be programmed to calculate and/or
monitor one or more light therapy sessions and their duration. A
user interface can display session information to the patient so
that, for example, the patient is aware of the number of sessions
completed and the time remaining in each session. The controller
can use any suitable power supply including, for example, a
UL-certified power supply. In some embodiments, the intra-oral
apparatus can include four treatment arrays, each of which can
include a flexible printed circuit board and a set of LEDs mounted
to a contoured heatsink and infrared-transmissible lens, in one
embodiment, a plastic lens, and having conductive cables that
attach to the controller.
[0105] FIG. 9 is a schematic diagram of an apparatus, according to
an embodiment. The apparatus can be configured for intra-oral light
therapy of a patient. The apparatus includes four panels 601, 602,
a light source 610, and optical fibers 620. The panels 601, 602,
603 and 604 can be configured to be disposed adjacent to the root
area of the upper jaw as well as the root area of the lower jaw,
for example, in a similar manner as described herein with respect
to FIGS. 1-8. More specifically, panels 601 and 602 can be disposed
adjacent to the anterior root area of the upper jaw (or lower jaw),
and panels 603 and 604 can be disposed adjacent to the posterior
root area of the upper jaw (or lower jaw). In other words, the
panels 601, 602, 603, 604 can be configured to be disposed anterior
(for panels 601, 602) and posterior (for panels 603, 604) to each
of the maxillary root area and the mandibular root area. In this
manner, in use, the panels 601, 602 can be configured to emit light
in a direction towards the panels 603, 604, and panels 603, 604 can
be configured to emit light in a direction towards the panels 601,
602. The panels 601, 602, 603 and 604, for example, can first be
disposed adjacent to the respective anterior or posterior root area
of the upper jaw; then, after orthodontic treatment of the upper
jaw is complete, the panels 601, 602, 603 and 604 can be removed
from the upper jaw and placed on the lower jaw such that they are
disposed adjacent to the respective anterior or posterior root area
of the lower jaw. In one embodiment, the panels 601, 602, 603 and
604 are in contact with the root area of the upper and/or lower
jaw; whereas, in other embodiments, the panels 601, 602, 603 and
604 are not in contact with the root area of the upper and/or lower
jaw but are within a certain distance (e.g., within 0.1 cm to 3 cm)
of the root area of the upper and/or lower jaw. In some
embodiments, the panels 601, 602 can be configured to be disposed
adjacent to (e.g., in contact with or within a certain distance of)
the upper and/or lower buccal lingual alveolar soft tissue and
panels 603, 604 can be configured to be disposed adjacent to the
upper and/or lower lingual alveolar soft tissue. Such
configurations can eliminate the need to place electronics in the
oral cavity.
[0106] The panels can be similar in one or more respects or
identical to any panel described herein, including, for example,
those described in reference to FIGS. 1-8. Each panel 601, 602,
603, 604 is associated with a bundle of optical fibers 620 that
extend to the light source 610. More specifically, each panel 601,
602, 603, 604 is associated with an emitter 632 of the light source
610 via a bundle of optical fibers 620. In this manner, each panel
601, 602, 603, 604, and any housing (not shown in FIG. 9) to which
the respective panel is coupled, is optically coupled to the
emitter 632 of the light source 610.
[0107] The light source 610 can be operable to emit light in the
same manner as the light source 410 in reference to FIG. 7 and/or
light source 510 in reference to FIG. 8. The light source 610 can
include, for example, one, two three, four or more (e.g., ten) LEDs
(including, for example, the LEDs 612, 614, 616, 618 shown in FIG.
9). At least a portion of the light source 610, for example,
including the LEDs 612, 614, 616, 618, can be disposed in an
external housing of the apparatus, at least a portion of which is
configured to be disposed extraorally when the panels 601, 602,
603, 604 are disposed in the oral cavity adjacent the root area as
described herein. For example, the external housing of the
apparatus can be extended through an opening formed by the
patient's lips when the panels 601, 602, 603, 604 are disposed in
the oral cavity adjacent the root area as described herein.
[0108] The apparatus can include a manifold 650 defining one or
more openings 652 therethrough. Each opening 652 of the manifold
650 can include a tapered surface portion 654 such that at least a
portion of the opening 652 is funnel-shaped. A bundle of optical
fibers 620 extending between the light source 610 (e.g., one of the
LEDs 612, 614, 616, 618) and one of the panels (e.g., panel 601)
can be disposed through the opening 652 of the manifold 650. As
illustrated in FIG. 10, ends of the optical fibers 620 in the
bundle are seated over, or adjacent, the LED 612. For example, in
some embodiments, ends of the optical fibers 620 in the bundle are
seated over an LED package (e.g., LED package 632, shown in FIG.
12, which can include, for example, LED 612) or other suitable
light source. At least one of the portion of the opening 652 of the
manifold 650 proximate to the LED package (or other emitter) 632,
or the LED package (or other emitter) 632, can have a diameter
equal to or narrower than a diameter of the optical fiber bundle.
For example, as shown in FIG. 12, each of the optical fiber bundle
620 and the manifold 650 opening 652 proximate to the LED package
632 has a diameter D. The use of the funnel-shaped manifold allows
for organization of the optical fibers 620 into groups of smaller
bundles, thereby eliminating any need for bulky on-board ferrules.
Such organization of the optical fibers 620 via the manifold 650
also provides for addressing of an individual panel 601, 602, 603,
604, as described in more detail herein.
[0109] The light can be conveyed from the LEDs (e.g., LED 612, 614,
616, 618) of the light source 610 to the panels 601, 602, 603
and/or 604 via the optical fibers 620. For example, a controller
(not shown in FIG. 9) can collectively and/or individually control
the on/off state, the intensity, the frequency, the pulse, the duty
factor, and/or any other suitable parameters of the light that is
delivered to the panels 601, 602, 603 and/or 604.
[0110] The optical fibers 620 can be coupled to the apparatus, as
shown in FIG. 9, such that bundles of optical fibers 620 are
electrically connected and/or directed to each panel 601, 602, 603,
604. For example, the optical fibers 620 can be coupled such that
proximal ends of the optical fibers 620 are coupled, or are
otherwise adjacent, at least one of the light source 610 and the
manifold 650 and such that distal ends of the optical fibers 620
are coupled, or are otherwise adjacent, to one or more panels 601,
602, 603 and/or 604. One or more of the optical fibers 620 (i.e.,
the distal end of one or more of the optical fibers) can terminate
adjacent to (e.g., within 0.1 cm to 3 cm) or at the root area,
similar to the apparatuses shown and described with reference to
FIGS. 4 and 5. Thus, each optical fiber 620 can direct light from
the light source 610 to the root area in the same manner as the
optical fibers 420 in reference to FIG. 7. The optical fibers 620
can be configured to optically couple the panels 601, 602, 603
and/or 604 together. The optical fibers 620 can be bundled in any
suitable number of fibers. For example, each panel 601, 602, 603
and/or 604 can be associated with a bundle of anywhere from 1 fiber
to 500 fibers depending on the specific light emission technology
or pattern used for the treatment. The optical fibers 620 can have
any suitable shape and/or size such that the fibers can comfortably
extend from the panel to the light source 610 disposed outside the
patient's mouth. The optical fibers 620 can, for example, have a
collective width of about 0.5 cm to about 1.0 cm. A collar 622 can
be disposed about one or more of the bundles of optical fibers 620
to maintain fiber bundles together. The apparatus shown in FIGS.
9-12 can be installed on either the upper or lower jaw, for
example, during orthodontic treatment.
[0111] FIG. 13 is a schematic diagram of an apparatus, according to
an embodiment. The apparatus can be configured for intra-oral light
therapy of a patient. The apparatus can be similar in one or more
respects or identical to other intra-oral light-therapy apparatuses
described herein, including, for example, the apparatus described
herein with reference to FIGS. 9-12. The apparatus includes an
intra-oral housing 780 and an external housing 790 that extends
from a front portion of the intra-oral housing such that at least a
portion of the housing is disposed extraorally when the intra-oral
housing is disposed within the oral cavity.
[0112] The intra-oral housing 780 includes one or more panels 701,
702, 703, 704. The panels 701, 702, 703, 704 can include light
emitting arrays, fiber mats, organic LEDs ("OLEDs"), or any
suitable combination of the foregoing. The panels 701, 702, 703,
704 can be configured to be disposed within the patient's oral
cavity in any manner described herein with respect to panels 601,
602, 603, 604.
[0113] The intra-oral housing 780 can be connected between the
panels 701, 702 configured to be positioned adjacent the anterior
root area of the jaw (or the buccal alveolar soft tissue) and the
panels 703, 704 configured to be positioned adjacent the posterior
root area of the jaw (or the lingual alveolar soft tissue). In some
embodiments, the intra-oral housing 780 includes a lower portion
configured to extend between a lower portion (not shown in FIG. 13)
of the panel 701 and a lower portion (not shown in FIG. 13) of the
panel 704, and similarly between a lower portion (not shown in FIG.
13) of the panel 702 and a lower portion (not shown in FIG. 13) of
the panel 703. In this manner, the intra-oral housing 780 can
include recessed portions 782, 783 defined by the lower portion of
the intra-oral housing and an upper portion of the intra-oral
housing including the panels 701, 702, 703, 704. The recessed
portions 782, 783 can be configured to receive, or be disposed
about, at least a portion of the patient's dentition. More
specifically, the recessed portions 782, 783 are configured to have
a depth sufficient to receive at least a portion of the patient's
dentition in the lower portion of the intra-oral housing such that
the upper portion of the intra-oral housing including the panels
701, 702, 703, 704 is disposed adjacent and/or in contact with the
alveolar soft tissue or the root area of the upper and/or lower
jaw.
[0114] Optical fibers 720 extend between the panels 701, 702, 703,
704 and a light source (not shown in FIG. 13) disposed in the
external housing 790 (e.g., at a front portion of the external
housing configured to remain outside the oral cavity when the
apparatus is in use) such that one or more optical fibers are
electrically connected and/or directed to each panel 701, 702, 703,
704. For example, one or more of the optical fibers 720 can
terminate adjacent to (e.g., within 0.1 cm to 3 cm) or at the root
area, similar to the apparatuses shown and described with reference
to FIGS. 4 and 7. Thus, each optical fiber 720 can direct light
from the light source to the root area in the same manner as the
optical fibers 420 described in reference to FIG. 7. The optical
fibers 720 can be configured to optically couple any combination of
the panels 701, 702, 703, 704 together. The apparatus can have any
suitable number of optical fibers. For example, the apparatus can
have anywhere from 1 fiber to 500 fibers for each panel 701, 702,
703, 704 depending on the specific light emission technology or
pattern used for the treatment. The optical fibers 720 can be
connected to the light source by a manifold 750. The manifold can
be similar in one or more respects or identical to the manifold 650
described with respect to FIGS. 10-12, and thus is not described in
detail herein.
[0115] The light source can be similar in one or more respects or
identical to the light source 610 described herein with reference
to FIGS. 9-12, and thus is not described in detail herein. The
light source can be operable to emit light. For example, in some
embodiments, the light source can output monochromatic light. For
example, the light source can be or include one or more of a laser,
an LED, and/or any other suitable light source. The light source
can be configured to emit a light having a wavelength ranging from
about 600 nm to about 1200 nm, or at any wavelength or wavelength
range disclosed herein; emit light output at more than one
wavelength; progress through a range of wavelengths; and/or emit a
broad spectrum light output or any suitable wavelength or
wavelengths. The light source can output light with any wavelength
or characteristic described herein.
[0116] The external housing 790 includes a power source 792 and an
electronic circuit 794, as shown in FIG. 14. The power source 792
can be a battery, including, for example, a rechargeable battery.
The electronic circuit 794 can include a circuit board. The
electronic circuit 794 and any associated electronics can be
configured to control the apparatus, i.e., during an orthodontic
treatment. For example, the electronic circuit is configured to
control at least one of an operational state of the light source
and/or optical fibers 720, a wavelength, an intensity, a frequency,
or a duration of light emission. Because the apparatus does not
require any physical connection to external components during the
treatment (e.g., does not require connection to an external light
source, external controller, or external power source), the
apparatus can be characterized as being self-contained.
[0117] The apparatus can be configured to determine whether the
apparatus is in an upright or upside down (e.g., rotated 180
degrees) position or orientation (i.e., whether the apparatus is
oriented with respect to the upper jaw or the lower jaw). For
example, in some embodiments, the external housing 790 includes at
least one of a position sensor, a gyroscope and an accelerometer.
The gyroscope and/or the accelerometer can be include one or more
sensors configured to determine the position (or orientation) of
the apparatus.
[0118] In some embodiments, the apparatus is included in a system
that also includes a charging station 770, as shown in FIG. 15. The
charging station 770 defines a receiving portion 774 configured to
receive at least a portion of the apparatus (e.g., at least a
portion of the intra-oral housing 780 and/or the external housing
790), a connection assembly 772, and a display 776. The connection
assembly 772 is configured to facilitate charging (or recharging)
of the power source 792 disposed in the external housing 790. In
some embodiments, the connection assembly 772 provides for a
physical or wired connection for coupling to a connection assembly
796 of the apparatus to facilitate charging of the power source
792. For example, the connection assembly 772 can include a socket
disposed on one of the apparatus or the charging station 770 and a
corresponding plug disposed on the other of the apparatus or the
charging station. In some embodiments, the connection assembly 772
is configured for wirelessly charging the power source 792. For
example, the connection assembly 772 can be configured to
inductively charge the power source 792. The display 776 of the
charging station 770 is configured to display information
associated with the apparatus and/or the charging station. For
example, the display 776 can be configured to display information
related to a status or amount of the charge of the power source
792, parameters associated with a treatment protocol, and/or
instructions for using one of the charging station 770 or the
apparatus. In some embodiments, the charging station 770 is
configured for uni-directional or bi-directional communication with
the apparatus. In this manner, information associated with the
treatment protocol and/or treatment history (e.g., patient usage or
compliance with the prescribed treatment protocol), including
updates including any changes to the treatment protocol and/or
treatment history since the most recent information transfer
between the apparatus and the charging station.
[0119] FIG. 16 is a schematic illustration of an apparatus,
according to an embodiment. The apparatus can be configured for
intra-oral light therapy of a patient. The apparatus can be similar
in one or more respects, and include components similar in one or
more respects, or identical, to the apparatus and associated
components described herein, including those described herein with
respect to FIGS. 13-15. For example, the apparatus includes an
intra-oral housing 880 and an external housing 890. The intra-oral
housing 880 is configured to be disposed in an oral cavity. The
external housing 890 is extended from a front of the intra-oral
housing 880 such that at least a portion of the external housing
can extend through an opening formed by the patient's lips and such
that at least a portion of the external housing is outside of the
oral cavity when the intra-oral housing is disposed in the oral
cavity.
[0120] The intra-oral housing 880 can be configured to be
positioned within the oral cavity in any suitable manner described
herein. The intra-oral housing 880 includes a first light emitting
array 801 configured to be disposed adjacent the anterior root area
of an upper and/or lower jaw (and/or the buccal alveolar soft
tissue) and a second light emitting array 802 configured to be
disposed adjacent the lingual root area of an upper and/or lower
jaw (and/or the lingual alveolar soft tissue). For example, from a
top view, as schematically shown in FIG. 16, the intra-oral housing
880 can have a shape similar to the shape of a U or a horseshoe.
Thus, said another way, the first light emitting array 801 is
disposed on an outer portion of the U-shape of the intra-oral
housing 880, and the second light emitting array 802 is disposed on
an inner portion of the U-shape of the intra-oral housing. In this
manner, in use, the light emitting arrays 801, 802 can be
configured to emit light in a direction towards the light emitting
arrays 803, 804, and light emitting arrays 803, 804 can be
configured to emit light in a direction towards the light emitting
arrays 801, 802.
[0121] The light emitting arrays 801, 802 are at least partially
embedded in a material of which the intra-oral housing 880 is
constructed. The intra-oral housing 880 can be constructed of any
suitable material, including, for example, silicone or another
soft, e.g., malleable, material. For example, the light emitting
arrays 801, 802 can include LEDs, OLEDs, light emitting
semiconductors, or any suitable combination thereof, at least
partially embedded in the material of which the intra-oral housing
880 is constructed. In some embodiments, the light emitting arrays
801, 802 are fully embedded in the intra-oral housing 880
material.
[0122] The intra-oral housing 880 can define a recessed portion 882
in a similar manner as that described with respect to recessed
portion 782 in reference to FIG. 13, and thus the recessed portion
782 is not described in detail herein.
[0123] The external housing 890 includes a power source 892,
electronic circuit 894, and an orientation-sensing mechanism (not
shown in FIG. 16). In this manner, the apparatus can be
characterized as being self-contained. The power source 892 (e.g.,
a battery) is configured to provide power to the light emitting
arrays 801, 802 via the electronic circuit 894. The electronic
circuit 894 can be configured to control the apparatus, e.g.,
during an orthodontic treatment. The orientation-sensing mechanism
is configured to determine a position or orientation of the
apparatus, e.g., whether the apparatus is upright for positioning
with respect to the upper jaw or upside down for positioning with
respect to the lower jaw. The orientation-sensing mechanism can
include at least one of a position sensor, a gyroscope (e.g., a
semi-gyroscope) and an accelerometer.
[0124] The apparatus can be configured to be used with a charging
station, such as charging station 770, in a similar manner as the
apparatus described herein with respect to FIGS. 13-15.
[0125] Although the apparatuses described with respect to FIGS.
13-16 have been described as being configured for use with a
charging station (e.g., charging station 770), in other
embodiments, a self-contained apparatus can be differently
configured for charging the power source and/or controlling the
emission of light by the apparatus. For example, referring to FIG.
17, an apparatus includes an intra-oral housing 980 configured to
be disposed in an oral cavity and an external housing 990
configured to extend through an opening formed by the patient's
lips such that at least a portion of the external housing is
outside of the oral cavity when the intra-oral housing is disposed
in the oral cavity. The intra-oral housing 980 can be similar in
one or more respects, and can include components that are similar
or identical to those of any intra-oral housing or apparatus for
intra-oral light therapy described herein. The external housing 990
can be similar in one or more respects, and can include components
that are similar or identical to those of external housings 790 and
890 described herein.
[0126] A power source (not shown in FIG. 17) in the external
housing 990 is configured to be charged via a connector 972 (e.g.,
a USB mini- or microplug). The apparatus can be electronically
linked, or paired, with an external electronic device, such as a
mobile phone, including smartphones (e.g., an iPhone.RTM. or an
Android.TM. based device). The apparatus can be configured for
wireless bi-directional communication with the external electronic
device, such as via a Bluetooth.RTM. or other wireless connection.
For example, the apparatus can be configured to transmit to the
external electronic device information associated with patient
usage and/or treatment protocol compliance, and can be configured
to receive from the external electronic device information
associated with a medical, e.g., an orthodontic, treatment. An
application loaded onto the external electronic device can be used
to monitor and control the orthodontic treatment using the
apparatus and/or to record and review patient usage history and/or
prescribed treatment protocol compliance history.
[0127] In some embodiments, an apparatus according to an embodiment
is configured to detect an amount of light, e.g., its intensity or
duration, that is irradiated at, absorbed by or reflected by a
patient's periodontia (e.g., a portion of the root area of the
upper and/or lower jaw and/or the alveolar soft tissue) by the
apparatus. In this manner, for example, an apparatus according to
an embodiment can be configured to assess patient compliance with a
prescribed orthodontic treatment protocol, as described herein.
Referring to FIG. 18A, an apparatus according to an embodiment can
include a light emitting array 1101, which can be similar or
identical to any light emitting array described herein, and one or
more photodetectors 1102. In some embodiments, the light emitting
array 1101 includes one or more emitters operable to illuminate a
region of or associated with a portion of the root area of the
upper and/or lower jaw and/or the alveolar soft tissue. At least a
portion of the photodetectors 1102, such as one or more sensors of
the photodetectors, are configured to be positioned within the oral
cavity to detect the transmission or reflectance of light (i.e.,
photons) emitted by the light emitting array 1101 from the alveolar
soft tissue (and associated alveolus). For example, the
photodetectors 1102, or a sensor thereof, can be positioned on a
palatial surface within the oral cavity, and can be in electrical
communication with a portion of the photodetector disposed outside
of the oral cavity. Detection of the light transmission by the
photodetectors 1102 during an orthodontic treatment activates the
photodetectors every few seconds. The apparatus can be configured
to power off if no light attenuation is detected by the
photodetectors within a predetermined period of time. The apparatus
can be configured to store a record of the history of light
detection and of the apparatus being powered off because of a lack
of detection. Such usage information can be used to determine
whether the patient is compliant with a prescribed orthodontic
treatment protocol. This configuration can also serve as a failsafe
mechanism to ensure that the light emitting array 1101 does not
operate unless the apparatus is within the mouth of the patient.
This configuration can also be used to obtain information about a
patient's bone density, where the information can be used to
customize a dosage of light therapy to be administered to a
patient, as described herein. The foregoing compliance assessment
mechanism can be included in, or otherwise incorporated into, any
apparatus for intra-oral light therapy described herein.
[0128] In another example, referring to FIG. 18B, an apparatus
according to an embodiment is configured to detect an amount of
light, e.g., its intensity or duration, that is irradiated at,
absorbed by or reflected by a patient's periodontia (e.g., a
portion of the root area of the upper and/or lower jaw and/or the
alveolar soft tissue) by the apparatus. For example, the apparatus
can be configured to determine an energy density that is irradiated
at, absorbed by or reflected by the root area from an amount or
dosage of light to which the root area was exposed. The apparatus
is also configured to determine whether an amount of light being
emitted by the apparatus should be adjusted based on the detected
amount, intensity and/or duration of light (or energy density) is
irradiated at, absorbed by or reflected by the patient's
periodontia, as described herein.
[0129] In some embodiments, the apparatus includes a mouthpiece
having a first flange 1110 and a second flange 1116. The first
flange 1110 includes one or a plurality of light emitters 1111, and
is configured to be disposed adjacent the buccal side of a first
portion of the root area of the upper and/or lower jaw and/or the
alveolar soft tissue (generally designated as tissue T) when the
mouthpiece is disposed within the patient's oral cavity. In some
embodiments, the one or plurality of light emitters 1111 can be at
least partially or wholly enclosed in the first flange. In some
embodiments, the one or plurality of light emitters 1111 is
disposed on a surface of the first flange. The one or plurality of
light emitters 1111 are positioned such that light emitted
therefrom is directed to the first portion of the root area of the
upper and/or lower jaw and/or the alveolar soft tissue. The one or
plurality of light emitters 1111 is configured to be in electrical
communication with a controller 1114, such as via pathway 1113. In
this manner, the controller 1114 can control parameters (e.g.,
duration, intensity, and wavelength) affecting the emission of
light by the one or plurality of light emitters 1111.
[0130] The second flange 1116 of the mouthpiece includes one or
more photodetectors 1112, and is configured to be disposed adjacent
the palatial or lingual side of a second portion, opposite to the
first portion, of the root area of the upper and/or lower jaw
and/or the alveolar soft tissue when the mouthpiece is disposed
within the patient's oral cavity (and the first flange is disposed
adjacent the buccal side of the first portion of the root area of
the upper and/or lower jaw and/or the alveolar soft tissue). The
photodetector 1112 can be at least partially or wholly enclosed
within the second flange 1116. The photodetector 1112 is configured
to receive light passed through the root area of the upper and/or
lower jaw and/or the alveolar soft tissue between the first portion
and the second portion. The photodetector 1112 is configured to be
in electrical communication with the controller 1114, such as via
pathway 1118. The photodetector 1112 is configured to convey
information associated with the light received by the photodetector
1112 to the controller 1114. For example, the photodetector 1112
can convey information to the controller 1114 associated with the
intensity of light received.
[0131] The controller 1114 is configured to execute an algorithm
for determining whether a parameter of light emission by the one or
plurality of light emitters 1111 should be adjusted, for example,
to achieve a target light transmission through the patient's
tissue. For example, the controller 1114 can execute the algorithm
based on the information associated with the light received by the
photodetector 1112 and conveyed to the controller 1114, as well as
one or more known parameters (e.g., duration, intensity, and
wavelength) associated with the light emission by the one or
plurality of light emitters 1111. The controller 1114 can be
configured to adjust one or more parameters of light emission by
the one or plurality of light emitters 1111 based on the foregoing
determination. The parameters of light emission that can be
adjusted, or otherwise controlled, by the controller 1114 include
an intensity of light emitted by the one or plurality of emitters
1111, a duration of emission of light by the one or plurality of
light emitters 1111, one or more wavelengths of light, or one or
more of the intensity, duration, and wavelength.
[0132] In some embodiments, the controller 1114 is configured to
determine whether the mouthpiece of the apparatus is positioned
with respect to (e.g., adjacent) the maxilla or mandible root
areas. For example, the controller 1114 can cause the one or
plurality of light emitters 1111 to emit light at a known
intensity, duration, or wavelength. The controller 1114 can then
receive information from the photodetector 1112 associated with the
transmission of light through the root area, and then determine
whether the light was transmitted through the maxillary root area
or the mandibular root area based on the received information. In
other words, the controller 1114 can determine whether the
mouthpiece was positioned with respect to the maxilla if the light
transmission received by the photodetector 1112 is within a first
value range, or whether the mouthpiece was positioned with respect
to the mandible if the light transmission received by the
photodetector 1112 is within a second value range.
[0133] In some embodiments, the apparatus is configured to be
calibrated prior to or at the beginning of a prescribed treatment
regime with respect to each of the mandible and maxilla. In this
manner, the mouthpiece is positioned with respect to the maxilla,
then light is emitted by the one or plurality of light emitters
1111 and an energy density based on the light transmitted through
the maxillary root area is detected by the photodetector 1112. With
respect to the maxilla, the value of light transmission or
reflectance (as the case may be), referred to herein as the
I.sub.ratio, can be calculated as follows, with I.sub.delivery
being the value (e.g., intensity measured in mW/cm.sup.2) of light
emitted by the emitter and I.sub.transmission being the value
(e.g., intensity measured in mW/cm.sup.2) of light received by the
photodetector:
I delivery ( max ) mW / cm 2 I transmission ( max ) mW / cm 2 = 1
max mW / cm 2 ##EQU00001##
Similarly, with respect to the mandible, the I.sub.ratio, can be
calculated as follows:
I delivery ( mnd ) mW / cm 2 I transmission ( mnd ) mW / cm 2 = 1
mnd mW / cm 2 ##EQU00002##
[0134] The I.sub.ratio can be, for example, based at least in part
on photon power density. The controller 1114 can be configured to
store an I.sub.ratio value (i.e., the .sub.1max and/or .sub.1mnd).
In this manner, the apparatus can reference the stored values to
determine whether the mouthpiece is optimally positioned with
respect to the maxilla or mandible. In a similar manner as
discussed herein with respect to FIG. 18A, the apparatus can be
configured to monitor patient compliance throughout the duration of
an orthodontic treatment regime. In use, each I.sub.ratio value can
be adjusted based on a patient's range of tolerance according to
the following calculation: .sub.1.+-.% range of tolerance. In some
embodiments, the controller 1114 is configured to adjust the
I.sub.delivery to achieve a desired I.sub.transmission, such as by
selectively changing (e.g., increasing or decreasing) the
I.sub.delivery intensity.
[0135] Although the I.sub.ratio is described herein as being
measured in mW/cm.sup.2, in some embodiments, the I.sub.ratio can
be measured using a different unit of measurement commensurate with
a desired lighting parameter, or characteristic. For example, the
I.sub.ratio can be measured with respect to light wavelength (in,
e.g., nanometers). In this manner, the controller 1114 can be
configured to, for example, analyze the cellular photo-absorption
state as represented by changes in wavelengths absorbed and/or
transmitted by chromophores in the patient's tissue.
[0136] Referring to FIG. 18C, an apparatus according to an
embodiment is configured to control an amount, intensity,
wavelength and/or duration of light emitted towards a portion of
the root area of the upper and/or lower jaw and/or the alveolar
soft tissue and to detect an amount, intensity, wavelength and/or
duration of light passed through the root area of the upper and/or
lower jaw and/or the alveolar soft tissue. The apparatus can be
similar in many respects, or identical to, or include components
similar in many respects, or identical, to components of, any other
apparatus described herein, such as, for example, apparatus
described herein with respect to FIGS. 18A and 18B. In some
embodiments, the apparatus includes a mouthpiece having a first
flange 1120 configured to be disposed on the buccal side of the
root area and a second flange 1126 configured to be disposed on the
palatial or lingual side of the root area.
[0137] One or more light emitters (e.g., a plurality of light
emitters) 1121 are disposed in the first flange 1120. The one or
more light emitters 1121 includes individually addressable (or
controllable) sections 1123. Parameters affecting the emission of
light (e.g., intensity, duration and/or wavelength) by a section of
the one or more light emitters 1121 can be controlled separately
from and independently of a different section of the one or more
light emitters. Stated another way, the intensity, duration, and/or
wavelength of light emitted by the one or more light emitters 1121
can vary among the various sections 1123 of the one or more light
emitters. The second flange 1126 includes one or more
photodetectors (e.g., a plurality of photodetectors 1122). The
plurality of photodetectors 1122 can include two or more discrete
photodetectors 1124. In some embodiments, the one or more
photodetectors 1122 includes a number of photodetectors 1124 equal
to the number of sections 1123 in the one or more light emitters
1121. In this manner, each photodetector 1124 can be configured to
receive light that was emitted by a corresponding section 1123 of
the one or more light emitters 1121 and that passed through the
root area between the section 1123 and the photodetector 1124. In
this manner, light emission by each section of the one or more
light emitters 1121 can be adjusted to accommodate variations in
treatment goals for and/or anatomy of different patients, whose
alveolar dimensions can vary. These adjustments can be based at
least in part on the light received by the corresponding
photodetector 1124.
[0138] In some embodiments, an apparatus including photodetectors
for sensing light transmission or reflectance, such as the
apparatus described herein with respect to FIGS. 18A-18C, is
configured to perform an initial calibration. For example, in some
embodiments, to calibrate the apparatus, the patient places the
apparatus in the upper arch of the oral cavity. The apparatus
registers its orientation (i.e., upright or upside down) using an
internal orientation-sensing mechanism (e.g., a gyroscope). A light
source, such as one or more LEDs, is activated. One or more optical
fibers act as receivers and photodetectors at their distal ends,
which are configured to determine photon, or light, transmission or
reflectance. Activation of the light source and determination of
the light transmission or reflectance by the receiver/photodetector
fibers is repeated, such as for two or three times. An average
value of light transmission or reflectance is calculated, and the
calculated average value is used as a threshold or range during the
orthodontic treatment. If the amount of light detected becomes
inconsistent with the threshold or range, then the apparatus
deactivates to stop the orthodontic treatment.
[0139] In some embodiments, an apparatus includes an intra-oral
housing that is contoured to complement curvature and/or other
physical attributes of a patient's tissue within the patient's oral
cavity. For example, referring to FIGS. 20-22, an apparatus
according to an embodiment includes an intra-oral housing 1280
including a front portion 1282 configured to be disposed adjacent
buccal alveolar soft tissue of a patient and a rear portion 1284
configured to be disposed adjacent lingual alveolar soft tissue of
the patient. A midline M divides left and right sides (also
referred to herein as wings or flanges) of the front and rear
portions 1282, 1284, respectively, of the intra-oral housing 1280.
In some embodiments, a height of the left and or right side is
configured to correspond to a length including an average incisor
root length and a length of the premolars. A portion of the side
that is configured to be adjacent the canine teeth can be slightly
under-extended compared to, or shorter than, a different (e.g.,
incisor) portion of the side. A first light emitting array or mat
(not shown in FIGS. 20-22) configured to be disposed adjacent the
buccal alveolar soft tissue, for example, can have a length
substantially equal to a width of two molar teeth. A second,
corresponding light emitting array or mat configured to be disposed
on the palatial side of the teeth, adjacent the lingual alveolar
soft tissue for example, can have a similar length as the first
light emitting array. The intra-oral housing 1280 can include a
palatial portion or wing 1288, which can be configured to move
vertically with respect to the first and second sides, e.g., up
against the upper hard palate.
[0140] The intra-oral housing 1280 includes one or more distinct
segments 1286 that each include a first portion extending (e.g.,
downwardly) from a lower surface of the front portion 1282 of the
intra-oral housing, a second portion extending (e.g., downwardly)
from a lower surface of the rear portion 1284 of the intra-oral
housing, and a third portion extending (e.g., horizontally) between
ends of the first portion and the second portion of the segment
1286. In this manner, the segments 1286 (also referred to as bite
pads) are configured to be disposed about at least a portion of
crowns of one or more teeth adjacent each segment when the
intra-oral housing 1280 is disposed in the oral cavity as described
herein. The segments 1286 are laterally spaced apart from each
other with respect to the front portion 1282 of the intra-oral
housing 1280. In this manner, when the intra-oral housing 1280 is
disposed in the oral cavity as described herein, the segments 1286,
or bite pads, are disposed about the crowns of fewer than all
teeth. In some embodiments, a first number of the patient's teeth
are covered by the segments 1286 and a second number, greater than
the first number, are not covered by the segments. For example,
each segment 1286 can have a sufficient height, width, and/or depth
for being disposed about the crowns of one or two teeth. In use,
the patient can bite down on the segments 1286 during the
orthodontic treatment, such as to maintain a position of the
intra-oral housing 1280 within the oral cavity. Use of the
segments, or bite pads, described herein also serves to reduce bulk
associated with the surface area of the apparatus, and thus
provides enhanced patient comfort.
[0141] The segments 1286 can be constructed of a material similar
or identical to or different than that of the front and rear
portions 1282, 1284 of the intra-oral housing 1280. For example,
the front and rear portions 1282, 1284 of the intra-oral housing
1280 can be constructed of a soft, e.g., malleable, material such
as silicone, and the segments 1286 can be constructed of a harder,
less malleable material, e.g., silicone, that is overmolded with a
soft material, such as the soft silicone.
[0142] In the embodiment illustrated in FIGS. 20-22, the intra-oral
housing 1280 includes three bite pad segments. The first segment is
extended from the lower surfaces of the front and rear portions
1282, 1284 along the midline M. The second and third segments are
extended from the lower surfaces of the front and rear portions
1282, 1284 at ends of the left and right sides of the intra-oral
housing 1280 opposite the midline M. In other embodiments, however,
the segments can extend from a different location along the lower
surfaces of the front and rear portions 1282, 1284. For example, as
shown in FIG. 23, an apparatus can include an intra-oral housing
1380 including a segment extending from the lower surfaces of front
and rear portions of the intra-oral housing at a midline (not shown
in FIG. 23) defined by the intra-oral housing, and one or more
segments extending from the lower surfaces of the front and rear
portions of the intra-oral housing from one or more locations
between the midline and left and right ends, respectively, of the
intra-oral housing opposite the midline.
[0143] In some embodiments, at least a portion of an apparatus is
biased towards a portion of the patient's body, which can, for
example, help maintain the position of the apparatus with respect
to a patient's oral cavity. As shown in FIG. 24, an apparatus can
include a first portion 1401 configured to be disposed adjacent a
root area of the jaw between the root area and the buccal mucosa,
and a second portion 1402 configured to be disposed adjacent the
palatial side of the root area of the jaw. The first portion 1401
is biased in a first direction towards the root area, and the
second portion 1402 is biased in a second, opposite direction
towards the root area. More specifically, the first portion 1401 is
spring-loaded such that a free end of the first portion is moved
toward and/or can apply a pressure upon the root area in the first
direction, indicated by arrow A1, and the second portion 1402 is
spring-loaded such that a free end of the second portion is moved
toward and/or can apply a pressure upon the root area in the second
direction, indicated by arrow A2. In some embodiments, the pressure
applied by the first portion 1401 and/or the second portion 1402 is
sufficient to displace at least a portion of the patient's tissue.
The first and second portions 1401, 1402 can be configured to pivot
at a joint disposed adjacent the root area, e.g., immediately above
the crown of the tooth.
[0144] In another example, as shown in FIG. 25, an apparatus can
include an intra-oral housing 1580 having a right flange 1501 and a
left flange 1502 divided by a midline M. The right flange 1501 and
left flange 1502 are each configured to be disposed adjacent a root
area of the jaw. The right flange 1501 is biased in a first
direction towards the root area. The right flange 1501 is coupled
to the apparatus by one or more hinges (e.g., two hinges 1503,
1505, as shown in FIG. 25) and includes one or more wires (e.g.,
two nitinol or other super-elastic wires, each associated with a
respective hinge, as shown in FIG. 25) embedded within the right
flange 1501 of the intra-oral housing 1580. For example, the hinges
1503, 1505 can move about a horizontal axis and the nitinol wires
1504, 1506 can be embedded in a silicone of the intra-oral housing
1580 along an axis substantially normal to the horizontal axis of
the hinges. The wires 1504, 1506 are configured to be biased
towards the root area. As such, the wires 1504, 1506 push against
an apical portion of the right flange and cause the right flange
1501 to push against the tissue of the root area. The left flange
1502 can be configured similarly to the right flange 1501. In some
embodiments, the hinges 1503, 1505 and/or wires 1504, 1506 can
produce a relatively large orthodontic and/or orthopedic force,
such as a force operable to urge one or more teeth to move.
[0145] In another example, an apparatus according to an embodiment
is illustrated in FIG. 26. The apparatus includes an intra-oral
housing 1680 having an upper portion 1681 extended between a first
end and a second end, and a lower portion 1682 extended between a
first end and a second end. The upper and lower portions 1681, 1682
are each configured to be disposed adjacent a root area within an
oral cavity. The upper and lower portions 1681, 1682 have a
curvature configured to substantially correspond to a curvature of
a patient's dentition (e.g., are U or horseshoe shaped). The first
end of the upper portion 1681 is coupled to the first end of the
lower portion 1682 by a shape retaining member 1687. The shape
retaining member 1687 can include, for example, a curved stiff
plastic material having shape memory characteristics. The shape
retaining member 1687 is biased towards an open configuration in
which the first end of the upper portion 1681 is moved in a first
direction, indicated by arrow A3, away from the first end of the
lower portion 1682 of the intra-oral housing 1680, and the first
end of the lower portion 1682 is moved in a second, opposite
direction, indicated by arrow A4, away from the first end portion
of the upper portion 1681 of the intra-oral housing 1680. The
second end of the upper portion 1681 is coupled to the second end
of the lower portion 1682 by a similar shape retaining member 1687.
As such, the second end of the upper portion 1681 and second end of
the lower portion 1682 are biased away from each other towards the
open configuration. In this manner, the upper and lower portions
1681, 1682 of the intra-oral housing 1680 are configured to remain
adjacent their respective root portions when the patient jaws are
opened. The biasing force exerted by the shape retaining member
1687 is sufficient to move the seating of at lest a portion of the
upper portion 1681 and/or lower portion 1682 toward a depth of the
patient's cheek/alveolus vestibule; such force alone, however, may
be insufficient to cause the jaw of the patient to open.
[0146] A portion of an apparatus according to an embodiment is
illustrated in FIG. 27. The apparatus includes a substantially U or
horseshoe shaped intra-oral housing. The intra-oral housing can be
constructed of a soft silicone. A wire 1787 (e.g., nitinol or other
super-elastic wire), or other shape retaining member, is embedded
in the intra-oral housing. A first end of the wire is disposed at a
first end 1782 of the intra-oral housing 1780, and a second end of
the wire is disposed at a second, opposite, end 1784 of the
intra-oral housing. The first and second ends of the wire are
inwardly biased such that the first end of the intra-oral housing
and second end of the intra-oral housing are (or can be) moved in a
direction towards each other. In other words, the wire is biased to
move from an open position in which the first and second ends 1782,
1784 of the intra-oral housing 1780 are disposed a first distance
from a midline M of the intra-oral housing, as shown by the solid
line in FIG. 27, to a closed position in which the first and second
ends 1782, 1784 are disposed a second distance less than the first
distance from the midline M of the intra-oral housing, as shown by
the dashed line in FIG. 27. In this manner, the wire causes a
portion of the intra-oral housing (e.g., left and right portions
and/or light emitting panels) to apply a gentle pressure on the
buccal side of the root area towards a lingual or palatial side of
the root area. Also in this manner, the intra-oral housing 1780 is
configured to cause displacement of a portion of oral soft tissue
over the tooth root.
[0147] In some embodiments, as shown in FIG. 28, an apparatus can
include an intra-oral housing 1880 having a wire 1887 (e.g.,
nitinol or other super-elastic wire), or other shape retaining
member, configured to bias first and second ends 1882, 1884,
respectively, of the intra-oral housing 1880 away from each other,
e.g., in a direction opposite to that shown and described with
reference to FIG. 27. In other words, the wire 1887 is biased to
move from a closed position in which the first and second ends
1882, 1884 are disposed a first distance from a midline M of the
intra-oral housing as shown by the solid line in FIG. 28 to an open
position in which the first and second ends 1882, 1884 are disposed
a second distance greater than the first distance from the midline
M of the intra-oral housing as shown by the dashed line in FIG. 28.
In this manner, the wire is configured to cause a portion of the
intra-oral housing (e.g., left and right portions and/or light
emitting panels, not shown in FIG. 28) to apply a gentle pressure
on the lingual or palatial side of the root area towards, or in the
direction of, the buccal side of the root area. Also in this
manner, the intra-oral housing 1880 is configured to cause
displacement of a portion of oral soft tissue over the tooth
root.
[0148] The wire 1887 can be disposed within the intra-oral housing
1880 in any suitable position. For example, as shown in FIG. 28,
the wire 1887 can be positioned adjacent an inner curvature of the
intra-oral housing 1880. In other embodiments, however, a wire 1987
can be positioned adjacent an outer curvature of an intra-oral
housing 1980, as shown in FIG. 29. The wire 1987 can be similar in
many respects to wire 1887, for example, in that the wire 1987 can
be configured to bias first and second ends 1982, 1984,
respectively, of the intra-oral housing 1980 away from each other,
e.g., in a direction opposite to that shown and described with
reference to FIG. 27 and similar to that shown and described with
reference to FIG. 28. In other words, the wire 1987 is biased to
move from a closed position (as shown by the solid line in FIG. 29)
to an open position (as shown by the dashed line in FIG. 28) in a
similar manner as described herein with respect to FIG. 28. Thus,
the wire 1987 is configured to cause a portion of the intra-oral
housing 1980 to apply a gentle laterally, and outwardly, directly
pressure on the lingual or palatial side of the root area.
[0149] Although the apparatuses illustrated and described with
respect to FIGS. 27 and 28 are described as including a wire (e.g.,
a nitinol wire) as the shape retaining member, in other
embodiments, a different shape retaining member (or biasing member)
can be included in the apparatus. For example, the shape retaining
member can include an overmolded plastic insert.
[0150] An intra-oral apparatus 2000 according to an embodiment of
the invention is illustrated in FIGS. 43 and 44. The apparatus 2000
can be the same as or similar in many respects to, or include
components the same as or similar in many respects to, the
intra-oral apparatuses described herein. The intra-oral apparatus
2000 includes an intra-oral housing 2080 configured to be disposed
in an oral cavity of a patient. In some embodiments, the intra-oral
housing 2080 is configured to be positioned within the oral cavity
of the patient with respect to the upper jaw, the lower jaw, or
each of the upper and lower jaws. The intra-oral housing 2080
includes at least one light emitting panel 2002. The light emitting
panel 2002 can include one or more light emitters 2004, such as
LEDs. The intra-oral apparatus 2000 can be configured to irradiate
light in any suitable manner described herein. In some embodiments,
for example, the intra-oral apparatus 2000 can be configured to
irradiate light at a density of about 60 mW/cm.sup.2.
[0151] Although the light emitting panel 2002 is illustrated as
including the one or more light emitters 2004 in three parallel
rows, in other embodiments, the one or more light emitters can be
differently positioned with respect to the light emitting panel
and/or the intra-oral housing (e.g., in one or more vertical rows,
one or more diagonal rows, a random pattern, or any other suitable
configuration). In some embodiments, the light emitting panel 2002
is at least partially enclosed within the intra-oral housing 2080.
For example, the light emitting panel 2002 can be embedded within
the intra-oral housing 2080. The intra-oral housing 2080 can be
constructed of any suitable material, including, for example, a
soft silicone material. The intra-oral housing 2080 is configured
to be electrically coupled to an electronic device, such as a
controller (not shown in FIGS. 43-44) as described herein. As shown
in FIG. 44, the intra-oral housing 2080 can be coupled to the
electronic device by a tether 2020.
[0152] The intra-oral apparatus 2000 can be configured for use in
an orthodontic treatment, including any such treatment described
herein. In some embodiments, for example, the intra-oral apparatus
2000 is used to irradiate at least a portion of the patient's upper
jaw for about 3 minutes, the patient's lower jaw for about 3
minutes, or each of the patient's upper and lower jaws for about 3
minutes.
[0153] An intra-oral apparatus 2100 according to an embodiment of
the invention is illustrated in FIGS. 45-50. The apparatus 2100 can
be the same as or similar in many respects to, or include
components the same as or similar in many respects to, the
intra-oral apparatuses described herein. The intra-oral apparatus
2100 includes an intra-oral housing 2180 configured to be disposed
in an oral cavity (e.g., in the mouth) of a patient and an
extra-oral housing 2190 (also referred to herein as a "bill")
coupled to the intra-oral housing 2180. The extra-oral housing 2190
is coupled to a front portion of the intra-oral housing 2180. For
example, the extra-oral housing 2190 can be coupled to the
intra-oral housing 2180 by a protrusion 2188. In this manner, the
protrusion 2188 is extended through the opening of the patient's
mouth, e.g., through the opening between the patient's lips, such
that at least a portion of the extra-oral housing 2190 is disposed
exterior to the oral cavity of the patient when the intra-oral
housing 2180 is disposed within the oral cavity of the patient.
Also in this manner, the extra-oral housing 2190, or bill, can be
supported with respect to the patient's mouth by the intra-oral
housing 2180 and/or the protrusion 2188 when the intra-oral housing
2180 is disposed within the patient's mouth. The extra-oral housing
2190 is configured to at least partially enclose one or more
electronic components of the apparatus 2100, as described in more
detail herein.
[0154] The intra-oral apparatus 2100 is configured to be useful for
light therapy with respect to each of the upper jaw and the lower
jaw of the patient. In other words, the intra-oral apparatus 2100
can be configured to administer light therapy with respect to the
patient's upper jaw when the apparatus is in an upright position,
and can be configured to administer light therapy with respect to
the patient's lower jaw when the apparatus is in an inverted
position. As such, the intra-oral housing 2180 can be configured to
be disposed within the patient's oral cavity with respect to each
of the upper and lower jaws of the patient. It should be noted that
although the intra-oral apparatus 2100 and intra-oral housing 2180
are described as being in the upright position when configured to
be oriented with respect to the upper jaw and in the inverted
position when configured to be oriented with respect to the lower
jaw, in other embodiments, the intra-oral apparatus 2100 and the
intra-oral housing 2180 are in the upright position when configured
to be oriented with respect to the lower jaw of the patient, and in
the inverted position when configured to be oriented with respect
to the upper jaw of the patient.
[0155] The intra-oral apparatus 2100 can be configured to determine
the orientation of the apparatus. Said another way, the intra-oral
apparatus 2100 can be configured to determine if the intra-oral
housing 2180 is oriented in the upright or inverted position. For
example, the intra-oral apparatus 2100 includes a gyroscope (not
shown in FIG. 47) configured to determine if the intra-oral housing
2180 is oriented in the upright or inverted position. The gyroscope
is disposed within, or otherwise coupled to, the extra-oral housing
2190 of the apparatus 2100.
[0156] The apparatus 2100 includes at least one battery, or other
suitable power source. For example, as shown in FIG. 47, a first
battery 2194 and a second battery 2195 are coupled to the
extra-oral housing 2190 of the apparatus 2100. For example, the
batteries 2194, 2195 can be disposed in the extra-oral housing
2190. Each battery 2194, 2195 can be configured to provide power to
one or more light-emitting panels (schematically illustrated in
FIG. 52) disposed within the intra-oral housing 2180, as described
in more detail herein. The first battery 2194 can include, for
example, a rechargeable lithium ion battery. The second battery
2195 can be configured for inductive charging. For example, the
second battery 2195 can include a Qi-based charging coil.
[0157] A microprocessor 2196 is coupled to the extra-oral housing
2190 of the apparatus 2100. The microprocessor 2196 can be disposed
in the extra-oral housing 2190. The microprocessor 2196 is
configured to store information related to the patient's use of the
intra-oral apparatus 2100. For example, the microprocessor 2196 can
be configured to store information associated with the patient's
treatment program and use of the apparatus 2100 during the
treatment program, including, for example, a schedule of one or
more treatment sessions included in the treatment program, an
orientation of the apparatus 2100 during a treatment session, a
duration of a treatment session, and a duration between a treatment
session and one or more previous treatment sessions. The
microprocessor 2196 can also be configured to determine whether the
patient's usage of the intra-oral apparatus 2100 is in compliance
with the patient's treatment program. In other words, the
microprocessor 2196 can be configured to determine whether a
patient's history of use (including, for example, a number of
treatment sessions applied to the upper and/or lower jaw of the
patient, duration of the treatment sessions, whether any treatment
session was interrupted, and the like) complies with a schedule of
treatment sessions specified by the patient's treatment program,
including identifying any deviation from the treatment program. The
microprocessor's 2196 determination regarding patient compliance
can be based, at least in part, on information received from the
proximity detector. For example, the proximity detector can be
configured to be activated when the device is placed fully into the
patient's mouth. The microprocessor 2196 can be configured to
transmit information associated with the patient's usage and/or
compliance of the apparatus 2100 with an external device. For
example, in some embodiments, the microprocessor 2196 is configured
to transmit the usage and/or compliance information to the external
device (e.g., a mobile phone, personal digital assistant, computer,
portable electronic device, or the like) via Bluetooth.RTM. or
another suitable wireless mechanism. For example, as shown in FIG.
47, a Bluetooth.RTM. communication module 2198 can be disposed
within the extra-oral housing 2190.
[0158] The extra-oral housing 2190 includes a communication
mechanism (not shown in FIG. 47) configured to provide indicia of
the status of a treatment session. The term "indicia," is used
herein as including the singular ("indicium") or the plural
("indicia"), unless the context clearly indicates otherwise. The
indicia can include one or more of an audible indicia (e.g., a
tone, beep, announcement, or the like), a tactile indicia (e.g., a
vibration or the like), or a visual indicia (e.g., a light, a
displayed message, or the like). More specifically, for example,
the extra-oral housing 2190 includes a light indicia that is
configured to indicate a status, or stage, of the treatment
session. The light indicia is configured to display no light during
a first stage of the treatment session, a blinking or pulsed light
during a second stage of the treatment session, and/or a solid
light during a third stage of the treatment session. The light
indicia can be, for example, configured to display a solid light
for a first predetermined duration (e.g., 2 minutes and 30 seconds,
2 minutes and 45 seconds, or 2 minutes and 10 seconds) upon
initiation of the treatment session. The light indicia can be
configured to display the blinking or pulsed light for a second
predetermined duration (e.g., 10, 15 or 30 seconds) following the
first predetermined duration as a signal to the patient that the
treatment session is nearing its end. The light indicia can be
configured to display no light when a treatment session is ended
(e.g., after 3 minutes from initiation of the treatment session)
and the apparatus 2100 is not irradiating light.
[0159] In some embodiments, the extra-oral housing 2190 has a
sufficient length (e.g., between a first end 2191 of the extra-oral
housing engaged with the intra-oral housing 2080 and a second,
opposite, end 2193 of the extra-oral housing (i.e., the end of the
extra-oral housing farthest from the patient's oral cavity when the
intra-oral housing is disposed in the patient's oral cavity)) such
that at least a portion of the extra-oral housing is visible to the
patient when the intra-oral housing is disposed in the patient's
oral cavity. In other words, at least a portion of the extra-oral
housing 2190, e.g., including the second end 2193 of the extra-oral
housing, is within the patient's line of sight when the intra-oral
housing 2180 is disposed with the patient's oral cavity. In this
manner, the light indicia can be coupled to the extra-oral housing
2190 in a manner such that the light indicia is within the
patient's line of sight during the treatment session.
[0160] As noted herein, the intra-oral housing 2180 is configured
to be positioned within the oral cavity of the patient with respect
to the upper jaw, the lower jaw, or is invertible for positioning
with respect to each of the upper and lower jaws. The intra-oral
housing 2180 can be similar in one or more respects, and include
components similar in one or more respects, or identical, to the
intra-oral housings described herein, including, for example, the
intra-oral housings described herein with respect to FIGS. 13-15
and 43-44. Accordingly, the intra-oral housing 2180 is not
described in detail.
[0161] The intra-oral housing 2180 includes a lower portion 2182
and an upper portion 2186. The lower portion 2182 has a first
plane, and the upper portion 2186 has a second plane different than
the first plane. For example, the upper portion 2186 can be
substantially vertical, and the lower portion 2182 can be
substantially horizontal when the intra-oral housing 2180 is
disposed within the patient's oral cavity for a treatment session.
In this manner, the upper portion 2186 can be disposed adjacent a
portion of a side of the patient's teeth and/or adjacent the
alveolar mucosa and the lower portion 2182 can be disposed adjacent
an occlusal surface of the patient's teeth. For example, the lower
portion 2182 can be configured as a bite pad for the patient to
bite down upon during a treatment session.
[0162] As shown in FIG. 46, the lower portion 2182 of the
intra-oral housing 2180 includes a ridge 2184. The ridge 2184 is
disposed along a midline of the intra-oral housing 2180 and is
elevated with respect to the first plane of the lower portion 2182.
The ridge 2184 facilitates positioning of the intra-oral housing
2180 within the patient's oral cavity by the patient when the
intra-oral housing 2180 is disposed within the patient's oral
cavity. For example, the intra-oral housing 2180 is configured to
be positioned within the patient's oral cavity such that the ridge
2184 is disposed between the patient's front central incisors.
Proprioception of the patient related to the teeth and periodontium
would permit sensory feedback to the patient regarding the position
of the ridge 2184 of the intra-oral housing 2180. In this manner,
the ridge 2184 facilitates centering of the intra-oral housing 2180
within the oral cavity, thus promoting symmetry of a light therapy
treatment on the alveolus, or other oral tissue, on both sides of
the patient's mouth. In other words, in order to promote the
symmetrical administration of light therapy to the root area, the
intra-oral housing 2180 can be positioned with the midline of the
intra-oral housing 2180 seated along the saggital plane or within
(i.e., plus or minus) 5 degrees of the saggital plane, and the
ridge 2184 can facilitate such obtaining such a position.
[0163] The upper portion 2186 includes a first (or left) flange
2187 and a second (or right) flange 2189. The flanges 2187, 2189
are each configured to apically displace oral soft tissue. More
specifically, the flanges 2187, 2189 are each configured to
displace buccal tissue away from the patient's alveolus. In some
embodiments, an inner face 2185 of the upper portion 2186 can be
spaced apart from the patient's alveolar tissue when the intra-oral
housing 2180 is disposed within the patient's mouth and the flanges
2187, 2189 are displacing the buccal tissue. In some embodiments,
at least a portion of the inner face 2185 of the upper portion 2186
can contact the patient's alveolar tissue when the intra-oral
housing 2180 is disposed within the patient's mouth and the flanges
2187, 2189 are displacing the buccal tissue.
[0164] The intra-oral housing 2180 can be constructed of any
suitable material, including, for example, an elastomeric material
(e.g., a soft silicone). More specifically, in some embodiments,
the intra-oral housing can be fabricated from medical-grade
injection molded highly flexible silicone. The ridge 2184 can be
constructed of the same material as the intra-oral housing 2180, or
at least the same material as the lower portion 2182 of the
intra-oral housing 2180. In this manner, when a patient bites
together with the upper and lower jaw, the lower portion 2182 of
the intra-oral housing 2180, including the ridge 2184, may deform
slightly from pressure exerted by an occlusal surface of the
patient's teeth. Nonetheless, the ridge 2184 is of sufficient
dimensions that the patient should be aware of its position,
despite any slight deformation of the lower portion 2182 and/or
ridge 2184.
[0165] The intra-oral housing 2180 includes at least one light
emitting panel 2102 (the circuitry 2130 of which is schematically
illustrated in FIG. 52). The light emitting panel 2102 can include
one or more light emitters 2132, such as a plurality of LEDs, and a
flexible circuit 2130. The intra-oral apparatus 2100 can be
configured to irradiate light in any suitable manner described
herein to irradiate the alveolus and/or root area of the patient.
The LEDs, or other suitable light emitter(s), can be included in
the light emitting panel 2102 in any suitable configuration,
including in any configuration described herein. In some
embodiments, the light emitting panel 2102 is at least partially
enclosed within the intra-oral housing 2180. For example, the light
emitting panel can be embedded within the intra-oral housing 2180
(e.g., in the inner face 2185 of the upper portion 2186 of the
intra-oral housing 2180. As noted herein, the intra-oral housing
2180 can be constructed of a soft silicone material. In this
manner, the light emitting panel, and thus any LED or light emitter
included in the panel, can be embedded in the silicone material
such that the light emitting panel is prevented from engaging a
portion of the patient's oral tissue when the intra-oral housing
2180 is disposed within the patient's oral cavity. The light
emitting panel 2102 can have any suitable dimensions for being
coupled to, or embedded in, the upper portion 2186 of the
intra-oral housing 2180. For example, as shown in FIG. 52, the
light emitting panel 2102 can have a height D.sub.1 and a width
D.sub.2 greater than the height D.sub.1. In some embodiments, for
example, the panel 2102 has a height of about 31.9 mm and a width
of about 92.5 mm. A portion of the height D.sub.1 of the panel 2102
can include a lower protrusion that extends downwardly from left
and right flanges 2187, 2189 of the intra-oral housing 2180. The
protrusion can have a height D.sub.3 and a width D.sub.4. In some
embodiments, for example, the protrusion has a height of about 6.9
mm and a width of about 12 mm. Although specific examples of the
dimensions of the panel 2102 are provided, such dimensions are
presented by way of example only, and not limitation.
[0166] The intra-oral housing 2180 can be configured to be disposed
within the patient's oral cavity such that an outer surface of the
intra-oral housing 2180 is spaced apart from the alveolar soft
tissue of the patient. In this manner, the intra-oral housing 2180
is configured to be spaced apart from (i.e., not touch) the
alveolar soft tissue of the patient during the treatment session.
In some embodiments, for example, at least a portion of the
intra-oral housing 2180 can be configured to be disposed over at
least a portion of the patient's teeth. A first portion of the
intra-oral housing 2180 is disposed about the portion of the
patient's teeth and a second portion of the intra-oral housing 2180
is disposed proximate to and spaced apart from the alveolar soft
tissue when the intra-oral housing 2180 is disposed in the
patient's mouth.
[0167] In some embodiments, at least a portion (e.g., the first
portion) of the intra-oral housing 2180 is configured to snap onto,
or otherwise snugly fit, at least a portion of the patient's teeth
when the intra-oral housing 2180 is disposed in the patient's mouth
for the treatment session. For example, at least a portion of the
intra-oral housing 2180 can be biased in a manner similar to that
described herein with respect to FIGS. 24 and/or 25. In some
embodiments, the intra-oral housing 2180 can include one or more
retractors configured to facilitate opening of the patient's mouth.
In some embodiments, at least a portion of the intra-oral housing
2180 can be configured to contact at least a portion of the
alveolar soft tissue when the intra-oral housing 1280 is disposed
within the patient's mouth for the treatment session. In some
embodiments, at least a portion of the intra-oral housing 2180 is
configured to not contact, but be within a certain distance (e.g.,
within 0.1 cm to 3 cm) of the alveolar soft tissue when the
intra-oral housing 2180 is disposed within the patient's mouth for
the treatment session.
[0168] Referring to FIGS. 49-51, the extra-oral housing 2190 can be
configured to be disposed on or otherwise coupled to an external
station 2170, for example, when the apparatus 2100 is not in use by
the patient. The external station 2170 can be, for example a
carrying case, charging caddy or station, or the like, or a
combination of the foregoing.
[0169] The station 2170 includes a base 2178 and a lid 2176 and
defines a cavity formed by and between the base 2178 and the lid
2176 when the lid is in a closed position (as shown in FIGS.
49-51). The lid 2176 can be coupled to the base 2178 using any
suitable coupling mechanism, for example, using a hinge as shown in
FIGS. 49-51. In this manner, the lid 2176 is conveniently moveable
between its closed position and an open position (not shown). The
base 2178 can define a first recess 2172 configured to receive at
least a portion of the intra-oral housing 2180 and a second recess
2174 configured to receive at least a portion of the extra-oral
housing 2190. A perimeter of the first recess 2172 can, for
example, complement the contour of the intra-oral housing 2180. A
perimeter of the second recess 2174 can, for example, complement
the contour of the extra-oral housing 2190.
[0170] The external station 2170 can be configured to charge the
apparatus 2100 when the apparatus 2100 is disposed on or otherwise
coupled to the station. In this manner, the battery 2194 can be
recharged when the extra-oral housing 2190 is coupled to the
charging station. In some embodiments, for example, the station
2170 is configured to inductively charge the apparatus 2100, e.g.,
by inductively charging the second battery 2195, described herein.
In some embodiments, the second end 2193 of the extra-oral housing
2190 includes a connector (not shown in FIGS. 45-51) configured to
be coupled to a complementary or mating connector (not shown in
FIGS. 45-51) of the external station 2170.
[0171] The intra-oral apparatus 2100 can be configured to determine
when the intra-oral housing 2180 is disposed within the patient's
mouth (i.e., in a manner suitable for the treatment session). In
some embodiments, for example, the intra-oral apparatus 2100
includes a sensor (not shown in FIGS. 45-49) configured to detect
reflection of light off of a patient's oral soft tissue. The sensor
can be, for example, a proximity detector included, or embedded, in
the flexible circuit 2130. Such a proximity detector can, for
example, include any suitable capacitance detection device. The
light emitting panel 2102 can be configured to blink or pulse the
LEDs included therein, for example, upon removal of the apparatus
2100 from the external station 2170 based, for example, on feedback
from the proximity detector. The LEDs can be configured to blink or
pulse at a predetermined rate.
[0172] At least a portion of light emitted from the pulsing or
blinking LEDs towards the oral soft tissue of the patient's mouth
is reflected to the intra-oral housing 2180 and is thereby detected
by a sensor or other light reflectance detection mechanism
(generally referred to as a "reflectance sensor;" not shown in
FIGS. 45-49). The reflectance sensor is configured to evaluate the
functionality of a portion of the light emitting array 2102 coupled
to the left side of the intra-oral housing 2180 and a portion of
the light emitting array 2102 coupled to the right side of the
intra-oral housing 2180. In this manner, the reflectance sensor
facilitates detection of any faulty operation of the apparatus 2100
with respect to each of the left and right sides of the intra-oral
housing 2180 before operation of the apparatus 2100 with respect to
the patient. Suitable reflectance thresholds can be established to
measure reflectance in order to determine that the LEDs of the
light emitting array 2102 are operating properly. The apparatus
2100 can be configured to initiate irradiation of the oral tissue
(i.e., begin a treatment session) when the reflectance sensor
detects the light reflection off of the oral soft tissue. In some
embodiments, the reflectance sensor is configured to transmit a
signal to the microprocessor 2196 to initiate the treatment session
when the reflectance sensor detects light reflection (e.g., at or
above a predetermined threshold) from the oral soft tissue.
[0173] The intra-oral apparatus 2100 can be configured for use in
an orthodontic treatment, including any treatment described herein.
In some embodiments, for example, the intra-oral apparatus 2100 is
useful to irradiate at least a portion of the patient's upper jaw
for about 3 minutes, the patient's lower jaw for about 3 minutes,
or each of the patient's upper and lower jaws for about 3 minutes.
More specifically, in one treatment program, the intra-oral
apparatus 2100 is useful to administer a light-therapy treatment
session in which the oral tissue associated with each of the upper
arch of the patient's mouth and the lower arch of the patient's
mouth (or vice versa) are consecutively irradiated for 3 minutes
per day, for a total treatment session of 6 minutes per day.
[0174] During the treatment session, for example, the apparatus
2100 is configured to administer the light therapy using 12
Joules/cm.sup.2. In some embodiments, the 12 Joules/cm.sup.2 is
administered at an intensity of 150 mW/cm.sup.2 for the three
minutes duration. As such, the LEDs tend to remain under a thermal
threshold of about 41 degrees Celsius in contact with, or within
the certain distance of, oral tissue (and thus under a maximum
limit of 43 degrees Celsius). In some embodiments, the 12
Joules/cm.sup.2 can be administered at a higher intensity, such as
at an intensity of about 600 mW/cm.sup.2 for about 20 seconds or
about 1 W/cm.sup.2 for about 12 seconds. In other embodiments, the
light is administered at an intensity of about 60-12
mW/cm.sup.2.
[0175] The light is emitted at a wavelength of 850 nm during the
treatment session. In some embodiments, the light is emitted at a
wavelength of 850 nm (.+-.5 nm) during the treatment session. In
other words, LEDs can emit light at a blend of wavelengths, and not
at a single wavelength like a laser. The peak light emission
wavelength (.lamda..sub.max) by the LEDs is 855 nm. The treatment
sessions can be administered for any suitable period, including,
but not limited to, a period of four to twelve months. Such a
treatment program can, for example, reduce the duration of an
average period a patient is expected to need to use an orthodontic
appliance (e.g., braces) to achieve a desired orthodontic result
from two years to six months. The foregoing treatment program
and/or any treatment program described herein can reduce a duration
of an orthodontic treatment administered without light therapy, as
described herein, by about 50 percent to about 75 percent.
[0176] Although the intra-oral housing (e.g., intra-oral housing
780, 880, 980, 1280, 1680, 1780, 1880, 1980, 2080, 2180) have been
illustrated and described herein as having an arch shape similar to
at least one of the upper or lower arch of a patient's teeth, in
other embodiments, an light therapy apparatus can include an
intra-oral housing having another suitable configuration. For
example, referring to FIG. 53, an intra-oral apparatus 2200
configured to administer light therapy to a patient's oral tissue
(e.g., the oral mucosa and/or root area) includes an intra-oral
housing 2280 and an extra-oral housing 2290 coupled to the
intra-oral housing. The extra-oral housing can be similar in many
respects, or identical, to the extra-oral housing 2190 described
herein with respect to FIGS. 45-47, and is therefore not described
in detail herein. Although the intra-oral housing 2280 is shown and
described as being coupled to the extra-oral housing 2290, in other
embodiments, the intra-oral housing 2280 can be configured to be
electrically coupled to a separate electronic device (e.g., via
fiber optic cable(s), or other electronic tether as shown and
described with respect to FIG. 44) configured to perform the
functions of the components of the extra-oral housing 2290.
[0177] The intra-oral housing 2280 includes a light emitting array
2202. The light emitting array 2202 can be the same as or similar
in many respects to a light emitting array described herein, and
thus is not described in detail with respect to FIG. 53. The
intra-oral housing 2280 can be configured to be received in the
oral cavity such that a light emitting array 2202 is wholly
disposed on the lingual side of the upper and/or lower arches of
the patient's teeth. The intra-oral housing 2280 can define a
substantially circular perimeter. For example, the intra-oral
housing 2280 can be spherical, disc shaped, or the like. For
descriptive purposes, the intra-oral housing 2280 can have a shape
and can be disposed within a patient's mouth similar to a lollipop.
In this manner, the light emitting array 2202 can be disposed
adjacent the perimeter of the intra-oral housing 2280 such that the
light emitting array 2202 emits light towards the patient's oral
tissue (e.g., the oral mucosa and/or the root area) in a direction
radiating from a central axis A, as shown by the arrows A.sub.1,
A.sub.2, A.sub.3, A.sub.4, A.sub.5 and A.sub.6, in FIG. 53. In some
embodiments, at least a portion of the intra-oral housing 2280 can
be configured to contact at least a portion of the alveolar soft
tissue when the intra-oral housing 2280 is disposed within the
patient's mouth. In some embodiments, at least a portion of the
intra-oral housing 2280 is configured to not contact, but be within
a certain distance (e.g., within 0.1 cm to 3 cm) of, the alveolar
soft tissue when the intra-oral housing 2280 is disposed within the
patient's mouth.
[0178] Although the intra-oral apparatus have been illustrated and
described herein as being configured to administer light therapy to
the upper and/or lower arch of a patient's teeth, in some
embodiments, an intra-oral apparatus is configured to administer
light therapy to a portion or section of the patient's oral mucosa
(e.g., the alveolus). For example, referring to FIG. 54, in some
embodiments, an apparatus 2300 is configured to administer light
therapy to three or four teeth of the patient, to a quadrant of the
patient's teeth, or to one arch of the patient's teeth. Such an
intra-oral apparatus can be beneficial in the case of implantology
and/or oral surgery.
[0179] The apparatus 2300 includes an intra-oral housing 2380
configured to be disposed within the oral cavity of the patient.
The intra-oral housing 2380 defines a first segment 2382, a second
segment 2384 and a third segment 2386 coupling the first segment
and the second segment. When the intra-oral housing 2380 is
disposed within the patient's oral cavity for a treatment session,
the first segment 2382 of the intra-oral housing is configured to
be disposed (e.g., vertically) between the patient's teeth and the
patient's buccal mucosa, the second segment 2384 is configured to
be disposed (e.g., vertically) on the lingual side of the crown of
the patient's teeth, and the third segment 2386 is configured to be
disposed (e.g., horizontally) adjacent and/or on the occlusal
surface of the patient's teeth. The second segment 2384 has a
sufficient height (i.e., measured in a direction from the occlusal
surface to the root area) to inhibit tipping of the intra-oral
housing 2380 towards the patient's cheek.
[0180] In some embodiments, a layer 2381 of moldable material is
disposed on an occlusal-facing surface of the third segment 2386 of
the intra-oral housing 2380. A moldable impression of the
designated teeth can be made using the layer 2381, thus
facilitating placement of the intra-oral housing 2380 when the
housing is later re-inserted into the oral cavity by the patient
(e.g., for a subsequent treatment session).
[0181] A flexible circuit 2330 is disposed within the first segment
2382 of the intra-oral housing 2380. The flexible circuit 2330
includes a light emitting array 2302 configured to administer light
therapy, in any manner described herein, to the patient's teeth.
For example, the flexible circuit 2330 can include a light emitting
array 2302 including 15 LEDs, or 15 LEDs per tooth that will be
subjected to light therapy. The light emitting array 2302 can
includes LEDs configured to administer, or emit, light within the
range of 600 to 1200 nm. The flexible circuit 2330 of the
intra-oral housing 2380 includes a sensor 2387. The sensor 2387 can
be the same as or similar in many respect to the sensor shown and
described herein with respect to FIG. 3A. The sensor 2387 can be
configured to detect the temperature of the apparatus 2300, the
patient's alveolar soft tissue and/or the patient's root area. For
example, a thermistor or similar temperature measuring device can
be placed in the circuit 2330 to monitor the temperature of the
light emitting array 2302, as well as measure the temperature
inside the patient's mouth. This information can serve as a method
of obtaining temperature-related information as well as monitoring
patient compliance. When the intra-oral housing 2380, and thus the
circuit 2330, is placed in the mouth and when the apparatus 2300
emits light, the temperature of the light emitting array 2302 will
rise from pre-treatment ambient temperature to closer to normal
body temperature. By monitoring the change in temperature, a
controller 2314, described in more detail herein, can monitor the
period of time that the light emitting array 2302 is in the oral
cavity, based on the period of time the temperature is elevated and
close to body temperature.
[0182] In some embodiments, the circuit 2330 includes a sensor (or
proximity detector) that is configured to detect contact of, or a
proximity within a certain distance (e.g., within 0.1 cm to 3 cm)
of, the first segment and/or light emitted by the light emitting
array 2302 with the patient's oral mucosa and/or root area. In this
manner, the controller 2314 can detect that the intra-oral housing
2380 is disposed within the patient's oral cavity, and therefore
can determine that a treatment session can be initiated.
[0183] Referring to FIG. 57, the intra-oral housing 2380 is
configured to be coupled to an external electronic device, e.g.,
via a wired or wireless connection. The external electronic device
can be configured to provide or convey power to the intra-oral
housing 2380, for example, for operation of the light emitting
array 2302 during a treatment session. The external electronic
device can also be configured to control operation of the
light-emitting array 2302.
[0184] In some embodiments, the external electronic device is a
controller 2314. The intra-oral housing 2380 can be removably
coupleable to the controller 2314. In some embodiments, the
intra-oral housing 2380 is disposable and the controller 2314 is
reusable. In this manner, the intra-oral housing 2380 can be
disposed of after a predetermined number of uses and/or after a
predetermined period of time, and a second intra-oral housing (not
shown) can optionally be used with the controller 2314. The
controller 2314 can be electrically coupled to a charger 2317, such
as a medical grade USB charger, via a cable 2315, such as a USB
cable.
[0185] The controller 2314 can be similar in many respects or
identical to any controller (e.g., controller 430, 1114) described
herein. The controller 2314 can also include many components the
same as or similar to those disposed within the extra-oral housing
2190 of apparatus 2100. For example, the controller 2314 can
include a microprocessor. Because the microprocessor can be the
same as or similar in many respects to any microprocessor described
herein (e.g., microprocessor 2196), it is not described in detail
herein. The controller 2314 can be preconfigured with a treatment
protocol. The controller 2314 includes a button 2318 for initiating
a treatment session. The button 2318 can also be configured to, for
example, pause or stop a treatment session.
[0186] The controller 2314 includes an LED indicator 2316 that can
be configured to provide an indicia to the patient of the status of
the controller, the intra-oral housing 2380, and/or the treatment
program. The LED indicator 2316 can be similar or identical, for
example, to the communication mechanism of extra-oral housing 2190,
described herein, in that it is configured to indicate a status, or
stage, of the treatment session. In some embodiments, the LED
indicator 2316 is configured to display no light during a first
stage of the treatment session, a blinking or pulsed light during a
second stage of the treatment session, and/or a solid light during
a third stage of the treatment session. The LED indicator 2316 can
be, for example, configured to display a solid light for a first
predetermined duration (e.g., 2 minutes and 30 seconds, 2 minutes
and 45 seconds, or 2 minutes and 10 seconds) upon initiation of the
treatment session. The LED indicator 2316 can be configured to
display the blinking or pulsed light for a second predetermined
duration (e.g., 10, 15 or 30 seconds) following the first
predetermined duration as a signal to the patient that the
treatment session is nearing its end. The LED indicator 2316 can be
configured to display no light when a treatment session is ended
(e.g., after 3 minutes from initiation of the treatment session)
and the apparatus 2100 is not irradiating light to the patient.
[0187] In some embodiments, the external electronic device 2314 is
a personal electronic device such as a mobile phone (e.g., a
smartphone, such as an iPhone.RTM., a tablet, such as an
iPad.RTM.), a personal digital assistant, or the like. The
intra-oral housing 2380 can be coupled to the device 2314 using a
connector 2319. In an embodiment in which the device 2390 includes,
for example, a smartphone, the smartphone can be configured to
perform any operation or function that the controller is configured
to perform. For example, the device 2314 can be configured to
provide power to the intra-oral housing 2380. In another example,
the device 2314 can include an application configured to provide an
interface for the patient, control the light-emitting array 2302,
and/or record usage information (e.g., compliance information) for
subsequent accessing of the information by the patient and/or a
physician.
[0188] In some embodiments, a system includes a first portion
configured to administer light therapy to a patient, as described
herein, for a first time period, and a second portion configured to
administer light therapy to the patient, as described herein, for a
second time period different than the first time period. For
example, in some embodiments, the system includes a plurality of
apparatus (or intra-oral housings), such that at least a portion of
each apparatus is configured to be disposed within the patient's
mouth. Each apparatus of the plurality can include any apparatus or
intra-oral housing described herein. For example, the system
includes a first intra-oral apparatus and a second intra-oral
apparatus distinct from the first intra-oral apparatus. The first
apparatus is configured to begin administering light therapy to a
patient at a first time period beginning at T.sub.0. T.sub.0
represents the start of a phototherapy session (e.g., corresponding
to a date the patient is assigned the first apparatus and/or starts
daily usage of the first apparatus). For at least some patients,
T.sub.0 can also represent the day of maxillary bonding and/or the
start of an orthodontic treatment (e.g., a conventional buccal
fixed orthodontic bracket treatment). The first apparatus can be
selected based on a position or configuration of the patient's
teeth prior to administration of the light therapy. The first
apparatus is configured to administer light at a first wavelength,
such as, but not limited to, about 850 nm.
[0189] The second apparatus is configured to administer light
therapy to a patient at a second time period beginning at
T.sub.>0, subsequent to T.sub.0. In some embodiments, the second
apparatus is optimally configured to administer light therapy to
the patient based on a position of the patient's teeth after
administration of at least a portion of the light therapy. For
example, the second apparatus can include a light emitting array
differently configured from a light emitting array of the first
apparatus. The second apparatus can be configured to administer
light at a second wavelength different than the first wavelength,
such as, but not limited to, about 620 nm. In this manner, the
second apparatus can be selected based, at least in part, on tooth
movement that occurred during the light therapy administered in
conjunction with the first apparatus and during a time period
between T.sub.0 and T.sub.>0. For example, the first apparatus
can be used by the patient at start of the light therapy program
and for the first time period, and the second apparatus can be used
by the patient beginning about three months after the beginning of
the light therapy program and for the second time period. The
system can include any suitable number of apparatus, such as two,
three, four or more apparatus configured to administer the light
therapy. For example, the system can include the first apparatus
configured to administer the light therapy beginning at T.sub.0,
the second apparatus configured to administer light therapy
beginning at T.sub.1, and a third apparatus configured to
administer light therapy beginning at T.sub.2.
[0190] In another example, the system can include an apparatus
having a first light emitting array (e.g., the first portion) and a
second light emitting array (e.g., the second portion). The first
light emitting array can be configured to administer light at a
first wavelength, such as, but not limited to, about 850 nm. The
second light emitting array can be configured to administer light
at a second wavelength different than the first wavelength, such
as, but not limited to, about 620 nm. The first light emitting
array and the second light emitting array can be included in a
single intra-oral housing. The system, which includes a first
portion configured to emit light at the first wavelength for the
first time period and at the second wavelength for the second time
period, is beneficial at least because it permits a transition
during a light therapy program from a higher light wavelength to a
lower light wavelength that can help start to increase bone
mineralization in the patient's treated area. Such an increase in
bone mineralization can facilitate ensuring a more stable result of
the moved teeth following an orthodontic treatment.
[0191] In some embodiments, the light therapy apparatus described
herein are configured for use in conjunction with a functional
dental appliance, as described in more detail herein. In other
embodiments, a light therapy apparatus is integrally formed with a
functional appliance configured to exert a force on the teeth of a
patient, such as a functional appliance described in more detail
herein. For example, referring to FIG. 57, a system 2400 according
to an embodiment is configured to regulate tooth movement. The
system 2400 includes one or more light emitters (e.g., fiber
optical cable(s)) 2420 and an orthodontic bracket system 2490. The
light emitters 2420 can be the same as or similar to any light
emitter described herein, including, but not limited to, optical
fiber cables 420 described herein with respect to FIG. 7. The light
emitters 2420 are coupled to the bracket system 2490. For example,
the light emitters 2420 can be coupled to one or more brackets 2492
of the bracket system 2490, to one or more wires 2494 of the
bracket system 2490, or any combination of the foregoing. In this
manner, a separate intra-oral housing is not needed to maintain a
position of the light emitters 2420 with respect to the patient's
tooth, root area and/or oral mucosa. The light emitters 2420 are
coupleable to a light source 2402. The light source 2402 can be any
suitable light source, including any light source described herein
(such as light source 402 described herein with respect to FIG.
7).
[0192] Methods for Regulating Tooth Movement
[0193] Methods for regulating tooth movement are provided herein.
Such methods comprise administering an effective amount of light to
a patient, wherein the effective amount of light is irradiated from
the emitter of an apparatus of the invention. In some embodiments,
at least a portion of the apparatus contacts the alveolar soft
tissue (e.g., the alveolar mucosa) when the light is administered.
In some embodiments, at least a portion of the apparatus does not
contact, but is within a certain distance (e.g., within 0.1 cm to 3
cm), the alveolar soft tissue when the light is administered. As is
described in more detail herein, the light is administered using
any one of the intra-oral apparatuses of the invention. In some
embodiments, the methods also comprise allowing a force, in one
embodiment, a heavy force, to be exerted on one or more teeth of
the patient in need thereof, wherein the light is administered
before, during or after the force is exerted.
[0194] Other embodiments of the invention provide methods for
reducing, minimizing or preventing tooth root resorption,
comprising administering an effective amount of light to a patient,
wherein the effective amount of light is irradiated from the
emitter of an apparatus of the invention. In some embodiments, at
least a portion of the apparatus contacts the alveolar soft tissue
when the light is administered. In some embodiments, the methods
also comprise allowing a force, in one embodiment, a heavy force,
to be exerted on one or more teeth of the patient in need thereof,
wherein the light is administered before, during, or after the
force is exerted. Methods for reducing bone resorption or
inflammatory dentin or cementum resorption of the tooth root or
periodontium are further provided in accordance with another aspect
of the invention. Such methods comprise administering an effective
amount of light to a patient, wherein the effective amount of light
is irradiated from the emitter of an apparatus of the invention. In
some embodiments, at least a portion of the apparatus contacts the
alveolar soft tissue when the light is administered. In some
embodiments, the methods also comprise allowing a force, in one
embodiment, a heavy force, to be exerted on one or more teeth of
the patient in need thereof, wherein the light is administered
before, during, or after the force is exerted.
[0195] Another aspect of the invention provides methods for
preventing or minimizing inflammation of tissue surrounding one or
more teeth upon which forces, force, in one embodiment, heavy
forces, are or were exerted, comprising administering an effective
amount of light to a patient, wherein the effective amount of light
is irradiated from the emitter of an apparatus of the invention. In
some embodiments, at least a portion of the apparatus contacts the
alveolar soft tissue when the light is administered. In some
embodiments, the methods also comprise allowing a force, in one
embodiment, a heavy force, to be exerted on one or more teeth of a
patient in need thereof, wherein the light is administered before,
during or after the force is exerted.
[0196] Another aspect of the invention provides methods for
regenerating maxillary or mandibular alveolar bone, comprising
administering an effective amount of light to a patient, wherein
the effective amount of light is irradiated from the emitter of an
apparatus of the invention. In some embodiments, at least a portion
of the apparatus contacts the alveolar soft tissue when the light
is administered. In some embodiments, the methods also comprise
allowing a force, in one embodiment, a heavy force, to be exerted
on one or more teeth of a patient in need thereof, wherein the
light is administered before, during, or after the force is
exerted.
[0197] In some embodiments, the methods further comprise allowing a
functional appliance to exert a force on one or more teeth of the
patient in need thereof; wherein the functional appliance exerts
the force before, during or after the force, in one embodiment, the
heavy force, is exerted and/or the light is administered. In this
manner, the force can be exerted in conjunction with or in lieu of
the force exerted by the functional appliance. In some embodiments,
the methods comprise further administering an effective amount of
vitamin D to the patient. The vitamin D can be administered before,
during or after the force is exerted, the functional appliance
exerts a force, and/or the light is administered. In this manner,
the vitamin D can be administered to the patient in conjunction
with or in lieu of the force being exerted or the functional
appliance exerting a force.
[0198] Exerting Forces
[0199] As indicated herein, in some embodiments, a force is allowed
to be exerted on one or more teeth of a patient in need thereof. In
some embodiments, the force is allowed to be exerted on one or more
teeth of the patient prior to, subsequent to or during
administration of light from an apparatus of the invention. In some
embodiments, the force can be an orthopedic force. For example, in
some embodiments, the orthopedic force includes a force applied to
one, two, or more teeth sufficient to cause movement in one or more
bones underlying the tooth (or teeth). In some embodiments, an
orthopedic force is a force having a magnitude of greater than
about 300 grams of force. In other embodiments, an orthopedic force
is a force having a magnitude of greater than or equal to about 350
grams of force, greater than or equal to about 400 grams of force,
greater than or equal to about 450 grams of force, greater than or
equal to about 500 grams of force, greater than or equal to about
550 grams of force, or greater than or equal to about 600 grams of
force. In other embodiments, an orthopedic force is a force having
a magnitude of less than or equal to about 500 grams of force, less
than or equal to about 550 grams of force, less than or equal to
about 600 grams of force, less than or equal to about 650 grams of
force, less than or equal to about 700 grams of force, less than or
equal to about 800 grams of force, less than or equal to about 900
grams of force, or less than or equal to about 1000 grams of force.
In other embodiments, an orthopedic force ranges from about 300
grams of force to about 1000 grams of force. In other embodiments,
an orthopedic force's lower range is about 300 grams of force,
about 350 grams of force, about 400 grams of force, about 500 grams
of force, about 600 grams of force or about 700 grams of force. In
other embodiments the orthopedic force's upper range is about 500
grams of force, about 550 grams of force, about 600 grams of force,
about 650 grams of force, about 700 grams of force, about 800 grams
of force, about 900 grams of force, or about 1000 grams of force.
In other embodiments, a force that is less than an orthopedic force
is exerted on one or more of a patient's teeth. In this embodiment,
the force has a magnitude of less than 100 grams of force, for
example, a magnitude of about 200 grams of force or about 300 grams
of force.
[0200] In some embodiments, the force is a less-than-orthopedic
force. In some embodiments, a less-than-orthopedic force is a force
having a magnitude of greater than about 30 grams of force. In
other embodiments, a less-than-orthopedic force is a force having a
magnitude of greater than or equal to about 50 grams of force,
greater than or equal to about 75 grams of force, greater than or
equal to about 100 grams of force, greater than or equal to about
150 grams of force, greater than or equal to about 200 grams of
force, or greater than or equal to about 250 grams of force. In
other embodiments, a less-than-orthopedic force is a force having a
magnitude of less than or equal to about 50 grams of force, less
than or equal to about 75 grams of force, less than or equal to
about 100 grams of force, less than or equal to about 150 grams of
force, less than or equal to about 200 grams of force, less than or
equal to about 250 grams of force, or less than or equal to about
275 grams of force. In other embodiments, a less-than-orthopedic
force ranges from about 30 grams of force to about 300 grams of
force. In other embodiments, a less-than-orthopedic force's lower
range is about 30 grams of force, about 50 grams of force, about 75
grams of force, about 100 grams of force, about 150 grams of force,
about 200 grams of force, or about 250 grams of force. In other
embodiments the less-than-orthopedic force's upper range is about
50 grams of force, about 75 grams of force, about 100 grams of
force, about 150 grams of force, about 200 grams of force, about
250 grams of force, or about 275 grams of force.
[0201] In some embodiments, the force is a heavy force. The phrase
"heavy force" as used herein refers to a force that ranges from
about 150 grams of force to about 1000 grams of force, and that is
exerted on a tooth. For example, in some embodiments, a heavy force
is a force having a magnitude of greater than about 150 grams of
force. In other embodiments, a heavy force is a force having a
magnitude of greater than or equal to about 175 grams of force,
greater than or equal to about 190 grams of force, greater than or
equal to about 200 grams of force, greater than or equal to about
210 grams of force, greater than or equal to about 225 grams of
force, or greater than or equal to about 250 grams of force. In
other embodiments, a heavy force is a force having a magnitude of
less than or equal to about 300 grams of force, less than or equal
to about 350 grams of force, less than or equal to about 400 grams
of force, less than or equal to about 450 grams of force, less than
or equal to about 500 grams of force, less than or equal to about
550 grams of force, or less than or equal to about 600 grams of
force, and so on up to less than or equal to about 1000 grams of
force. In other embodiments, however, a heavy force ranges from
about 150 grams of force to about 600 grams of force. In other
embodiments, the heavy force's lower range is about 175 grams of
force, about 190 grams of force, about 200 grams of force, about
210 grams of force, about 225 grams of force or about 250 grams of
force. In other embodiments, the heavy force's upper range is about
300 grams of force, about 350 grams of force, about 400 grams of
force, about 450 grams of force, about 500 grams of force, about
550 grams of force, or about 600 grams of force, and so on up to
about 1000 grams of force. In some embodiments, the heavy force
ranges from about 200 grams of force to about 500 grams of force.
In other embodiments, the heavy force ranges from about 250 grams
of force to about 450 grams of force. In one embodiment, the heavy
force ranges from about 150 grams of force to about 300 grams of
force.
[0202] In some embodiments, a heavy force is exerted on one or more
teeth of the patient. For example, a heavy force can be exerted on
one or more of the patient's teeth before, during, or after being
administered with an effective amount of light to a region of the
patient's gum (e.g., the alveolar soft tissue). In other
embodiments, however, a force that is less than a heavy force is
exerted on one or more of a patient's teeth. In this embodiment,
the force has a magnitude of less than 150 grams of force, for
example, a magnitude of about 100 grams of force or about 125 grams
of force.
[0203] In some embodiments, the force exerted on one or more teeth
of the patient can be a less-than-heavy force. Such a force can be
exerted, for example, by a functional appliance or an orthodontic
appliance. In some embodiments, a less-than-heavy force is a force
having a magnitude of greater than about 10 grams of force. In
other embodiments, a less-than-heavy force is a force having a
magnitude of greater than or equal to about 20 grams of force,
greater than or equal to about 30 grams of force, greater than or
equal to about 40 grams of force, greater than or equal to about 50
grams of force, greater than or equal to about 75 grams of force,
greater than or equal to about 100 grams of force, or greater than
or equal to about 125 grams of force. In other embodiments, a
less-than-heavy force is a force having a magnitude of less than or
equal to about 30 grams of force, less than or equal to about 40
grams of force, less than or equal to about 50 grams of force, less
than or equal to about 75 grams of force, less than or equal to
about 100 grams of force, or less than or equal to about 150 grams
of force. In other embodiments, a less-than-heavy force ranges from
about 10 grams of force to about 150 grams of force. In other
embodiments, a less-than-heavy force's lower range is about 10
grams of force, about 20 grams of force, about 30 grams of force,
about 50 grams of force, about 75 grams of force, about 100 grams
of force, or about 125 grams of force. In other embodiments the
less-than-heavy force's upper range is about 30 grams of force,
about 40 grams of force, about 50 grams of force, about 75 grams of
force, about 100 grams of force, or less than about 150 grams of
force.
[0204] The phrase "magnitude of force" as used herein refers to the
amount of force exerted per tooth. Alternatively, the "magnitude of
force" can refer to the amount of force exerted on a plurality of
teeth. The magnitude of force exerted per tooth in the latter
instance is the total magnitude of force divided by the number of
teeth. For example, if about 300 grams of force are exerted on to
two teeth, then the force exerted on each tooth is about 150 grams.
The phrase "gram of force" as used herein refers to a unit of force
equal to the magnitude of force exerted on one gram of mass by a
force of 9.80665 m/s.sup.2 (i.e., standard gravity). In some
embodiments, the magnitude of force is a gram of force that is
exerted on a tooth. In other embodiments, the magnitude of force is
a gram of force that is exerted on a plurality of teeth.
[0205] In some embodiments, a force is a force of sufficient
magnitude to cause at least some amount of tooth-root resorption.
In some embodiments, an amount of tooth-root resorption caused by a
force is correlated to the amount of force exerted such that an
increase in the force exerted causes an increase in the amount of
tooth-root resorption. In some embodiments, a force has sufficient
magnitude to have pathophysiological effects, to create a
hyalinized zone or tissue death, to cause cell death, or to cause
tissue inflammation when the force is exerted without any other
form of treatment, such as light treatment. The force can be an
excessive pathophysiological force. A pathophysiological force may
cause necrosis or root resorption. The force can also cause
pressure on the periodontium that can result in ischemia, decreased
blood flow, or cell death.
[0206] A force can be exerted on a tooth in any suitable manner.
For example, in some embodiments, the force is exerted normal
(e.g., orthogonal or at a 90 degree angle) relative to a side of
one or more teeth. In some embodiments, the force is exerted at an
angle relative to a side of one or more teeth. For example, the
force can be exerted at an angle of about 45 degrees, about 60
degrees, about 70 degrees, about 75 degrees, about 80 degrees,
about 85 degrees, about 90 degrees, about 95 degrees, about 100
degrees, about 105 degrees, about 110 degrees, about 120 degrees,
or about 135 degrees relative to a side of one or more teeth. A
force can be exerted normal (e.g., orthogonal or at a 90 degree
angle) to, downwards to, or upwards to one or more teeth at any
angle. In some embodiments, a proximal force is applied to one or
more teeth. In some other embodiments, a distal force is applied to
one or more tooth. In some embodiments, the force is coronal
pressure, e.g., a pressure exerted in the direction of or on the
crown of the tooth, which is useful to intrude teeth; in other
embodiments, the force is apical pressure, e.g., a pressure exerted
in the direction of or on the root, which is useful to extrude
teeth. In some embodiments, a force is exerted on a mesial (e.g.,
side of tooth towards front of mouth) side of the tooth. In some
embodiments, a force is exerted on a distal, e.g., side of tooth
towards back of mouth) side of the tooth. A force can be exerted on
a buccal, e.g., side of tooth towards cheek, side of the tooth, or
a force can be exerted on a lingual, e.g., side of tooth towards
tongue, side of the tooth. A force can be exerted on an occlusal
surface of a tooth. A force can be exerted on an incisal surface of
a tooth. A force can be exerted on a proximal surface of a tooth,
e.g., mesial or distal surfaces in between teeth. A force can be
exerted on an apical, e.g., toward a root end, surface of a tooth.
In some embodiments, a force exerted on a tooth is translated to be
exerted on the mandibular bone or maxillary bone. The force can be
exerted by a functional appliance for regulating oral or
maxillofacial bone remodeling. In some embodiments, the force can
be exerted by an orthodontic appliance for regulating tooth
movement.
[0207] A force can be directed to push one or more teeth toward one
another. A force may be directed to push one or more teeth apart. A
force may be directed to move one or more teeth toward a side. In
some embodiments, a force may shift a tooth sideways along a
maxilla or mandible. Alternatively, a force may move a tooth
forwards or backwards relative to a maxilla or mandible. In some
embodiments, a force can be directed to move a mandibular bone or
maxillary bone forward in an anterior direction. A force can be
directed to move a mandibular bone or maxillary bone backward in a
posterior direction. A force can be directed to adjust an angle of
a mandibular bone or maxillary bone. For example, the angle of a
mandibular bone can be adjusted by moving a right side or a left
side of a mandibular bone forward or backward. If a right side of a
mandibular bone is moved forward or lengthened, while the left side
of the mandibular bone maintains the same position or is moved
backward or shortened, the mandibular bone can be angled more
leftward (e.g., shifted sideways or to the left side). In other
words, a force can be directed to move one or more teeth toward a
side.
[0208] In some embodiments, a force is exerted at any point or
region along a side of one or more teeth and/or along a side of an
oral or maxillofacial bone, muscle, or soft tissue. In some
embodiments, a force is exerted at or near the top of one or more
teeth, i.e., the side of a tooth opposite its root or roots. In
some embodiments, a force is exerted at or near the middle of the
clinical crown, e.g., exposed to the air, above the gums, of one or
more teeth. In other embodiments, a force is exerted at or near the
bottom of the clinical crown of one or more teeth, i.e., the
clinical crown of a tooth closer to its root. In some embodiments,
the force is applied to the root of the one or more teeth. A force
can be exerted on one or more of the points or regions described
herein on one or more teeth. In some embodiments, a force is
exerted along the side of the tooth. Depending on where or for how
long the force is exerted, some or no tipped movement may occur to
the tooth. Tipped movement is described in more detail herein.
[0209] In some embodiments, however, a force is exerted at or near
a temporomandibular joint, condyle, or glenoid fossa. In some
embodiments, a force is exerted on one or more of the right
temporomandibular joint, right condyle, or right glenoid fossa; one
or more of the left temporomandibular joint, left condyle, or left
glenoid fossa; or one or more of both right and left
temporomandibular joints, both right and left condyles, and both
right and left glenoid fossa. In some embodiments, the force is
exerted on the right temporomandibular joint without being exerted
on the left temporomandibular joint, the right condyle without
being exerted on the left condyle, the right glenoid fossa without
being exerted on the left glenoid fossa, the left temporomandibular
joint without being exerted on the right temporomandibular joint,
the left condyle without being exerted on the right condyle, or the
left glenoid fossa without being exerted on the right glenoid
fossa. In some embodiments, the force is exerted on mandibular or
maxillary alveolar bone. In some embodiments, the force is exerted
on an anterior portion of the maxillary bone, mandibular bone, or
temporal bone.
[0210] Depending on where or for how long the force is exerted,
some or no tooth tipped movement may occur. In some embodiments, a
force can increase the velocity of tooth movement as compared to
where no force or a lighter force is exerted. In these embodiments,
in other words, the force reduces the amount of time it takes for
the tooth to move to its desired position within the gum. Exertion
of a force on the maxillary bone, mandibular bone, temporal bone,
or one or more of a patient's teeth, particularly where the patient
is administered with an effective amount of light to his or her
maxillary bone, mandibular bone, or one or more teeth, can further
reduce the amount of time of orthodontic treatment that a patient
might undergo.
[0211] In some embodiments, a force is exerted on one or more teeth
of a patient by one or more orthodontic appliances. Accordingly, in
one embodiment, an orthodontic appliance can exert a force on one
or more of the patient's teeth to facilitate tooth movement. In
some embodiments, a functional appliance exerts a force on oral or
maxillofacial bone, muscle, soft tissue, or one or more teeth. The
functional appliance can exert a force on only the mandibular bone
of the patient. Alternatively, the functional appliance can exert a
force only the maxillary bone of the patient. In some embodiments,
the functional appliance exerts a force on only the temporal bone
of the patient. The functional appliance can exert a force on both
the mandibular bone and maxillary bone of the patient. The
functional appliance can optionally exert a force on a maxillary
bone, mandibular bone, or temporal bone by exerting a force on one
or more tooth of the patient. The functional appliance can exert a
force on only the jaw muscle. The functional appliance can exert a
force on only the jaw soft tissue.
[0212] In some embodiments, the orthodontic appliance can be
present on one or more of the patient's teeth, other oral regions
of the patient, or the patient's head or face. In some embodiments,
the patient wears two or more orthodontic appliances and less than
all of these appliances exert a force on one or more of the
patient's teeth. For example, the orthodontic appliance can exert a
force on only one tooth of the patient or, alternatively, the
orthodontic appliance can exert a force on a plurality of teeth of
the patient. In another embodiment, the orthodontic appliance can
selectively exert a force on less than all the teeth of the
patient. Orthodontic appliances that exert forces can also include
other intra-oral appliances and/or extra-oral appliances.
[0213] In some embodiments, the orthodontic appliance for exerting
a force can be used for external anchorage, and can be the form of
a temporary anchorage device or in the form of headgear. For
example, a patient that uses the intra-oral apparatus can
concurrently wear a second orthodontic appliance, e.g., in the form
of headgear, for temporary period of time, e.g., at night. In some
embodiments, the externally worn headgear can physically or
electronically communicate with an intra-oral apparatus to
facilitate tooth movement. External anchorage can be used to
facilitate the exertion of forces to prevent untoward movement of
anchorage teeth during use of forces.
[0214] As is described in more detail herein, the patient can wear
an orthodontic appliance that exerts forces subsequent to
initiating the administration of light. For example, the patient
can wear an orthodontic appliance that exerts forces after one or
more light treatment sessions are completed while using an
intra-oral apparatus. In this manner, a force can be exerted on one
or more teeth of the patient by the orthodontic appliance(s)
subsequent to initiating the administration of light via an
intra-oral apparatus. In some embodiments, however, a force is
exerted on one or more teeth of the patient prior to or during the
administration of light. In such an embodiment, the patient wears
an orthodontic appliance and uses an intra-oral apparatus at the
same time. In other embodiments, a force is exerted on one or more
teeth of the patient prior to and during the administration of
light. In some embodiments, a force is exerted on one or more teeth
of the patient and the intra-oral apparatus emits light during the
alignment phase of orthodontic treatment. In another embodiment,
the patient uses a single intra-oral apparatus that both
administers light and exerts a force. In other embodiments, a force
is exerted on one or more teeth of the patient prior to initiating
the administration of light. The patient, for example, could wear
his or her orthodontic appliance for any length of time before
beginning the light treatment.
[0215] In some instances, heavy forces can cause a periodontal
ligament to compress, which can eventually lead to ischemia or cell
death. To prevent ischemia or eventual cell death, the heavy force
is exerted with the light treatment as described herein. In one
embodiment, however, the heavy force is exerted after the light
treatment has started. In some embodiments, the heavy force is
exerted minutes, hours, or days after light treatment has started.
In this manner, the light treatment can provide additional
adenosine-5'-triphosphate (ATP) energy to tissue cells that will
become stressed and could potentially become ischemic as a result
of the heavy force. Illustrative frequencies of light treatment
used by an intra-oral apparatus are described herein. In some
embodiments, the heavy force is exerted concurrently with
administration of light. In other embodiments, the heavy force is
exerted subsequent to administration of light.
[0216] As described herein, a heavy force can be exerted on one of
more teeth from any direction. More particularly, in some
embodiments, the force pushes two or more teeth together or apart,
or pushes one or more teeth to one side or area of a patient's
mouth. For example, in some embodiments, the force can push two or
more teeth toward the front of the patient's mouth, to the back of
the patient's mouth, to the left of the patient's mouth, or to the
right of the patient's mouth.
[0217] Regulating oral or maxillofacial bone remodeling can include
changing the position of the mandibular bone or maxillary bone
relative to one another or to the skull of the patient. Regulating
oral or maxillofacial bone remodeling can also include controlling
the position (e.g., forward, backward, sideways or angle) of the
mandibular bone or maxillary bone, lengthening or shortening the
mandibular bone or maxillary bone, lengthening or shortening a side
of the mandibular bone or maxillary bone, altering the shape or
dimensions of the mandibular bone or maxillary bone, or regulating
(e.g., increasing, decreasing or maintaining) the velocity of the
movement of the mandibular bone or maxillary bone relative to one
another. For example, regulating oral or maxillofacial bone
remodeling can include increasing the velocity of oral or
maxillofacial bone remodeling.
[0218] By repositioning a mandibular bone forward or backwards,
muscle tension can be caused on the joint area of the mandibular
bone, or other parts of the mandibular bone. This tension can
stimulate osteoblastic activity or bone remodeling, which can
lengthen the mandibular bone through bone deposition on the
condylar head and glenoid fossa of the temporal bone of the skull.
Also, the tension can effect dental movement forward of the entire
lower arch. In some cases, antagonistic force on the maxillary bone
can retard the growth of the maxillary bone and cause remodeling
and dental movement posteriorly. This can be desirable in
situations where the oral or maxillofacial bone remodeling is
regulated in order to remodel the maxillary bone posteriorly.
Malocclusion can exist when there is a misalignment of teeth or the
upper dental arch and the lower dental arch do not line up. The
antagonist force on the maxillary bone can be more or less
desirable depending on the severity of the malocclusion and whether
the maxillary bone is protrusive. If the maxillary bone is
protrusive, it can be desirable to retard maxillary forward growth
or even retrude maxillary teeth and the jaw bone. A maxillary
headgear can be used to retard or decrease the growth of the
maxilla forward. In one example, a functional appliance can be used
to reposition a mandibular bone forward while utilizing upper teeth
or the maxillary bone as anchorage. An equal and opposite force can
be exerted on the maxillary bone, which can lead to dental
orthodontic movement and bone remodeling on the maxillary bone.
[0219] Some functional appliances (e.g., Bionator or Frankel), can
prevent antagonist muscles from pushing on the bone and teeth. This
can permit opposite agonist muscles to push on the bone and teeth.
Thus, in some embodiments, allowing a force to be exerted on a oral
or maxillofacial bone, muscle, or soft tissue, or one or more
teeth, can include preventing a first group of muscles from
exerting a force on the oral or maxillofacial bone, muscle, or soft
tissue, or one or more teeth, thereby allowing a second group of
muscles to exert the force. Some examples of muscles whose forces
can be withheld, include cheek and lip (peri-oral) muscles.
Examples of such muscles can include masseters, buccinators,
mentalis muscle and orbicularis. This can allow other muscles, such
as the tongue, to exert a force on the oral or maxillofacial bone,
muscle, or soft tissue, or one or more teeth. In some cases, it can
be desirable to prevent the tongue from interfering with and
pushing on teeth, so a functional appliance or an orthodontic
appliance can be inserted to prevent the tongue from pushing on the
front teeth during swallowing. This could allow cheek and lip
muscles to push on teeth and bone to retract and allow teeth to
erupt into a normal position previously presented by an overactive
and poorly positioned tongue. In one example, a Frankel appliance
can hold the cheek and lip muscles away from the teeth to allow
them room to grow into the correct position. While the cheek and
lip muscles (opposing muscles) are held away from the teeth, the
tongue (an agonist muscle pushing against the teeth from the
inside) can push on the teeth, thereby allowing a lower arch, upper
arch, or both lower and upper arch to expand without interference
from the opposing cheek and lip muscles.
[0220] In some embodiments, the force exerted by a functional
appliance can prevent muscles of a first group from exerting a
first force, or can substantially reduce the amount of the first
force, allowing muscles in a second group to exert a second force,
which can result in bone remodeling caused by the second force. The
muscles in the first group and the muscles in the second group can
typically exert forces in different directions. For example,
muscles can exert forces anteriorly, posteriorly, laterally to the
left, laterally to the right, radially inward, radially outward,
upward, or downward. In some embodiments, the muscles of the first
group and the muscles of the second group can exert forces in a
substantially opposite direction. The muscles in the first group
and the muscles in the second group can exert forces in different
directions. Alternatively, the force exerted by the functional
appliance can alter the angle of the overall force applied to the
region by increasing the relative effect of the second force, which
can result in bone remodeling caused by the increased magnitude on
the second force relative to the first force. Any number of muscle
groups (e.g., 1, 2, 3, 4, 5, 6, or more) can exert force in any
direction. The force exerted by the functional appliance can
prevent one or more of the muscle groups from exerting a force or
can reduce the amount of force exerted by one or more groups.
[0221] In some embodiments, a functional appliance can keep muscles
away from the teeth so that the muscles that oppose those that are
withdrawn via the functional appliance then can exert forces on the
teeth to cause tooth movement and possible bone remodeling due to
"imbalance" of previously balanced muscular pressure. In some
embodiments, the functional appliance exerts a force on the oral or
maxillofacial muscle or soft tissue in order to keep the muscles
away.
[0222] The phrase "regulating tooth movement" as used herein refers
to and includes one or more of the following functions and/or
operations. For example, regulating tooth movement can include
regulating, in one embodiment, aligning, the position of one or
more teeth relative to a supporting tissue. Regulating tooth
movement can also include increasing, decreasing or maintaining the
velocity of tooth movement relative to a supporting tissue. For
example, regulating tooth movement can include increasing the
velocity, or speed, of tooth movement. Regulating tooth movement
can also include increasing, decreasing or maintaining the degree
of bodily movement, e.g., relative to the degree of tipped
movement, of one or more teeth. Regulating tooth movement can
comprise moving one or more teeth bodily. "Bodily" movement means
generally perpendicular tooth movement relative to the supporting
tissue. "Tipped" movement means that the crown or coronal region of
the tooth advances more quickly than the root or apical region of
the tooth. Bodily tooth movement can occur without causing
significant tipped movement of the tooth. By "significant tipped
movement" is meant that about 20% of the tooth does not move in the
same lateral direction as the remaining about 80%; in another
embodiment about 10% of the tooth does not move in the same lateral
direction as the remaining about 90%; in another embodiment about
5% of the tooth does not move in the same lateral direction as the
remaining about 95%. Tooth movement can include lateral
displacement, rotation, extrusion or intrusion of one or more
teeth. Regulating tooth movement can include inducing the tilting
or tipped movement of one or more teeth, minimizing or preventing
the tilting or tipped movement one or more teeth, or maintaining or
inducing alignment or orientation of the one or more teeth.
Regulating tooth movement can also include stabilizing, retarding
the rate of or preventing tooth movement. In some instances,
regulating tooth movement can include causing one or more teeth to
maintain their position. In some embodiments, regulating tooth
movement can include causing one or both of (i) the displacement of
one or more teeth and (ii) the maintenance of one or more other
teeth in their position. In some embodiments, regulating tooth
movement occurs prior to, subsequent to or during orthodontic
treatment with an orthodontic appliance. In some embodiments,
regulating tooth movement occurs prior to, subsequent to or during
the alignment phase of orthodontic treatment. In some embodiments,
tooth movement occurs during bone remodeling.
[0223] In some embodiments, regulating tooth movement occurs during
an alignment phase of orthodontic treatment. Tooth movement during
this phase can include the tipping movement of one or more teeth,
the rotation of one or more teeth, and/or the extrusion or
intrusion of one or more teeth. The extrusion or intrusion of one
or more teeth can be a bodily movement that occurs during the
alignment phase. In general, however, bodily movement does not
usually occur during the alignment phase of orthodontic treatment.
Rather, bodily movement typically occurs after the alignment phase
of orthodontic treatment, when the teeth are aligned and crowding
of the teeth is minimized. In some embodiments, regulating tooth
movement occurs after the alignment phase of orthodontic treatment.
In other embodiments, regulating tooth movement occurs prior to the
alignment phase of orthodontic treatment.
[0224] In some embodiments, the type or shape of wire used in an
orthodontic appliance can assist in regulating tooth movement. For
example, an orthodontic appliance comprising a round wire worn by a
patient during an alignment phase of orthodontic treatment can
exert a force that increases the velocity of tipping movement,
rotation, extrusion or intrusion of one or more teeth. An
orthodontic appliance comprising a rectangular wire is generally
worn after the alignment phase, e.g., during the finishing or
detailing phase and/or the retention phase, or when the one or more
teeth of the patient are aligned within the same horizontal plane
such that crowding is minimal. A rectangular wire is generally
stiffer than a round wire and can facilitate the bodily movement of
one or more teeth.
[0225] In some embodiments, tooth movement is measured by a change
in Little's Irregularity Index (LII). LII measures the degree of
discrepancy between teeth and is the sum of the five (5) linear
distances from one contact point to an adjacent contact point of
the six (6) anterior teeth. An LII score of "0" indicates that the
teeth are perfectly aligned. An LII score of 1 mm or greater
indicates that the teeth are misaligned and that tooth movement is
needed for correction. A contact point measurement of 0 (zero) mm
indicates perfect alignment of the two adjacent teeth. A contact
point measure of, for example, 0.22 mm indicates that there is a
discrepancy of 0.22 mm between the two adjacent teeth. In general,
the higher the LII score, the less aligned are the teeth. For
example, an LII score greater than 10 mm general indicates a severe
misalignment. Additional details regarding LII and its calculations
can be found in the following publication, which is incorporated by
reference herein in its entirety: Little, R. M., "The irregularity
index: a quantitative score of mandibular anterior alignment," Am.
J. Orthod., 1975 November, 68(5): 554-63.
[0226] Orthodontic Appliances
[0227] The present methods can be performed on a patient prior to
being applied with one or more functional appliances and/or
orthodontic appliances, during a time when the patient wears one or
more functional appliances and/or orthodontic appliances, or after
one or more functional appliances and/or orthodontic appliances has
been removed from the patient. The one or more functional
appliances and/or orthodontic appliances can be used in addition to
the intra-oral apparatus. A functional appliance or orthodontic
appliance can be fixed or movable with respect to a patient's teeth
and/or the intra-oral apparatus. As is disclosed herein,
orthodontic appliances can include, for example, fixed active
appliances such as pin and tube appliances, appliances using wires
or brackets or springs, ribbon arch appliances, Begg lightwire
appliances, edgewise appliances, pre-adjusted edgewise appliances,
self-ligating edgewise appliances, bi-helix, tri-helix, quad-helix,
rapid maxillary expansion appliance (RME); removable active
appliances such as expansion and labial segment alignment appliance
INVISALIGN.TM.; orthodontic headgear including reverse headgear and
conventional headgear; and other types of orthodontic apparatus. In
one embodiment the orthodontic appliance comprises wires and
brackets (examples of which are discussed herein, with respect to
the section entitled "Examples").
[0228] In one embodiment, the orthodontic appliance is fixed.
Examples of fixed orthodontic appliances include pin and tube
appliances, ribbon arch appliances, Begg Lightwire appliances,
edgewise appliances, pre-adjusted edgewise appliances,
self-ligating edgewise appliances, hi-helix appliances, tri-helix
appliances, quad helix appliances, rapid maxillary expansion
appliances (RME), or pin stripe appliances. Fixed orthodontic
appliances can be fixed to the patient's teeth during orthodontic
treatment. In one embodiment, the orthodontic appliance is fixed
and comprises wires and brackets. In another embodiment, the
orthodontic appliance is removable. Examples of removable
orthodontic appliances include Active Hawley appliances, Invisalign
aligners, aligners, fan expanders, or sagittal appliances.
[0229] In some embodiments, the functional appliance is a
mandibular repositioner or any other intra-oral apparatus that
repositions the mandible to create tension on tissue to stimulate
bone remodeling or tooth movement. Some examples of mandibular
repositioners are Herbst, Twin Block, Fixed Twin Block, Bonded Twin
Block, Biobloc, Forsus Fatigue (e.g., EZ2), Xbow (Crossbow),
mandibular anterior repositioning appliance (Mara), Bass Dynamax,
Bionator, Open Face Activator, Activator, Woodside Activator,
Frankel (e.g., Frankel I, II, III, IV, V), Teuscher appliance,
Andreson appliance, 3-Way Sagittal, Lower Schwartz, 3 Way Expander,
jaw repositioning appliances, removable orthotic appliances, Series
2000.RTM., BioPedic Appliance, Rick-A-Nator.TM., Ritto Appliance,
Eureka Spring.TM., Twin Force Bite Corrector.TM., Alpern Class II
Closers, Rapid palatal expander, Tandem.TM., facemask, reverse pull
headgear, and conventional orthodontic headgear.
[0230] In one embodiment, the functional appliance is fixed. A
fixed functional appliance can be cemented, for example, on one or
more teeth. Some examples of fixed functional appliances include
Herbst, Fixed Twin Block, Bonded Twin Block, Forsus Fatigue (e.g.,
EZ2), Xbow (Crossbow), Series 2000.RTM., BioPedic Appliance,
Rick-A-Nator.TM., Ritto Appliance, Eureka Spring.TM., Twin Force
Bite Corrector.TM., Alpern Class II Closers, and Rapid palatal
expander. In another embodiment, the functional appliance is
removable. Some examples of removable functional appliances include
Twin Block, Biobloc, mandibular anterior repositioning appliance
(Mara), Bass Dynamax, Bionator, Open Face Activator, Activator,
Woodside Activator, Frankel (e.g., Frankel I, II, III, IV, V),
Teuscher appliance, Andreson appliance, 3-Way Sagittal, Lower
Schwartz, 3 Way Expander, jaw repositioning appliances, and
removable orthotic appliances. In some embodiments, the functional
appliance is a combination fixed-removable functional appliance. A
combination fixed-removable functional appliance can include one or
more component that is fixed to a patient's teeth and one or more
component that is removable from the fixed component. Some examples
of combination fixed-removable functional appliances include
Tandem.TM., a facemask, reverse pull headgear, and conventional
orthodontic headgear.
[0231] In some embodiments, the functional appliance is a Class II
corrector. Some examples of Class II correctors include Herbst,
Twin Block, Forsus Fatigue, and Mara. In other embodiments, the
functional appliance is a Class I corrector that is useful for
creating and bony and dental expansion of crowded and lower arches.
In other embodiments, the functional appliance is a Class III
corrector that is useful for stimulating maxillary forward growth,
or retruding or limiting mandibular growth.
[0232] In some embodiments, the functional appliances reposition a
patient's mandibular bone anteriorly. The functional appliance can
be a fixed functional mandibular repositioner. Examples of such
functional appliances are a Herbst, Twin Block, Bonded Twin Block,
Biobloc, and Bass Dynamax. In some embodiments, the functional
appliances expand the jaw (e.g., using muscular pressure or lack of
muscular forces to allow teeth to move and/or bone to remodel).
Examples of such functional appliances can include Bionator, Open
Face Activator, Activator, Woodside Activator, or Frankel. Light
can be administered to the alveolar soft tissue and/or alveolar
bones and teeth, as these appliances can cause orthodontic movement
of teeth as well as bone remodeling. In some embodiments, the
functional appliances control growth of the maxillary bone or
mandibular bone. Examples of such functional appliances can include
a facemask, or reverse pull headgear. Light can be administered to
apical areas of the jaw, which can cause some orthodontic movement,
but primarily remodels and provides anterior movement of maxillary
bone. In some embodiments, the functional appliances exert a force
on, or cause bone remodeling at, a temporomandibular joint,
condyle, or glenoid fossa of a patient.
[0233] A functional appliance functions by exerting a force that
causes muscle or tissue to exert a force directly on, for example,
a tooth such that some aspect of the tooth changes as a result of
said force from the muscle or tissue. In one specific example, a
patient can wear a functional appliance to reposition his or her
jaw, and the resultant position of the jaw exerts a force on
surrounding tissue thereby allowing remodeling to occur. Functional
changes can include changes in the maxillary bone, the mandibular
bone, tooth position, bine and jaw function, and chewing. In
contrast to functional appliances, orthodontic appliances function
by exerting a force directly on, for example, a tooth to change
some aspect of the tooth (e.g., to change the position of the tooth
relative to another tooth).
[0234] Orthodontic appliances are commercially available and can
include specifications (or other documentation) that specify the
magnitude of force that the appliance is capable of exerting on one
or more teeth. In some embodiments, an orthodontic appliance
comprises steel wires, nickel titanium wires, or titanium
molybdenum wires. In some embodiments, an orthodontic appliance
comprises wires or springs that are of a high gauge. Some examples
of wires that an orthodontic appliance can comprise are stainless
steel or nickel-titanium wires having wire dimensions of one of the
following:
TABLE-US-00001 0.0160'' square 0.406 mm square 0.0160'' .times.
0.0220'' 0.406 mm .times. 0.559 mm 0.0170'' square 0.432 mm square
0.0170'' .times. 0.0220'' 0.432 mm .times. 0.559 mm 0.0170''
.times. 0.0250'' 0.432 mm .times. 0.635 mm 0.0180'' square 0.457 mm
square 0.0180'' .times. 0.0220'' 0.457 mm .times. 0.559 mm 0.0180''
.times. 0.0250'' 0.457 mm .times. 0.635 mm 0.0190'' square 0.483 mm
square 0.0190'' .times. 0.0250'' 0.483 mm .times. 0.635 mm 0.0200''
square 0.508 mm square 0.0210'' .times. 0.0250'' 0.533 mm .times.
0.635 mm
[0235] An orthodontic appliance can comprise brackets and wires.
Commercially available brackets include those offered by SPEED
System (www.speedsystem.com), DENTSPLY GAC International
(www.gacinovation.com), or Ormco Corporation (www.ormco.com). Wires
can be nickel titanium and can have a diameter of 0.012 inch, 0.014
inch or 0.016 inch. In some embodiments, the wires are square or
rectangular. In one embodiment, the wires are square and have a
dimension of 0.015 inch.times.0.015 inch. In another embodiment,
the wire is rectangular and have a dimension of 0.017
inch.times.0.025 inch.
[0236] Nickel-titanium closed or open-coil springs can be used.
Some examples can include an elastomeric power chain, which can be
capable of providing 100-800 grams of force, or intra-arch
elastics. In some embodiments, the orthodontic appliance comprises
an elastic material. An orthodontic appliance can exert a force on
one or more teeth of the patient in addition to or in lieu of the
intra-oral apparatus exerting a force on one or more teeth. For
example, in some embodiments, the orthodontic appliance can exert
or be configured to exert a heavy force on one or more teeth of the
patient in addition to or in lieu of the intra-oral apparatus
exerting a heavy force on one or more teeth. The orthodontic
appliance can cause one or more teeth to move or maintain its
position. In some embodiments, an orthodontic appliance causes bone
remodeling of an oral or maxillofacial bone, or one or more tooth,
such as a mandibular bone, maxillary bone, or temporal bone. In
some embodiments, an apparatus of the invention does not exert a
force on a patient's teeth. In some embodiments, an apparatus of
the invention does not exert a heavy force on a patient's
teeth.
[0237] A force, such as a heavy force, can be measured using a
dynamometer or any similar device. For example, a dynamometer can
measure the force that a wire, spring or similar mechanism from an
orthodontic appliance exerts on one or more teeth or gums. In one
example, the dynamometer (or similar device) can measure the force
that the wires 12 from the intra-oral apparatus illustrated and
described with respect to FIG. 3A exert on one or more teeth or
gums. The measured force can depend on any number of parameters
such as, for example, the gauge of the wire or the stiffness of the
wire. In this manner, in some embodiments, a force can be
calculated, in part, by measuring the tension or stiffness of the
appliance's wire (or spring or similar mechanism), e.g., when such
force is exerted on one or more teeth. Furthermore, in some
embodiments, the appliance's wire (or spring or similar mechanism)
is constructed from a material that is sensitive to temperature
such that the stiffness of the wire, and therefore the heavy force
exerted by that wire, can change based on the temperature of the
wire. For example, in some embodiments, the stiffness of the wire
(or spring or similar mechanism) increases when the wire
temperature increases, and decreases when the wire temperature
decreases. Thus, in some such embodiments, a force can be
calculated, in part, by measuring the temperature of the wire (or
spring or similar mechanism) or estimating its temperature when
present in a patient's oral cavity. With respect to the gauge of
the wire, it is generally well known in the art that increasing the
gauge (or cross-section) of a wire can increase the stiffness of
the wire which ultimately increases the heavy force that the wire
exerts on one or more teeth.
[0238] Although the methods are described herein as being
performable on a patient (1) prior to the patient being applied
with one or more functional appliances and/or orthodontic
appliances, (2) during a time when the patient wears one or more
functional appliances and/or orthodontic appliances, or (3) after
one or more functional appliances and/or orthodontic appliances has
been removed from the patient, in some embodiments, the methods
described herein can be performed on the patient independently of
or without usage of a functional appliance and/or orthodontic
appliance.
[0239] In one embodiment, a patient can use an intra-oral apparatus
of the invention prior to, subsequent to or during a time that the
patient wears an orthodontic appliance.
[0240] In some embodiments the invention provides methods for
regulating tooth movement, maintaining oral tissue health or
improving oral tissue health, comprising administering to a patient
in need thereof an effective amount of light from the emitter of an
intra-oral apparatus of the invention. In some embodiments, at
least a portion of the apparatus is configured to contact the
patient's alveolar soft tissue. In some embodiments, the patient
wears an orthodontic appliance that exerts a force on one or more
teeth of the patient. In some embodiments, the light is
administered during the alignment phase of orthodontic treatment.
In some embodiments, the light is administered during only the
alignment phase of orthodontic treatment. In some embodiments, the
alveolar soft tissue is alveolar mucosa. In some embodiments, the
force is a heavy force. In some embodiments, the patient wears the
same or a different orthodontic appliance that exerts a force on
one or more teeth of the patient during the retention phase of
orthodontic treatment. In some embodiments, the force exerted
during the retention phase is a heavy force.
[0241] In some embodiments the invention provides methods for
orthodontic treatment, comprising administering to a patient in
need thereof an effective amount of light from the emitter of an
intra-oral apparatus of the invention. In some embodiments, at
least a portion of the apparatus is configured to contact the
patient's alveolar soft tissue. In some embodiments, the patient
wears an orthodontic appliance that exerts a force on one or more
teeth of the patient. In some embodiments, the light is
administered during the alignment phase of orthodontic treatment.
In some embodiments, the light is administered during only the
alignment phase of orthodontic treatment. In some embodiments, the
alveolar soft tissue is alveolar mucosa. In some embodiments, the
force is effective for regulating tooth movement, maintaining oral
tissue health or improving oral tissue health. In some embodiments,
the force is a heavy force. In some embodiments, the patient wears
the same or a different orthodontic appliance that exerts a force
on one or more teeth of the patient during the retention phase of
orthodontic treatment. In some embodiments, the force exerted
during the retention phase is a heavy force.
[0242] In some embodiments the invention provides methods for
orthodontic treatment, comprising administering to a patient who
wears an orthodontic appliance or is in need of orthodontic
treatment an effective amount of light from the emitter of an
intra-oral apparatus of the invention. In some embodiments, at
least a portion of the apparatus is configured to contact the
patient's alveolar soft tissue. In some embodiments, the patient
wears an orthodontic appliance that exerts a force on one or more
teeth of the patient. In some embodiments, the light is
administered during the alignment phase of orthodontic treatment.
In some embodiments, the light is administered during only the
alignment phase of orthodontic treatment. In some embodiments, the
alveolar soft tissue is alveolar mucosa. In some embodiments, the
force is effective for regulating tooth movement, maintaining oral
tissue health or improving oral tissue health. In some embodiments,
the force is a heavy force. In some embodiments, the patient wears
the same or a different orthodontic appliance that exerts a force
on one or more teeth of the patient during the retention phase of
orthodontic treatment. In some embodiments, the force exerted
during the retention phase is a heavy force.
[0243] In some embodiments the invention provides methods for
orthodontic treatment, comprising administering to a patient who
wears an orthodontic appliance and is in need of orthodontic
treatment an effective amount of light from the emitter of an
intra-oral apparatus of the invention. In some embodiments, at
least a portion of the apparatus is configured to contact the
patient's alveolar soft tissue. In some embodiments, the
orthodontic appliance exerts a force on one or more teeth of the
patient. In some embodiments, the light is administered during the
alignment phase of orthodontic treatment. In some embodiments, the
light is administered during only the alignment phase of
orthodontic treatment. In some embodiments, the alveolar soft
tissue is alveolar mucosa. In some embodiments, the force is
effective for regulating tooth movement, maintaining oral tissue
health or improving oral tissue health. In some embodiments, the
force is a heavy force. In some embodiments, the patient wears the
same or a different orthodontic appliance that exerts a force on
one or more teeth of the patient during the retention phase of
orthodontic treatment. In some embodiments, the force exerted
during the retention phase is a heavy force.
[0244] Vitamin D
[0245] As described herein, the present methods can further
comprise administering vitamin D to the patient. Vitamin D is
essential for normal bone metabolism--it promotes calcium
absorption and bone resorption and maintains the necessary calcium
and phosphate levels for bone formation. Patients deficient in
vitamin D have an increased risk of bone loss and bone fracture,
among many other risks. Insufficient vitamin D levels can also
interfere with osteoclastic activity, which is essential to tooth
movement, resulting in slower tooth movement. Thus, administering
vitamin D can be an important part of orthodontic treatment.
[0246] The vitamin D can be, for example, vitamin D1, D2, D3, D4,
D5, 1,25-dihydroxycholecalciferol, or mixtures thereof. In some
embodiments, the vitamin D supplements other vitamin D sources for
the patient.
[0247] The vitamin D can be administered in any suitable manner.
For example, the vitamin D can be administered orally, via
transdermal gel, by a patch, by a cream, by injection, by
electrophoresis, or by insolation. Where the present methods
further comprise administering vitamin D, in some embodiments, the
vitamin D is not administered by insolation. In some embodiments,
the vitamin D is administered via a vitamin D conveyance. For
example, the vitamin D can be present in a composition suitable for
oral administration, for example, a pill, capsule, tablet,
chewable, gel, or liquid. In other embodiments, the vitamin D is
administered transdermally. In one example, the vitamin D can be
administered transdermally via a transdermal gel, cream, ointment,
liquid, or paste that can be applied to the skin, gums, or any soft
tissue. In another example, vitamin D can be administered
transdermally via insolation, such as exposure to ultraviolet (UV)
rays from the sun or artificially through tanning beds. The vitamin
D can also be administered transdermally via a patch or microneedle
on the skin, gums, or other soft tissue of the patient. In some
embodiments, the vitamin D is be administered by injection using a
syringe or needle at the skin, gums, or other soft tissue (such as,
for example, oral tissue) of the patient. The injection can be
intradermal, subcutaneous, intramuscular, intravenous,
intraosseous, or intraperitoneal. In some embodiments, the vitamin
D is administered electrophetically. The vitamin D can be applied,
for example, to the surface of the skin, gums, or any other soft
tissue, and a weak electrical current can drive the compound
through the tissue.
[0248] Any combination of the various vitamin D administration
techniques described herein can be employed. For example, a patient
can be orally administered with vitamin D and also receive an
injection of vitamin D as part of the administration process. In
some embodiments, the administered vitamin D increases or maintains
the vitamin D blood serum levels. In other embodiments, the
administered vitamin D increases or maintains local vitamin D
levels where the vitamin D is administered.
[0249] In some embodiments, the vitamin D is administered to a
region, or in the proximity of a region. The region can be, for
example, an oral region. The region can be, for example, on or in
the proximity of oral or maxillofacial bone, muscle, or soft
tissue. The region can be on or in the proximity of one or more
tooth, the mandibular bone, the maxillary bone, or the temporal
bone. In some embodiments, the vitamin D is orally administered,
for example, via an oral composition that comprises vitamin D. In
other embodiments, the vitamin D is administered locally to a
region. The region can be on the skin of the patient overlying the
patient's face, jawbone, lips, cheek, or chin. The region can be on
the right side, the left side, a central region, or any combination
thereof, of the patient's body such as, for example, the patient's
face. The region can be within the patient's oral cavity. For
example, the region can be the gums of the patient, or any other
oral soft tissue. The region need not be an oral region; rather,
the region can be, for example, on the neck, arm, leg, or torso of
the patient. In some embodiments, the vitamin D can be administered
systemically to the patient. For example, the vitamin D can be
administered via insolation through a tanning bed that surrounds
the patient's body. The region can include any area previously
described.
[0250] In some embodiments, the vitamin D is administered to a
region that is the same as or in the proximity of a region that is
administered with light. In some embodiments, the vitamin D is
administered to the same region that is administered with light. In
some other embodiments, the vitamin D is administered to a region
having the same, greater, or smaller size than the region
administered with light. The vitamin D can be administered to a
region adjacent to a region administered with light. In some
embodiments, vitamin D is administered to a region within about 1
mm, about 2 mm, about 3 mm, about 5 mm, about 7 mm, about 10 mm,
about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 40 mm,
about 50 mm, about 60 mm, about 70 mm, about 10 cm, about 15 cm,
about 20 cm, about 30 cm, about 50 cm from a region that is
administered with light. In other embodiments, the vitamin D is
administered to a region that is different from the region that is
administered with light. In some embodiments vitamin D is not
administered to a region that is administered with light. In some
embodiments, vitamin D is administered to a region other than the
region that is administered with light. In some embodiments,
vitamin D is administered systemically, which can encompass the
region administered with light. In some instances, the vitamin D is
administered systemically, raising overall vitamin D levels, which
can include vitamin D levels in the region administered with
light.
[0251] In some embodiments, the vitamin D is administered to a
region that is proximate to a region upon which a force is exerted.
The force can be, for example, a heavy force, a force exerted by an
orthodontic appliance, or a force exerted by a functional
appliance. In some embodiments, the vitamin D is administered to
the same region upon which a force is exerted. In some embodiments,
the region where the vitamin D is administered and the region upon
which the force is exerted are the same size. In other embodiments,
however, the size of the region where the vitamin D is administered
is different from the size of the region upon which the force is
exerted. The region where the vitamin D is administered can be, for
example, smaller or larger than the region upon which the force is
exerted. In some embodiments, the vitamin D is administered to a
region adjacent to a region upon which a force is exerted. The
vitamin D can be administered to a region, for example, within
about 1 mm, about 2 mm, about 3 mm, about 5 mm, about 7 mm, about
10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 40
mm, about 50 mm, about 60 mm, about 70 mm, about 10 cm, about 15
cm, about 20 cm, about 30 cm, about 50 cm of a region upon which a
force is exerted.
[0252] In some embodiments, the vitamin D is administered to a
region that is different from the region upon which a force is
exerted. In other words, the vitamin D is not administered to a
region upon which a force is exerted. In some embodiments, vitamin
D is administered systemically and can encompass the region upon
which a force is exerted. For example, in some instances, the
vitamin D is administered systemically and raises overall vitamin D
levels, including the vitamin D levels in the region upon which a
force is exerted.
[0253] The present methods can include administering an effective
amount of vitamin D to a patient in need thereof, and administering
an effective amount of light to, for example, the alveolar soft
tissue, or any other oral or maxillofacial bone, muscle, or soft
tissue, or one or more teeth of the patient. In some embodiments,
the effective amount of vitamin D is administered to an oral region
of the patient. Alternatively, the effective amount of vitamin D
can be administered systemically to the patient. In some
embodiments, the method further comprises testing the patient to
determine his or her vitamin D level. For example, the patient can
undergo blood testing to determine the patient's vitamin D level.
If necessary, a patient can receive a vitamin D supplement or
treatment. Light can be administered to the alveolar soft tissue
and/or teeth in conjunction with orthodontic treatment and normal
or higher vitamin D levels, which can accelerate orthodontic tooth
movement.
[0254] The present methods can comprise administering an effective
amount of vitamin D to a patient and providing any intra-oral light
therapy apparatus described herein with reference to FIGS. 1-8. The
method can optionally include determining whether the patient is
vitamin D deficient. The method can optionally include measuring
the patient's vitamin D blood serum level. In some embodiments, if
the patient's vitamin D blood serum level is below a predetermined
threshold, the patient can administer or be administered with a
dosage of vitamin D. In some embodiments, the dosage of vitamin D
is determined based on the patient's blood serum level and
administered to the patient. The dosage of vitamin D to be
administered to the patient can be determined, for example, based
on the patient's blood serum level, so that the patient is
administered with an effective amount of vitamin D. For example, if
the patient is very deficient in vitamin D (i.e., has very low
vitamin D blood serum levels), the patient can receive a greater
dosage of vitamin D than if the patient is only slightly deficient
in vitamin D (i.e., has higher vitamin D blood serum levels). In
other embodiments, regardless of the vitamin D blood serum level,
if the patient is vitamin D deficient, the patient receives the
same vitamin D dosage. In yet other embodiments, a dosage of
vitamin D is administered to the patient even if the patient is not
vitamin D deficient. In embodiments where the patient is vitamin D
deficient, the length of vitamin D treatment can vary depending on
the degree of vitamin D deficiency.
[0255] The vitamin D can be administered in one or more dosages. In
some embodiments, as described herein, a dosage of vitamin D is an
effective amount of vitamin D. In other embodiments, a single
dosage of vitamin D can be greater than or less than an effective
amount of vitamin D. A dosage of vitamin D can be provided for a
period of time. For example, the vitamin D can be administered
daily. In some embodiments, the vitamin D is administered every
hour, several times a day, once a day, once every several days,
once a week, once every few weeks, once a month, once every few
months, once a quarter, or with any other frequency. Vitamin D can
be administered on a regular basis (e.g., every 6 hours, every day,
every 10 days), or can be provided at irregular intervals (e.g.,
twice one day, skip a day, once the next day). In some embodiments,
vitamin D is administered on an as-needed basis.
[0256] In some embodiments, the dosage is greater than about, is
less than about, or is about 100 IU, about 200 IU, about 400 IU,
about 500 IU, about 600 IU, about 800 IU, about 1,000 IU, about
1,200 IU, about 1,500 IU, about 1,600 IU, about 2,000 IU, about
2,500 IU, about 3,000 IU, about 4,000 IU, about 5,000 IU, about
6,000 IU, about 7,000 IU, about 8,000 IU, about 9,000 IU, about
10,000 IU, about 12,000 IU, about 15,000 IU, about 17,000 IU, about
20,000 IU, about 25,000 IU, about 30,000 IU, about 40,000 IU, about
50,000 IU, about 70,000 IU, about 100,000 IU, about 150,000 IU,
about 200,000 IU, about 300,000 IU, about 400,000 IU, about 500,000
IU, about 600,000 IU, or about 800,000 IU. In some embodiments, the
dosage amount varies each time the vitamin D is administered to the
patient. In other embodiments, the dosage amount is a daily amount
of vitamin D administered to the patient. In other embodiments, the
dosage amount is the total vitamin D amount administered for a
treatment regimen. For example, a daily oral dosage of vitamin D
can range from 400 IU to 6,000 IU per day. In another example, a
daily oral dosage of vitamin D can range from 2,000 IU to 6,000 IU
per day. A daily oral supplement of 2,000 IU to 6,000 IU of vitamin
D in adults has been shown to increase blood levels of vitamin D to
40 ng/mL within 3 months. In some regimens, higher initial dosages
of vitamin D have shown increases in vitamin D blood levels. The
dosage of vitamin D can be a single dose of 600,000 IU of oral
vitamin D. Based on one clinical trial, a single dose of 600,000 IU
of oral vitamin D was comparable to a dose of 20,000 IU per day of
oral vitamin D for 30 days. In another embodiment, the dosage is
20,000 IU per day of oral vitamin D for 30 days.
[0257] The dosage of vitamin D can be sufficient to raise the
vitamin D blood level from about 40 to about 60 ng/mL of venous
blood. The dosage of vitamin D can be sufficient to raise vitamin D
blood level to at least about, no more than about, or to about 20
ng/mL, about 30 ng/mL, about 35 ng/mL, about 40 ng/mL, about 45
ng/mL, about 50 ng/mL, about 55 ng/mL, about 60 ng/mL, about 65
ng/mL, about 70 ng/mL, about 75 ng/mL, or about 80 ng/mL. In some
embodiments, the dosage of vitamin D is sufficient to raise the
vitamin D blood level by any amount. For example, the dosage of
vitamin D can be sufficient to raise the vitamin D blood level by
about 5 ng/mL, about 10 ng/mL, about 15 ng/mL, about 20 ng/mL,
about 25 ng/mL, about 30 ng/mL, about 35 ng/mL, about 40 ng/mL,
about 45 ng/mL, about 50 ng/mL, about 55 ng/mL, or about 60 ng/mL.
The vitamin D blood level can be raised to a desired level or by a
desired amount within a period of time. For example, the period of
time can be within one or more days, one or more weeks, one or more
months, or one or more years. For example, a dosage of vitamin D
administered daily can raise vitamin D blood serum levels to a
desired level within 30 days, or within 3 months.
[0258] Vitamin D can be administered to the patient prior to,
concurrently with, or subsequent to administering light therapy to
the patient. Vitamin D can be administered to the patient prior to
initiation of the light therapy administration, or prior to the
completion of the light therapy administration. In some
embodiments, a dosage of vitamin D is administered at a period of
time (e.g., seconds, minutes, hours, days, weeks, months) prior to
initiation of the light therapy administration or prior to
completion of the light therapy administration. In some
embodiments, a dosage of vitamin D is administered at a period of
time (e.g., seconds, minutes, hours, days, weeks, months)
subsequent to initiation of the light therapy administration or
subsequent to completion of the light therapy administration. In
some embodiments, a vitamin D treatment regimen (which can span one
or more doses of vitamin D) is initiated or completed prior to
initiation of light therapy administration or prior to completion
of light therapy administration. In other embodiments, the vitamin
D treatment regimen is initiated or completed subsequent to the
initiation of light therapy administration or subsequent to
completion of light therapy administration. The vitamin D treatment
regimen can be in progress during light therapy administration.
[0259] Vitamin D can be administered to the patient prior to,
currently with, or subsequent to engaging an intra-oral light
therapy apparatus with the patient. The intra-oral light therapy
apparatus can be any of the apparatus illustrated and described
with respect to FIGS. 1-8. Vitamin D can also be administered to
the patient prior to removing the intra-oral light therapy
apparatus from the patient. In some embodiments, a dosage of
vitamin D can be administered at a period of time (e.g., seconds,
minutes, hours, days, weeks, months) prior to engaging the
intra-oral light therapy apparatus with the patient or prior to
removing the intra-oral light therapy apparatus from the patient.
In some embodiments, a dosage of vitamin D is administered at a
period of time (e.g., seconds, minutes, hours, days, weeks, months)
subsequent to engaging the intra-oral light therapy apparatus with
the patient or subsequent to removing the intra-oral light therapy
apparatus from the patient. In some embodiments, a vitamin D
treatment regimen (which can span one or more doses of vitamin D)
is initiated or completed prior to engaging the intra-oral light
therapy apparatus with the patient or prior to removing the
intra-oral light therapy apparatus from the patient. In other
embodiments, the vitamin D treatment regimen is initiated or
completed subsequent to engaging the intra-oral light therapy
apparatus with the patient or subsequent to removing the intra-oral
light therapy apparatus from the patient. The vitamin D treatment
regimen can be in progress during light therapy administration.
[0260] Vitamin D can be administered to the patient prior to,
currently with, or subsequent to exerting a force on one or more
teeth of the patient. The force can be, for example, a heavy force,
a force exerted by an orthodontic appliance, or a force exerted by
a functional appliance. In some embodiments, the force can be less
than a heavy force. In some embodiments, the vitamin D is
administered to the patient prior to initiation of exerting a force
on one or more teeth of the patient, or prior to the completion of
exerting a force on one or more teeth of the patient. In some
embodiments, a dosage of vitamin D is administered at a period of
time (e.g., seconds, minutes, hours, days, weeks, months) prior to
initiation of exerting a force on one or more teeth of the patient
or prior to completion of exerting a force on one or more teeth of
the patient. In other embodiments, a dosage of vitamin D is
administered at a period of time (e.g., seconds, minutes, hours,
days, weeks, months) subsequent to initiation of exerting a force
on one or more teeth of the patient or subsequent to completion of
exerting a force on one or more teeth of the patient. In some
embodiments, a vitamin D treatment regimen (which can span one or
more doses of vitamin D) is initiated or completed prior to
initiation of exerting a force on one or more teeth of the patient
or prior to completion of exerting a force on one or more teeth of
the patient. In other embodiments, the vitamin D treatment regimen
is initiated or completed subsequent to the initiation of exerting
a force on one or more teeth of the patient or subsequent to
completion of exerting a force on one or more teeth of the patient.
The vitamin D treatment regimen can be in progress while exerting a
force on one or more teeth of the patient.
[0261] Vitamin D can be administered to the patient prior to,
concurrently with, or subsequent to installing one or more
orthodontic appliances on the patient's teeth or functional
appliances in the patient's oral cavity. In some embodiments, the
vitamin D is administered to the patient prior to removing one or
more orthodontic appliances from the patient's teeth. In some
embodiments, a dosage of vitamin D is administered at a period of
time (e.g., seconds, minutes, hours, days, weeks, months) prior to
installing one or more orthodontic appliances on the patient's
teeth or prior to removing one or more orthodontic appliances from
the patient's teeth. In other embodiments, a dosage of vitamin D is
administered at a period of time (e.g., seconds, minutes, hours,
days, weeks, months) subsequent to installing one or more
orthodontic appliances on the patient's teeth or subsequent to
removing one or more orthodontic appliances from the patient's
teeth. In some embodiments, a vitamin D treatment regimen (which
can span one or more doses of vitamin D) is initiated or completed
prior to installing one or more orthodontic appliances on the
patient's teeth or prior to removing one or more orthodontic
appliances from the patient's teeth. In other embodiments, the
vitamin D treatment regimen is initiated or completed subsequent to
the installing one or more orthodontic appliances on the patient's
teeth or subsequent to removing one or more orthodontic appliances
from the patient's teeth. The vitamin D treatment regimen can be in
progress while an orthodontic appliance is installed on the
patient's teeth.
[0262] The administration of vitamin D can increase the amount of
tooth movement compared to treatment methods where vitamin D is not
administered. The administration of vitamin D can also increase the
rate of tooth movement compared to treatment methods where vitamin
D is not administered. In some embodiments, the administration of
vitamin D increases the velocity of tooth movement by about 5%,
about 10%, about 15%, about 20%, about 25%, about 30%, about 40%,
about 50%, about 60%, about 70%, about 80%, about 90%, or by any
percentage falling within about 1% to about 90%, relative to
treatment methods for regulating tooth movement that do not
comprise administering vitamin D. In some embodiments, the
administration of vitamin D increases the rate of bone remodeling
compared to treatment methods where vitamin D is not administered.
In some embodiments, the administration of vitamin D increases the
velocity of bone remodeling by about 5%, about 10%, about 15%,
about 20%, about 25%, about 30%, about 40%, about 50%, about 60%,
about 70%, about 80%, about 90%, or by any percentage falling
within about 1% to about 90%, relative to treatment methods for
regulating bone remodeling that do not comprise administering
vitamin D.
[0263] The administration of vitamin D can reduce the amount of
time that the patient undergoes orthodontic treatment. The
administration of vitamin D can also reduce the amount of time that
a force is exerted on one or more teeth of the patient. In some
embodiments, the administration of vitamin D reduces the amount of
time that a patient undergoes orthodontic treatment or that a force
is exerted on one or more teeth of the patient by about 5%, about
10%, about 15%, about 20%, about 25%, about 30%, about 40%, about
50%, about 60%, about 70%, about 80%, about 90%, or by any
percentage falling within about 1% to about 90%, relative to
treatment methods that do not comprise administering vitamin D.
[0264] The administration of vitamin D can increase the rate of
bone remodeling compared to treatment methods where vitamin D is
not administered. The administration of vitamin D can also increase
the rate of one or both of bone deposition and resorption compared
to treatment methods where vitamin D is not administered. In some
embodiments, the administration of vitamin D increases the rate of
one or both of bone deposition or resorption by about 5%, about
10%, about 15%, about 20%, about 25%, about 30%, about 40%, about
50%, about 60%, about 70%, about 80%, about 90%, or by any
percentage falling within about 1% to about 90%, relative to
treatment methods that do not comprise administering vitamin D.
[0265] In one example, an adult patient's Vitamin D3 blood-serum
level is measured during his routine orthodontic-examination and
-records appointment. Laboratory results can indicate that the
patient's vitamin D3 serum levels are at 20 ng/ml, which is
considered to be deficient and abnormal. In this example, the
patient's orthodontic diagnosis is Class I mild crowding with 4 mm
of crowding on the upper arch and 4 mm on the lower arch. An
orthodontic treatment plan can be formulated to include the
installation of a fixed orthodontic appliance with some mild
expansion of the upper and lower arches.
[0266] In this example, the patient self-administers oral oil-based
vitamin D3 capsules at an amount of 6000 IU per day for 3 months to
increase and normalize his vitamin D3 serum levels. Laboratory
serum testing can optionally be performed again after 3 months of
vitamin D3 supplementation. The patient can maintains or adjusts
his oral dose of vitamin D3 based on his subsequent lab results. It
should be understood that there are a number of alternative oral
and/or systemic dosing protocols for vitamin D administration that
could be followed to achieve similar results. The dosing protocol
outlined above is merely one of many approaches.
[0267] In this example, orthodontic treatment can start either
after the 3 month period or within three months prior. The
orthodontic treatment can include conventional fixed orthodontic
brackets and bands placed on the patient's teeth. Light can be
administered to the patient on a daily basis, for example, for 20
minutes at an intensity of 50 mW/cm2 at wavelength of about 850 nm
using an intra-oral light therapy apparatus, such as the one shown
in FIG. 1. The orthodontic treatment can continue with the
finishing of teeth once the arches have been expanded. In this
example, it is believed that the active orthodontic treatment would
be completed in 50% to 75% less time than orthodontic treatment
without light therapy due to the combination of daily
administration of light and vitamin D3 supplementation.
[0268] At a passive stage of orthodontic treatment, i.e., retention
phase, a fixed retention orthodontic appliance can be installed on
the patient's teeth. In one embodiment, a Hawley retainer, which is
a removable appliance that is designed to maintain tooth position
of the anterior teeth, is installed on a patient's anterior teeth.
In some embodiments, a fixed retainer appliance, such as one
including orthodontic brackets, is bonded to the upper 6, lower 6,
or upper 6 and lower 6, anterior teeth. The patient can continue
with vitamin D3 supplementation. In some examples, the patient
self-administers 2000 IU per day to 12,000 IU orally per day. The
dosage can be determined based on vitamin D blood serum levels
which can be measured periodically to determine dosing. As a
result, alveolar bone density around the teeth can be increased
during the passive stage. During the passive stage, the patient can
be administered once per week with light having a wavelength of
about 625 nm using an intra-oral light therapy apparatus, such as
the light therapy apparatus shown in FIG. 1 and/or FIG. 6, in areas
of the upper and lower arch.
[0269] Administering Light Treatment
[0270] Light can be administered to the patient using an intra-oral
apparatus in any of the following ways. The act or process of
administering light is also referred to herein as "light
treatment". These terms are used interchangeably herein but are
intended to have similar meanings unless otherwise stated.
[0271] Light can be administered to a region of the patient's
mouth. Some examples of these regions include, but are not limited
to, one or more teeth (e.g., incisor, canine, premolar, or molar,
such as a maxillary central incisor, maxillary lateral incisor,
maxillary canine, maxillary first premolar, maxillary second
premolar, maxillary first molar, maxillary second molar, maxillary
third molar, mandibular central incisor, mandibular lateral
incisor, mandibular canine, mandibular first premolar, mandibular
second premolar, mandibular first molar, mandibular second molar,
or mandibular third molar), a root of one or more teeth (e.g.,
wherein a root of a tooth may include a portion of one or more
roots supporting the tooth, one root supporting the tooth, a
plurality of roots supporting the tooth, or all of the roots
supporting the tooth), tissue supporting one or more teeth, a
portion of the maxilla (e.g., portion of the patient's maxillary
alveolar bone), a portion of the mandible (e.g., portion of the
patient's mandibular alveolar bone), alveolus, basal tissue,
gingiva (e.g., alveolar soft tissue), periodontal ligaments,
cementum, periodontium, a region of a jaw bone or tissue, or at
least a portion of the patient's other oral soft tissue or bone
tissue. The region can be located on a left side or right side of
the patient's mouth. In some embodiments, one or more regions are
located on both the left and right side of the patient's mouth. In
some embodiments, the region can be located in the front of the
patient's mouth. The region can include one, two, three, four,
five, six, seven, eight, or more teeth, or tissue surrounding or
supporting the teeth. The region can include one or more roots of
one, two, three, four, five, six, seven, eight, or more teeth, or
periodontium of teeth. Regions can include tissue (e.g., alveolar
or basal tissue) surrounding or supporting any of the teeth
specifically described with or without including the tooth itself.
Regions can include teeth or tissue supported by the maxilla or
teeth supported by the mandible. One or more regions can be
adjacent to one another, continuous with one another, or separate
from one another. Any description herein of regions or examples of
regions can apply to any other region or examples of treatment
regions provided herein.
[0272] In some embodiments, light irradiates a region that can
include a portion of tissue (e.g., bone tissue, or soft tissue) or
other regions within the patient's oral cavity without irradiating
one or more other portions of the patient's oral cavity. For
example, light can irradiate the mandibular first molar on the
right side of the patient's oral cavity without irradiating the
mandibular third molar that is also located on the right side of
the patient's oral cavity. In some embodiments, light is
administered to one or more roots of only one tooth root and to
only one periodontium. Alternatively, light is administered to one
or more roots of a plurality of teeth and to a plurality of
periodontia. Light can be administered to one or more roots of all
or less than all the teeth and periodontia in the patient's oral
cavity. One or more selected teeth, roots or periodontia can be
irradiated with light. For example, the mandibular first molar and
the mandibular third molar on the right side of the patient's oral
cavity can be irradiated without the mandibular second molar being
irradiated.
[0273] In some embodiments, light is administered to a patient's
alveolar soft tissue, wherein an effective amount of light is
irradiated from one or more emitters of an apparatus of the
invention. In one embodiment, the alveolar soft tissue is alveolar
mucosa.
[0274] In some embodiments, light from an intra-oral apparatus can
irradiate a region that includes a portion of tissue (e.g., bone
tissue, or soft tissue) at a much greater intensity than it
irradiates other portions of the patient's tissue within the mouth.
For example, light can irradiate a first tissue region (e.g., the
region of tissue covered by panel 2 shown in FIG. 1) at an
intensity that is 3.times., 5.times., 10.times., 20.times.,
50.times., or 100.times. greater than the intensity that irradiates
any other region or portion of the patient's tissue (e.g., the
regions of tissue covered by remaining panels 1 and 3-6 shown in
FIG. 1). In one embodiment, light can irradiate a portion of a
patient's alveolar soft tissue at a greater intensity than that of
light that irradiates any of the patient's teeth. In another
embodiment, light can irradiate or be focused with a greater
intensity on the one or more teeth upon which heavy forces are
optionally applied (that are desired to be moved), relative to the
one or more teeth on which heavy forces are not exerted. Teeth with
lower forces or anchorage teeth can be selectively shielded from
light or irradiated at lower light intensity so that they can move
less and the anchorage effect can be enhanced. In some embodiments,
this is achieved by applying to the intra-oral apparatus, or
adjusting within the intra-oral apparatus, one or more masks that
shield from light one or more non-regions, as described with
respect to FIG. 5. In some embodiments, light reaching a region can
have an intensity that is greater than a threshold value. In some
embodiments, this is achieved by applying to the intra-oral
apparatus, or adjusting within the intra-oral apparatus, the
density of emitters adjacent one or more regions, as described with
respect to FIG. 19. In some embodiments, the threshold value can
have an intensity as described elsewhere herein.
[0275] In some embodiments, the region can be close to a surface
within the patient's mouth, or within a soft tissue or bone tissue.
The region can be at a depth from the surface within the patient's
mouth. For example, the region can be about 1 .mu.m, about 1 .mu.m,
about 10 .mu.m, about 50.mu., about 100 .mu.m, about 200 .mu.m,
about 300 .mu.m, about 500 .mu.m, about 750 .mu.m, about 1 mm,
about 2 mm, about 3 mm, about 4 mm, about 5 mm, about 7 mm, about
10 mm, about 15 mm, about 20 mm, about 25 mm, about 30 mm, about 40
mm, about 50 mm, about 60 mm, or about 70 mm from the surface
within the patient's mouth. Light can irradiate a region, which can
have an area greater than, less than, or about 1 nm.sup.2, about 1
.mu.m.sup.2, about 0.1 mm.sup.2, about 0.2 mm.sup.2, about 0.3
mm.sup.2, about 0.4 mm.sup.2, about 0.5 mm.sup.2, about 0.7
mm.sup.2, about 1 mm.sup.2, about 10 mm.sup.2, about 0.2 cm.sup.2,
about 0.5 cm.sup.2, about 1 cm.sup.2, about 2 cm.sup.2, about 3
cm.sup.2, about 5 cm.sup.2, about 7 cm.sup.2, about 10 cm.sup.2,
about 15 cm.sup.2, about 20 cm.sup.2, about 25 cm.sup.2, about 30
cm.sup.2, about 35 cm.sup.2, about 40 cm.sup.2, about 50 cm.sup.2,
about 60 cm.sup.2, about 80 cm.sup.2, about 100 cm.sup.2, about 120
cm.sup.2, about 140 cm.sup.2, about 160 cm.sup.2, about 180
cm.sup.2 or about 200 cm.sup.2. Light can irradiate one area, a
plurality of areas, a point, or a plurality of points. In some
embodiments, light irradiates a particular area without irradiating
with significant intensity surrounding areas. For example, light
can irradiate a particular tooth or set of teeth without
significant amounts of light irradiating adjacent teeth. In one
embodiment, irradiating a tooth includes irradiating an exposed
surface of the tooth, a tooth root, or a periodontium of the tooth
(see, for example, FIG. 4 and associated description).
[0276] The light administered by an intra-oral apparatus can be
emitted from multiple light sources (e.g., emitters 32 shown in
FIG. 3A). Light can irradiate a continuous region or one or more
discrete regions based on the location of the light sources or
emitters within the intra-oral apparatus, as described herein.
Light can irradiate various regions from different directions. For
example, light can be administered from a right side of a patient's
mouth (e.g., from panel 1 shown in FIG. 1) and from a left side of
a patient's mouth (e.g., from panel 3 shown in FIG. 1). The light
sources or emitters can be adjusted within an intra-oral apparatus
such that the administered light is angled upward toward a region,
or angled downward to toward a region. The light source or emitters
can be displaced, can be angled, can be rotated, or any combination
thereof within the intra-oral apparatus.
[0277] As described herein, an effective amount of light can be
administered via the intra-oral apparatus. An effective amount of
light is an amount of light that is effective for regulating
tooth-movement; reducing, preventing or minimizing tooth-root
resorption; reducing bone resorption, inflammatory dentin
resorption or cementum resorption; preventing or minimizing
inflammation, or remodeling of tissue surrounding one or more teeth
upon which heavy forces are or were exerted; regenerating maxillary
or mandibular alveolar bone; or for other methods disclosed herein.
The light's properties can include, but are not limited to: its
intensity, wavelength, coherency, range, peak wavelength of
emission, energy density, continuity, pulsing, duty cycle,
frequency or duration.
[0278] In some embodiments, a method for regulating tooth movement
can further comprise determining an effective amount of light. The
determination can be based on an intended tooth movement regulation
effect. The method can further comprise selecting one or more light
properties to provide the effective amount of light. The method can
further comprise receiving instructions from a controller, and
emitting light having particular properties. The controller can be,
for example, controller 430 shown in FIG. 7, the external
electronic device described with respect to FIG. 17, or any other
controller described herein. The controller can implement any of
the steps described herein.
[0279] Light can be administered from one or more light source
within an intra-oral apparatus capable of irradiating light having
intended properties. As described herein, the intra-oral apparatus
can emit light from one or more light emitters, such as emitters
32, 132, 232, and/or 332. In some embodiments, the intra-oral
apparatus comprises about 10 to about 15 emitters, about 15 to
about 20 emitters, about 20 to about 30 emitters, about 30 to about
40 emitters, about 40 to about 50 emitters, about 50 to about 70
emitters, or about 70 emitters to about 100 emitters. For example,
light can be administered from one or more of the following
emitters: a light-emitting diode (LED), which can be present in an
array; and a laser, for example, a vertical cavity surface emitting
laser (VCSEL) or other suitable light emitter such as an
Indium-Gallium-Aluminum-Phosphide (InGaAIP) laser, a
Gallium-Arsenic Phosphide/Gallium Phosphide (GaAsP/GaP) laser, or a
Gallium-Aluminum-Arsenide/Gallium-Aluminum-Arsenide (GaAlAs/GaAs)
laser. In one embodiment, the intra-oral apparatus comprises a
plurality of lasers. A plurality of light emitters can emit light
at one or more different wavelengths. Alternatively, one or more
light emitters can emit light at the same wavelength. The one or
more light emitters can be arranged on or within the intra-oral
apparatus in any manner, such as a linear array or another
arrangement described herein.
[0280] An effective amount of light can have an intensity that is
effective for regulating tooth movement. In one embodiment, the
light intensity is at least about 10 mW/cm.sup.2. In other
embodiments, the light intensity is about 1 mW/cm.sup.2 or greater,
about 3 mW/cm.sup.2 or greater, about 5 mW/cm.sup.2 or greater,
about 7 mW/cm.sup.2 or greater, about 12 mW/cm.sup.2 or greater,
about 15 mW/cm.sup.2 or greater, about 20 mW/cm.sup.2 or greater,
about 30 mW/cm.sup.2 or greater, about 50 mW/cm.sup.2 or greater,
about 75 mW/cm.sup.2 or greater, about 100 mW/cm.sup.2 or greater,
about 200 mW/cm.sup.2 or greater, about 500 mW/cm.sup.2 or greater,
or about 1 W/cm.sup.2 or greater. In other embodiments, the light
intensity is about 20 mW/cm.sup.2 or less, about 30 mW/cm.sup.2 or
less, about 50 mW/cm.sup.2 or less, about 75 mW/cm.sup.2 or less,
about 100 mW/cm.sup.2 or less, about 200 mW/cm.sup.2 or less, about
500 mW/cm.sup.2 or less, about 1 W/cm.sup.2 or less, about 2
W/cm.sup.2 or less, about 5 W/cm.sup.2 or less, or about 10
W/cm.sup.2 or less. In one embodiment the light intensity ranges
from about 1 mW/cm.sup.2 to about 10 W/cm.sup.2. In another
embodiment, the light intensity's lower range is about 3
mW/cm.sup.2, about 5 mW/cm.sup.2, about 7 mW/cm.sup.2, about 12
mW/cm.sup.2, about 15 mW/cm.sup.2, about 20 mW/cm.sup.2, about 30
mW/cm.sup.2, about 50 mW/cm.sup.2, about 75 mW/cm.sup.2, about 100
mW/cm.sup.2, about 200 mW/cm.sup.2, about 500 mW/cm.sup.2, or about
1 W/cm.sup.2. In another embodiment, the light intensity's upper
range is about 20 mW/cm.sup.2, about 30 mW/cm.sup.2, about 50
mW/cm.sup.2, about 75 mW/cm.sup.2, about 100 mW/cm.sup.2, about 200
mW/cm.sup.2, about 500 mW/cm.sup.2, about 1 W/cm.sup.2, about 2
W/cm.sup.2, about 5 W/cm.sup.2, or about 10 W/cm.sup.2. In yet
another embodiment, the light intensity is at 15 mW/cm.sup.2. Light
can be administered having an intensity falling within a range
determined by any of the intensities described herein. In some
embodiments, the intensity is an average intensity. In some
embodiments, the light has an intensity in the range of about 10
mW/cm.sup.2 to about 60 mW/cm.sup.2, or about 20 mW/cm.sup.2 to
about 60 mW/cm.sup.2. In such embodiments, the peak light intensity
can about 50 mW/cm.sup.2 or greater. A peak wavelength is the
wavelength at which the highest intensity of light is emitted. In
some embodiments, light can be pulsed. In other embodiments, the
output of light is continuous. In some embodiments, the light
intensity can vary over time in a cyclical or non-cyclical fashion.
The light intensity can vary with or without pulsing. In some
embodiments, pulse width modulation can be used to affect a desired
light intensity. If one or more wavelengths of light are
administered, then each wavelength can be administered at its own
intensity. In some embodiments, an effective amount or dosage of
light can include administering light having an intensity of about
15 mW/cm.sup.2 for less than or up to three minutes duration.
Additional details regarding effective amounts or dosages of light
are described herein.
[0281] In some embodiments, an effective amount of light can
include light having a wavelength that is within in a particular
range, or light of a range of wavelengths. The light is not
necessarily visible light. For example, the light can include
infrared light or near-infrared light. The light can also be
provided in the visible light region. Light can be administered
having one or more wavelengths ranging from about 620 nm to about
1000 nm. In some embodiments, administered light has one or more
wavelengths ranging from about 585 nm to about 665 nm, about 815 nm
to about 895 nm, about 640 nm to about 680 nm, or about 740 nm to
about 780 nm, or any given wavelength or range of wavelengths
within those ranges, such as, for example, about 625 nm or about
855 nm, or about 605 nm to about 645 nm, or about 835 nm to about
875 nm. In some embodiments, the administered light has one or more
wavelengths from about 605 nm to about 645 nm, or from about 835 nm
to about 875 nm. In some embodiments, the administered light has
one or more wavelengths from about 615 nm to about 635 nm, or from
about 845 nm to about 865 nm. In some embodiments, the wavelengths
of the administered light are about 625 nm or about 855 nm. In
additional embodiments, the administered light has one or more
wavelengths ranging from about 400 nm to about 1200 nm. In
particular embodiments, the administered light has one or more
wavelengths ranging from about 500 nm to about 700 nm, about 585 nm
to about 665 nm, about 605 nm to about 630 nm, about 620 nm to
about 680 nm, about 815 nm to about 895 nm, about 820 nm to about
890 nm, about 640 nm to about 680 nm, or about 740 nm to about 780
nm. In some embodiments the administered light has one or more
wavelengths in one or both of the following wavelength ranges:
about 820 to about 890 nm and about 620 to about 680 nm. In some
embodiments, the administered light has one or more wavelengths in
the ranges of about 820 to about 890 nm and about 620 nm to about
680 nm. In some embodiments, the administered light has one or more
wavelengths in the ranges of about 815 to about 895 nm and about
585 to about 665 nm. The administered light can alternatively have
one or more wavelengths in one or more of the following ranges:
about 613 nm to about 624 nm, about 667 nm to about 684 nm, about
750 nm to about 773 nm, about 812 nm to about 846 nm. In one
embodiment, the light wavelength's lower range is about 400 nm,
about 450 nm, about 500 nm, about 550 nm, about 585 nm, about 595
nm, about 605 nm, about 613 nm, about 615 nm, about 620 nm, about
624 nm, about 625 nm, about 640 nm, about 650 nm, about 667 nm,
about 680 nm, about 710 nm, about 740 nm, about 750 nm, about 770
nm, about 812 nm, about 815 nm, about 820 nm, about 835 nm, about
845 nm, or about 860 nm. In another embodiment, the light
wavelength's upper range is about 585 nm, about 605 nm, about 624
nm, about 630 nm, about 635 nm, about 645 nm, about 655 nm, about
660 nm, about 665 nm, about 680 nm, about 684 nm, about 700 nm,
about 725 nm, about 755 nm, about 773 nm, about 780 nm, about 795
nm, about 815 nm, about 830 nm, about 846 nm, about 855 nm, about
865 nm, about 875 nm, about 890 nm, about 895 nm, about 935 nm,
about 975 nm, about 1000 nm, about 1050 nm, about 1100 nm, or about
1200 nm.
[0282] The wavelengths of light administered comprise or consists
of the wavelength values described herein.
[0283] For example, in some embodiments, light administered to a
region does not comprise one or more wavelengths exceeding one or
more of the following: about 585 nm, about 605 nm, about 624 nm,
about 630 nm, about 635 nm, about 645 nm, about 655 nm, about 660
nm, about 665 nm, about 680 nm, about 684 nm, about 700 nm, about
725 nm, about 755 nm, about 773 nm, about 780 nm, about 795 nm,
about 815 nm, about 830 nm, about 846 nm, about 855 nm, about 865
nm, about 875 nm, about 890 nm, about 895 nm, about 905 nm, about
910 nm, about 915 nm, about 920 nm, about 935 nm, about 975 nm,
about 1000 nm, about 1050 nm, about 1100 nm, or about 1200 nm. For
example, in some embodiments, no light exceeding about 585 nm,
about 605 nm, about 624 nm, about 630 nm, about 635 nm, about 645
nm, about 655 nm, about 660 nm, about 665 nm, about 680 nm, about
684 nm, about 700 nm, about 725 nm, about 755 nm, about 773 nm,
about 780 nm, about 795 nm, about 815 nm, about 830 nm, about 846
nm, about 855 nm, about 865 nm, about 875 nm, about 890 nm, about
895 nm, about 905 nm, about 910 nm, about 915 nm, about 920 nm,
about 935 nm, about 975 nm, about 1000 nm, about 1050 nm, about
1100 nm, or about 1200 nm is administered to a selected region. In
some embodiments, light administered to a region does not comprise
one or more wavelengths below one or more of the following: about
400 nm, about 450 nm, about 500 nm, about 550 nm, about 585 nm,
about 595 nm, about 605 nm, about 613 nm, about 615 nm, about 620
nm, about 624 nm, about 625 nm, about 640 nm, about 650 nm, about
667 nm, about 680 nm, about 710 nm, about 740 nm, about 750 nm,
about 770 nm, about 812 nm, about 815 nm, about 820 nm, about 835
nm, about 845 nm, or about 860 nm. For example, in some
embodiments, no light below about 400 nm, about 450 nm, about 500
nm, about 550 nm, about 585 nm, about 595 nm, about 605 nm, about
613 nm, about 615 nm, about 620 nm, about 624 nm, about 625 nm,
about 640 nm, about 650 nm, about 667 nm, about 680 nm, about 710
nm, about 740 nm, about 750 nm, about 770 nm, about 812 nm, about
815 nm, about 820 nm, about 835 nm, about 845 nm, or about 860 nm
is administered to a selected region. In some embodiments, the
light administered does not comprise a wavelength of about 600 nm
or less. In some embodiments, the light administered does not
comprise a wavelength of about 1000 nm or greater. In some
embodiments, the light administered does not comprise a wavelength
of about 600 nm or less and does not comprise a wavelength of about
1000 nm or greater.
[0284] In some embodiments, light administered to a region with a
sufficient intensity to be an effective amount in the present
methods does not comprise one or more wavelengths exceeding one or
more of the following: about 585 nm, about 605 nm, about 624 nm,
about 630 nm, about 635 nm, about 645 nm, about 655 nm, about 660
nm, about 665 nm, about 680 nm, about 684 nm, about 700 nm, about
725 nm, about 755 nm, about 773 nm, about 780 nm, about 795 nm,
about 815 nm, about 830 nm, about 846 nm, about 855 nm, about 865
nm, about 875 nm, about 890 nm, about 895 nm, about 905 nm, about
910 nm, about 915 nm, about 920 nm, about 935 nm, about 975 nm,
about 1000 nm, about 1050 nm, about 1100 nm, or about 1200 nm. For
example, in some embodiments, no light having a sufficient
intensity to be an effective amount for oral or maxillofacial bone
remodeling and exceeding about 585 nm, about 605 nm, about 624 nm,
about 630 nm, about 635 nm, about 645 nm, about 655 nm, about 660
nm, about 665 nm, about 680 nm, about 684 nm, about 700 nm, about
725 nm, about 755 nm, about 773 nm, about 780 nm, about 795 nm,
about 815 nm, about 830 nm, about 846 nm, about 855 nm, about 865
nm, about 875 nm, about 890 nm, about 895 nm, about 905 nm, about
910 nm, about 915 nm, about 920 nm, about 935 nm, about 975 nm,
about 1000 nm, about 1050 nm, about 1100 nm, or about 1200 nm is
administered to a selected region. In some embodiments, light
administered to a region with a sufficient intensity to be an
effective amount in the present methods does not comprise one or
more wavelengths exceeding one or more of the following: about 400
nm, about 450 nm, about 500 nm, about 550 nm, about 585 nm, about
595 nm, about 605 nm, about 613 nm, about 615 nm, about 620 nm,
about 624 nm, about 625 nm, about 640 nm, about 650 nm, about 667
nm, about 680 nm, about 710 nm, about 740 nm, about 750 nm, about
770 nm, about 812 nm, about 815 nm, about 820 nm, about 835 nm,
about 845 nm, or about 860 nm. For example, in some embodiments, no
light having a sufficient intensity to be an effective amount in
the present methods and below about 400 nm, about 450 nm, about 500
nm, about 550 nm, about 585 nm, about 595 nm, about 605 nm, about
613 nm, about 615 nm, about 620 nm, about 624 nm, about 625 nm,
about 640 nm, about 650 nm, about 667 nm, about 680 nm, about 710
nm, about 740 nm, about 750 nm, about 770 nm, about 812 nm, about
815 nm, about 820 nm, about 835 nm, about 845 nm, or about 860 nm
is administered to a selected region. In some embodiments, the
light administered does not comprise a wavelength of about 600 nm
or less having a sufficient intensity to be an effective amount for
the present methods. In some embodiments, the light administered
does not comprise a wavelength of about 1000 nm or greater having a
sufficient intensity to be an effective amount for the present
methods. In some embodiments, the light administered does not
comprise a wavelength of about 600 nm or less having a sufficient
intensity to be an effective amount for the present methods and
does not comprise a wavelength of about 1000 nm or greater having a
sufficient intensity to be an effective amount for the present
methods.
[0285] In some embodiments, certain treatments respond better to
specific wavelength ranges. For example, in some embodiments, tooth
movement (or, more particularly, rapid tooth movement) is more
effective when the amount of light administered has a wavelength
from about 700 nm to about 900 nm. In some embodiments, bone
healing or bone grafting is more effective when the amount of light
administered has a wavelength from about 600 nm to about 700
nm.
[0286] In one embodiment, the intra-oral apparatus irradiates light
having a wavelength of about 850 nm and with an intensity of less
than 100 mW/cm.sup.2 continuous wave.
[0287] In some embodiments, light is administered at one, two, or
more of the light ranges described. In some instances, light is not
administered outside of one, two, or more of the light ranges
described. In other embodiments, administered light has other
wavelengths, as desired for a particular application. In some
embodiments, light having a first set of characteristics (e.g.,
wavelength, intensity, pulsing, timing) can be administered to a
first region (e.g., the region at the panel 1 shown in FIG. 1), and
light with a second set of characteristics can be administered to a
second region (e.g., the region at panel 3 shown in FIG. 1). The
first region and the second region can be the same region, can
partially overlap, or can not overlap. The first set of
characteristics can be the same as the second set of
characteristics, can partially overlap with the second set, or can
all be different from the second set. In one embodiment, one region
of a jaw can receive light within a first wavelength range, while
another region of the jaw can receive light within a second
wavelength range. The first and second wavelengths can overlap.
Alternatively, in other embodiments, the first and second
wavelengths do not overlap.
[0288] In some embodiments, one or more wavelengths of light can be
sequentially or simultaneously administered to the patient. For
example, an intra-oral apparatus of the invention can include a
first emitter that emits light having a wavelength of about 850 nm
and a second emitter that sequentially or simultaneously emits
light having a wavelength of about 620 nm. In some embodiments, the
first emitter can be configured to emit light during a first period
of time and the second emitter can be configured to emit light
during a second period of time following the first period of time.
Stated another way, the second emitter emits light having a
wavelength of about 850 nm after the first emitter begins emitting
light having a wavelength of about 620 nm, or the second emitter
emits light having a wavelength of about 620 nm after the first
emitter begins emitting light having a wavelength of about 850 nm.
In some embodiments, light having a wavelength of about 850 nm is
administered daily to a patient until one or more of the following
orthodontic treatment phases are complete or almost complete: the
alignment phase, the space-closure phase, the
finishing-or-detailing phase or the retention phase. Once one or
more of these phases are complete or almost complete, the patient
can begin receiving a blended light treatment, which comprises
administering light having a wavelength of, e.g., about 850 nm and
about 620 nm. The about 850 nm wavelength of light can be
administered to the patient sequentially or simultaneously with the
about 620 nm wavelength of light. Once the teeth have moved into
their final position, the passive stage of orthodontic treatment
can begin and the patient can begin receiving light having a
wavelength of about 620 nm only.
[0289] Although examples of light wavelength ranges are provided
below for different applications, light having any other light
wavelength value, which can include those described herein, can be
administered for those applications.
[0290] In some embodiments, administering light having a wavelength
in the range of about 815 nm to about 895 nm, such as about 835 nm
to about 875 nm, or about 855 nm, is useful in the present methods,
in one embodiment, for increasing the rate of movement of teeth. In
one embodiment, increasing the rate of tooth movement does not
increase the tipping motion of teeth beyond that which is
experienced by orthodontic patients who are not provided with light
via the intra-oral apparatus. In some embodiments, administering
light having a wavelength in the range of about 585 nm to about 665
nm, such as about 605 nm to about 645 nm, or about 625 nm, is
likewise useful in the present methods, in one embodiment, for
increasing the rate of movement of teeth. In some embodiments,
administering light having any of the aforementioned wavelengths,
in conjunction with using a functional appliance, exerting a heavy
force and/or administering vitamin D, is useful in the present
methods, in one embodiment, for increasing the rate of movement of
teeth.
[0291] In one embodiment, administration of light having a
wavelength in the range of about 585 nm to about 665 nm increases
the amount or extent of bodily tooth movement to a greater degree
than administration with light having a wavelength in the range of
about 815 nm to about 895 nm. In such embodiments, administering
light having a wavelength in the aforementioned ranges, in
conjunction with a using functional appliance, exerting a heavy
force and/or administering vitamin D can further increase the
amount or extent of bodily tooth movement to a greater degree than
administering light alone. Administering light having a wavelength
in the range of about 585 nm to about 665 nm (e.g., about 625 nm)
can result in about 10% to about 50% less tipped movement than the
administration of light having a wavelength in the range of about
815 nm to about 895 nm (e.g., about 855 nm). For example, about
10%, about 15%, about 20%, about 25%, about 30%, about 35%, about
40%, about 45%, or about 50% less tipped movement can occur.
Particular wavelengths of light can minimize tipped movement. In
some embodiments, particular wavelengths administered in
conjunction with using a functional appliance, exerting a heavy
force and/or administering vitamin D can further minimize tipped
movement of teeth.
[0292] Thus, in one embodiment, administration of light having a
wavelength in the range of about 605 nm to about 645 nm, such as
about 625 nm, is useful in the present methods, in one embodiment,
for facilitating the bodily movement of teeth in orthodontic
treatment and optionally increasing bone regeneration. In some
embodiments, the methods further comprise increasing bone
regeneration. In another embodiment, administration of light having
a wavelength in the range of about 835 to about 875 nm, such as
about 855 nm, is useful in the present methods, in one embodiment,
for increasing the rate of movement of teeth for which some degree
of tipped movement is desirable or acceptable and optionally
increasing bone regeneration. In the aforementioned embodiments,
administering light of these respective ranges, in conjunction with
using a functional appliance, exerting a heavy force and/or
administering vitamin D, can be useful, for example, for
facilitating the bodily movement of teeth in orthodontic treatment
and optionally increasing bone regeneration.
[0293] In other embodiments, administration of light having a
wavelength as described herein, in one embodiment in the range of
about 605 nm to about 645 nm, such as about 625 nm, is useful for
increasing the quality or degree of bone remodeling. Accordingly
the present invention further relates to methods for increasing the
quality or degree of bone remodeling, comprising administering an
effective amount of light to a patient, wherein the effective
amount of light is irradiated from the emitter of an apparatus of
the invention. In some embodiments, at least a portion of the
apparatus contacts the alveolar soft tissue when the light is
administered. In some embodiments, the methods for increasing the
quality or degree of bone remodeling further comprise allowing a
heavy force to be exerted on one or more teeth of a patient in need
thereof and/or administering vitamin D to a patient.
[0294] Bone remodeling can include changes in any bone
characteristic, such as, but not limited to, bone shape, bone
volume, bone density, or bone mineral content. In some embodiments,
bone remodeling can include bone growth or resorption. Effecting
bone growth or bone resorption can result in altering bone shape or
position (i.e., tooth movement). Increasing the quality or degree
of bone remodeling can aid in adjusting the shape or position of
bone (such as a mandibular bone or maxillary bone), or can aid in
increasing the retention of teeth in a particular position, for
example, in a position resulting from orthodontic treatment, such
as an appliance of one or more orthodontic appliances, decreasing
the potential for teeth to move back to a previous position, for
example, a position prior to orthodontic treatment, such as any
appliance of one or more orthodontic appliances. Thus,
administration of light having a wavelength in the range of about
585 nm to about 665 nm, or about 605 nm to about 645 nm, or about
615 nm to about 635 nm, or about 625 nm, optionally also with light
in the range of 815 nm to 895 nm, can be useful in the present
methods, for example, for stabilizing the movement of teeth prior
to, subsequent to or concurrently with orthodontic treatment.
Accordingly, in other embodiments, the present methods further
comprise performing orthodontic treatment, such as installing one
or more orthodontic appliances on the patient, prior to, subsequent
to or concurrently with the administration of light via the
intra-oral apparatus. In one embodiment the orthodontic appliance
is a retainer device or a passive orthodontic appliance. Other
suitable orthodontic appliances can include, for example, removable
retainers such as a Hawley retainer or a vacuum formed retainer, or
fixed retainers such as a bonded lingual retainer. These appliances
can assist in maintaining tooth position prior to, subsequent to or
concurrently with the administration of light, for example, by
stimulating bone regeneration or remodeling. In some embodiments,
the present methods further comprise regulating oral or
maxillofacial bone remodeling, such as installing one or more
functional appliances to a patient prior to, subsequent to or
concurrently with the administration of light. Administration with
light having a wavelength in the range of about 815 nm to about 895
nm, or about 835 nm to about 875 nm, or about 845 nm to about 865
nm, or about 855 nm, can also be useful for stabilizing tooth
movement, in one embodiment prior to, subsequent to or concurrently
with orthodontic treatment. In one embodiment administration of
light having wavelengths in the range of about 585 nm to about 665
nm increases bone regeneration or remodeling to a greater degree or
extent that does administration of light having wavelengths in the
range of about 815 nm to about 895 nm.
[0295] Tooth-root resorption can include breakdown or destruction,
or subsequent loss, of the root structure of a tooth. Tooth-root
resorption can be caused by differentiation of macrophages into
osteoclasts in surrounding tissue which, if in close proximity to
the root surface can resorb the root surface cementum and
underlying root dentine. Tooth-root resorption can be exacerbated
by heavy or supra-physiologic orthodontic forces that exert on
periodontal tissue pressure that is higher than the normal
physiologic capillary and interstitial pressure. This prevents
normal blood flow, which can cause schema (lack of blood supply)
and ultimately cell death of soft tissue and bone in the
periodontium. These dead tissues, also known as a "hyalinized
zone," are removed through multi-nucleated cells and undermining
respiration process and in many cases healthy bone, cementum and
dentin are resorbed through this process.
[0296] Accordingly, administering light having a particular
wavelength, is useful for modulating the speed, quality and type of
tooth movement, e.g., bodily versus tipped, and for increasing or
stabilizing tooth movement. In some embodiments, stabilizing tooth
movement can comprise moving one or more teeth with less tipped
movement. Stabilizing tooth movement can also include retarding or
arresting tooth movements in particular ways. For example, this can
include minimizing the amount of, or eliminating, slanting (or
tipped movement). Administration of light can also be useful for
increasing (or inducing) bone regeneration or remodeling.
Administration of light can also be useful for reducing,
minimizing, or preventing tooth root resorption, bone resorption,
inflammatory dentin or cementum resorption, or inflammation of
tissue. Administering light, in conjunction with using a functional
appliance, exerting a heavy force, and/or administering vitamin D,
can further be useful for these purposes.
[0297] In some embodiments, the light can be administered to at
least a portion of a patient's alveolar soft tissue or other oral
tissue, or to it entirely. Alternatively, using an intra-oral
apparatus, light of one or more particular wavelengths can be
administered to different selected regions of a patient's alveolar
soft tissue in order to effect movement of teeth (e.g. anchor (no
movement), bodily, or tipped) in one or more regions of a patient's
mouth. For example, one or more regions in which it is desired that
the teeth not be moved, or that the teeth serve as an anchor to
facilitate movement of teeth in other selected regions of a
patient's jaw, can be optionally screened or masked such that they
receive no light, as described herein with respect to FIG. 5.
Alternatively, the one or more regions in which it is desired that
the teeth not be moved, or that the teeth serve as an anchor to
facilitate movement of teeth in other selected regions of a
patient's jaw, do not receive light as the light emitters over such
regions are turned off. Regions in which it is desired that the
teeth be moved bodily can be administered with light having a
wavelength in the range of about 585 nm to about 665 nm, in the
range of about 605 nm to about 645 nm, about 615 nm to about 635
nm, or about 625 nm. Regions in which it is desired to increase
tooth movement but permit some tipped movement of the teeth can be
administered with light having a wavelength in the range of about
815 nm to about 895 nm, about 835 nm to about 875 nm, about 845 nm
to about 865 nm, or about 855 nm. Tooth movement can be selectively
regulated by administering an effective amount of light having one
wavelength to one or more selected regions of a patient's alveolar
soft tissue, and by administering an effective amount of light
having a different wavelength to one or more different selected
regions of the mucosa.
[0298] In some embodiments, light can be administered within a
narrow range of wavelengths (e.g., 50 nm or less, 30 nm or less, 20
nm or less, 10 nm or less, 5 nm or less), or at a single
wavelength. In some embodiments, light is administered at a limited
wavelength range (e.g., 1000 nm or less, 700 nm or less, 600 nm or
less, 500 nm or less, 400 nm or less, 300 nm or less, 250 nm or
less, 200 nm or less, 150 nm or less, 100 nm or less, or 75 nm or
less). In some embodiments, the light administered does not include
wavelengths beyond the narrow or limited range of wavelengths. The
narrow or limited range of wavelengths can have any of the upper or
lower limits of wavelength as described previously. In some
embodiments, however, the light administered does not include light
having a sufficient intensity to constitute an effective amount
having wavelengths beyond the narrow or limited range of
wavelengths.
[0299] In some embodiments, light can be emitted at one, two, or
more peak wavelengths of emission. A peak wavelength is the
wavelength at which the highest intensity of light is emitted. In
some embodiments, light can be administered at a range of
wavelengths that includes a peak wavelength having the highest
intensity within the range. In some embodiments, a peak wavelength
can be at about 620 nm, about 640 nm, about 650 nm, about 655 nm,
about 660 nm, about 665 nm, about 670 nm, about 680 nm, about 690
nm, about 800 nm, about 820 nm, about 830 nm, about 835 nm, about
840 nm, about 845 nm, about 850 nm, about 860 nm, about 870 nm,
about 890 nm, about 910 or about 930 nm. In some embodiments, the
administered light does not have wavelengths that vary from the
peak wavelength by more than about 1 nm, about 2 nm, about 3 nm,
about 5 nm, about 10 nm, about 15 nm, about 20 nm, about 30 nm,
about 40 nm, about 50 nm, about 75 nm, about 100 nm, about 150 nm,
about 200 nm, about 250 nm, about 300 nm, about 400 nm, or about
500 nm.
[0300] Where two or more light wavelengths are administered, the
light can be administered at any ratio of each wavelength's
intensity. For example, light administered at a first wavelength
can have an intensity that is about 1.1.times., 1.2.times.,
1.3.times., 1.5.times., 1.7.times., 2.0.times., 2.5.times.,
3.0.times., 3.5.times., 4.0.times., 5.0.times., 10.times.,
12.times., 15.times., 20.times., 30.times., 50.times., 100.times.
that of light administered at a second wavelength. In some
embodiments, the administered light is emitted from one or more
light emitters, in another embodiment, from one or more light
emitters having a first set of properties and, optionally, from a
second set of light emitters having a second set of properties. In
other embodiments, the number of light emitters having a first set
of characteristics exceeds that of the light emitters having a
second set of characteristics. For example, the number of light
emitters having the first set of characteristics can be about
1.1.times., 1.2.times., 1.3.times., 1.5.times., 1.7.times.,
2.0.times., 2.5.times., 3.0.times., 3.5.times., 4.0.times.,
5.0.times., 10.times., 12.times., 15.times., 20.times., 30.times.,
50.times., 100.times. the number of light emitters having the
second set of characteristics, or vice versa.
[0301] The light can optionally be monochrome or substantially
monochrome, e.g., having a wavelength from about 10 nm less than to
about 10 nm greater than a specific wavelength. When light is
"substantially monochrome" it consists of a single wavelength or
comprises other wavelengths that are emitted at an intensity that
is ineffective in the present methods, including for regulating
oral or maxillofacial bone remodeling when administered to the oral
or maxillofacial bone, muscle, or soft tissue, or one or more teeth
of a patient, with or without allowing a functional appliance to
exert a force on oral or maxillofacial bone, muscle, or soft
tissue, or one or more teeth of the patient. In some embodiments,
substantially monochrome light is emitted at a narrow range of
wavelengths without being emitted at other wavelengths outside the
range or without an effective intensity of light being emitted at
other wavelengths outside the range. In some embodiments,
substantially monochrome light is emitted within an about 5 nm or
less, about 10 nm or less, or about 20 nm or less wavelength range
without being emitted at other wavelengths outside the range or
without an effective intensity of light being emitted at other
wavelengths outside the range. Administering light from light
emitters that emit at multiple wavelengths can allow for
irradiation over multiple wavelengths or greater selectivity and
precision in administration. The light can optionally comprise
incoherent light. In some embodiments, light can be administered at
a single frequency, light can have a phase that drifts relatively
quickly, a pulse of light waves can have an amplitude that changes
quickly, or a light wave can encompass a broad range of
frequencies.
[0302] Light can be administered directly from a light emitter to a
region in the patient's mouth. In some embodiments, light can be
modified by optics before reaching or traveling through the surface
within the patient's mouth (e.g., the alveolar soft tissue). For
example, light can be diffused, focused, parallel, reflected,
redirected, or filtered after it is emitted and before it reaches
or travels through the surface within the patient's mouth. Such
modification can be achieved, for example, by using a foil or other
suitable material with the intra-oral apparatus, such as the
reflective backing 20 illustrated and described with respect to
FIG. 3A. In one embodiment, light of one or more wavelengths can be
selectively blocked or partially filtered before reaching the
surface within the patient's mouth. In some embodiments, light can
diverge or converge from an emission source before reaching the
region. For example, light can diverge in a beam having an included
angle .THETA. in the range of about 45-60.degree.. The emitted
light diverge to have an included angle .THETA. of 0 to about
15.degree., 0 to about 30.degree., 0 to about 45.degree., 0 to
about 60.degree., 0 to about 75.degree., 0 to about 90.degree., or
0 to about 120.degree..
[0303] In some embodiments, industry standard LEDs are used to
produce the light. The LEDs can include one or more emitter arrays
arranged on a series of treatment arrays to cover the target area
of the alveolus of both the maxilla and mandible.
[0304] Light that irradiates the region can optionally have the
same or about the same characteristics as light that is emitted. In
some embodiments, light that reaches the region does not have the
same characteristics as the light that is emitted. One or more of
the light characteristics can optionally be altered prior to
administration or when it passes through the oral tissue of the
patient. One or more of the light characteristics can optionally be
altered when it passes through optics, such as one or more lenses
or mirrors, that is coupled to or disposed within the intra-oral
apparatus. For example, one or more of the light characteristics
can be altered in the range of about .+-.20% or less, about .+-.15%
or less, about .+-.10% or less, about .+-.5% or less, about .+-.3%
or less, about .+-.1% or less, about .+-.0.5% or less, or about
.+-.0.1% or less.
[0305] The dosage or effective amount of light that irradiates
from, for example, the light emitters, can range from about 24
J/cm.sup.2 to about 200 J/cm.sup.2. The effective dosage of light
can be administered once or repetitively. In some embodiments, the
effective amount can have an irradiated light energy density that
is from about 30 J/cm.sup.2 to about 100 J/cm.sup.2. In other
embodiments, the effective amount can be about 5 J/cm.sup.2 or
less, about 10 J/cm.sup.2 or less, about 20 J/cm.sup.2 or less,
about 30 J/cm.sup.2 or less, about 50 J/cm.sup.2 or less, about 75
J/cm.sup.2 or less, about 100 J/cm.sup.2 or less, about 125
J/cm.sup.2 or less, about 150 J/cm.sup.2 or less, about 175
J/cm.sup.2 or less, or about 200 J/cm.sup.2 or less. The effective
amount of irradiated light can be about 1 J/cm.sup.2 or more, about
5 J/cm.sup.2 or more, about 10 J/cm.sup.2 or more, about 20
J/cm.sup.2 or more, about 25 J/cm.sup.2 or more, about 30
J/cm.sup.2 or more, about 40 J/cm.sup.2 or more, about 50
J/cm.sup.2 or more, about 60 J/cm.sup.2 or more, about 75
J/cm.sup.2 or more, about 100 J/cm.sup.2 or less, about 125
J/cm.sup.2 or more, about 150 J/cm.sup.2 or more, or about 175
J/cm.sup.2 or more. The effective amount of irradiated light can be
in a range bounded by any of the energy density values described
herein. The effective amount of irradiated light can be increased,
for example, by using a light source that emits light having a
relatively higher average intensity, or by increasing the duration
of administration of light.
[0306] An effective amount of light can have an energy density that
reaches a region, such as the mandibular bone or maxillary bone.
For example, an effective amount of light that reaches a region can
be from about 0.5 J/cm.sup.2 to about 100 J/cm.sup.2. The effective
amount of light that reaches the region can be administered once or
repetitively. In some other embodiments, the effective amount has
an irradiated light energy density that is from about 1 J/cm.sup.2
to about 50 J/cm.sup.2. In other embodiments, the effective amount
of light is about 0.5 J/cm.sup.2 or less, about 1 J/cm.sup.2 or
less, about 2 J/cm.sup.2 or less, about 5 J/cm.sup.2 or less, about
10 J/cm.sup.2 or less, about 15 J/cm.sup.2 or less, about 20
J/cm.sup.2 or less, about 30 J/cm.sup.2 or less, about 40
J/cm.sup.2 or less, about 50 J/cm.sup.2 or less, about 70
J/cm.sup.2 or less, about 80 J/cm.sup.2 or less, about 90
J/cm.sup.2 or less, or about 100 J/cm.sup.2 or less. The effective
amount of light can be about 0.5 J/cm.sup.2 or more, about 1
J/cm.sup.2 or more, about 2 J/cm.sup.2 or more, about 3 J/cm.sup.2
or more, about 5 J/cm.sup.2 or more, about 10 J/cm.sup.2 or more,
about 15 J/cm.sup.2 or more, about 20 J/cm.sup.2 or more, about 30
J/cm.sup.2 or more, about 40 J/cm.sup.2 or more, about 50
J/cm.sup.2 or less, about 60 J/cm.sup.2 or more, about 70
J/cm.sup.2 or more, or about 80 J/cm.sup.2 or more. The effective
amount of light that reaches the region can be in a range bounded
by any of the energy density values described herein.
[0307] The duration over which the effective amount, which is
optionally repetitive, is administered via the intra-oral apparatus
can range from about 10 to about 40 minutes. In other embodiments,
dosage can be administered in a period of time of about 30 seconds
or more, about 1 minute or more, about 2 minutes or more, about 3
minutes or more, about 5 minutes or more, about 7 minutes or more,
about 10 minutes or more, about 15 minutes or more, about 20
minutes or more, about 25 minutes or more, about 30 minutes or
more, about 40 minutes or more, about 50 minutes or more, about 1
hour or more, about 1 hour 15 minutes or more, about 1 hour 30
minutes or more, or about 2 hours or more. The effective amount can
be administered in a period of time of about 3 minutes or less,
about 5 minutes or less, about 10 minutes or less, about 15 minutes
or less, about 20 minutes or less, about 25 minutes or less, about
30 minutes or less, about 35 minutes or less, about 40 minutes or
less, about 50 minutes or less, about 1 hour or less, about 1 hour
15 minutes or less, about 1 hour 30 minutes or less, about 2 hours
or less, or about 4 hours or less. The effective amount can be
administered in a range of time within any of the time values
described herein. In some embodiments, one or more light blocking
masks or shades can be used with the intra-oral apparatus. An oral
mask can block one or more wavelengths of light, or can reduce the
intensity of one or more wavelengths of light, from reaching a
region covered by the oral mask. This can include an upper arch
(e.g., maxillary teeth), or lower arch (e.g., mandibulary teeth).
In some embodiments, the oral mask contacts oral tissue or one or
more teeth of a patient.
[0308] Any time period can be provided between dosages of light.
For example, the time period between dosages can be on the order of
seconds, minutes, hours, days, weeks, months, quarter of a year, or
years.
[0309] The effective amount, which in some embodiments is
repetitive, can be administered with any desired frequency, e.g.,
four times daily, three times daily, twice daily, daily, every
second day, weekly, biweekly, monthly, or quarterly. In some
embodiments, dosage can be administered at regular intervals (e.g.,
daily), while in other embodiments, the dosage is not administered
at regular intervals (e.g., administration can occur 2 times a week
at any time during the week). In one embodiment, light can be
administered in the morning and at night. Light can be administered
throughout the time period that a patient is undergoing bone
remodeling or tooth movement. In some embodiments, a patient
undergoes orthodontic treatment in addition to undergoing bone
remodeling or tooth movement. Orthodontic treatment can occur prior
to, subsequent to, or concurrently with oral or maxillofacial bone
remodeling. Light can be administered throughout the time period
that a patient is undergoing orthodontic treatment, or following
treatment to stabilize tooth movement. For example, light can be
administered after a functional appliance or an orthodontic
appliance is applied, removed, adjusted, after an appointment, or
after an active stage, as described herein. It can be desirable to
administer light with greater frequency, e.g. four times daily,
three times daily, twice daily, daily or every second day, while a
patient is undergoing orthodontic treatment. Where light is being
administered, for example, to stabilize tooth movement or reduce
tooth-root resorption, treatments of reduced frequency, e.g.
weekly, biweekly, monthly, or quarterly, can be used to minimize
inconvenience to patients. In some embodiments, the effective
amount of light maintains the ATP energy levels of tissue cells,
e.g., ischemic tissue cells, to prevent cell death, as described
herein. In some embodiments, light is administered no less than
about every second day. In some embodiments, a patient receives
light treatment at least three or four times a week.
[0310] Light can be administered for any length of time. In some
embodiments, light can be administered on the order of seconds,
minutes, hours, days, weeks, months, quarters, or years. For
example, light can be administered while an orthodontic appliance
or a functional appliance exerts a force. One or more dosages of
light can be administered over a period of time during which a
patient is undergoing oral or maxillofacial bone remodeling during
which an orthodontic appliance or a functional appliance exerts a
force. In some embodiments, one or more dosages of light can be
administered over a period of time during which a force is exerted
on one or more teeth, during which a patient is wearing an
orthodontic appliance that itself can exert a force, such as a
heavy force, or during which a patient is undergoing orthodontic
treatment during which a force, such as a heavy force may be
applied. In some embodiments, while a patient is undergoing
orthodontic treatment or is wearing a secondary appliance, the
patient is administered with light via the intra-oral apparatus. In
other embodiments, the intra-oral apparatus exerts a heavy force on
one or more teeth such that no secondary appliance is necessary.
Administration of light, which can include regular, irregular,
continuous or discontinuous administration of light, can be on the
order of days, weeks, months, quarters, or years. In some
embodiments, light is administered over a plurality of days, weeks,
months, quarters, or years. In some embodiments, light is
administered over a plurality of sessions. In some embodiments, one
or more hours, days, weeks, months, quarters, or years occur
between sessions.
[0311] If the light emitters are pulsed, then their duty cycle can
be adjusted as desired; e.g., light can be administered with a duty
cycle of about 10%, about 20%, about 30%, about 40%, about 50%,
about 60%, about 70%, about 80%, or about 90%. The pulsing can
occur with any frequency. For example, light can be pulsed every
picosecond, nanosecond, microsecond, millisecond, second, multiple
seconds, or minutes. Frequencies can include, but are not limited
to, about 1 mHz, about 10 mHz, about 50 mHz, about 100 mHz, about
500 mHz, about 1 Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 15
Hz, about 20 Hz, about 25 Hz, about 30 Hz, about 35 Hz, about 40
Hz, about 50 Hz, about 70 Hz, about 100 Hz, about 200 Hz, about 500
Hz, or about 1 kHz. Any of the aforementioned characteristics of
light emission (e.g., whether the light is on or off, continuous or
pulsed, duty cycle, frequency, intensity, wavelength) can be varied
or maintained. Where the light is emitted from a source having a
controller, any characteristics of light emission can be varied or
maintained in accordance with instructions from its controller.
[0312] In some embodiments, the emitters of the intra-oral
apparatus can be controlled so that the number of lights that are
on or off at a given period can be individually controllable. For
example, a light source or emitter can be turned on or off relative
to other light sources or emitters (such as, e.g., the apparatus
illustrated and described herein with respect to FIG. 18C). Various
light sources can be modulated individually (e.g., one or more
properties of a particular light source can be varied) or otherwise
individually controlled, to expose individual sections of a
patient's alveolar soft tissue or other regions to a desired energy
density. This can be desirable when it is desirable to administer
light to different regions (e.g., via the various panels of the
intra-oral apparatus). Thus, the position of light being
administered can be varied. In another embodiment, different types
of light sources can be turned on or off relative to other light
emitters. For example, at some times, light emitted in a first
wavelength range can be turned on while light emitted in a second
wavelength range can be turned off, vice versa, or both types of
light emitters can be turned on or off. Thus, the wavelength of
light being administered can be varied. In some embodiments, the
intensity of light being administered can be varied (e.g., by
turning some light sources on or off, or varying the intensity
emitted by the light sources). Administering light selectively can
enable an increased anchorage effect (by reason of lower tooth
mobility) of teeth which are not exposed to any light, which can
thereby permit for more precise bone remodeling or movement of
teeth to which light is administered.
[0313] In some embodiments, particularly where infrared light is
administered to a patient, the present methods further comprise
providing emission of a visible light. In one embodiment the
visible light is bright enough to aid in the apparatus's
positioning if performed by a person other than the patient. The
visible light can be, but is not necessarily, of a wavelength or
wavelength range that is beneficial for light treatment or
regulation of tooth movement. In some embodiments, the ratio of the
intensities of the visible and infrared components of the light is
1 part or less visible light to 5 parts or more infrared light. In
other embodiments, the ratio of the intensities of visible and
infrared components is about 1 part or more visible light to 5
parts or more infrared light, 1 part or more visible light to 3
parts infrared light, 1 part or more visible light to 2 parts
infrared light, 1 part or more visible light to 1 part infra red
light, 2 parts or more visible light to 1 part infrared light, 3
parts or more visible light to 1 part infrared light, 5 parts or
more visible light to 1 part infrared light, 10 parts or more
visible light to 1 part infrared light, or substantially no
infrared light. In some embodiments, light can be emitted within a
range can include wavelengths less than an order of magnitude
relative to one another. Alternatively, the range can include
wavelengths emitted at one, two, three or more orders of magnitude
relative to one another.
[0314] The region and desired light characteristics can vary from
patient to patient. A physician, dentist, other health-care
provider or patient can determine a light treatment regimen for a
patient wearing an intra-oral apparatus.
[0315] In some instances, it can be desirable to administer light
to less than all regions of the patient's alveolar soft tissue, for
example, if it is desired that teeth in other regions do not need
to be moved (e.g. it can be desired to regulate the movement of
only the upper teeth of a patient, or only the lower teeth, or to
use certain teeth as an anchor when regulating the movement of
other teeth by administering no light to, e.g., blocking light
from, the anchor teeth). Administering light to selected regions of
the patient's alveolar soft tissue can comprise causing light to
irradiate one or more selected tooth roots through the tissue or
mucosa.
[0316] In one embodiment, light is selectively administered to less
than all regions of the patient's alveolar soft tissue before,
during, or after the exertion of heavy forces. In one embodiment,
light is not administered to an anchor tooth. In this embodiment, a
secondary appliance, such as a functional appliance, is located
between the anchor region or tooth and one or more selected bone
region sought to be remodeled. The secondary appliance can exert a
force on the selected bone region, for example, on another tooth.
In some embodiments, the force is a heavy force. In some
embodiments, an effective amount of light is administered to the
selected bone region or other tooth and not to the anchor region or
anchored tooth via the intra-oral apparatus. The administration of
light can increase the rate of the selected bone remodeling region
or velocity (or rate of movement) of the other tooth and reduce,
minimize, or prevent root resorption of the other tooth, while not
increasing the rate of bone remodeling of the non-selected regions
or velocity of the anchor tooth.
[0317] It can also be desirable to administer light of different
wavelengths to different regions of the patient's alveolar soft
tissue, if it is desired to differentially manipulate the movement
of a patient's teeth, as described herein. For example, light of a
first wavelength can be administered to a first region and light of
a second wavelength can be administered to a second region. The
first and second wavelengths can include any wavelengths described
elsewhere herein, such as for example, about 585 nm to about 665
nm, or about 815 nm to about 895 nm.
[0318] Light can be administered over an area (also referred to
herein as a "light irradiation area"). For example, light can be
administered to a region with an area. In some embodiments, light
characteristics (e.g., light intensity) can remain uniform over the
area. In other embodiments, light characteristics can vary over the
area. For example, light intensity can be uniform or can vary over
an area of a region. The area of light administration can have any
shape or size.
[0319] Light can be administered to a light irradiation area of any
size and shape. For example, a region, such as a specified region
of the patient's alveolar soft tissue, can have any size or shape.
The light irradiation area can have one or more dimensions (e.g.,
length, width, diameter) that range from about 1 to about 80 mm or
from about 1 to about 70 mm. In some embodiments, one or more
dimensions (e.g., length, width, diameter) of a light irradiation
area can range from about 1 to about 3 mm, about 3 to about 5 mm,
about 5 to about 7 mm, about 7 to about 10 mm, about 10 to about 15
mm, about 15 to about 20 mm, about 20 to about 25 mm, about 25 to
about 30 mm, about 30 to about 35 mm, about 35 to about 40 mm,
about 40 to about 50 mm, about 50 to about 60 mm, or about 60 to
about 80 mm.
[0320] A light-irradiation area can have any shape, which can
include, but is not limited to, a substantially rectangular shape,
square shape, triangular shape, hexagonal shape, octagonal shape,
trapezoidal shape, circular shape, elliptical shape, crescent
shape, cylindrical shape or half-circle. In some embodiments, the
dimensions of a light emitter can be about the same as dimensions
for a light irradiation area. In other embodiments, the dimensions
of a light source can be greater than the dimensions of a light
irradiation area. Alternatively, the dimensions of a light source
can be less than the dimensions of the light irradiation area. The
relative areas of a light source and light irradiation area can
depend on any angle, which can be a parallel, convergence, or
divergence angle, at which light is emitted.
[0321] In some embodiments, an effective amount of light can be
provided in a treatment regimen using the intra-oral apparatus. The
treatment regimen can be used in the present methods.
[0322] In one embodiment, a typical treatment regimen provides a
dose of light daily. Each of the daily doses of light can be
administered over a period lasting from a few minutes to about an
hour when the patient is using the intra-oral apparatus. For
example, daily 1/2 hour doses of light can be effective and are not
unduly inconvenient for patients. A single daily dose can be as
effective as dividing the same dose into multiple sessions
administered at different times during the day. Some treatment
regimens can comprise administering light in 5 treatments per week
for 12 weeks. Each treatment can last 1/2 hour and irradiate the
patient's oral tissue with light having wavelengths of 660 nm and
840 nm. The 660 nm light can have an intensity of about 20
mW/cm.sup.2 at the skin's surface. The 840 nm light can have an
intensity of about 10 mW/cm.sup.2 at the skin's surface. These
treatment regimens can enhance bone density.
[0323] Other treatment regimens can comprise administering light in
daily treatments for 21 days. Each treatment lasts from about 20
minutes to about one hour and illuminates the tissues of a
patient's mouth with light having a wavelength of 618 nm and an
intensity of 20 mW/cm.sup.2 at the skin's surface. These treatment
regimens can accelerate healing of bone grafts.
[0324] Another treatment regimen can include a twice-daily
administration of light for six months. Light can be administered,
via the intra-oral apparatus, at a wavelength of about 660 nm or
about 840 nm, or at both wavelengths. The intensity of the light
can be about 20 mW/cm.sup.2 at the target surface within the
patient's mouth. An orthodontic appliance or a functional appliance
can be present in the patient's mouth while the light is
administered. Subsequent to the first 6 month period, a second 6
month period can be provided where light is administered once every
other day. The same functional appliance or one or more orthodontic
appliances can be present in the patient's mouth at this time. The
administration of light can optionally become less frequent or be
administered at a lower intensity as treatment progresses. In some
embodiments, the same intra-oral apparatus is used throughout the
treatment regimen. In other embodiments, however, one or more
different intra-oral apparatus are used throughout the treatment
regimen.
[0325] Another treatment regimen can include administering light to
a patient having an orthodontic appliance or a functional
appliance, and then subsequently adjusting the appliance. In one
such embodiment, the patient uses both the intra-oral apparatus and
the appliance (e.g., braces). The intra-oral apparatus can, for
example, fit over the secondary appliance such that the intra-oral
apparatus and orthodontic appliance can be used simultaneously. In
some embodiments, two or more other orthodontic appliances can be
used with the intra-oral apparatus. In other embodiments, an
orthodontic appliance and a functional appliance are used with the
intra-oral apparatus. The orthodontic appliance can be installed on
the patient's teeth prior to, subsequent to, or concurrently with
the installation of a functional appliance. In some embodiments,
the orthodontic appliance worn and adjusted is the intra-oral
apparatus, which also administers the light. In some embodiments,
adjusting an orthodontic appliance may increase or alter the
magnitude of a force applied on one or more teeth. Adjusting an
orthodontic appliance may alter the direction of a force applied on
one or more teeth. Light can be administered to one or more
selected teeth for up to an hour prior to adjusting an orthodontic
appliance. Adjusting the orthodontic appliance can cause a heavy
force to be exerted on the one or more teeth. Adjusting the
appliance can change the magnitude or direction, or both, of the
force exerted. Adjusting the appliance can comprise tightening,
loosening or replacing one or more of the appliance's wires,
springs or elastic devices. Different sizes, materials, or shapes
of such components can be used. Light can then be administered
daily to the one or more selected teeth, until the next adjustment
of the appliance. This administration of light can reduce,
minimize, or prevent tooth-root resorption, bone resorption, tissue
inflammation, periodontium resorption or cementum resorption.
[0326] Another treatment regimen can include administering vitamin
D to a patient; administering light to a region of the alveolar
soft tissue, or the mandibular bone, maxillary bone, or one or more
teeth; installing a functional appliance or an orthodontic
appliance; and subsequently adjusting the orthodontic appliance or
functional appliance. In some embodiments, adjusting a functional
appliance or an orthodontic appliance increases or decreases the
magnitude of a force exerted on one or more teeth, mandibular bone,
maxillary bone, or temporal bone. Adjusting a functional appliance
also can alter the direction of a force exerted. Light can be
administered to one or more selected regions for up to an hour
prior to adjusting a functional appliance or an orthodontic
appliance. Adjusting the functional appliance or orthodontic
appliance can cause a force to be exerted on the one or more teeth,
mandibular bone, maxillary bone, or temporal bone. Adjusting the
functional appliance or orthodontic appliance can change the
magnitude or direction, or both, of the force exerted. Adjusting
the functional appliance or orthodontic appliance can comprise
tightening, loosening or replacing one or more of the appliance's
wires, springs or elastic devices. Different sizes, materials, or
shapes of such components can be used. Light can then be
administered, for example, daily, to the one or more selected
regions, until the next adjustment of the functional appliance or
orthodontic appliance. This administration of light can regulate
oral or maxillofacial bone remodeling. In some embodiments, the
administration of light regulates tooth movement. For example, the
administration of vitamin D and administration of light can
increase the rate of bone remodeling or tooth movement. This can
decrease the amount of time that a functional appliance or an
orthodontic appliance is worn or needs to be worn by a patient.
[0327] The present methods can further comprise controlling
temperature of the apparatus of the invention, the patient's mouth,
the patient's alveolar soft tissue or of any light source that is
directed at or that contacts the patient's mouth or region thereof.
As described herein, the intra-oral apparatus can include a
temperature sensor (or other like sensor) that monitors the
temperature of the patient's mouth, the patient's alveolar soft
tissue and/or light emitters. The method can comprise cooling,
heating, or maintaining the temperature at a patient's mouth. A
patient's mouth, for example, the patient's alveolar soft tissue,
can be contacted with a temperature control mechanism, which can
cause the removal or provision of heat. In some embodiments, such a
temperature control mechanism is coupled to or disposed within the
intra-oral apparatus. In some embodiments, the temperature of the
light source can be controlled. The temperature control mechanism
can communicate with the light source. Heat can be removed from or
provided to the light source. Any embodiments for temperature
regulation described herein can be used within the method. The
method can further comprise measuring a temperature of the
patient's mouth, measuring a temperature at a particular surface
region within the patient's mouth, e.g., the alveolar soft tissue,
or measuring a temperature at one or more of the light emitters.
Temperature regulation can optionally occur in response to one or
more temperature measurements made.
[0328] In one embodiment the present methods are performed prior
to, subsequent to or concurrently with orthodontic treatment of a
patient. In one embodiment the administration of light is
repetitive.
[0329] Oral or maxillofacial bone remodeling can occur at the
mandibular bone, maxillary bone, or temporal bone. In some
embodiments, oral or maxillofacial bone remodeling can occur at a
joint, such as the temporomandibular joint. The some embodiments,
oral or maxillofacial bone remodeling can occur at a condyle or
glenoid fossa. The regulation of oral or maxillofacial bone
remodeling can result in the repositioning of the mandibular bone
or maxillary bone, the lengthening or shortening of the mandibular
bone or maxillary bone, or altering the angle, shape, or dimensions
of the mandibular bone or maxillary bone.
[0330] Oral or maxillofacial bone remodeling can include the
installation of a functional appliance in a patient. A functional
appliance can be present on one or more teeth of a patient. The
methods can comprise installing a functional appliance in a
patient, such as installing the appliance on one or more teeth, the
patient's gums, the patient's maxillary or mandibular bone, or
other oral or maxillofacial features of the patient, adjusting a
functional appliance of the patient, or can comprise removing a
functional appliance from the patient. A treatment for oral or
maxillofacial bone remodeling can include a period of time during
which the functional appliance is installed in the patient. In some
embodiments, treatment for oral or maxillofacial bone remodeling
can include a period of time after the functional appliance has
been installed in or removed from the patient. In some embodiments,
treatment for oral or maxillofacial bone remodeling can include a
period of time preceding the installation of a functional
appliance. In other embodiments treatment for oral or maxillofacial
bone remodeling includes a period of time prior to, during, or
subsequent to the exertion of a force on oral or maxillofacial
bone, muscle, soft tissue, or one or more teeth, such as mandibular
bone, maxillary bone, temporal bone, or on one or more oral muscles
that can prevent the oral muscles from exerting a force on the one
or more teeth, mandibular bone, maxillary bone, temporal bone.
Treatment for oral or maxillofacial bone remodeling can include a
period of time while a patient is seeing or consulting with an
orthodontist or other dental specialist.
[0331] Treatment for oral or maxillofacial bone remodeling,
including methods for regulating such remodeling, can include an
active stage and a passive stage. An active stage can include some
time during which a functional appliance is installed in and/or on
the patient. In some embodiments, an active stage includes a time
during which a force is exerted on a tooth, mandibular bone,
maxillary bone, temporal bone. An active stage can include a period
during which the patient is undergoing one or more adjustments to
the patient's functional appliance. In some embodiments, the active
stage includes the alignment phase of orthodontic treatment. A
passive stage can include a period after a functional appliance has
been removed from the patient. In some embodiments, a passive stage
includes a period during which a functional appliance is installed,
but is no longer undergoing adjustments. In some embodiments, a
passive stage includes a period during which there is no further
muscular tension on the jaw or teeth when the functional appliance
is in position, which typically occurs after a period of treatment
and bone remodeling. In some embodiments, a passive stage includes
a period during which a functional appliance is not providing force
to effect bone remodeling. Instead, the passive stage can include a
period during which a functional appliance is installed in a
patient and that maintains the maxillary bone or mandibular bone in
its position. Any stage of oral or maxillofacial bone remodeling
can last on the order of days, weeks, months, quarters, or
years.
[0332] An orthodontic treatment can cause one or more teeth to move
or maintain its position relative to a supporting maxilla or
mandible, or can include regulation of tooth movement. In some
instances, orthodontic treatment can include aligning teeth.
Orthodontic treatment can include treating malocclusion, which can
occur when teeth fit together improperly, for example, as a result
of their individual positions or positions of underlying jaw bone
as they relate to one another. Malocclusion can be treated using
light treatment or tooth movement regulation according to the
methods described herein. Accordingly, the present invention
further relates to methods for treating or preventing malocclusion,
comprising administering an effective amount of light to a patient,
wherein the effective amount of light is irradiated from the
emitter of an apparatus of the invention. In some embodiments, at
least a portion of the apparatus contacts the alveolar soft tissue
when the light is administered. In some embodiments, the methods
further comprise allowing a heavy force to be exerted on one or
more teeth of a patient in need thereof. In some embodiments, the
light is administered before, during or after the heavy force is
exerted.
[0333] An orthodontic treatment can include the installation of an
orthodontic appliance in a patient. An orthodontic appliance can be
present on one or more teeth of a patient. The methods can comprise
installing an orthodontic appliance in a patient, such as
installing the appliance to one or more teeth of the patient,
adjusting an orthodontic appliance of the patient, or can comprise
removing an orthodontic appliance from the patient. In some
embodiments, an orthodontic appliance can be installed or removed
prior to, subsequent to, or concurrently with the installation or
removal of a functional appliance. Orthodontic treatment can
include a period of time during which the orthodontic appliance is
applied to the patient. In some embodiments, orthodontic treatment
can include a period of time after the orthodontic appliance has
been applied or removed from the patient. In some embodiments,
orthodontic treatment can include a period of time preceding the
application of an orthodontic appliance. In other embodiments
orthodontic treatment includes a period of time prior to, during,
or subsequent to the exertion of a heavy force on one or more
teeth. Orthodontic treatment can include a period of time while a
patient is seeing or consulting with an orthodontist.
[0334] In some embodiments, orthodontic treatment can include an
active stage and a passive stage. An active stage can include time
during which an orthodontic appliance is installed in the patient.
In some instances, an active stage can include time during which a
force is applied to one or more teeth to effect tooth movement. In
some embodiments, the force applied to one or more teeth during an
active stage is a heavy force. An active stage can include a period
during which the patient is undergoing one or more adjustments to
the patient's appliance. In some embodiments, the active stage
includes one or more of the following phases of orthodontic
treatment: the alignment phase, a space-closure phase, and a
finishing-or-detailing phase. The alignment phase is described
herein. The space-closure phase typically occurs after the
alignment phase, if the alignment phase is needed. In general,
during the space-closure phase, one or more teeth are moved so that
any gaps between the teeth are minimized. The
finishing-or-detailing phase typically occurs after the
space-closure phase, if the space-closure phase is needed. In
general, during the finishing-or-detailing phase, square or
rectangular wires are installed on one or more teeth of the
patient, in some embodiments, as part of an orthodontic appliance
that comprises brackets, and used to torque one or more of the
teeth so that the teeth are set to a final, corrected position.
Bodily movement of one or more teeth typically occurs during one or
both of the space-closure phase and the finishing-or-detailing
phase. Light treatment can be administered to the patient during
any one or more of the phases of the active stage or during the
passive stage.
[0335] A passive stage, which comprises the retention phase, can
include a period after an appliance has been removed from the
patient. In some instances, a passive stage can include a period
during which an appliance is installed but is no longer undergoing
adjustments. In some instances a passive stage can include a period
during which an orthodontic appliance no longer exerts a force on
the teeth. In some embodiments, a passive stage can include a
period during which, for example, an orthodontic appliance is not
providing force to effect movement of a tooth. Instead, the passive
stage can include a period during which an appliance is installed
in a patient and that maintains one or more teeth in its position.
In some embodiments, any stage of orthodontic treatment can last on
the order of days, weeks, months, quarters, or years.
[0336] In some embodiments, orthodontic treatment can result in
bone remodeling. In some embodiments, orthodontic treatment and
bone remodeling or tooth movement occurs concurrently. In some
embodiments, in addition to light treatment, force can be exerted
on one or more tooth, any region of the jaw, or any other region of
the mouth or head. Force can be exerted by the intra-oral apparatus
and/or an orthodontic appliance. In some embodiments, the force is
a heavy force. Bone remodeling can involve altering the position or
morphology of bone, including the jaw bone. For example, a jaw bone
can be moved forward, or can be lengthened. Other examples of bone
remodeling, as disclosed herein, can also be applicable. In some
embodiments, bone remodeling can occur in conjunction with
regulating tooth movement. Accordingly, the present methods are
useful for and, in one embodiment, result in bone remodeling. Light
can be administered to a region, such as any oral bone or tissue,
and is useful for bone remodeling. Accordingly, the invention
further provides methods for inducing bone remodeling, comprising
administering an effective amount of light to a patient, wherein
the effective amount of light is irradiated from the emitter of an
apparatus of the invention. In some embodiments, at least a portion
of the apparatus contacts the alveolar soft tissue when the light
is administered. In some embodiments, the methods further comprise
allowing a heavy force to be exerted on one or more teeth of a
patient in need thereof. In some embodiments, the light is
administered before, during or after the heavy force is exerted.
Light treatment can increase the rate of bone remodeling, and can
be provided in conjunction with forces for bone remodeling. For
example, administering an effective amount of light as described in
the present methods can reduce the amount of time to achieve the
same degree of bone remodeling without light by about 10%, about
20%, about 30%, about 40%, about 50%, about 60%, about 70%, about
80%, or about 90%. Light treatment can promote bone remodeling
which can increase the rate of teeth movement. This can allow
heavier forces to be used, which could accelerate tooth movement
even more than with lighter forces. Such forces can be exerted by
one or more orthodontic appliances.
[0337] Installing, adjusting, or removing of an orthodontic
appliance can occur before or after administering an effective
amount of light via the intra-oral apparatus. In some embodiments,
the effective amount of light can aid in regulating or accelerating
the movement of teeth during orthodontic treatment with an
orthodontic appliance, or regulating or accelerating bone
remodeling during oral or maxillofacial bone remodeling with a
functional appliance. The effective amount of light can be useful
for reducing the amount of time an orthodontic appliance is worn
during an orthodontic treatment, or that a functional appliance is
worn during treatment for oral or maxillofacial bone remodeling.
For example, according to the methods of the present invention, the
application of light can reduce treatment time (e.g., wearing a
functional appliance or an orthodontic appliance) by up to about
10%, about 20%, about 30%, about 40%, about 50%, about 60%, about
70%, about 75%, about 80%, about 85%, or about 90% of the treatment
time. For example, administering light having a wavelength in the
range of about 585 nm to about 665 nm (e.g., about 625 nm) can
reduce the amount of time that a patient wears an orthodontic
appliance or a functional appliance by about 5% to about 90%, for
example, by about 5%, about 10%, about 20%, about 30%, about 40%,
about 50%, about 60%, about 70%, about 75%, about 80%, about 85%,
or about 90%. Administering light having a wavelength in the range
of about 815 nm to about 895 nm (e.g., about 855 nm) can reduce the
amount of time that a patient wears an orthodontic appliance or a
functional appliance by about 5% to about 90%, for example, by
about 5%, about 10%, about 20%, about 30%, about 40%, about 50%,
about 60%, about 70%, about 75%, about 80%, about 85%, or about
90%.
[0338] In some embodiments, administering an effective amount of
light with desired light characteristics results in an overall
reductions in the amount of time necessary for treatment. For
example, a treatment can include the installation of a functional
appliance, the removal of the functional appliance, and the
installation or removal of an orthodontic appliance. By combining
the use of a functional appliance and an orthodontic appliance, the
overall treatment time can be reduced. Furthermore, increased
control on the bone remodeling and tooth movement can be delivered.
This can be particularly advantageous during a patient's adolescent
growth phase.
[0339] Administering light having a wavelength in the range of
about 585 nm to about 665 nm (e.g., about 625 nm) can result in a
rate of tooth movement that is about 5% to about 90% faster than
the rate of tooth movement without the administration of light. For
example, the rate of tooth movement can be about 5%, about 10%,
about 20%, about 30%, about 40%, about 50%, about 60%, about 70%,
about 75%, about 80%, about 85%, or about 90% faster than the rate
of tooth movement without the administration of light.
[0340] Administering light having a wavelength in the range of
about 815 nm to about 895 nm (e.g., about 855 nm) can result in a
rate of tooth movement that is about 5% to about 60% faster than
the rate of tooth movement resulting from the administration of
light having a wavelength in the range of 585 nm to about 665 nm
(e.g., about 625 nm). For example, the rate of tooth movement can
be about 5%, about 10%, about 20%, about 30%, about 40%, about 50%,
about 55%, or about 60% faster than the rate of tooth movement
resulting from the administration of light having a wavelength in
the range of 585 nm to about 665 nm (e.g., about 625 nm).
[0341] Administering light having a wavelength in the range of
about 815 nm to about 895 nm (e.g., about 855 nm) can result in a
rate of tooth movement that is about 5% to about 95% faster than
the rate of tooth movement without the administration of light. For
example, the rate of tooth movement can be about 5%, about 10%,
about 20%, about 30%, about 40%, about 50%, about 60%, about 70%,
about 75%, about 80%, about 85%, about 90%, or about 95% faster
than the rate of tooth movement without the administration of
light.
[0342] In some embodiments, in addition to light treatment,
orthodontic treatments, particularly those that comprise the use of
an orthodontic appliance, can exert forces, such as heavy forces,
on one or more teeth. This can result in a rate of tooth movement
that is about 5% to about 80% faster than the rate of tooth
movement without the exertion of heavy forces. For example, the
exertion of heavy forces in one or more teeth can increase the rate
of tooth movement by about 5%, about 10%, about 20%, about 30%,
about 40%, about 50%, about 60%, about 70%, about 75%, or about
80%. Heavy forces can result in tooth-root resorption, bone
resorption, inflammatory resorption of dentin, cementum resorption,
or tissue inflammation.
[0343] In some embodiments, the administration of an effective
amount of light can aid in reducing, preventing or minimizing
tooth-root resorption when a heavy force is allowed to be exerted
on one or more tooth. The effective amount of light can be useful
for reducing the amount of tooth-root resorption as compared to
when a heavy force is allowed to be exerted on one or more tooth
without administering the effective amount of light. For example,
according to the methods of the present invention, the
administration of light can reduce tooth-root resorption by up to
about 1%, about 2%, about 3%, about 5%, about 7%, about 10%, about
15%, about 20%, about 25%, about 30%, about 40%, about 50%, about
60%, about 70%, about 80%, or about 90%. Reducing tooth-root
resorption, particularly while applying heavy forces, may allow for
a reduction of the amount of time for orthodontic treatment, or the
amount of time that a patient wears an orthodontic appliance.
Administering an effective amount of light can reduce the amount of
time that a patient wears orthodontic appliances by about 5% to
about 90%, for example, by about 5%, about 10%, about 20%, about
30%, about 40%, about 50%, about 60%, about 70%, about 75%, about
80%, about 85%, or about 90%.
[0344] In some embodiments, administration of an effective amount
of light can aid in reducing, preventing or minimizing bone
resorption or inflammatory dentin or cementum resorption of the
tooth root or periodontium. The effective amount of light can be
useful for reducing bone resorption or inflammatory dentin or
cementum resorption of the tooth root and periodontium, as compared
to when a heavy force is allowed to be exerted on one or more teeth
without administering the effective amount of light. For example,
according to the methods of the present invention, the
administration of light can reduce bone resorption or inflammatory
dentin or cementum resorption of the tooth root or periodontium by
up to about 1%, about 2%, about 3%, about 5%, about 7%, about 10%,
about 15%, about 20%, about 25%, about 30%, about 40%, about 50%,
about 60%, about 70%, about 80%, or about 90%. Reducing bone
resorption or inflammatory resorption of dentin or cementum
resorption of the tooth root or periodontium while exerting heavy
forces can reduce the amount of time for orthodontic treatment, or
amount of time that a patient wears an orthodontic appliance.
Administering an effective amount of light can reduce the amount of
time that a patient wears orthodontic appliances by about 5% to
about 90%, for example, by about 5%, about 10%, about 20%, about
30%, about 40%, about 50%, about 60%, about 70%, about 75%, about
80%, about 85%, or about 90%.
[0345] In some embodiments, administration of the effective amount
of light can aid in reducing, preventing or minimizing inflammation
of tissue surrounding one or more teeth upon which heavy forces are
or were exerted. The effective amount of light can be useful for
reducing the amount of inflammation of tissue surrounding one or
more teeth upon which heavy forces are or were exerted, as compared
to when a heavy force is allowed to be exerted on one or more tooth
without administering the effective amount of light. In one
embodiment, according to the methods of the present invention, the
administration of light can reduce inflammation of tissue
surrounding one or more teeth upon which heavy forces are or were
exerted by up to about 1%, about 2%, about 3%, about 5%, about 7%,
about 10%, about 15%, about 20%, about 25%, about 30%, about 40%,
about 50%, about 60%, about 70%, about 80%, or about 90%. Reducing
inflammation of tissue surrounding one or more teeth upon which
heavy forces are or were exerted while applying heavy forces can
reduce the amount of time for orthodontic treatment, or amount of
time that a patient wears an orthodontic appliance. Administering
an effective amount of light can reduce the amount of time that a
patient wears an orthodontic appliance by about 5% to about 90%,
for example, by about 5%, about 10%, about 20%, about 30%, about
40%, about 50%, about 60%, about 70%, about 75%, about 80%, about
85%, or about 90%.
[0346] The light can be administered via the intra-oral apparatus
in accordance with a treatment regimen. In some embodiments, when a
functional appliance (or an orthodontic appliance is used in
conjunction with the intra-oral apparatus, the functional appliance
or orthodontic appliance can be installed prior to administering
the light via the intra-oral apparatus, the functional appliance or
orthodontic appliance can be installed concurrently with
administering the light via the intra-oral apparatus, the
functional appliance or orthodontic appliance can be installed
subsequent to administering the light via the intra-oral apparatus,
or any combination thereof. In some embodiments, a functional
appliance or an orthodontic appliance can be removed prior to
administering the light via the intra-oral apparatus, the
functional appliance or orthodontic appliance can be removed
concurrently with administering the light via the intra-oral
apparatus, the functional or orthodontic appliance can be removed
subsequent to administering the light via the intra-oral apparatus,
or any combination thereof. In some embodiments, a functional
appliance or orthodontic appliance can be adjusted prior to
administering the light via the intra-oral apparatus, the
functional appliance or orthodontic appliance can be adjusted
concurrently with administering the light via the intra-oral
apparatus, the functional appliance or orthodontic appliance can be
adjusted subsequent to administering the light via the intra-oral
apparatus, or any combination thereof.
[0347] The functional appliance or orthodontic appliance can exert
a force on one or more teeth of the patient in addition to or in
lieu of the intra-oral apparatus exerting a force on one or more
teeth. A force can be exerted (e.g., by the functional appliance
and/or the orthodontic appliance subsequent to, concurrently with,
or prior to the administration of light via the intra-oral
apparatus. A force may be exerted subsequent to, concurrently with,
or prior to initiation of the administration of light. A force can
be exerted subsequent to, concurrently with, or prior to the
initiation of a light treatment regimen involving the intra-oral
apparatus. A force can be exerted subsequent to, concurrently with,
or prior to the initiation of a light treatment session involving
the intra-oral apparatus. In some embodiments, a force can be
exerted one or more seconds, one or more minutes, one or more
hours, one or more days or one or more weeks subsequent to
administering the light and/or one or fewer days, one or fewer
weeks, or one or fewer weeks subsequent to administering the light.
The light can be administered by the intra-oral apparatus for any
length of time. In some embodiments, a force is exerted one or more
seconds, one or more minutes, one or more hours, one or more days
or one or more weeks subsequent to initiating light administration
and/or one or fewer days, one or fewer weeks, or one or fewer weeks
subsequent to initiating light administration. In some embodiments,
a force can be exerted one or more seconds, one or more minutes,
one or more hours, one or more days or one or more weeks subsequent
to ending light administration and/or one or fewer days, one or
fewer weeks, or one or fewer weeks subsequent to ending light
administration. The force can be, for example, a heavy force.
[0348] Light can be administered for any period of time before,
during, or after the exertion of a heavy force. For example, light
can be administered for about 1 minute, about 2 minutes, about 3
minutes, about 5 minutes, about 10 minutes, about 15 minutes, about
20 minutes, about 30 minutes, about 45 minutes, about 1 hour, about
90 minutes, about 2 hours, about 3 hours, about 4 hours, or about 6
hours prior to, during, or after the exertion of a force, such as a
heavy force. In some embodiments, light is administered for about 5
minutes to about 10 minutes. In some embodiments, light is
administered at any amount of time prior to, during, or after the
initiation of the exertion of a force. For example, light can be
administered about 1 minute, about 2 minutes, about 3 minutes,
about 5 minutes, about 10 minutes, about 15 minutes, about 20
minutes, about 30 minutes, about 45 minutes, about 1 hour, about 90
minutes, about 2 hours, about 3 hours, about 4 hours, about 6
hours, about 12 hours, about 1 day, about 36 hours, about 2 days,
about 3 days, about 4 days, about 1 week, about 2 weeks, or about 1
month prior to, during, or after the initiation of the exertion of
a force. In some embodiments, light is administered for about 5
minutes to about 10 minutes.
[0349] Administering light prior to initiating or exerting a force,
as described herein, can be part of a pretreatment regimen. In some
embodiments, however, no such pretreatment occurs and the
functional appliance or orthodontic appliance exerts a force prior
to any light being administered. The functional appliance or
orthodontic appliance can exert a force, for example, at one or
more seconds, one or more minutes, one or more hours, one or more
days or one or more weeks prior to administering the light and/or
one or fewer days, one or fewer weeks, or one or fewer weeks prior
to administering the light. Thus, a follow-up treatment of light
can be provided after the exertion of the force. In some
embodiments, a force is exerted during the administration of light,
or at one or more stages of the administration of light.
[0350] In some embodiments, the functional appliance or orthodontic
appliance exerts the force at the same region as the region that is
administered with light. In other embodiments, the functional
appliance or orthodontic appliance exerts the force on a region
that is different from the region that is administered with light.
In some embodiments, allowing the functional appliance or
orthodontic to exert a force on a region other than the region
administered with light can result in allowing a force to be
exerted to a region that is administered with light.
[0351] In one embodiment, the dosage or effective amount of light
has a density that ranges from about 24 J/cm.sup.2 to about 200
J/cm.sup.2, and has a wavelength in the range of about 585 nm to
about 665 nm, or about 815 nm to about 895 nm. Administration of
light having a wavelength in the range of about 585 nm to about 665
nm can be useful in the present methods, in one embodiment, for
promoting bodily movement of teeth or minimize tipped movement of
teeth, or both. Administration of light having a wavelength in the
range of 815 nm to about 895 nm, can also be useful in the present
methods, for example, for increasing the velocity of teeth through
the patient's bone. In some other embodiments, an effective dosage
of light can have any of the light characteristics as described
anywhere herein. Teeth in a region of the patient's maxillary or
mandibular alveolar bone to which light is not administered can be
used as an anchor to facilitate movement of teeth in the selected
region. Light is administered directly to a specific region of the
patient's mouth, e.g., the patient's alveolar soft tissue, using
the intra-oral apparatus, as described herein.
[0352] In some embodiments, the present methods comprise
administering to a patient in need thereof, via an intra-oral
apparatus, an effective amount of light having a first wavelength
to a selected first region of the patient's mouth (e.g., a first
region of the alveolar soft tissue), and further comprise
administering, via the intra-oral apparatus, an effective amount of
light having a second wavelength to a selected second region of the
patient's mouth (e.g., a second region of the alveolar soft
tissue). In one embodiment the effective amount of light having a
first wavelength is a repetitive dosage. In another embodiment the
effective amount of light having a second wavelength is a
repetitive dosage. Regions other than alveolar soft tissue can
receive the first or second wavelength of light. In one embodiment,
the effective amount of light can be in the range of 24 J/cm.sup.2
to 200 J/cm.sup.2. The first wavelength can be in the range of
about 585 nm to about 665 nm, and the second wavelength can be in
the range of about 815 nm to about 895 nm. In other embodiments, an
effective amount of light can have any light characteristics as
described anywhere herein.
[0353] In some embodiments, the methods further comprise installing
the intra-oral apparatus and/or a secondary appliance (such as, for
example, a functional appliance or an orthodontic appliance),
removing the intra-oral apparatus and/or a secondary appliance, or
adjusting the intra-oral apparatus and/or a secondary appliance. In
other embodiments, the methods comprise administering light via the
intra-oral apparatus until orthodontic treatment is complete.
Orthodontic treatment can be deemed complete after appointments
with an orthodontic specialist are completed, after the movement of
one or more teeth has been stabilized to remain in the
substantially same position, e.g., within about 1 to about 3
millimeters of a specific position, without the aid of any type of
orthodontic appliance, or during a passive stage of orthodontic
treatment as described in greater detail herein. Light can be
administered to the region before, during, after, or any
combination thereof, a secondary appliance is installed, adjusted,
or removed. The secondary appliance can be applied, adjusted, or
removed before, during, after, or any combination thereof, the
application of light via the intra-oral apparatus. In some
embodiments, a force, such as a heavy force, can be exerted when
the orthodontic appliance is installed or adjusted, or for a period
of time following such installation or adjustment.
[0354] As described herein, the speed of tooth movement, e.g.,
through the bone, or the quality of that movement (e.g., "bodily"
or "tipped" movement) can be regulated by administration of light.
In one embodiment the present methods are useful for effecting bone
regeneration, which can occur concurrently with the present
methods. Bone regeneration can be enhanced by administering light
according to the present methods. Where orthodontic treatment is
performed, light can be administered before, during or after
orthodontic treatment using the intra-oral apparatus. The light can
be emitted from the intra-oral light-therapy apparatus in any
manner described herein. Bone regeneration can include bone growth
or bone resorption. This can include osteoblast or osteoclast
activation. Tooth movement can require osteoclastic and
osteoblastic activity. In one embodiment, the administration of
light according to the present methods stimulates osteoclasts or
osteoblasts and, accordingly, stimulates osteoclastic and
osteoblastic activity. The administration of light can increase the
rate of tooth movement that can accompany bone remodeling.
[0355] For example, the present methods, in one embodiment for
regulating tooth movement, can also comprise applying, adjusting or
removing a tooth mask or other oral mask. The mask can be coupled
to, disposed within, or otherwise part of the intra-oral apparatus.
In some embodiments, one or more of the panels of the intra-oral
apparatus can include a mask. In other embodiments, the mask is
separate from the intra-oral apparatus but is configured to contact
the intra-oral apparatus when the patient is wearing the intra-oral
apparatus. A tooth mask can be applied or removed prior to, during,
or after the administration of light. Light can be administered to
a region before, during, after, or any combination thereof, an oral
mask or tooth mask is applied, adjusted, or removed. In some
embodiments, one or more of a patient's teeth, or other region of
the patient's mouth, can be at least partially covered with a mask
that can block at least some of the light. A mask can block one or
more wavelengths of light. In some embodiments, the mask can
completely block one or more wavelength of light, and in other
embodiments, the mask can reduce the amount or intensity of light
reaching the teeth, or other region of the patient's mouth. In some
embodiments, the intensity of the light administered to the teeth,
or other region of the patient's mouth, can be zero, or can be less
than the intensity of the light emitted from a light source.
[0356] In accordance with another aspect of the invention, the
present methods, in one embodiment for tooth-movement regulation,
can regulate the bone regeneration. For example, the present
methods can increase the rate of bone regeneration. In some
embodiments, bone regeneration can facilitate tooth-movement
regulation, for example, can increase the velocity or quality of
movement, or can stabilize tooth movement. For example, bone
regeneration can occur prior to, during or following tooth
movement. Bone regeneration can include bone growth, bone
strengthening or bone resorption. For example, during bone
regeneration, bone mineral density (BMD) can increase, bone volume
(BV) can increase, bone mineral content (BMC) can increase, and the
ratio of bone volume to total volume (BV/TV) or bone density can
increase. Higher BV/TV can indicate denser bone, where less bone
regeneration can occur, which is desirable after tooth movement has
occurred to enhance the stability of teeth. Specifically, teeth
move more slowly through denser and more mineralized bone, and
maintain their position longer than in less dense bone. Teeth are
therefore less likely to relapse and move back to their original,
misaligned state. In this manner, light treatment can increase the
quality of the bone or, more specifically, increase the mineral
density of the bone to prevent relapse after orthodontic treatment.
In some such embodiments, the light treatment occurs after force is
applied to the one or more teeth of the patient (i.e., when force
is no longer being applied to the patient's teeth). In one
embodiment, the patient wears an orthodontic appliance during such
light treatment. In another embodiment, the patient does not wear
an orthodontic appliance during such light treatment.
[0357] Other examples of parameters that can be affected during
bone regeneration can include trabecular bone surface, bone
quality, osteoclastic activity (e.g., osteoclast and preosteoclast
counts), bone resorption. Light treatment can enhance existing
cellular processes. Bone regeneration can occur in any bone tissue
or oral region. For example, bone regeneration can occur in a
portion or all of a maxillary alveolar bone, in mandibular alveolar
bone, or around one or more teeth. In some embodiments, bone
regeneration can occur around one or more teeth, which can include
a periodontium. In some embodiments, the region around one or more
teeth can be within about 1 mm, about 2 mm, or about 3 mm from the
surface of the teeth.
[0358] In some embodiments, light treatment according to the
present methods can also result in treating or preventing jaw
osteonecrosis. Accordingly, the present methods are useful for
treating or preventing jaw osteonecrosis. Accordingly, the
invention further provides methods for treating or preventing jaw
osteonecrosis, comprising administering an effective amount of
light to a patient, wherein the effective amount of light is
irradiated from the emitter of an apparatus of the present
invention. In some embodiments, at least a portion of the apparatus
contacts the alveolar soft tissue when the light is administered.
The methods optionally include allowing a heavy force to be exerted
on one or more teeth of the patient, who is in need thereof. When
applicable, light can be administered before, during or after the
heavy force is exerted. Treating or preventing jaw osteonecrosis
can comprise reversing osteonecrosis through the use of light
treatment according to the methods described herein. Jaw
osteonecrosis can occur with respect to any bone tissue. For
example, jaw osteonecrosis, can occur with respect to a portion or
all of a maxillary alveolar bone, mandibular alveolar bone, or one
or more teeth. In some embodiments, methods for treating or
preventing jaw osteonecrosis further comprise administering to the
patient an effective amount of vitamin D.
[0359] In some embodiments, light treatment according to the
present methods can also result in reducing, minimizing, or
preventing tooth-root resorption, bone resorption, inflammatory
resorption of dentin or cementum resorption, or inflammation of
tissue. Accordingly, the present methods are useful for reducing,
minimizing, or preventing tooth-root resorption, bone resorption,
inflammatory dentin or cementum resorption, or inflammation of
tissue. Accordingly, the invention further provides methods for
reducing, minimizing, or preventing tooth-root resorption, bone
resorption, inflammatory dentin or cementum resorption, or
inflammation of tissue, comprising administering an effective
amount of light to a patient, wherein the effective amount of light
is irradiated from the emitter of an apparatus of the invention,
and, optionally, allowing a heavy force to be exerted on one or
more teeth of the patient, who is in need thereof. In some
embodiments, at least a portion of the apparatus contacts the
alveolar soft tissue when the light is administered. When
applicable, light can be administered before, during, or after the
heavy force is exerted. Such light-treatment methods may be used or
useful in conjunction with heavy forces applied to one or more
tooth.
[0360] In some embodiments, light treatment regulates tooth
movement during an alignment phase of orthodontic treatment. In
another embodiment, light treatment regulates tooth movement during
a phase other than the alignment phase of orthodontic treatment. In
yet another embodiment, light therapy regulates tooth movement
following the alignment phase of orthodontic treatment.
[0361] In some embodiments, the region to which light is
administered is any oral tissue, such as soft tissue or bone
tissue, including the alveolar soft tissue and, in some
embodiments, the alveolar mucosa. In some embodiments, the oral
tissue is that on which oral surgery was performed. The present
methods are useful for treating tissue after oral surgery. The oral
surgery can be periodontal surgery or that relating to bone grafts.
The oral tissue can be: a portion or all of tissue supporting one
or more teeth, the gums (i.e., gingiva), the alveolar soft tissue,
a maxillary alveolar bone, mandibular alveolar bone, or one or more
teeth. Accordingly, the invention further provides methods for
treating tissue after oral surgery, comprising administering an
effective amount of light to a patient, wherein the effective
amount of light is irradiated from the emitter of an apparatus of
the invention. In some embodiments, at least a portion of the
apparatus contacts when the light is administered a region of the
patient's alveolar soft tissue on which surgery was performed. In
some embodiments, the method also includes allowing a heavy force
to be exerted on one or more teeth of the patient, who is in need
thereof. When applicable, light can be administered before, during
or after the heavy force is exerted. The present methods are also
useful for increasing the rate of oral-tissue healing following
oral surgery. Accordingly the invention further provides methods
for increasing the rate of oral-tissue healing following oral
surgery, comprising administering an effective amount of light to a
patient, wherein the effective amount of light is irradiated from
the emitter of an apparatus of the invention. In some embodiments,
at least a portion of the apparatus contacts, when the light is
administered, a region of the patient's alveolar soft tissue on
which surgery is intended to be performed. In some embodiments, the
method also includes allowing a heavy force to be exerted on one or
more teeth of the patient, who is in need thereof. When applicable,
light can be administered before, during or after the heavy force
is exerted. In some embodiments, the methods further comprise
performing oral surgery on the oral tissue. The oral surgery can be
performed prior to or subsequent to the administration of light
treatment according to the present methods. In some embodiments,
the region of light administration can be the alveolar bone or the
alveolar soft tissue. In some embodiments, the administration
occurs for about 20 minutes. In some embodiments, the wavelength of
administered light is about 625 nm. In some embodiments, the light
may be administered following oral surgery, prior to oral surgery,
or during oral surgery.
[0362] In other embodiments, the invention relates to methods for
healing dental implants, for example, endosseous dental implants,
or accelerating osseo-integration of endosseous dental implants,
comprising administering an effective amount of light to a patient,
wherein the effective amount of light is irradiated from the
emitter of an apparatus of the invention. In some embodiments, at
least a portion of the apparatus contacts the alveolar soft tissue
when the light is administered. In some embodiments, the methods
further comprise allowing a heavy force to be exerted on one or
more teeth of the patient who is in need thereof. When applicable,
light can be administered before, during or after the heavy force
is exerted. In one embodiment, these methods can be performed
according to the teachings disclosed herein for the methods for
regulating tooth movement.
[0363] In some embodiments, the present methods can further
comprise applying a substance to a region, such as an oral region,
e.g., the alveolar soft tissue, or in the proximity of a region,
before, during, or after the administration of light. The substance
can be applied before, during, or after the intra-oral apparatus is
within the mouth of the patient. In some embodiments the methods do
not comprise applying a substance to a region, or in the proximity
of a region, before, during, or after the administration of light,
or before, during, or after the exertion of heavy forces. In some
instances, a substance can already occur at a region naturally. The
substance can enhance or inhibit the effects of the light
administration. In one embodiment, the substance can be a
visible-light- or infrared-light-absorbing substance, such as a
dye. One or more light characteristics, such as wavelength, can be
selected in response to the presence or application of the
substance.
[0364] One aspect of the invention provides for a light treatment
kit comprising an intra-oral light-therapy apparatus as described
herein and instructions for use in the present methods. The kit can
further comprise a light source that is separate from the
intra-oral light-therapy apparatus. The separate light source
and/or the light sources of the intra-oral light-therapy apparatus
can be removable and disposable, so that they can be easily
replaced after a given amount of use. In some embodiments, a
light-therapy apparatus and separate light sources can be
individually packaged or can be packaged together. The separate
light source can operate in conjunction with the light sources of
the intra-oral light-therapy apparatus to aid in light
administration. The separate light sources can emit light in any
manner described herein and can further have any wavelength of
characteristic described herein.
[0365] The kit can also comprise a programmable controller as
described herein. The kit can further comprise any components
useful for the controller to operate. For example, the kit can
comprise a component to power the controller or the intra-oral
light-therapy apparatus. The kit can also comprise a component that
allows the controller to operably connect with an intra-oral
light-therapy apparatus.
[0366] The kit can also comprise software, an algorithm, or a set
of computer readable media that can provide instructions to a
controller. The software, algorithm, or set of computer readable
media can be provided on a memory medium. The memory medium can be
a removable or portable, such as a CD, USB flash drive, or external
hard drive
[0367] The kit can be conveniently packaged and can be commercially
available. The kit can also include written instructions for use or
maintenance of items therein.
Example 1
[0368] A male adult patient's Vitamin D3 blood-serum level is
measured during his routine orthodontic-examination and -records
appointment. Laboratory results indicate that the patient's vitamin
D3 serum levels are at 20 ng/ml, which is considered to be
deficient and abnormal. The patient's orthodontic diagnosis is
Class I mild crowding with 4 mm of crowding on the upper arch and 4
mm on the lower arch. An orthodontic treatment plan is formulated
to include the installation of a fixed orthodontic appliance with
some mild expansion of the upper and lower arches.
[0369] The patient self-administers oral oil-based vitamin D3
capsules at an amount of 6000 IU per day for 3 months to increase
and normalize his vitamin D3 serum levels. Laboratory serum testing
is optionally performed again after 3 months of vitamin D3
supplementation. The patient maintains or adjusts his oral dose of
vitamin D3 based on his subsequent lab results.
[0370] Orthodontic treatment is started either after the 3 month
period or within three months prior. The orthodontic treatment
includes conventional fixed orthodontic brackets and bands placed
on the patient's teeth using an initial 0.016 inch NiTi wire tied
in place with silicone ligatures. Light is administered to the
patient on a daily basis for 20 minutes at an intensity of 50
mW/cm2 at wavelength of about 850 nm using an intra-oral light
therapy apparatus, such as the one shown in FIG. 1. The orthodontic
treatment continues with the finishing of teeth once the arches
have been expanded. It is believed that the active orthodontic
treatment would be completed in 50% to 75% less time than
orthodontic treatment without light therapy due to the combination
of daily administration of light and vitamin D3
supplementation.
[0371] At a passive stage of orthodontic treatment, i.e., retention
phase, a fixed retention orthodontic appliance can be installed on
the patient's teeth. In one embodiment, a Hawley retainer, which is
a removable appliance that is designed to maintain tooth position
of the anterior teeth, is installed on a patient's anterior teeth.
In some embodiments, a fixed retainer appliance, such as one
including orthodontic brackets, is bonded to the lower 6 anterior
teeth. The patient continues with vitamin D3 supplementation. In
some examples, the patient self-administers 2000 IU per day to
12,000 IU orally per day. The dosage can be determined based on
vitamin D blood serum levels which can be measured periodically to
determine dosing. As a result, alveolar bone density around the
teeth can be increased during the passive stage. During the passive
stage, the patient is administered once per week with light having
a wavelength of about 625 nm using an intra-oral light therapy
apparatus, such as the light therapy apparatus shown in FIG. 1
and/or FIG. 6, in areas of the upper and lower arch.
Example 2
[0372] In one study, a maxillary anterior intra-oral (MAIO) device,
shown and described with respect to FIG. 38, was used during the
alignment phase of orthodontic treatment to irradiate the maxillary
anterior teeth of three (3) patients. For example, the MAIO device
included an intra-oral housing with a light-emitting panel (e.g., a
fabric panel) embedded in, or otherwise coupled to or disposed on,
buccal and lingual/palatial flanges of the intra-oral housing, and
a LED light source disposed exterior to the mouth of the patient.
Each patient was provided with his or her own MAIO device, which
was used in conjunction with a conventional buccal fixed
orthodontic bracket treatment protocol. The treatment and results
of three of the patients--Patient A, Patient B, and Patient C--are
discussed in detail herein.
[0373] During the study, the MAIO device was used by each patient
every day until he or she achieved an LII value of 1 mm or less.
When in use, the MAIO device contacted each patient's maxillary
alveolar soft tissue and irradiated the tissue with light having a
wavelength of about 850 nm for about six minutes per day.
[0374] During the study, the patients visited a clinician every two
(2) weeks. At each visit, the clinician performed regular
orthodontic procedures, collected data that included intra-oral
photographs and study models, recorded patient compliance and
checked the functionality of the MAIO device. To assess the
effectiveness of the treatment, the clinician used the LII grading
system to score the model produced at each appointment. MAIO light
therapy continued every day until the clinician determined that the
patient's LII score decreased to 1 mm or less.
[0375] Patients were selected for participation in this study based
on, at least, the following criteria: (1) the patient was eligible
for full mouth fixed orthodontic treatment of the upper arch to
correct crowding, misalignment and rotated teeth; (2) a presence of
permanent dentition (i.e., permanent, or adult, teeth); (3) the
upper-arch teeth had an LII from 5 mm to 12 mm, provided that no
tooth was blocked out of alignment; and (4) the patient was from 12
to 45 years old. The following types of individuals were excluded
from this study: (1) pregnant women; (2) individuals enrolled in
another study with periodontally involved teeth; (3) individuals
who use bisphosphonates; or (4) individuals with any compromised
dental or medical conditions.
[0376] Patient A
[0377] Patient A is a thirteen (13)-year-old female who wore SPEED
System.TM. brackets and 0.016 inch Supercable nickel titanium wires
during the alignment phase of her orthodontic treatment. On day 1
of the study, Patient A's upper-arch LII was about 5.1 mm. FIG. 39
is a photograph of Patient A's upper arch on day 1 of the study.
After only 30 days of using the MAIO device for light treatment in
combination with the SPEED System.TM. brackets and the wires,
Patient A's LII was reduced to 0.5 mm. The rate of Patient A's
tooth movement during that period was about 1.07 mm/week. FIG. 40
is a photograph showing the corrected orientation of the teeth in
Patient A's upper arch on day 30 of the study.
[0378] Comparison to Control
[0379] The results for Patient A were compared to those from a
13-year-old control patient who also wore SPEED System.TM. brackets
and 0.016 inch Supercable nickel titanium wires during the
alignment phase of her orthodontic treatment, but who did not
receive light therapy. The control patient had an upper-arch LII of
about 5.2 mm on day 1. In contrast to the tooth-movement time for
Patient A, it took 78 days for the control patient's upper-arch LII
to reduce to 1 mm or less. The rate of the control patient's tooth
movement during that period was only about 0.42 mm/week.
[0380] Patient B
[0381] Patient B is also a thirteen (13)-year-old female who wore
SPEED System.TM. brackets and 0.016 inch Supercable nickel titanium
wires during the alignment phase of her orthodontic treatment. On
day 1 of the study, Patient B's upper-arch LII was about 9.3 mm.
FIG. 41 is a photograph of Patient B's upper arch on day 1 of the
study. After only 41 days of using the MAIO device for light
treatment in combination with the SPEED System.TM. brackets and the
wires, Patient B's LII was reduced to 0.8 mm. The rate of Patient
B's tooth movement during that period was about 1.45 mm/week. FIG.
42 is a photograph showing the corrected orientation of the teeth
in Patient B's upper arch on day 41 of the study.
[0382] Comparison to Control
[0383] The results for Patient B were compared to those from a
similar-age, control patient who also wore SPEED System.TM.
brackets and 0.016 inch Supercable nickel titanium wires during the
alignment phase of orthodontic treatment, but who did not receive
light therapy. The control patient had an upper-arch LII of about
8.8 mm on day 1. In contrast to the tooth-movement time for Patient
B, it took 129 days for the control patient's upper-arch LII to
reduce to 0.3 mm. The rate of the control patient's tooth movement
during that period was only about 0.46 mm/week.
[0384] Patient C
[0385] Patient C is an eighteen (18)-year-old male who wore
In-Ovation L Straightwire system brackets and both 0.012 inch and
0.016 inch nickel titanium wires during the alignment phase of his
orthodontic treatment. On day 1 of the study, Patient C's
upper-arch LII was about 5.02 mm. After only 42 days of using the
MAIO device for light treatment in combination with the In-Ovation
L Straightwire system and the wires, Patient C's LII was reduced to
zero. The rate of Patient C's tooth movement during that period was
about 0.84 mm/week.
Example 3
[0386] In one study, a maxillary anterior intra-oral (MAIO) device,
shown and described with respect to FIG. 45, was used during the
alignment phase of orthodontic treatment to irradiate the maxillary
anterior teeth of two (2) patients. For example, the MAIO device
included an intra-oral housing with LEDs mounted on a flexible
circuit and embedded in, or otherwise disposed on or coupled to,
soft flexible buccal flanges of the intra-oral housing. Each
patient was provided with his or her own MAIO device, which was
used in conjunction with a conventional buccal fixed orthodontic
bracket treatment protocol. The treatment and results of the four
patients--Patient D, Patient E, Patient F, and Patient G--are
discussed in detail herein. During the study, each patient wore
0.018 slot Mini-Diamond.RTM. brackets (obtained commercially from
Ormco Corporation, Orange, Calif.). The brackets were aligned with
(a) 0.014 or 0.016 inch nickel titanium wire, (b) 0.016 inch by
0.016 inch (also referred to as "16.times.16") nickel titanium
wire, (c) 0.016 inch by 0.016 inch (also referred to as
"16.times.16") stainless steel or 0.016 inch by 0.022 inch (also
referred to as "16.times.22") nickel titanium wire, and/or (d)
0.016 inch by 0.022 inch (also referred to as "16.times.22")
stainless steel wire.
[0387] During the study, the MAIO device was used by each patient
every day until he or she achieved an LII value of 1 mm or less,
with no contact point greater than 0.25 mm. When in use, the MAIO
device irradiated the tissue with light having a wavelength of
about 850 nm (.+-.5 nm).
[0388] During the study, the patients visited a clinician every two
(2) to three (3) weeks. At each visit, the clinician performed
regular orthodontic procedures, collected data that included
intra-oral photographs and study models, recorded patient
compliance and checked the functionality of the MAIO device. To
assess the effectiveness of the treatment, the clinician used the
LII grading system to score the model produced at each appointment.
MAIO light therapy continued every day until the clinician
determined that the patient's LII score decreased to 1 mm or less,
with no contact point greater than 0.25 mm. The clinician also
collected dental impressions and models at T.sub.0, which
represents the day of maxillary bonding, start of orthodontic
treatment, date of patient assignment of the MAIO device, and start
of the patient's daily usage of the MAIO device, and at T.sub.1,
which represents the day at which the clinician determined the
patient achieved an LII value of 1 mm or less, with no contact
point greater than 0.25 mm.
[0389] Patients were selected for participation in this study based
on, at least, the following criteria: (1) the patient was eligible
for full mouth fixed orthodontic treatment of the upper arch to
correct crowding, misalignment and rotated teeth; (2) a presence of
permanent dentition (i.e., permanent, or adult, teeth); (3) the
upper-arch teeth had an LII from 5 mm to 12 mm, provided that no
tooth was blocked out of alignment; and (4) the patient was from 12
to 45 years old. The following types of individuals were excluded
from this study: (1) pregnant women; (2) individuals enrolled in
another study with periodontally involved teeth; (3) individuals
who use bisphosphonates; or (4) individuals with any compromised
dental or medical conditions.
[0390] Patient D
[0391] Patient D is a twelve (12)-year-old (specifically, a
12.8-year-old) male. For any age herein that is represented to the
nearest tenth, indicates the age in years and fraction of the year.
For example, Patient D is 12 years and 8/10 of a year old. On day 1
(i.e., T.sub.0) of the study, Patient D's upper-arch LII was about
5.7 mm. Light therapy was administered for about three minutes per
dental arch per day, and at a light output intensity of about 67
mW/cm.sup.2. The patient received a light therapy dose of 12.1
J/cm.sup.2 per day. After only 17 days of using the MAIO device for
light treatment in combination with the Mini-Diamond.RTM. brackets
and the wires, Patient D's LII was reduced to 0 mm. The rate of
Patient D's tooth movement during the study period was about 2.35
mm/week.
[0392] Patient E
[0393] Patient E is a twelve (12)-year-old (specifically, a
12.6-year-old) female. On day 1 of the study, Patient E's
upper-arch LII was about 6.0 mm. Light therapy was administered for
about three minutes per dental arch per day, and at a light output
intensity of about 70 mW/cm.sup.2. The patient received a light
therapy dose of 12.6 J/cm.sup.2 per day. After only 21 days of
using the MAIO device for light treatment in combination with the
Mini-Diamond.RTM. brackets and the wires, Patient E's LII was
reduced to 0 mm. The rate of Patient E's tooth movement during the
study period was about 2.0 mm/week.
[0394] Patient F
[0395] Patient is a thirteen (13)-year-old (specifically, a
13.2-year-old) female. On day 1 of the study, Patient F's
upper-arch LII was about 3.6 mm. Light therapy was administered for
about three minutes per dental arch two times per day, and at a
light output intensity of about 61 mW/cm.sup.2 (e.g., 61.04
mW/cm.sup.2). After only 39 days of using the MAIO device for light
treatment in combination with the Mini-Diamond.RTM. brackets and
the wires, Patient F's LII was reduced to 0 mm. The rate of Patient
F's tooth movement during the study period was about 0.65 mm/week.
It is noted that the patient missed a scheduled visit with the
clinician at twenty-one (21) days, which may have resulted in the
foregoing alignment rate being significantly underestimated.
[0396] Patient G
[0397] Patient G is a fourteen (14)-year-old (specifically, a
14.3-year-old) male. On day 1 of the study, Patient G's upper-arch
LII was about 12.1 mm. Light therapy was administered for about
three minutes per day, and at a light output intensity of about 78
mW/cm.sup.2. After only 49 days of using the MAIO device for light
treatment in combination with the Mini-Diamond.RTM. brackets and
the wires, Patient G's LII was reduced to 0 mm. The rate of Patient
G's tooth movement during the study period was about 1.73
mm/week.
[0398] Comparison to Controls
[0399] The results for Patients D, E, F and G were compared to
those from two control patients, identified here as Control A and
Control B. The control patients were selected, in part, for having
a similar age and initial LII of the upper-arch as Patients D and
E. The same clinician evaluated Patients D and E and Controls A and
B.
[0400] Control A is a 14-year-old female control patient who also
wore Mini-Diamond brackets and wires, as described herein, during
the alignment phase of her orthodontic treatment, but who did not
receive light therapy. Control A had an upper-arch LII of about 5.9
mm on day 1. In contrast to the tooth-movement time for Patients D,
E, F and G, it took 92 days for Control A's upper-arch LII to
reduce to 0 mm. The rate of the Control A's tooth movement during
that the study period was only about 0.45 mm/week.
[0401] Control B is an 11-year-old female who also wore
Mini-Diamond.RTM. brackets and wires, as described herein, during
the alignment phase of her orthodontic treatment, but who did not
receive light therapy. Control B had an upper-arch LII of about 6.6
mm on day 1. In contrast to the tooth movement time for Patients D,
E, F and G, it took 105 days for Control B's upper-arch LII to
reduce to 1 mm or less (i.e., Control B's LII reduced to 0.7 mm).
The rate of Control B's tooth movement during the study period was
only about 0.39 mm/week.
[0402] The control group had a mean rate of tooth movement of about
0.50 mm (e.g., 0.49 mm) per week, which was determined based, at
least in part, on multi-center pooled data of alignment rates for
control patients showed a rate of tooth movement of about 0.50
mm/week. In comparison, the mean rate of tooth movement during the
study period for Patients D, E, F and G was about 1.67 mm per week,
which is about 3.34 (or about 3.4, based on the mean rate of 0.49
mm per week) times greater than expected based on the rate of tooth
movement of the control patients.
[0403] While various embodiments of the invention have been
described herein, it should be understood that they have been
presented by way of example only, and not limitation. For example,
although apparatus (e.g., apparatus 2100) have been described
herein as including a gyroscope, in other embodiments, an apparatus
can include any suitable mechanism for detecting tilt and/or
spatial orientation of the apparatus such that the mechanism can
help determine whether the apparatus is in an upright or inverted
position. In another example, although apparatus (e.g., apparatus
2100) have been illustrated and described herein as including an
intra-oral housing configured to be positioned within the patient's
mouth selectively with respect to the upper jaw and the lower jaw,
in other embodiments, an apparatus includes an intra-oral housing
with upper and lower flanges, each including an LED array coupled
to or embedded therein. In this manner, the apparatus is configured
to concurrently administer light therapy with respect to the upper
and lower jaws. Where schematics and/or embodiments described
herein indicate certain components arranged in certain orientations
or positions, the arrangement of components may be modified, unless
the context clearly indicates otherwise. Similarly, where methods
and/or events described above indicate certain events and/or
procedures occurring in certain order, the ordering of certain
events and/or procedures may be modified, unless the context
clearly indicates otherwise. Although various embodiments have been
described as having particular features and/or combinations of
components, other embodiments are possible having a combination of
any features and/or components from any of embodiments where
appropriate.
* * * * *
References