U.S. patent application number 11/271283 was filed with the patent office on 2006-05-11 for dental whitening systems.
This patent application is currently assigned to Discus Dental Impressions, Inc.. Invention is credited to Angela Jinmin Lee, Jeff MacDonald, Nancy N. Quan.
Application Number | 20060099155 11/271283 |
Document ID | / |
Family ID | 36096109 |
Filed Date | 2006-05-11 |
United States Patent
Application |
20060099155 |
Kind Code |
A1 |
MacDonald; Jeff ; et
al. |
May 11, 2006 |
Dental whitening systems
Abstract
A system and method for tooth whitening are disclosed wherein at
least one peroxide-containing gel and at least one transition metal
compound-containing gel, particularly at least one lower atomic
number transition metal compound, more particularly at least a
ferrous compound including gluconate, sulfate, nitrate, acetate or
mixtures thereof, are applied to a patient's mouth. Gelling agent
is also included. The activation of the peroxide whitens the
patient's teeth. The system may be used with or without the
application of light. The system further provides an additional gel
including a sensitivity reduction compound including potassium
nitrate, sodium nitrate or mixtures thereof for possible
sensitivity treatment if needed.
Inventors: |
MacDonald; Jeff; (Pomona,
CA) ; Jinmin Lee; Angela; (Glendale, CA) ;
Quan; Nancy N.; (North Hills, CA) |
Correspondence
Address: |
DISCUS DENTAL IMPRESSIONS, INC.
8550 HIGUERA STREET
CULVER CITY
CA
90232
US
|
Assignee: |
Discus Dental Impressions,
Inc.
|
Family ID: |
36096109 |
Appl. No.: |
11/271283 |
Filed: |
November 9, 2005 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
60626407 |
Nov 9, 2004 |
|
|
|
60631121 |
Nov 26, 2004 |
|
|
|
60643309 |
Jan 13, 2005 |
|
|
|
60653421 |
Feb 15, 2005 |
|
|
|
Current U.S.
Class: |
424/53 |
Current CPC
Class: |
A61K 8/60 20130101; A61Q
11/00 20130101; A61K 8/22 20130101; A61K 2800/88 20130101; A61C
19/066 20130101; A61K 8/19 20130101 |
Class at
Publication: |
424/053 |
International
Class: |
A61K 8/22 20060101
A61K008/22 |
Claims
1. A two-component dental whitening system comprising: a first gel
comprising at least one peroxide; and a second gel comprising an
orally compatible Activator Gel comprising at least one transition
metal salt; wherein said Activator Gel catalyzes the decomposition
of the peroxide.
2. The dental whitening system of claim 1, wherein the peroxide
content is provided in an amount from about 5% by weight to about
35% by weight of the peroxide-containing gel.
3. The dental whitening system of claim 1 wherein said transition
metal is a lower atomic number transition metal of from about 21 to
30.
4. The dental whitening system of claim 3, wherein said transition
metal is selected from the group consisting of iron, manganese,
cobalt, copper and mixtures thereof.
5. The dental whitening system of claim 1 wherein said transition
metal is present in an amount from about 0.01% by weight to about
4% by weight of the Activator Gel component.
6. The dental whitening system of claim 1 wherein said
peroxide-containing gel and said Activator Gel each further
comprises a non-ionic surfactant.
7. The dental whitening system of claim 6 wherein said non-ionic
surfactant comprises a block copolymer.
8. The dental whitening system of claim 6 wherein said non-ionic
surfactant comprises a hydrophobic block component hydrophobic
component and a hydrophilic block component.
9. The dental whitening system of claim 8 wherein said non-ionic
surfactant comprises a ethylene oxide block and a propylene oxide
block.
10. The dental whitening system of claim 8 wherein said non-ionic
surfactant is present from about 15% to about 45% by weight in the
peroxide-containing gel and from about 15% to about 30% by weight
in the Activator Gel.
11. The dental whitening system of claim 1 wherein said
peroxide-containing gel further comprises at least one ingredient
selected from the group consisting of a source of calcium, a
gelling agent, an aliphatic polyol, a gel stabilizing agent, a
foaming agent, glycerine, water and mixtures thereof.
12. The dental whitening system of claim 11 wherein said source of
calcium is present in an amount of from about 0.25% by weight to
about 1.5% by weight.
13. The dental whitening system of claim 11 wherein said Activator
Gel further comprises a source of phosphate.
14. The dental whitening system of claim 11 wherein said gel
stabilizer is selected from the group consisting of potassium
nitrate, sodium salts such as sodium nitrate, vitamin E oil, anise,
eugenol, natural mint flavors and mixtures thereof.
15. The dental whitening system of claim 1 wherein said system is
foamable.
16. The dental whitening system of claim 13 wherein said source of
phosphate is selected from the group consisting of monosodium
phosphate, disodium phosphate and mixtures thereof.
17. The dental whitening system of claim 1 wherein said Activator
Gel further comprises at least one ingredient selected from the
group consisting of a source of phosphate, a gelling agent, an
aliphatic polyol, a foaming agent, a gel stabilizing agent,
glycerine, water and mixtures thereof.
18. A foamable two-component dental whitening composition
comprising: a first gel comprising at least one peroxide; and an
orally compatible Activator Gel comprising at least one ferrous
salt and at least one foaming agent; wherein the two components
combine to form a foam having a half life of from about 10 to about
120 minutes.
19. The foamable two-component dental whitening composition of
claim 18 wherein said peroxide-containing gel further comprises at
least one ingredient selected from the group consisting of a source
of calcium, aliphatic polyol, gel stabilizer, a foaming agent,
glycerine, water and mixtures thereof.
20. The foamable two-component dental whitening system of claim 19
wherein said source of calcium is present in an amount of from
about 0.25% by weight to about 1.5% by weight.
21. The foamable two-component dental whitening system of claim 19
wherein said Activator Gel further comprises a source of
phosphate.
22. The foamable two-component dental whitening system of claim 19
wherein said gel stabilizer is selected from the group consisting
of potassium nitrate, sodium salts such as sodium nitrate, vitamin
E oil, anise, eugenol, natural mint flavors and mixtures
thereof.
23. The foamable two-component dental whitening system of claim 21
wherein said source of phosphate is selected from the group
consisting of monosodium phosphate, disodium phosphate and mixtures
thereof.
24. The foamable two-component whitening system of claim 1 wherein
said Activator Gel further comprises at least one ingredient
selected from the group consisting of a source of phosphate,
glycol, aliphatic polyol, gel stabilizer, glycerine, water and
mixtures thereof.
25. A two-component dental whitening system comprising: a first gel
comprising at least one peroxide; and an orally compatible
Activator Gel comprising at least one ferrous salt; wherein said
Activator Gel catalyzes the decomposition of the peroxide.
26. The two-component dental whitening system of claim 25 wherein
said ferrous salt is selected from the group consisting of ferrous
gluconate, ferrous sulfate, ferrous nitrate, ferrous acetate and
mixtures thereof.
27. The two-component dental whitening system of claim 25 wherein
said ferrous salt is present in an amount from about 0.001 to about
4% by weight.
28. The two-component dental whitening system of claim 25 wherein
said peroxide-containing gel comprises a total peroxide content of
from about 10 to about 20% by weight.
29. The two-component dental whitening system of claim 25 further
comprising at least one component selected from the group
consisting of a gelling agent, a source of calcium, a source of
phosophate, a gel stabilizing agent, glycerine, an aliphatic
polyol, water and mixtures thereof.
30. The two-component dental whitening system of claim 29 wherein
said gelling agent comprises a non-ionic surfactant.
31. The two-component dental whitening system of claim 30 wherein
said non-ionic surfactant comprises a hydrophobic block component
hydrophobic component and a hydrophilic block component.
32. The two-component dental whitening system of claim 25 wherein
said system is foamable.
33. The two-component dental whitening system of claim 28 wherein
said whitening system is light activatable.
34. A light-activatable 2-component dental whitening system
comprising: a first gel comprising from about 5% to about 35% to by
weight of at least one peroxide; and an orally compatible Activator
Gel comprising from about 0.01% to about 4% by weight of at least
one ferrous salt; wherein said Activator Gel catalyzes the
decomposition of the peroxide in the presence of light.
35. The light-activatable 2-component dental whitening system of
claim 34 further comprising at least one component selected from
the group consisting of a gelling agent, a source of calcium, a
source of phosphate, a gel stabilizing agent, a foaming agent, a pH
adjusting agent, glycerine, an aliphatic polyol, water and mixtures
thereof.
36. The light-activatable 2-component dental whitening system of
claim 34 wherein said peroxide gel comprises: about 15 to about 45%
by weight of at least one non-ionic surfactant comprising a
hydrophobe and a hydrophile; from about 0.25% to about 1.5% of at
least one calcium salt; from about 1 to about 5% by weight of at
least one aliphatic polyol; and from about 0.25% to about 5% of at
least one gel stabilizer selected from the group consisting of
potassium nitrate, sodium salts such as sodium nitrate, vitamin E
oil, anise, eugenol, natural mint flavors and mixtures thereof; and
wherein said orally compatible Activator Gel comprises: from about
and at least about 15 to about 30% by weight of a non-ionic
surfactant comprising a hydrophobe and a hydrophile; from about 0.5
to about 5% by weight of a source of phosphate; from about 5 to
about 20% by weight of at least one glycol; and from about 2 to
about 15% by weight of at least one aliphatic polyol.
37. The light-activatable 2-component dental whitening system of
claim 34 wherein said system is foamable.
38. The light-activatable 2-component dental whitening system of
claim 34 wherein said whitening system shortens the time to produce
the same whitening effect for an identical or higher peroxide
content whitening composition without the transition metal salt in
the Activator Gel by at least about 15%.
39. The two-component dental whitening system of claim 34 wherein
said ratio of the peroxide-containing gel component to the
compatible Activator Gel component is from about a 1:2 to a
5:1.
40. The two-component dental whitening system of claim 34 wherein
said peroxide-containing gel component and said compatible
Activator Gel component are packaged in a double-barreled
syringe.
41. The two-component dental whitening system of claim 34 wherein
said gel is substantially free of an abrasive.
42. The two-component dental whitening system of claim 1 wherein
said whitening system shortens the time to produce the same
whitening effect for an identical peroxide content whitening
composition without the transition metal salt in the Activator Gel
by about 15%.
43. The two-component dental whitening system of claim 1 wherein
said ratio of the peroxide-containing gel component to the
compatible Activator Gel component is from about a 1:2 to a
5:1.
44. The two-component dental whitening system of claim 1 wherein
said peroxide-containing gel component and said compatible
Activator Gel component are packaged in a double-barreled
syringe.
45. The foamable two-component dental whitening system of claim 18
wherein said whitening system shortens the time to produce the same
whitening effect for an identical peroxide content whitening
composition without the transition metal salt in the Activator Gel
by about 15%.
46. The foamable two-component dental whitening system of claim 18
wherein said ratio of the peroxide-containing gel component to the
compatible Activator Gel component is from about a 1:2 to a
5:1.
47. The foamable two-component dental whitening system of claim 18
wherein said peroxide-containing gel component and said compatible
Activator Gel component are packaged in a double-barreled
syringe.
48. The two-component dental whitening system of claim 25 wherein
said whitening system shortens the time to produce the same
whitening effect for an identical peroxide content whitening
composition without the transition metal salt in the Activator Gel
by about 15%.
49. A system of teeth whitening with sensitivity relief,
comprising: a two-component whitening gel comprising: a first gel
comprising at least one peroxide; an orally compatible Activator
Gel comprising at least one transition metal salt that catalyzes
the whitening action of the peroxide to produce effective whitening
at typical or lower peroxide concentrations; and a one-component
viscous gel comprising between about 3% to about 5% by weight of
potassium nitrate and a source of fluoride ion at a concentration
of up to about 1000 ppm, said gel having a viscosity comparable to
that of the two-component whitening gel.
50. The dental whitening system of claim 49 wherein said
two-component whitening gel is foamable.
51. The dental whitening system according to claim 49, further
comprising at least one ingredient selected from the group
consisting of a gelling agent, a source of calcium, a source of
phosophate, a gel stabilizing agent, a foaming agent, a pH
adjusting agent, glycerine, an aliphatic polyol, water and mixtures
thereof.
52. The dental whitening system according to claim 49 further
comprising amorphous calcium phosphate.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
patent application Ser. No. 60/626,407, filed Nov. 9, 2004,
entitled "Tooth Whitening Compositions"; 60/631,121, filed Nov. 26,
2004, entitled "Whitening System"; 60/643,309, filed Jan. 22, 2005
entitled "Dental Whitening"; and 60/653,421, filed Feb. 15, 2005,
entitled "Whitening System Capable of Effective Whitening Action";
the contents of which are hereby incorporated by reference.
FIELD OF INVENTION
[0002] This invention relates to tooth whitening compositions. More
particularly, this invention relates to a two-component tooth
whitening system.
BACKGROUND OF INVENTION
[0003] A tooth is composed of an inner dentin layer an inner dentin
layer and outer hard enamel that is coated with a protective layer
called the acquired pellicle. The enamel layer of a tooth is
composed of hydroxyapatite mineral crystals that create a somewhat
porous surface. The pellicle or the enamel may become stained or
discolored. It is believed that this porous nature of the enamel
layer is what allows staining agents and discolor substances to
permeate the enamel and discolor the tooth.
[0004] Many substances that a person's teeth confront or come in
contact with on a daily basis can "stain" or reduce the "whiteness"
of one's teeth. In particular, food products, tobacco products and
fluids such as tea and coffee that one consumes tend to stain one's
teeth. These staining and discoloring substances can then permeate
the enamel and causing noticeable discoloration of one's teeth.
[0005] One solution to this problem is through tooth bleaching.
Some dentrifices, like toothpastes, gels, and powders, contain
active oxygen or hydrogen peroxide liberating bleaching agents
including peroxides, percarbonates and perborates of the alkali and
alkaline earth metals or complex compounds containing hydrogen
peroxide.
[0006] Commonly used dental bleaching agent include hydrogen
peroxide, carbamide peroxide (CO(NH.sub.2).sub.2H.sub.2O.sub.2), or
urea hydrogen peroxide, hydrogen peroxide carbamide, and
perhydrol-urea. Carbamides and hydrogen peroxides are used in
over-the-counter compositions as well as bleaching gels are
dispensed by dentists and commonly dispensed ones include those
containing hydrogen peroxide (available as "DayWhite" from Discus
Dental, Inc.) and those containing a mixture of hydrogen peroxide
and carbamide peroxide (available as "NiteWhite", also from Discus
Dental, Inc.).
[0007] Some prior art discloses the use of concentrated
carboxypolymethylene compositions for producing a matrix material
having a sufficiently high viscosity, low solubility in saliva, and
is sufficiently tacky to retain and hold a dental tray positioned
over the patient's teeth for a period greater than about 2 hours
without any significant mechanical pressure from the dental tray so
as to provide for the dental bleaching agent to be in contact with
the tooth surfaces thereby providing bleaching of the tooth
surfaces.
[0008] The amount of whitening obtained during tooth bleaching is
dependent upon (1) the length of time each day the tray is worn;
(2) the number of days the tray is worn; (3) the susceptibility of
the teeth to the bleaching agent and (4) concentration of active
peroxide. For maximum whitening, an accelerated treatment time of
approximately 18-20 hours per day is recommended.
[0009] One concern with some bleaching compositions is the
prolonged period that is needed for effective bleaching. Another is
the highly concentrated bleaching agents present in the
composition. Both of these can contribute to tooth sensitivity
following treatment. Accordingly, there is a need for a dental
bleaching composition that has improved whitening action with
normal or reduced amounts of bleaching agent and can produce
effective bleaching at shorter times.
SUMMARY OF THE INVENTION
[0010] The present invention discloses a two-component dental
whitening system, a first component includes at least one peroxide
compound, and a second component includes an orally compatible
Activator including at least one transition metal compound. The
transition metal compound catalyzes the whitening action of the
peroxide compound to produce improved whitening at typical to lower
peroxide concentrations.
[0011] The present invention also discloses a two-component dental
whitening system, a first gel component includes at least one
peroxide compound and a second component includes an orally
compatible Activator Gel including at least one lower oxidative
state transition metal compound. The metal compound catalyzes the
whitening action of the peroxide compound to produce faster
effective whitening at lower peroxide concentrations.
[0012] The present invention further discloses a two-component
dental photobleaching system, a first gel component includes at
least one peroxide compound and a second component includes an
orally compatible Activator Gel including at least one lower
oxidative state transition metal compound. The metal compound
catalyzes the whitening action of the peroxide to produce faster
effective whitening at typical or lower peroxide concentrations
upon irradiating with light.
[0013] In one aspect of the invention, the peroxide compound is
present, for example, from about 5% by weight to about 35% by
weight of the first gel component.
[0014] In another aspect of the invention, the ratio of the
Activator Gel component is, for example, from about a 1:2 to a
5:1.
[0015] In another aspect of the invention, the two components of
the system may be provided in a two barrel syringe. In one
embodiment, the syringe may be provided with a dispensing tip. In
another embodiment, the dispensing tip is adapted for foaming. In a
further embodiment, the tip may include a mixer.
[0016] In a further aspect of the invention, the transition metal
compound is present at a concentration of from about 0.01% by
weight to about 4% by weight of the Activator Gel component.
[0017] Any of the composition disclosed above may be in an
unfoamed, foam or foamable state, all capable of delivering faster
whitening action.
[0018] The present invention even further discloses a 2-component
foamable composition having a first component including at least
one peroxide compound; and a second component including an orally
compatible Activator Gel including at least one transition metal
compound and at least one foaming agent; wherein the two components
combine to form a foam having a half life of at least about 10
minutes.
[0019] The transition metal compound catalyzes the whitening action
of the peroxide to produce improved whitening at typical to lower
peroxide concentrations.
[0020] In one embodiment, the 2-component foamable composition
includes a first component including at least one peroxide compound
in an aqueous solution; and a second component including at least
one transition metal compound and at least one foaming agent in
solid form.
[0021] In another embodiment, the 2-component foamable composition
includes a first component including at least one peroxide compound
in an aqueous solution and at least one peroxide stabilizer in the
form of an ion scavenger; and a second component including at least
one foaming agent and at least one transition metal compound
peroxide activator; wherein said activator promotes the rapid
decomposition of the peroxide compound and additional foaming
action not related to the foaming agent.
[0022] Additionally, the present invention includes a
light-activatable, 2-component foamable composition having a first
component including at least one peroxide compound; and a second
component including at least one foaming agent and one lower
oxidative state transition metal compound; wherein the two
components combine to form a foam having a half life of at least
about 10 minutes.
[0023] The present invention still further includes a
one-component, multi-phase, foamable composition including at least
one peroxide compound in an aqueous phase and at least one
transition metal compound and at least one foaming agent in an oil
phase, wherein the two phases combine to form a foam having a half
life of at least about 10 minutes.
[0024] In one aspect, a remineralizing agent may be present in any
of the above compositions, to aid in remineralizing and
de-sensitizing tooth or teeth.
[0025] The present invention additionally provides for a method for
using the two-component dental whitening system, including the
steps of:
[0026] (a) providing a first gel component including at least one
peroxide;
[0027] (b) providing an Activator Gel including at least one
transition metal compound capable of catalyzing the whitening
action of the peroxide gel;
[0028] (c) applying the peroxide gel and the Activator Gel onto the
teeth; and
[0029] (e) illuminating the teeth with light;
[0030] wherein said whitening system may be in an unfoamed, foamed
or foamable state.
[0031] Furthermore, the present invention provides for a system of
teeth whitening with sensitivity relief, including:
[0032] a two-component whitening gel inclduing a first component
gel includes at least one peroxide compound and a second component
includes an orally compatible Activator Gel including a transition
metal compound that catalyzes the whitening action of the peroxide
to produce effective whitening at typical or lower peroxide
concentrations; and [0033] a one-component viscous gel including
between about 3% to about 5% by weight of alkali metal salt, such
as potassium nitrate and a source of fluoride ion at a
concentration of up to about 1100 ppm, said gel having a viscosity
comparable to that of the two-component whitening gel.
[0034] The present invention together with the above and other
advantages may best be understood from the following detailed
description of the exemplary embodiments of the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0035] The detailed description set forth below is intended as a
description of the presently exemplified tooth whitening
composition provided in accordance with aspects of the present
invention and is not intended to represent the only forms in which
the present invention may be prepared or utilized. The description
sets forth the features and the steps for preparing and using the
tooth whitening compositions of the present invention. It is to be
understood, however, that the same or equivalent functions and
ingredients incorporated in the tooth whitening compositions may be
accomplished by different embodiments that are also intended to be
encompassed within the spirit and scope of the invention.
[0036] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood to one of
ordinary skill in the art to which this invention belongs. Although
any methods, devices and materials similar or equivalent to those
described herein may be used in the practice or testing of the
invention, the exemplified methods, devices and materials are now
described.
[0037] All publications mentioned herein are incorporated herein by
reference for the purpose of describing and disclosing, for
example, the compositions and methodologies that are described in
the publications which might be used in connection with the
presently described invention. The publications listed or discussed
above, below and throughout the text are provided solely for their
disclosure prior to the filing date of the present application.
Nothing herein is to be construed as an admission that the
inventors are not entitled to antedate such disclosure by virtue of
prior invention.
[0038] The coronal portion of the tooth consists of enamel, dentin
and the pulp. In the mouth of humans, the enamel is coated with an
acquired pellicle. The tooth structures that are generally
responsible for presenting a stained appearance are enamel, dentin,
and the acquired pellicle. Tooth enamel is predominantly formed
from inorganic material, mostly in the form of hydroxyapatite
crystals, and may further contain approximately 5% organic material
primarily in the form of collagen. In contrast, dentin is composed
of about 20% protein including collagen, the balance consisting of
inorganic material, predominantly hydroxyapatite crystals, similar
to that found in enamel. The acquired pellicle is a proteinaceous
layer or matrix that forms continuously over the surface of the
tooth. Although the acquired pellicle may be removed through
intensive mechanical cleaning, it quickly regenerates soon
thereafter.
[0039] Discoloration of teeth may result from intrinsic and/or
extrinsic staining. Intrinsic staining occurs when staining
compounds penetrate the enamel and even the dentin, or
alternatively, such staining arises from sources within the tooth.
Typically such staining may only be removed through chemical
methods of tooth cleaning.
[0040] As noted above, the amount of whitening obtained during
tooth whitening is generally dependent upon (1) the length of time
the teeth is in contact with the whitening agent; (2) the number of
days the treatment is carried out; (3) the susceptibility of the
teeth to the whitening agent and (4) concentration of active
peroxide. For maximum whitening, a long treatment time with a
highly concentrated whitening composition is generally recommended.
Such treatments usually take place in a dentist's office as highly
concentrated whitening compositions are not recommended for
unsupervised home use. However, extended treatment times are also
not amenable for office visits. Even treatments with concentrated
whitening compositions followed by irradiation with a light source
generally take more than an hour per visit to accomplish. For take
home treatments, a relatively low concentration of whitening
composition followed by extended hours of treatment time still do
not produce the same good results as office treatments.
[0041] The present inventors have invented a whitening composition
including a two-component dental whitening composition, including a
first gel including at least one peroxide compound (the "peroxide
gel"), and at least one transition metal compound containing gel
(the "Activator Gel") that catalyzes the whitening action. The
resulting composition has superior whitening properties at typical
or lower peroxide concentration.
[0042] The present invention is also directed to a two-component
dental whitening composition that generates faster effective
whitening at shorter whitening times when compared with other
photoactivatable whitening compositions.
[0043] The exemplary peroxide gel includes metal ion free peroxide
compounds. Examples of suitable metal ion free peroxide compounds
include hydrogen peroxide and organic peroxides including urea
peroxide (carbamide peroxide), glyceryl peroxide, benzoyl peroxide
and the like. In general, hydrogen peroxide, carbamide peroxide and
mixtures thereof are used, with hydrogen peroxide being the more
generally used. The total peroxide present in the gel, for example,
ranges form about 5% by weight to about 35% by weight of the
peroxide gel, more for example, from about 10% by weight to about
32% by weight of the peroxide gel, even more for example, from
about 12% by weight to about 25% by weight of the
peroxide-containing gel.
[0044] When hydrogen peroxide is used, it is usually provided as a
50% aqueous solution. When used alone, the amount ranges, for
example, from about 10% to about 60% (5% to 30% in the absence of
water), more for example, the amount ranges from about 20% to about
40% (10% to 20% in the absence of water).
[0045] On the other hand, when carbamide peroxide is used, it is,
for example, used in combination with hydrogen peroxide in an
amount from about 9% to about 20%, more for example, from about 5%
to about 16%. At the same time, if hydrogen peroxide is also
present, it is for example, provided as a 50% aqueous solution and
is generally present in an amount of from about 5% to about 50%
(2.5% to 25% in the absence of water).
[0046] As mentioned above, the composition of the present invention
may be an unfoamed, foamed or foamable composition. In general, a
foamed composition may include the same or higher peroxide
concentration as that present in an unfoamed composition. On the
other hand, a foamable composition may include a higher peroxide
concentration in the unfoamed state so that the concentration of
peroxide after foaming may be the same or higher than the level
present in a typical gel. For foamable compositions, the amounts of
peroxide noted above represent those in the foamed state.
[0047] Sequestering agents such as salts of ethylene diamine
tetraacetic acid, diethylene triamine pentaacetic acid,
phosphonates such as Dequest (trademark) available from Monsanto
Chemical Company and azacycloheptane 2',2' diphosphonate are
generally used as chelating agents to stabilize the peroxide
containing compositions by chelating metal ions such as Fe (III),
Mn(II), and Cu(II) that might be present in the peroxide-containing
compositions. Surprisingly, when a small amount of a transition
metal compound is present in the Activator Gel component of the
whitening composition, the compound acts as a catalyzing agent for
the peroxide gel component of the whitening composition so that
when the peroxide compound or compounds is present in typical or
even lower concentrations generally used in a dentist's office, the
time needed for producing the same whitening effect is reduced by,
for example, at least about 15%, more for example, at least about
20%, and eve more for example, at least about 25%.
[0048] The exemplary transition metals are those of lower atomic
numbers including lower atomic number transition metals-such as
those ranging from atomic number 21 to 30. Also, useful ones
include those with lower oxidative states, for example, iron(II),
manganese(II), cobalt(II), copper(II) and mixtures thereof, and
more for example, Iron(II).
[0049] Without wishing to be bound by a particular theory, it is
surmised that the above mentioned transition metal compounds
participate in either a Fenton reaction or a photoFenton reaction,
in which a lower oxidative state transition metal, such as Fe(II),
may react with peroxides such as hydrogen peroxide, either
thermally or upon exposure to light, to facilitate the dissociation
of peroxide into active whitening species such as hydroxyl
radicals, perhydroxy anions or superoxide radicals, as exemplified
below: H.sub.2O.sub.2+Fe.sup.2++-->Fe.sup.3++HO.sup.-+HO*
[0050] Surprising, only a very small amount of transition metal
compound is needed, for example, from about 0.01% by weight to
about 4% by weight, more for example, from about 0.03% by weight to
about 2% by weight, and even more for example, from about 0.04% to
about 1% by weight, as the lower oxidative state transition metal
is regenerated in the whitening action, as exemplifies below:
HO*+Fe.sup.3+-->HO.sup.++Fe.sup.2+
[0051] It is further surmised that when the transition metal
compounds are at their most effective when they remain in solution
and do not precipitate out of the gel. Thus, anions may be chosen
so that the transition metal compounds have good solubility in the
Activator Gel component after mixing with the peroxide gel. Those
anions may include gluconates, sulfates, nitrates, acetates and
mixtures thereof. It is surmised also that the chelating effect of
an anion does not play any role in the catalyzing action, as
chelating action tends to stabilize the peroxides, rather than to
catalyze their decomposition. Thus, though gluconates are capable
of chelating with transition metals, are present merely to aid in
solubilizing the transition metals, and any chelating effect may be
negligible.
[0052] The amounts of transition metal compounds present in the
Activator Gel may also affect their solubility. Soluble compounds
tend to be better catalysts. Thus, it is surmised that usefuel
transition metal compounds do not precipitate out of solution, as
noted above. Fortunately, small amounts of such compounds are
effective. The effect of their solubility and low concentration of
transition metal compounds act to improve the whitening action of
the peroxide gel as noted above.
[0053] Other ingredients may be added to improve both the peroxide
and gel stability. These include gelling agents, gel stabilizers,
surfactants, any compound having a strongly ionic component, pH
adjusting agents, humectants, and other adjuvants for improving gel
consistency may be added to both the peroxide gel and the Activator
Gel component.
[0054] Examples of gelling agents include non-ionic surfactants
such as those having both a hydrophilic component and a hydrophobic
component, including copolymers of ethylene oxide and propylene
oxide. The copolymers may be block copolymers of propylene oxide
(hydrophobic component), and ethylene oxide (hydrophilic
component). The propylene oxide block may generally be sandwiched
between two ethylene oxide blocks. Literally hundreds of versions
of such non-ionic surfactants having both hydrophobic and
hydrophilic blocks are possible by incremental alteration of both
hydrophobe and hydrophile. In addition, heteric or alternating
ethylene oxide/propylene oxide structures may be introduced
internally or at the end of the molecule. The generally used ones
include Pluronic F-127, P-84 or mixtures thereof, available from
BASF Corporation (North Mount Olive, N.J., USA).
[0055] Other gelling agents suitable for use in the preparation of
both peroxide and Activator Gels may include, for example, other
non-ionic surfactants, such as the classes that limit the number of
available hydrophobes and effect changes in surfactant function
only by altering the hydrophile, are suitable.
[0056] Still other gelling agents which may be used in the
preparation of whitening gels may include, for example, cellulosic
gums, fumed silica, for example, CAB-O-SIL fumed silica provided by
Cabot Corporation, and emulsifying waxes such as Polawax
(emulsifying wax NF) or Crodafos CES (cetearyl alcohol (and)
dicetyl phosphate (and) ceteth-10 phosphate), provided by Croda,
Inc., and mixtures thereof, in amounts to provide a stable gel.
Some examples of cellulosic gum may include `Klucel` GF, a
hydroxymethyl propylcellulose from Hercules.
[0057] The amount of surfactants present in the gel may determine
whether a gel can or cannot form as well as the gel's stability.
With too little gelling agent, no gel may form. With too much
gelling agent, no gel formation is possible. Stable gels are formed
when the gelling agents are present within the appropriate range.
Exemplary percent of hydrophobic components in the gelling agents
ranges, for example, from about 10 to about 80, more for example,
from about 30 to about 60, even more for example, from about 31 to
about 38, and still even more for example, from about 33 to about
36.
[0058] For example, the non-ionic surfactant may be present in an
amount that provides a stable dental peroxide gel and may, for
example, range from about 15% to about 45% by weight of the
peroxide gel, more for example, from about 20% by weight to about
40% by weight. In the Activator Gel component, the non-ionic
surfactant may be present, for example, from about 15% to about
30%, more for example, from about 20% to about 25% by weight.
[0059] The total molecular weight may also be varied. For example,
molecular weights may range from about 300 to about 20,000, more
for example, from about 5,000 to about 12,000.
[0060] Other ingredients that may also be added to aid the
stability of a gel may include any compound having a strongly ionic
component, as mentioned above. Exemplary ones may include alkali
compounds, for example, potassium compounds (such as potassium
nitrate), sodium compounds (such as sodium nitrate), vitamin E oil,
anise, eugenol, natural mint flavors or mixtures thereof. Less
favored ones, though still effective, may include heavy metal
halides, especially chlorine-containing compounds.
[0061] For example, an insoluble stabilizer such as vitamin E oil,
anise, eugenol, natural mint flavors and mixtures thereof may be
added to help the stability of the gel formation in both components
of the whitening gel.
[0062] The total weight % of the stabilizer varies from, for
example, about 0.25 to about 5, more for example, from about 0.5 to
about 4, even more for example, from about 1 to about 3 in the
peroxide gel; and for example, from about 1 to about 20, more for
example, from about 2 to about 15, and even more for example, from
about 4 to about 12 in the Activator Gel.
[0063] Alkali metals such as potassium and sodium compounds,
including potassium nitrate, when added, may be present at the
higher end of the range to stabilize the peroxide gel and increase
gel shelf life. Some, such as potassium nitrate, may also increase
the sensitivity relief of the gel, as further discussed below.
[0064] For example, the peroxide gel may also include a source of
calcium, strontium or combinations thereof. The source of calcium,
strontium or combinations thereof in the peroxide component may
include, for example, a calcium compound, a strontium compound, or
mixtures thereof, more for example, a calcium compound such as
calcium nitrate, in an amount of, for example, from about 0.25% by
weight to about 1.5% by weight, more for example, about 0.3% to
about 1% by weight.
[0065] When calcium compound is present in the peroxide-containing
gel, it is useful that the Activator Gel also contains a source of,
for example, phosphate. For example, the source of phosphate in the
Activator Gel may include monosodium phosphate (NAH.sub.2PO.sub.4),
disodium phosphate, tetrapotassium pyrophosphate or mixtures
thereof. The source of phosphate may be, for example, present in an
amount of from about 0.2% to about 5% by weight, more for example,
between about 0.2% to about 4% by weight.
[0066] When the two gel components are mixed, combines with
phosphate to form the various amorphous calcium and/or strontium
phosphates.
[0067] Amorphous calcium compounds such as amorphous calcium
phosphate (ACP), amorphous calcium phosphate fluoride (ACPF),
amorphous calcium carbonate phosphate (ACCP), amorphous calcium
carbonate phosphate (ACCP), and amorphous calcium carbonate
phosphate fluoride (ACCPF) are useful for aiding in remineralizing
teeth. These amorphous compounds are disclosed in U.S. Pat. Nos.
5,037,639, 5,268,167, 5,437,857, 5,562,895, 6,000,341, and
6,056,930, the disclosure of each is hereby incorporated by
reference in its entirety.
[0068] In addition to amorphous calcium compounds, amorphous
strontium compounds such as amorphous strontium phosphate (ASP),
amorphous strontium phosphate fluoride (ASPF), amorphous strontium
calcium phosphate (ASCP), amorphous strontium calcium carbonate
phosphate (ASCCP), amorphous strontium carbonate phosphate fluoride
(ASCPF) and amorphous strontium calcium carbonate phosphate
fluoride (ASCCPF) may be used in re-mineralization, as noted above.
These compounds are disclosed in U.S. Pat. No. 5,534,244, the
content of which is hereby incorporated by reference in its
entirety.
[0069] When applied to the teeth, amorphous calcium phosphate or
others mentioned above may precipitate onto the surface of the
teeth where it may be incorporated into hydroxyapatite, assisting
in remineralization of the tooth enamel, as is also discussed in
U.S. Pat. Nos. 5,037,639, 5,268,167, 5,460,803, 5,534,244,
6,000,341, and 6,056,930, incorporated herein by reference.
[0070] Some of the compounds mentioned above may also be used in
fluoridating teeth. All of the above amorphous compounds or
solutions which form the amorphous compounds, when applied either
onto or into dental tissue, may in addition, aid to prevent and/or
repair dental weaknesses such as dental caries, exposed roots and
dentin sensitivity.
[0071] Surprisingly, the amorphous calcium and/or strontium
compounds present in the composition may also act as sensitivity
relief agents. In fact, the present inventors have found that the
de-sensitizing effect provided by amorphous calcium phosphate is at
least as effective as, if not more effective than, the typical
de-sensitizing agents normally used, including some of those
discussed below. Therefore, the presence of amorphous calcium
and/or strontium compounds may potentially replace traditional
de-sensitizing agents.
[0072] In practice, as much phosphate as possible or practicable
may be included. However, amounts of monosodium phosphate in excess
of about 4% by weight may tend to affect gel stability.
[0073] Surprisingly, the phosphate component present in the first
component according to the ranges mentioned above may also act to
stabilize the gel. The levels may be present from, for example,
about 0.5% to about 5% by weight, more for example, from about 1%
to about 4% by weight. At higher levels, the stabilizing effect
gradually disappears. For monosodium phosphate, amounts in excess
of about 4% by weight may tend to affect gel stability.
[0074] Additionally, the phosphate compound may further act to
adjust the pH of the first component. The pH of the system is, for
example, from about 5 to about 8, more for example, from about 5.5
to about 6.5.
[0075] In one embodiment of the present invention, the Activator
Gel may have, for example, a pH of from about 2 to about 7; more
for example, from about 3 to 6, and even more for example, from
about 3 to about 5.5. To keep the transition metal compounds from
precipitating out of solution, a lower pH of the Activator Gel may
be used. However, some compounds may be added to keep the metal
compound from precipitating out even at higher pH. These may
include glyconic acid, gallic acid or mixtures thereof. Gallic acid
is generally used as a high pH additive.
[0076] As noted, the lower the pH of the Activator Gel, the less
likely the transition metal compounds will precipitate out.
However, lower pH may contribute to demineralization of teeth. In
the present invention, a pH of the composition as low as about 1 to
about 3 may be used by virtue of the addition of amorphous calcium
phosphate or others mentioned-above, the shorter exposure time and
the lower concentration of the peroxide. Any one or combinations of
these factors may aid to reduce the effect of demineralization.
[0077] Additional components added to improve gel consistency and
stability may be added to one or both components.
[0078] According to the manufacturer of the PLURONIC.TM. products,
glycols such as propylene glycol and ethylene glycol are not
recommended as they tend to degrade the PLURONIC.TM. gels formed.
Therefore, it is not desirable to include any propylene glycol, and
humectants in the peroxide gel normally do not contain any
glycols.
[0079] Surprisingly, in the formulation of the Activator Gel,
glycols such as propylene glycol, polyethylene glycol or mixtures
thereof may actually aid in the formation and stability of the
gels. Amounts, for example, from about 5% by weight to about 20% by
weight, more for example, about 10% to about 15% by weight may be
used. Other non-toxic glycols may also used or be present in
addition.
[0080] When the two-components are mixed, any glycols present in
the Activator Gel surprisingly do not affect the stability of the
combined gel and the whitening gel may be applied as if no glycols
were present.
[0081] Exemplary gel modifying polyols for use in the
peroxide-containing gel also include aliphatic polyols in an
amount, for example, from about 1% by weight to about 10% by
weight, more for example, from about 2% to about 5% by weight. An
exemplary polyol may be glycerine (Merck Index #4493, 12th Ed.),
present, for example, in an amount up to about 2% by weight. For
the Activator Gel, an aliphatic polyol such as glycerine may be
present in an amount, for example, from about 2% by weight to about
15% by weight, more for example, from about 4% to about 12% by
weight.
[0082] In addition to the addition of heat, light and/or chemicals,
the amount of whitening obtained during a whitening process is
generally dependent upon (1) the length of time the teeth is in
contact with the whitening agent; (2) the number of days the
treatment is carried out; (3) the susceptibility of the teeth to
the whitening agent and (4) concentration of active peroxide, as
noted above. For maximum whitening, a long treatment time with a
highly concentrated whitening composition is generally recommended,
as noted before.
[0083] Whitening activity of a peroxide compound is generally
dictated by the availability of active peroxides, and not by the
actual concentration of peroxide present in the composition. When
peroxide is present in solution, active peroxides are readily
available. However, a solution, by its nature, is not easily
contained, and/or not amenable for sustain action when applied to a
patient's teeth, again because it is difficult to confine it any
desired location for any length of time. Thus, a less concentrated
peroxide solution requiring longer contact time to be effective is
not a practical solution environment. A more concentrated solution
of peroxide, though more efficient in whitening, is likewise not
suitable in a solution environment because it will not solve the
confinement and prolonged contact problem. In addition, any
concentrated peroxide solution that may come into contact with soft
tissue inside a patient's mouth may potentially cause tissue
damage. Therefore, to maintain effective bleaching with good
containment so as to minimize potential tissue damage, various
gelling agents, thickeners, adhesion promoters and/or similar
additives may be used, as discussed above in the unfoamed system.
These result in the formation of paste, gels, and similar forms,
which are effective whitening systems. It is surmised that some of
the additives used, though effective in containment and bleaching,
may somewhat decrease the bleaching activity by inhibiting the
availability of active peroxides, especially if the composition
contain thickeners or adhesion promoters derived from polymers of
acrylic acid (carbomer), pyrrolidone analog thickeners, or others.
Such additives may lead to diminished whitening capacity of
peroxides through ionic and covalent interactions within the gel,
and act against the desired effect of tooth whitening.
[0084] Foaming may be another way to improve substantivity without
some of the above mentioned additives. Foamed compositions may also
provide prolonged contact without high amounts of additives that
may tend to somewhat inhibit the activity of active peroxides, thus
further improving the whitening activity. Foams may be formulated
with the same or higher amounts of active ingredients and smaller
amounts of inactive ingredients. In a given volume, smaller amounts
of inactive ingredients such as gelling agents, thickeners,
adhesion promoters or similar may be present in the foamed state
compared to unfoamed state. Without wishing to be bound to a
theory, it is surmised that air performs the function of an
inactive ingredient such as a gelling agent, a thickener, an
adhesion promoter or mixtures thereof, to give the needed
substantivity; but air molecules in general do not inhibit the
availability of active peroxides to the same extent as other
inactive ingredients needed for substantivity in an unfoamed gel.
Thus, a foamed composition has the substantivity of a composition
having higher amounts of ingredients such as gelling agents,
thickeners, adhesion promoters or similar inactive ingredients, but
with more availability of active peroxides for bleaching action
even if the same concentration of peroxide is present. In other
words, foaming may in effect substitute air bubbles for gelling
agents to create substantivity.
[0085] Thus, a foamed or foamable composition of the present
invention may increase the rate of whitening activity, if desired,
without the problems encountered by solutions. Not only is a foamed
composition manageable without confinement problems during use, it
may also be capable of delivering a high concentration of active
peroxide by not inhibiting the availability of active peroxides,
and at the same time, may also seek to fill crevices, sometimes
seeping into gaps where gaps are not apparent, thus offering
effective whitening action not only to the front surface of a
tooth, but surfaces in-between teeth as well. Therefore, foaming
may potentially provide all the benefits that are not currently
available to other whitening systems.
[0086] Foams in general also have lower surface tension than their
unfoamed counterparts and may therefore be spread as thin as one
molecule thick sheets, while at the same time increasing its
surface area, thus covering more area with the same volume of
whitening composition than their unfoamed counterparts. The ability
to lower surface tension may also make the stains easier to
remove.
[0087] The foamed bubbles, through the forces of capillary action
and lowered surface tension, are also themselves good wetting
agents, so that a bleaching solution may penetrate through smaller
openings, as noted above. The rapid penetration into the tightest
spots may also be aided by the distribution of the sizes and shapes
of bubbles. Thus, foams may even cause deeper penetration of active
peroxide molecules.
[0088] It is further surmised that active peroxides may also be
captured inside the bubbles of foams. As the bubbles collapse, the
active peroxide agent is released to perform whitening actions.
[0089] Foam formation may be effected by any agitation or whipping
action, use of foaming agents and combinations thereof. In some
embodiments, foaming agents may be present to render the
composition foamable so that foams are generated just prior to use.
Some foaming agents may also aid in increasing the adhesion of the
gel to a solid surface by allowing it to spread over a greater
surface area. In others embodiments, foams are formed just prior to
use by agitation with or without any foaming agent.
[0090] Thus, some compositions may include at least one foaming
agent. Different categories of foaming agents are suitable, and
they may produce foams in different ways. Suitable foaming agents
may include certain surfactants such as anionic, nonionic,
amphoteric, zwitterionic, cationic, or mixtures thereof.
[0091] Some of these aids in foam formation and some do not. Some
surfactants are useful purely for their foaming properties alone,
some act only as emulsifiers or wetting agents without foaming, and
some even act to reduce foaming. The functions of the surfactants
are not necessarily determined by the category they belong to.
[0092] Anionic surfactants include, but not limited to
water-soluble compounds of alkyl sulfates having from about 8 to
about 20 carbon atoms in the alkyl radical (such as sodium alkyl
sulfate), water-soluble compounds of sulfonated monoglycerides of
fatty acids having from about 8 to about 20 carbon atoms and
mixtures thereof. Examples of anionic surfactants include Sodium
lauryl sulfate, sodium coconut monoglyceride sulfonates,
phospholipids, sarcosinates, such as sodium lauryl sarcosinate,
taurates, sodium lauryl sulfoacetate, sodium lauroyl isethionate,
sodium laureth carboxylate, and sodium dodecyl benzenesulfonate.
Many of these anionic surfactants are disclosed in U.S. Pat. No.
3,959,458, the content of which is incorporated herein in its
entirety by reference.
[0093] Nonionic surfactants may include, but not limited, to
compounds including a hydrophilic and hydrophobic components (which
maybe produced by the condensation of alkylene oxide groups
(hydrophilic in nature) with an organic hydrophobic compound which
may be aliphatic or alkyl-aromatic in nature). Examples of suitable
nonionic surfactants include low viscosity poloxamers (sold under
the trade name Pluronic), low viscosity hydroxyethyl cellulose,
polysorbates, polyoxyethylene sorbitan esters (sold under the trade
name Tweens), fatty alcohol ethoxylates, polyethylene oxide
condensates of alkyl phenols, products derived from the
condensation of ethylene oxide with the reaction product of
propylene oxide and ethylene diamine, ethylene oxide condensates of
aliphatic alcohols, long chain tertiary amine oxides, long chain
tertiary phosphine oxides, long chain dialkyl sulfoxides, and
mixtures thereof.
[0094] Amphoteric surfactants may include, but is not limited to
derivatives of aliphatic secondary and tertiary amines in which the
aliphatic component may be a straight chain or branched and one of
the aliphatic substituents contains from about 8 to about 18 carbon
atoms and one contains an anionic water-solubilizing group, such as
carboxylate, sulfonate, sulfate, phosphate, phosphonate, betaines,
specifically cocamidopropyl betaine, and mixtures thereof.
[0095] Many of these nonionic and amphoteric surfactants are
disclosed in U.S. Pat. No. 4,051,234, the content of which is
incorporated herein by reference in its entirety.
[0096] In the present invention, the exemplified surfactants, when
used in foamable compositions, are those that not only have foaming
capabilities, but also those with the ability to act as wetting
agents.
[0097] Actually, any asymmetrical molecule dissolved in water will
make at least a weak surfactant. Such weak surfactants may normally
not be an effective foaming agent, but its effectiveness may be
improved if a foaming dispenser is used. Asymmetrical molecules as
used herein include those that include a hydrophilic and a
hydrophobic segment, such as some of the nonionic surfactants
mentioned above. One end of the molecule is thus polar in nature
and dissolves in water, while the other end is nonpolar in nature
and avoids water. When in water, the surfactant molecules oriented
themselves with their polar ends towards the water molecules,
leaving the nonpolar ends free to attract nonpolar molecules. It is
surmised that in a foamed or foamable composition of the present
invention, the non-polar ends help to lift tooth surface stains,
allowing them to be washed away with the water.
[0098] The amount of foaming agents may range, for example, from
about 0.1% to about 5% by weight of the foamable composition, more
for example, from about 0.5% to about 3% by weight, even more for
example, less than about 1% by weight.
[0099] Still other foaming agents may include reaction products of
any base with an acid. These may include, for example, an alkali
metal carbonate or bicarbonate, such as sodium bicarbonate,
potassium bicarbonate, sodium carbonate or potassium carbonate, or
an alkaline metal carbonate or bicarbonate such as magnesium or
calcium bicarbonate or carbonate. The amount used may range, for
example, from about 1% to about 10% by weight, more for example,
from about 3% to about 7%, still more for example, from about 3.5
to about 5.5% by weight of the composition. The amount used may
also depend on the volume of foam required. Thus, by varying the
amount of foaming agents, the amount of foam produced may be varied
accordingly.
[0100] Generally, the ratio of acid and base ranges, for example,
from about 1:0.5 to 1:25, more for example, from about 1:1 to 1:4,
by weight. Suitable acids include strong acids such as water
soluble carboxylic acids, phosphoric acids, nitric acids, and/or
sulfuric acids.
[0101] Additionally, a foaming agent may also be a gaseous
material. The gaseous material may be any inert gas or a gas
generated by mixing a basic peroxide solution with an acid
solution.
[0102] Since the whitening activity results when active peroxide
comes into contact with the tooth, the foams generated just prior
to use may for example, not need to be too long lasting, if the
active ingredients are surmized to be captured within the bubbles,
but have a substantive body so that the amount of liquid formed,
i.e., the collapsing of the foam bubbles to release active
peroxide, may be controlled and balanced. Therefore, the exemplary
compositions are not only foamable, but are also capable of
producing longer lasting, collapsible foams.
[0103] The foams generated by a foamable composition generally have
half lives of, for example, at least about 10 minutes, more for
example, from about 10 minutes to about 120 minutes. A foam having
a half life of 10 minutes means that 50% of the bubbles would
collapse to release the encapsulated whitening agent, or that the
volume of the foam is reduced by 50% in about 10 minutes after
formation, and 75% of all the bubbles are gone, or the volume of
the foam is reduced by 75% in about 20 minutes.
[0104] The collapse time or half lives of the foam depends on a
number of factors. For example, the greater the amount of bubbles
formed, the longer the collapse time. Also, the lower the viscosity
of the thickeners, and/or other inactive ingredients, the shorter
the collapse time. The collapse time may also depend on the nature
of the other additives to the composition, which have surface
active properties e.g., surfactants or preservatives as well as the
environment. For example, a drier environment may contribute to
faster collapse of bubbles.
[0105] For foamed compositions, the collapsible bubbles typically
have very extended half lives when confined in the package, for
example, at least about a month, more for example, at least about
three months. During use, the collapse of the foamed bubbles is
aided by the environment, such as the loss of water or solvent to
the environment, and the saliva in the patient's mouth. A packaging
may be designed so that a foamed composition may have a desired
shelf life after the package or container has been opened and the
remaining has been exposed to air. A single-use packaging may also
be designed.
[0106] For example, a lower viscosity gelling agent or thickener
may be used. They are not as likely to inhibit the availability of
active peroxides to the same extent as a higher viscosity gelling
agent. The viscosity is for example, generally less than about
10,000 cps, more for example, less than about 8,000 cps, and even
more for example, less than about 5,000 cps.
[0107] Suitable foaming agents include foamable surfactants
including at least some sodium lauryl Sulfate as the primary
foaming agent.
[0108] As discussed above, substantivity, i.e. the ability of a
product to linger, is a desirable property in any whitening
composition. On the other hand when the desired property of a
product is the ability to be rinsed off easily, a foaming
surfactant would not be used. However, there is a general desire
that a whitening composition may both have substantivity and the
ease to be rinsed off. When this is desired, foams generated in a
"foaming pump", a dispensing tip adapted for foaming, or a
dispensing tip including a mixer adapted for foaming may be used.
Such foaming devices again may produce foams with desirable
properties, while using a minimum of amount of surfactants, for
example, less than about 0.5%. At the same time, some combinations
of additives may be chosen to produce the desired effect as well,
such as by the addition of other foaming agents.
[0109] The gels may be prepared using any known method. Typically,
in preparing the peroxide gel, the peroxide compound, stabilizing
polyols such as glycerin, and water sufficient to produce the
desired concentration of peroxide are completely mixed, then any
compounds, such as calcium nitrate and/or potassium nitrate, are
added and mixed at high speed until completely dissolved. A gelling
agent such as PLURONIC.RTM. F-127 is added at high speed until the
gelling agent is completely dispersed and the resulting composition
is almost whipped in texture.
[0110] Eugenol and/or natural mint flavorings, preferably
undiluted, are next added, resulting in a thickening of the
whitening gel. The gel may be mixed at ambient temperatures for
about thirty to forty minutes, or until the desired consistency is
achieved, then vacuum degassed.
[0111] Alternatively, following addition of eugenol and/or mint
flavorings, the peroxide gel may be stored at temperatures
sufficiently low to liquify the gelling agent, approximately
10.degree. F. when PLURONIC.RTM. F-127 is used, allowing air
trapped in the gel to rise to the surface, where it may be scrapped
off as foam or removed by vacuum degassing.
[0112] For peroxide gels, water is present in an amount of, for
example, between 10% to about 20%, more for example, from about 13%
to about 16% by weight. In the Activator Gels, water is present,
for example, from about 30% to about 70% by weight, more for
example, from about 40% to about 60% by weight.
[0113] Both components of the whitening system may be substantially
free of abrasives.
[0114] Non-limiting examples of peroxide gels provided in
accordance with practice of the present invention are as
follows:
[0115] Peroxide Gel 1: TABLE-US-00001 Material % by weight Grams
(300 g total) Water 15.5 46.5 Glycerin 2.0 6 50% H.sub.2O.sub.2 (in
water) 40.0 120 Ca(NO3)2 0.5 1.5 KNO.sub.3 1.0 3.0 PLURONIC .RTM.
F-127 40.5 121.5 Eugenol 0.25 0.75 Natural Mint 0.25 0.75
[0116] Peroxide Gel 2: TABLE-US-00002 Material % by weight Grams
(300 g total) Water 13.65 40.95 Glycerin 2.0 6.0 50% H.sub.2O.sub.2
(in water) 50.0 150 Ca(NO3)2 0.5 1.5 KNO.sub.3 2.0 6.0 PLURONIC
.RTM. F-127 30.0 90.0 Eugenol 0.75 2.25 Natural Mint 1.1 3.3
[0117] Peroxide Gel 3 TABLE-US-00003 Material Trade name % Grams
Water 0.00 0 Glycerin 4.65 9.3 Hydrogen Peroxide 50% CG 64.00 128
Poly dimethyl siloxane Antifoam 1520-US QS QS Poloxomer 407
Pluronic F-127 28.00 56 Eugenol 0.75 1.5 Natural Peppermint Oil
1.10 2.2 KNO3 1.50 3 Total 100.00
[0118] Peroxide Gel 4 TABLE-US-00004 Material Trade name % Grams
Water 2.65 5.3 Glycerin 2.00 4 KNO3 1.50 3 Hydrogen Peroxide 50%
64.00 128 CG Poly dimethyl siloxane Antifoam 1520-US 0.00 0
Poloxomer 407 Pluronic F-127 28.00 56 Eugenol 0.75 1.5 Natural
Peppermint Oil 1.10 2.2 100.00
[0119] Peroxide Gel 5 TABLE-US-00005 Material % Grams Water 27.75
55.5 Polysorbate 80 0.5 1 SLS 0.25 0.5 Glycerin 2 4 50% H2O2 28 56
Pluronic F-127 41 82 Eugenol 0.25 0.5 Natural Mint 0.25 0.5 100
200
[0120] Peroxide Gel 6 TABLE-US-00006 Material % Grams Phosphoric
Acid 0.25 0.75 Polysorbate 80 0.5 1.5 Water 11.5 34.5 Sodium Laurel
Sulfate 0.25 0.75 50% H2O2 48 144 Pluronic F-127 39 117 Eugenol
0.25 0.75 Natural Mint 0.25 0.75 100
[0121] Peroxide Gel 7 TABLE-US-00007 Material % Grams Water 26.5
79.5 Glycerin 2 6 50% H2O2 40 120 Ca(NO3)2 0.5 1.5 Potassium
Nitrate 1 3 Pluronic F-127 28 84 Eugenol 0.75 2.25 Natural Mint
1.25 3.75 100 300
[0122] Peroxide Gel 8 TABLE-US-00008 Material % Grams Water 15 45
Glycerin 2 6 50% H2O2 40 120 Ca(NO3)2 0.5 1.5 Potassium Nitrate 1 3
Pluronic F-127 40.5 121.5 Natural Mint 1 3 100 300
[0123] Peroxide Gel 9 TABLE-US-00009 Material % Grams Water 14.25
42.75 Glycerin 2 6 50% H2O2 50 150 Ca(NO3)2 0.5 1.5 KNO3 2 6
Pluronic F-127 30 90 Natural Mint 1.25 3.75 100 300
[0124] Peroxide Gel 10 TABLE-US-00010 Material % Grams Water 15.5
46.5 Glycerin 2 6 50% H2O2 40 120 Ca(NO3)2 0.5 1.5 Potassium
Nitrate 1 3 Pluronic F-127 40.5 121.5 Eugenol 0.25 0.75 Natural
Mint 0.25 0.75 Total 100 300
[0125] Peroxide Gel 11 TABLE-US-00011 Material % Grams Water 22 66
Glycerin 2 6 50% H2O2 40 120 Ca(NO3)2 0.5 1.5 Pluronic F-127 35 105
Eugenol 0.25 0.75 Natural Mint 0.25 0.75 Total 100 300
[0126] Peroxide Gel 12 TABLE-US-00012 Material % Grams Water 18.65
55.95 Glycerin 2 6 50% H2O2 45 135 Ca(NO3)2 0.5 1.5 KNO3 2 6
Pluronic F-127 30 90 Eugenol 0.75 2.25 Natural Mint 1.1 3.3 Total
100 300
[0127] Peroxide Gel 13 TABLE-US-00013 Material % Grams Water 14.9
44.7 Glycerin 2 6 50% H2O2 48.75 146.25 Ca(NO3)2 0.5 1.5 KNO3 2 6
10% KOH QS Pluronic F-127 30 90 Eugenol 0.75 2.25 Natural Mint 1.1
3.3 Total 100 300
[0128] Peroxide Gel 14 TABLE-US-00014 Material % Grams Water 14.9
44.7 Glycerin 2 6 50% H2O2 48.75 146.25 Ca(NO3)2 0.5 1.5 KNO3 2 6
10% KOH QS Pluronic F-127 30 90 Eugenol 0.75 2.25 Natural Mint 1.1
3.3 Total 100 300
[0129] Peroxide Gel 15 TABLE-US-00015 Material % Grams Water 13.65
40.95 Glycerin 2 6 50% H2O2 50 150 Ca(NO3)2 0.5 1.5 KNO3 2 6
Pluronic F-127 30 90 Eugenol 0.75 2.25 Natural Mint 1.1 3.3 Total
100 300
[0130] Peroxide Gel 16 TABLE-US-00016 Material % Grams Water 18.65
55.95 Glycerin 2 6 50% H2O2 45 135 Ca(NO3)2 0.5 1.5 KNO3 2 6
Pluronic F-127 30 90 Eugenol 0.75 2.25 Natural Mint 1.1 3.3 Total
100 300
[0131] Peroxide Gel 17 TABLE-US-00017 Material Trade name % Grams
Water 9.65 19.3 Glycerin 2.00 4 KNO3 1.50 3 Ca(NO3)2 1.00 2
Hydrogen CG 56.00 112 Peroxide 50% Poly dimethyl Antifoam 0.00 0
siloxane 1520-US Poloxomer 407 Pluronic F- 28.00 56 127 Eugenol
0.75 1.5 Natural 1.10 2.2 Peppermint Oil Total 100.00
[0132] Peroxide Gel 18 TABLE-US-00018 Material % Grams Water 16 48
Glycerin 2 6 50% H2O2 40 120 Ca(NO3)2 0.5 1.5 Pluronic F-127 41 123
Eugenol 0.25 0.75 Natural Mint 0.25 0.75 Total 100 300
[0133] Peroxide Gel 19 TABLE-US-00019 Material % Grams Water 16 32
Glycerin 2 4 50% H2O2 40 80 TKPP 0.5 1 Pluronic F-127 41 82 Eugenol
0.25 0.5 Natural Mint 0.25 0.5 Total 100 200
[0134] Peroxide Gel 20 TABLE-US-00020 Material % Grams Water 27.75
55.5 Polysorbate 80 0.5 1 SLS 0.25 0.5 Glycerin 2 4 50% H2O2 28 56
Pluronic F-127 41 82 Eugenol 0.25 0.5 Natural Mint 0.25 0.5 Total
100 200
[0135] Peroxide Gel 21 TABLE-US-00021 Material % Grams Water 28.5
57 Glycerin 2 4 50% H2O2 28 56 Pluronic F-127 41 82 Eugenol 0.25
0.5 Natural Mint 0.25 0.5 Total 100 200
[0136] Peroxide Gel 22 TABLE-US-00022 Material % Grams Water 31.5
63 Glycerin 2 4 50% H2O2 25 50 Pluronic F-127 41 82 Eugenol 0.25
0.5 Natural Mint 0.25 0.5 Total 100 200
[0137] Peroxide Gel 23 TABLE-US-00023 Material % Grams Water 24.5
49 Glycerin 2 4 50% H2O2 32 64 Pluronic F-127 41 82 Eugenol 0.25
0.5 Natural Mint 0.25 0.5 Total 100 200
[0138] Peroxide Gel 24 TABLE-US-00024 Material % Grams Water 16.5
33 Glycerin 2 4 50% H2O2 40 80 Pluronic F-127 41 82 Eugenol 0.25
0.5 Natural Mint 0.25 0.5 Total 100 200
[0139] Peroxide Gel 25 TABLE-US-00025 Material % Grams Phosphoric
Acid 0 0 Polysorbate 80 0 0 Water 18.5 37 Sodium Laurel 0 0 Sulfate
50% H2O2 40 80 Pluronic F-127 41 82 Eugenol 0.25 0.5 Natural Mint
0.25 0.5 100 200
[0140] Peroxide Gel 26 TABLE-US-00026 Material % Grams Phosphoric
Acid 0 0 Polysorbate 80 0.5 1 Water 25.75 51.5 Sodium Laurel 0.25
0.5 Sulfate 50% H2O2 32 64 Pluronic F-127 41 82 Eugenol 0.25 0.5
Natural Mint 0.25 0.5 Total 100 200
[0141] Peroxide gel 27 TABLE-US-00027 Material % Grams Phosphoric
Acid 0.25 0.5 Polysorbate 80 0.5 1 Water 17.5 35 Sodium Laurel 0.25
0.5 Sulfate 50% H2O2 40 80 Pluronic F-127 41 82 Eugenol 0.25 0.5
Natural Mint 0.25 0.5 Total 100 200
[0142] Peroxide Gel 28 TABLE-US-00028 Material % Grams Water 27.25
81.75 Glycerin 2 6 50% H2O2 40 120 Ca(NO3)2 0.5 1.5 Potassium 1 3
Nitrate Pluronic F-127 28 84 Eugenol 0 0 Natural Mint 1.25 3.75
Total 100 300
[0143] An exemplary method for preparing the Activator Gel is as
follows: In preparing the Activator Gel, the aqueous solution of
ferrous compound is preferably combined with potassium nitrate and
monosodium phosphate, plus an amount of water sufficient to produce
the desired concentration of components in the Activator Gel, and
mixed until all components are completely dissolved. The mixture is
then titrated with a pH adjusting agent, such as disodium
phosphate, to the desired pH.
[0144] Glycerine and/or other polyols are added to the mixture
along with propylene glycol, and mixed until dissolved. The gelling
agent is then whipped into the mixture at high speed, producing a
stiff gel. Finally, any natural mint flavors, such as natural
peppermint oil, are whipped into the gel, further stiffening of the
Activator Gel. The gel is mixed at ambient temperatures for about
thirty to forty minutes, or until the desired consistency is
achieved, then vacuum degassed at about 75-100 Torr, for example,
at less than 100 Torr.
[0145] Non-limiting examples of Activator Gels provided in
accordance with practice of the present invention are as
follows:
[0146] Activator Gel 1: TABLE-US-00029 Material % by weight Water
55.65 Potassium nitrate 2.5 Ferrous gluconate (premix with 0.042
water) Water (premix with ferrous 1.208 gluconate) Monosodium
phosphate 3.75 Disodium phosphate Qs to pH 5.3-5.4 Propylene glycol
11.1 Glycerin 4.25 PLURONIC .RTM. F-127 20.5 Natural Peppermint Oil
1.0
[0147] Activator Gel 2: TABLE-US-00030 Grams Material % by wt (200
g total) Water 54.65 109.3 KNO.sub.3 5.25 10.5 NaH.sub.2PO.sub.4 2
4 Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in 1 2 water
Antifoam QS QS Propylene Glycol 11.1 22.2 Glycerin 4.5 9 PLURONIC
.RTM. F-127 20.5 41 Natural Mint 1 2
[0148] Activator Gel 3: TABLE-US-00031 Grams Material % by wt (200
g total) Water 51.55 103.1 KNO.sub.3 3 6 NaH.sub.2PO.sub.4 2 4
Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in water 1.25
2.5 Antifoam QS QS Propylene Glycol 11.1 22.2 Glycerin 9.6 19.2
PLURONIC .RTM. F-127 20.5 41 Natural Mint 1 2
[0149] Activator Gel 4: TABLE-US-00032 Grams Material % by wt (200
g total) Water 49.55 99.1 KNO.sub.3 5 10 NaH.sub.2PO.sub.4 2 4
Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in water 1.25
2.5 Antifoam QS QS Propylene Glycol 11.1 22.2 Glycerin 9.6 19.2
PLURONIC .RTM. F-127 20.5 41 Natural Mint 1 2
[0150] Activator Gel 5: TABLE-US-00033 Grams Material % by wt (200
g total) Water 47.55 95.1 KNO.sub.3 7 4 NaH.sub.2PO.sub.4 2 4
Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in water 1.25
2.5 Antifoam QS QS Propylene Glycol 11.1 22.2 Glycerin 9.6 19.2
PLURONIC .RTM. F-127 20.5 41 Natural Mint 1 2
[0151] Activator Gel 6: TABLE-US-00034 Grams Material % by wt (200
g total) Water 47.55 95.1 KNO.sub.3 7 14 NaH.sub.2PO.sub.4 2 4
Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in water 1.25
2.5 Antifoam QS QS Propylene Glycol 11.1 22.2 Glycerin 9.6 19.2
PLURONIC .RTM. F-127 20.5 41 Natural Mint 1 2
[0152] Activator Gel 7: TABLE-US-00035 Grams Material % by wt (200
g total) Water 49.55 99.1 KNO.sub.3 3 6 KCl 2 4 NaH.sub.2PO.sub.4 2
4 Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in water
1.25 2.5 Antifoam QS QS Propylene Glycol 11.1 22.2 Glycerin 9.6
19.2 PLURONIC .RTM. F-127 20.5 41 Natural Mint 1 2
[0153] Activator Gel 8: TABLE-US-00036 Grams Material % by wt (200
g total) Water 47.55 95.1 KNO.sub.3 5 10 KCl 2 4 NaH.sub.2PO.sub.4
2 4 Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in water
1.25 2.5 Antifoam QS QS Propylene Glycol 11.1 22.2 Glycerin 9.6
19.2 PLURONIC .RTM. F-127 20.5 41 Natural Mint 1 2
[0154] Activator Gel 9: TABLE-US-00037 Grams Material % by wt (200
g total) Water 47.55 95.1 KNO.sub.3 3 6 KCl 4 8 NaH.sub.2PO.sub.4 2
4 Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in water
1.25 2.5 Antifoam QS QS Propylene Glycol 11.1 22.2 Glycerin 9.6
19.2 PLURONIC .RTM. F-127 20.5 41 Natural Mint 1 2
[0155] Activator Gel 10: TABLE-US-00038 Grams Material % by wt (200
g total) Water 45.55 91.1 KNO.sub.3 5 10 KCl 4 8 NaH.sub.2PO.sub.4
2 4 Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in water
1.25 2.5 Antifoam QS QS Propylene Glycol 11.1 22.2 Glycerin 9.6
19.2 PLURONIC .RTM. F-127 20.5 41 Natural Mint 1 2
[0156] Activator Gel 11: TABLE-US-00039 Grams Material % by wt (200
g total) Water 43.55 87.1 KNO.sub.3 7 14 KCl 4 8 NaH.sub.2PO.sub.4
2 4 Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in water
1.25 2.5 Antifoam QS QS Propylene Glycol 11.1 22.2 Glycerin 9.6
19.2 PLURONIC .RTM. F-127 20.5 41 Natural Mint 1 2
[0157] Activator Gel 12: TABLE-US-00040 Grams Material % by wt (200
g total) Water 52.55 105.1 KNO.sub.3 3 6 NaH.sub.2PO.sub.4 2 4
Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in water 1.25
2.5 Antifoam QS QS Propylene Glycol 11.1 22.2 Glycerin 9.6 19.2
PLURONIC .RTM. F-127 20.5 41 Natural Mint 1 2
[0158] Activator Gel 13: TABLE-US-00041 Grams Material % by wt (200
g total) Water 50.55 101.1 KNO.sub.3 3 6 NaH.sub.2PO.sub.4 2 4
Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in 1.25 2.5
water Antifoam QS QS Propylene Glycol 11.1 22.2 Glycerin 9.6 19.2
PLURONIC .RTM. F-127 20.5 41 Natural Mint 2 4
[0159] Activator Gel 14: TABLE-US-00042 Grams Material % by wt (200
g total) Water 57.55 115.1 KNO.sub.3 3 6 NaH.sub.2PO.sub.4 2 4
Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in 1.25 2.5
water Antifoam QS QS Propylene Glycol 8.1 16.2 Glycerin 6.6 13.2
PLURONIC .RTM. F-127 20.5 41 Natural Mint 1 2
[0160] Activator Gel 15: TABLE-US-00043 Grams Material % by wt (200
g total) Water 45.55 91.1 KNO.sub.3 3 6 NaH.sub.2PO.sub.4 2 4
Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in 1.25 2.5
water Antifoam QS QS Propylene Glycol 14.1 28.2 Glycerin 12.6 25.2
PLURONIC .RTM. F-127 20.5 41 Natural Mint 1 2
[0161] Activator Gel 16: TABLE-US-00044 Grams Material % by wt (200
g total) Water 49.55 99.1 KNO.sub.3 3 6 NaCl 2 4 NaH.sub.2PO.sub.4
2 4 Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in 1.25
2.5 water Antifoam QS QS Propylene Glycol 11.1 22.2 Glycerin 9.6
19.2 PLURONIC .RTM. F-127 20.5 41 Natural Mint 1 2
[0162] Activator Gel 17: TABLE-US-00045 Grams Material % by wt (200
g total) Water 47.55 95.1 KNO.sub.3 3 6 NaCl 4 8 NaH.sub.2PO.sub.4
2 4 Na.sub.2HPO.sub.4 QS QS to pH 5.1-5.3 3.33% Fe Gluc. in 1.25
2.5 water Antifoam QS QS Propylene Glycol 11.1 22.2 Glycerin 9.6
19.2 PLURONIC .RTM. F-127 20.5 41 Natural Mint 1 2
[0163] Any or all of the above formulation, or any of the
previously described compositions may be foamed. In some
embodiments, a foaming agent may be added.
[0164] In packaging the tooth whitening composition of the present
invention, any convenient means for effecting the separation of the
peroxide gel from the Activator Gel before use may be utilized. For
example, a single container may be compartmentalized so that the
peroxide gel and the Activator Gel are housed in separate
compartments and are dispensed simultaneously and admixed prior to
application on the teeth. Alternatively, the peroxide gel and the
Activator Gel may be housed in separate containers from which the
respective phases are dispensed for admixture just prior to use. An
exemplary packaging is disclosed in U.S. Pat. Nos. 5,819,988,
6,065,645, 6,394,314, 6,564,972 and 6,698,622, incorporate herein
by reference. Also, the dispenser may be fitted with an agitator or
pump for foaming.
[0165] In any of the packaging methods described, the syringe or
the dual-compartment container may be provided with a dispensing
tip, or a dispensing tip including a mixer. The mixers may be
dynamic or static. Examples of static mixers may include those also
disclosed in U.S. Pat. Nos. 5,819,988, 6,065,645, 6,394,314,
6,564,972 and 6,698,622, incorporated herein by reference. Examples
of some dynamic mixers may include those disclosed in U.S. Pat.
Nos. 6,443,612, and 6,457,609; and U.S. Patent Publication No.
2002/0190082; the contents of these are hereby incorporated by
reference.
[0166] One exemplary embodiment of the present invention, the two
components may be provided in separate chambers of a dual barrel
syringe. Immediately before use, the two components are mixed
together in, for example, a 1:2 to a 5:1 ratio (peroxide gel to
Activator Gel) by actuating the syringe, more for example, the gels
are mixed in the 4:1 ratio. The admixed whitening gel is applied to
the surface of the teeth directly from the syringe. Other
combinations of the peroxide gel and Activator Gel are contemplated
by the present invention, depending on the desired final
concentration of peroxide in the whitening gel. Typically, the
peroxide content of the whitening gel is, for example, from about
5% to about 45%, more for example, about 10% to about 40%, as noted
above.
[0167] Exemplary methods of using the whitening composition include
those involving the use of light to activate the whitening
compositions. One exemplary method is described in detail in U.S.
Ser. No. 10/715,681, entitled "Tooth Whitening Process", filed Nov.
17, 2003; Ser. No. 11/173,839 "Illumination System For Dentistry
Applications", filed Jun. 30, 2005; Ser. No. 11/173,371 entitled
"Support Structure for Dental Applications" filed Jun. 30, 2005,
the entire contents of which are hereby incorporated by
reference.
[0168] Preliminarily, if the peroxide gel and/or the whitening gel
have been refrigerated, it is recommended that both are brought to
room temperature prior to use to reconstitute a viscous gel. Upon
combination of the peroxide gel and the Activator Gel, the
resultant whitening gel may be sufficiently stiff so that it may
remain on the teeth when applied. Typically, the gel(s) is, for
example, removed from refrigeration at least six hours before use,
and more for example, the night before, to allow it to reach room
temperature. Alternatively, the refrigerated gels may be brought to
room temperature more quickly by gently heating them as, for
example, by submerging the container holding the gels in hot water
(about 120.degree. F./49.degree. C.) for approximately ten minutes.
If the gel(s) is/are heated in this manner, it is customary to wait
about 5 minutes before combining the gels and applying them to the
teeth, and care is taken to ensure that the temperature of the gels
do not cause discomfort or injury to the patient when applied to
the teeth.
[0169] Briefly, the first stage of the method in accordance with
aspects of the present invention may involve isolation of the teeth
and protection of the non-tooth surfaces that might otherwise be
exposed to the whitening composition in the absence of protection.
Optionally, a commercially available protective lip cream is
applied to the lips to protect the lips. A cotton swab may be used
to coat the lips with the cream. The cream is configured to keep
the lips moist during the procedure and provide added protection
from light exposure. Exemplary protective lip creams include paba
free creams with high SPF rating, of about 30 or higher.
[0170] Next, a lip retractor, such as the Zoom!.TM. Retractor from
Discus Dental, Inc., of Culver City, Calif., is installed to pull
the lips away from the teeth. For additional isolation, a dentist
may optionally apply medical grade petroleum jelly in the upper and
lower vestibules, and cover the area with 2''.times.2'' four-ply
gauze squares (Banta Healthcare Group), cotton rolls, or other
suitable materials having suitable size to cover any remaining
exposed tissues within the oral cavity.
[0171] A protective material may be applied to the gingiva to
protect the gums from exposure to the whitening composition and the
light radiation to be applied thereon. Preferably, a light-cured
dental resin, such as Discus Dental's Liquidam.TM. Dental Dam, is
applied and cured. The gingiva is generally dried prior to
application of the protective material. The protective materials,
which may generally be a light curable resin-based material, may be
syringed directly onto the gingiva with sufficient amount for full
gingival protection. The application extends distally for at least
one tooth beyond the area to receive the whitening application. The
application also may extend up or down to meet the gauze or
retractor cover to protect the margins. Once the application of the
dental dam is complete, the margins are rechecked to ensure that
the dam is sealed against the enamel to prevent leakage and
oxidation of tissue during the whitening procedure.
[0172] Immediately before use, the peroxide gel and the Activator
Gel may be mixed together to form the whitening gel. The whitening
gel is applied directly to the surface of the teeth as, for
example, from the tip of a dual barrel syringe. The gel is applied
to an approximate depth of about 1-2 mm. A brush may be used to
ensure proper placement of the gel. Alternatively, the whitening
composition may be dispensed into a dappen dish or into a mixing
pad for placement onto the tooth surface with a brush. If contact
occurs between the whitening gel and tissue during application of
the whitening composition, Vitamin E Oil may be applied to the
oxidized tissue. The oil material will help sooth the tissue and
create a barrier so that the whitening procedure may continue.
[0173] Once the whitening gel is applied to the teeth, a lamp, such
as a short arc metal halide lamp, is directed at the patient's
smile zone to illuminate the whitening gel and thereby activate the
whitening process. An exemplary suitable lamp is the SMR-150UV1,
Model No. 04-1001, from Ushio America, Inc., of Cypress, Calif.
[0174] Sometimes filters may be placed in front of the lamp to
screen out unwanted or harmful wavelengths. Suitable filters
include a UV filter (available from Optical Industrial of Houston,
Tex., Part No. 03-1013), an IR filter (available from Swift Glass
of Elmira, N.Y., part No. 03-1017), and/or a diffuser filter
(available from Edmund Industrial Optics of Barrington, N.J., part
No. 03-1020).
[0175] The IR filter may be selected to filter all IR wavelengths
to thereby reduce heat emitted to the patient. The UV filter may
also be selected to remove some, but not all, of the ultraviolet
wavelengths. Also, UV wavelengths below about 345 nm are filtered
by the UV filter and only about 10-15% of wavelengths above about
400 nm are allowed to pass through the filter. The diffuser filter
may be configured to diffuse the light rays and minimize the
intensity of light irradiating onto the target area of the mouth.
In one exemplary embodiment, the edge of the lamp may be positioned
about 118 mm from the diffuser filter.
[0176] Once the lamp is secured in place and the smile zone
illuminated, the whitening cycle may begin by activating the light.
For the compositions of the instant invention, this will involve an
approximately, for example, a 10- to 20-minute, more for example, a
15-minute, cycle. If the light assembly has not been used recently,
a warm up cycle of a few minutes may be initiated. At the end of
the cycle, the gel is suctioned from the patient's teeth and any
remaining gel removed with a damp gauze.
[0177] For the whitening compositions of the present invention and
light assembly described, a second and a third application of the
whitening gel and light activating cycle may be used. However, more
cycles may be used if necessary to achieve the desired degree of
whitening.
[0178] After the final cycle has been completed, the lamp is
removed and the remaining whitening gel is suctioned and wiped from
the teeth. The isolation materials (gauze, cotton rolls, gingival
protection) are then removed and, with the retractor in place, the
oral cavity is thoroughly rinsed and suctioned. Dental floss may be
used to remove any dental resin material that remains
interproximally.
[0179] As noted above, compositions of the present invention
requires about 15% less time to produce the same whitening effect
for an identical or even higher peroxide content whitening
composition without the transition metal compound catalyst. Some
representative test results are shown below:
[0180] With the retractor still in place, various post-treatment
procedures may optionally be carried out. For example, the facial
area of the teeth may be dried and a fluoride solution (such as
1.1% Neutral Sodium Fluoride) may be applied, for example, by
syringing it directly onto the teeth, approximately 2-3 mm thick,
and allowing it to remain on the teeth for about 5 minutes before
suctioning and rinsing.
[0181] As noted before, the whitening system of the present
invention can perform faster whitening employing typical or lower
levels of peroxide content compared to one without the transition
metal compound or compounds. An exemplary side by side comparison,
using the same whitening protocol was carried out between a gel
with and without a transition metal compound and the results are
shown below: ##STR1## ##STR2##
[0182] For the Zoom 2 composition (identical to the Zoom 1
composition, with the addition of ferrous gluconate), the time
required to achieve equivalent whitening is reduced from 20 minutes
to 15 minutes for each of the "Zoom Light TX" (light exposure)
steps.
[0183] A foamed system may be applied according to the same method
described above. For a foamed system, the amount of time needed for
producing similar effects as a non-foamed system may be
shortened.
[0184] As noted above, with the present invention, shorter time is
required to effect teeth whitening, though typical or lower
concentration of peroxide is present in the composition. In
addition, the amorphous calcium or strontium phosphate may also aid
in sensitivity relief. However, even at the reduced time of
application and reduced peroxide concentrations and amorphous
phosphate compounds, some patients may still experience teeth
sensitivity after treatment. For those patients, a separate gel
treatment may be provided. This de-sensitizing gel includes
potassium nitrate desensitizer gels including a dissolved sodium
fluoride at a concentration of, for example, between about 500 ppm
to about 1500 ppm, more for example, from about 800 to about 1100
ppm and dissolved potassium nitrate, for example, at about 2.5% to
about 6% by weight, more for example, from about 3% to about 5% by
weight. The gelling matrix is formed primarily with non-ionic
surfactants including ethylene oxide block co-polymers, as
described above in the gel formation of the peroxide gel or
Activator Gel, for example, PLURONIC.TM. F-127. The gelling agent
is, for example, present from about 20% to about 40% by weight of
the gel, more for example, from about 25% to about 35% of the
gel.
[0185] Other ingredients may be present. These include gel
stabilizers such, or any of the above mentioned ingredients useful
in the whitening system. The stabilizers are present, for example,
from about 0.1% to about 8%, more for example, from about 1% to
about 5% by weight.
[0186] Aliphatic polyols such as glycerine may also be added in the
amount of, for example, about 0% to about 10%, more for example,
from about 1% to about 4% by weight.
[0187] Water is added in an amount of, for example, from about 50%
to about 70%, more for example, from about 55% to about 65%.
[0188] The product may be applied generally after a whitening
session, either at the dentist office or at home in a similar
manner as that used for applying the whitening gel described above.
It may be applied directly to a patient's teeth for a clinically
relevant time period, usually 5-15 minutes and then suctioned off.
An alternative means of application is by means of "night guard"
form fitting tooth trays.
[0189] There is a significant improvement in the handling
characteristics of the gel in that it is more easily applied by the
dentist, and significantly more easily removed than many currently
available products. Improved ease of use translates into faster
procedures, reduced "office time" and a potential for reduced cost,
increased profitability for the dental office. A second advantage
could be the increased wetting ability of this composition and
reduced gumminess that may indicate an increased availability of
active ingredients and a possible improvement in overall
efficacy.
[0190] The de-sensitizing gel may be made in the same manner as the
above peroxide and/or Activator Gels. A representative formulation
of this de-sensitizing gel is exemplified below: TABLE-US-00046
Material Trade Name % Grams Water 62.66 125.32 Glycerin 2.00 4 KNO3
5.00 10 Sodium Fluoride 0.243 0.486 Sodium Saccharin 0.25 0.5
Poloxomer 407 Pluronic F-127 28.00 56 Eugenol 0.75 1.5 Natural
Peppermint 1.10 2.2 Oil Total 100.00
[0191] While this invention is described in detail with reference
to a certain preferred embodiments, it should be appreciated that
the present invention is not limited to those precise embodiments.
Rather, in view of the present disclosure which describes the
current best mode for practicing the invention, many modifications
and variations would present themselves to those of skill in the
art without departing from the scope and spirit of this invention.
In particular, it is to be understood that this invention is not
limited to the particular methodology, protocols, and reagents
described as such may vary, as will be appreciated by one of skill
in the art.
* * * * *