U.S. patent application number 09/791529 was filed with the patent office on 2001-08-09 for device for heating the teeth and uses therefor.
Invention is credited to Darnell, Daniel Henry.
Application Number | 20010012608 09/791529 |
Document ID | / |
Family ID | 27400008 |
Filed Date | 2001-08-09 |
United States Patent
Application |
20010012608 |
Kind Code |
A1 |
Darnell, Daniel Henry |
August 9, 2001 |
Device for heating the teeth and uses therefor
Abstract
There is disclosed a novel device for providing heat to dental
and periodontal structures and a novel process for brightening
teeth, together with a novel use of old known processes for
brightening teeth. The novel device comprises a splint/stint or
vacumformed dental tray, containing a heating element to be placed
around the tooth or teeth to be brightened. The novel process for
brightening/whitening teeth entails using the splint containing the
heating element in conjunction with standard tooth whiteners with a
brightening agent. The heating element is attached to a power
source, preferably mobile and transportable, so that the process
may be accelerated by the heating of the brightening agent, in
accordance with the Q10 rule.
Inventors: |
Darnell, Daniel Henry;
(Hanceville, AL) |
Correspondence
Address: |
LANIER FORD SHAVER & PAYNE
P O BOX 2087
HUNTSVILLE
AL
35804
US
|
Family ID: |
27400008 |
Appl. No.: |
09/791529 |
Filed: |
February 23, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09791529 |
Feb 23, 2001 |
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09506847 |
Feb 18, 2000 |
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09506847 |
Feb 18, 2000 |
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09247124 |
Feb 8, 1999 |
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6102705 |
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09247124 |
Feb 8, 1999 |
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08968802 |
Nov 22, 1997 |
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Current U.S.
Class: |
433/216 ;
433/32 |
Current CPC
Class: |
A61C 9/00 20130101; A61C
19/063 20130101; A61C 19/066 20130101 |
Class at
Publication: |
433/216 ;
433/32 |
International
Class: |
A61C 015/00; A61C
019/00 |
Claims
I claim:
1. A device for heating the teeth, comprising: a) a dental splint
having an inner aspect for contacting the front surface of the
teeth directly, said splint constructed to cover the entire
structure of the teeth but not the gingival tissue; b) a heating
element within said inner aspect of said splint adapted to contact
the front surface of the teeth directly and to heat the front
surface of the teeth directly; c) a means for increasing the
temperature of said heating element; d) said splint having a
reservoir to hold a fluid treatment solution in contact with the
teeth but not in contact with the gingival tissue; and e) said
splint constructed to fit entirely within the mouth and to cover
the entire structure of the teeth.
2. The device of claim 1 wherein the heating element reaches a
temperature between 90-160.degree. F.
3. The device of claim 2 wherein said means for increasing the
temperature of said heating element comprises a battery powered
electrical circuit connected to said heating element.
4. The device of claim 3 wherein said means for increasing the
temperature of said heating element is comprised of: a) a power
source; b) a first electrically conductive wire having a first and
second end; and c) a second electrically conductive wire having a
first and second end, wherein the first end of both the first and
second wire are connected to said heating element and the second
end of both the first and second wire are connected to the power
source such that an electrical circuit is created that causes the
heating element to increase in temperature.
5. The device of claim 4 wherein said power source comprises one or
more batteries.
6. The device of claim 5 wherein the heating element is comprised
of a nickel-chromium alloy and wherein said heating element reaches
a temperature between 90-160.degree. F.
7. The device of claim 6 wherein said heating element is comprised
of a nickel-chromium alloy, polyamide/FEP, etched foil, mica,
ceramics, carbon-based conducting materials, or a combination
thereof.
8. The device of claim 7 wherein said means for increasing the
temperature of said heating element is embedded within the material
forming the splint.
9. The device of claim 8 wherein said heating element is embedded
within the material forming the splint.
10. The device of claim 9 wherein said heating element, within said
inner aspect of said splint, is encased in a heat dispensing pad,
bonded and enclosed by said splint.
11. The device of claim 10 wherein said splint is custom fitted to
the teeth of a user.
12. The device of claim 11 wherein said splint is a semi-custom
tray fitted by heat fitting by a user in need thereof.
13. The device of claim 12 further comprising a means for
regulating the voltage provided by the power source to the
electrical circuit.
14. The device of claim 5 wherein said battery is one or more
C-cell batteries.
15. The device according to claim 14 wherein said fluid treatment
solution contains peroxide, carbamide peroxide, fluoride,
conventional mouthwash solutions, or a combination thereof to
reduce mouth odor.
16. The device according to claim 14 wherein said fluid treatment
solution contains a whitening agent to whiten the teeth.
17. The device according to claim 14 wherein said fluid treatment
solution contains potassium nitrate, fluoride, strontium chloride,
sodium citrate, glutaraldehyde, or combinations thereof to reduce
dentin sensitivity.
18. The device according to claim 14 wherein said fluid treatment
solution contains calcium, phosphate, and fluoride to prevent
demineralization and to remineralize the teeth.
19. The device according to claim 14 wherein said fluid treatment
solution contains one or more antibacterial agents to prevent and
treat tooth decay and periodontal disease.
20. A method of treating teeth, comprising the steps of: a)
providing a splint constructed to cover the entire structure of the
teeth but not the gingival tissue, said splint having an inner
aspect for contacting the front surface of the teeth directly, and
having a heating element within said inner aspect to contact the
teeth directly and to heat the front surface of the teeth directly;
b) dispensing a fluid treatment solution into said splint, said
splint having a reservoir to hold said fluid treatment solution in
contact with the teeth but not in contact with the gingival tissue;
c) placing said splint entirely within the mouth; d) placing said
splint over the entire tooth or plurality of teeth to be treated
such that the fluid treatment solution comes in contact with the
tooth or plurality of teeth but not in contact with the gingival
tissue; and e) providing heat directly to the teeth by increasing
the temperature of the heating element contained therein with a
power source so that the fluid treatment solution is heated at the
front surface of the teeth.
21. The method of claim 20 wherein the heating element reaches a
temperature between 90-160.degree. F.
22. The method claim 21 wherein said power source for said heating
element comprises an electrical circuit connected to said heating
element.
23. The method of claim 22 wherein said power source for increasing
the temperature of said heating element is comprised of: a) one or
more batteries; b) a first electrically conductive wire having a
first and second end; and c) a second electrically conductive wire
having a first and second end, wherein the first end of both the
first and second wire are connected to said heating element and the
second end of both the first and second wire are connected to the
power source such that an electrical circuit is created that causes
the heating element to increase in temperature.
24. The method of claim 23 wherein the heating element is comprised
of a nickel-chromium alloy and wherein said heating element reaches
a temperature between 90-160.degree. F.
25. The method of claim 24 wherein said heating element is
comprised of a nickel-chromium alloy, polyamide/FEP, etched foil,
mica, ceramics, carbon-based conducting materials, or a combination
thereof.
26. The method of claim 25 wherein said power source for said
heating element is embedded within the material forming the
splint.
27. The method of claim 26 wherein said heating element is embedded
within the material forming the splint.
28. The method of claim 27 wherein said heating element, within
said splint, is encased in a heat dispensing pad, bonded and
enclosed by said splint.
29. The method of claim 28 wherein said splint is custom
fitted.
30. The method of claim 28 wherein said splint is a semi-custom
tray fitted by heat fitting by a user in need thereof.
31. The method of claim 20 wherein a means for regulating the
voltage provided by the power source to the electrical circuit is
connected within the electrical circuit.
32. The method of claim 20 wherein the fluid treatment solution
comprises a carbamide peroxide solution for whitening the
teeth.
33. The method of claim 20 wherein the fluid treatment solution
comprises a compound selected from the group consisting of
carbamide peroxide, peroxide formulations, and fluoride for
whitening the teeth.
34. The method of claim 32 wherein the fluid treatment composition
consists essentially of from 5% to 44% carbamide peroxide.
35. The method of claim 20 wherein said fluid treatment solution
contains peroxide, carbamide peroxide, fluoride, conventional
mouthwash solutions, or a combination thereof to reduce mouth
odor.
36. The method according to claim 20 wherein said fluid treatment
solution contains potassium nitrate, fluoride, strontium chloride,
sodium citrate, glutaraldehyde, or combinations thereof to reduce
dentin sensitivity.
37. The method according to claim 20 wherein said fluid treatment
solution contains calcium, phosphate, and fluoride to prevent
demineralization and to remineralize the teeth.
38. The method according to claim 20 wherein said fluid treatment
solution contains one or more antibacterial agents to prevent and
treat tooth decay and periodontal disease.
39. The method according to claim 20 wherein no fluid treatment
solution is used in said splint to heat the teeth to treat mouth
odor.
40. The method according to claim 20 wherein the treatment of the
teeth with said splint is entirely within the control and ability
of a user in need of treatment of the teeth.
Description
[0001] This is a continuation of U.S. patent application Ser. No.
09/506,847, filed Feb. 18, 2000, which is a continuation-in-part of
U.S. patent application Ser. No. 09/247,124, filed Feb. 8, 1999,
issued as U.S. Pat. No. 6,102,705, which is a continuation-in-part
of U.S. patent application Ser. No. 08/968,802 filed on Nov. 22,
1997.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to an improved process and apparatus
for brightening teeth, utilizing a heating element that activates a
brightening agent, and more particularly to such a process that is
user activated and controlled, within a short interval of time,
thus decreasing the conventional time required for effective teeth
whitening.
[0004] 2. Technical Background
[0005] The importance of cosmetically attractive, whitened or
brightened, teeth in today's society cannot seriously be
questioned. During the past ten years, there has been a virtual
explosion of supposed new and improved processes for the
simplification and efficacy of teeth whitening and brightening.
However, each such process has had several drawbacks creating a
negative impact on the user, including high costs of the new
treatments, repeated visits to the dentist/cosmetician for repeated
treatments, difficulty of use, length of time to achieve the
desired results, and need for professional help.
[0006] The prior art has known many devices and methods for
externally treating a tooth or teeth of a patient. The most
primitive method of externally treating a tooth involved the direct
application of an active agent to the tooth of the patient.
Examples of the external treatment of a tooth include the direct
application of active agents such as fluoride, tooth whiteners,
antibiotics, antihistamines and topical anesthetics.
[0007] Although the external treatment of a tooth by the direct
application of an active agent has achieved some success, several
problems exist with this method. First, the direct application of
an active agent is generally inefficient since the active agent can
be applied to the surface of the tooth for only a relatively short
period of time with only modest results. The relatively short
period of time of application is determined by the length of time
the active agent remains on the tooth of the patient. The length of
time the active agent remains on the tooth of the patient is
generally determined by the viscosity of the active agent and the
ability of the active agent to remain on the tooth as well as the
ability of the patient to remain immobile during the treatment.
[0008] In an effort to overcome these problems, some in the prior
art have increased the concentration of the active agent in an
effort to produce satisfactory results within the limited period of
time permitted by the direct application of the active agent.
Unfortunately, the increase in concentration of the active agent
produces undesirable side effects for the patient.
[0009] Many other prior art treatment processes have also involved
the direct application of a physical process to the external
surface of a tooth to brighten same, involving, for example, the
use of bonding to mask previously existing stains on the tooth,
crowns or porcelain veneers physically attached to the tooth to in
effect hide the stains, or application of high physical heat
through the past use of a modified soldering iron, a heat lamp or
today's equivalent, a laser. However, all of these applications
involved the direct need for a professional doctor and/or dentist
chair time and the resulting associated costs. The user has had
little control over the process being applied to his teeth, and had
to frequently revisit his doctor/dentist for follow-up application
and treatments.
[0010] The remaining treatment processes have tried to give the
user some sort of control over the bleaching and whitening process,
but usually at the expense of time and efficiency, and with varying
results. For example, others in the prior art have utilized a
plastic splint or stint molded to overlay the teeth of the patient
in an effort to retain a tooth whitening agent in contact with the
teeth of the patient over an extended period of time. Such a method
is set forth in an article entitled "Nightguard Vital Bleaching"
which has been published in Quintessence International, Volume 20,
March, 1989. In this method, a stint is molded to fit the entire
upper or lower teeth of the patient and to seal with the gingiva of
the patient. The active agent is introduced into the stint and the
stint is inserted upon the teeth of the patient to retain the
active agent in close contact with the teeth of the patient.
[0011] Although the use of a plastic stint allowed the active agent
to remain in contact with the teeth for an extended period of time,
the use of the plastic stint had certain disadvantages. First,
since the plastic stint was molded to intimately fit with the
entire upper or lower teeth of the patient, the stint was
uncomfortable due to the tightness of the fit with the teeth.
Second, the stint sealed with the gingiva of the patient, making
the stint incapable of fitting with a single tooth or just several
teeth. Third, the stint had to be cut back adjacent to the gingival
margin to prevent undesired deterioration of the gingiva due to the
intimate contact of the stint with the gingiva during the treatment
process. Forth, the intimate fit of the stint with the entire upper
or lower teeth of the patient prevented ingress and egress of
oxygen to the internal regions of the stint. Fifth, the intimate
fit of the stint with the entire upper or lower teeth of the
patient made the stint difficult to remove in some instances.
Sixth, notwithstanding the intimate region of the stint with the
entire upper or lower teeth of the patient, the active agent within
the internal region of the stint would over time migrate from the
stint, thus reducing the effectiveness of the active agent upon the
teeth.
[0012] The liquid splints/stints utilized by the Munro patent, U.S.
Pat. No. RE 34,196, the disclosure of which is hereby incorporated
by reference, constituted a great advance in the art at the time
and did permit some freedom of use by the user. However, the
splints still required several hours of use of the liquid splint
per day for many days to achieve the desired brightening effects,
and were uncomfortable to some due to their tightness over the
teeth. There was also a problem involving the retention of the
brightening agent on the treated teeth. Several inventions followed
which attempted to resolve the problems of the whitening agent
being swallowed, dissolved/weakened by saliva, or leaking out of
the splint onto the gums/gingiva or labia. Several other new
processes were introduced which addressed the retention of
whitening agent through the additions of a retaining
material/reservoir (U.S. Pat. No. 4,968,251) and plurality of
indentations/baffles to prevent the loss of the whitening agent
(U.S. Pat. No. 5,575,655). However, these later
inventions/processes did not sufficiently address the time and
efficiency issues of the user, though they did allow the user more
freedom in his control over the bleaching process.
[0013] In the effort to reduce the time needed for the bleaching
process, some in the prior art have tried to increase the
concentration and/or the viscosity of the whitening agent (see,
e.g. Fischer U.S. Pat. No. 5,098,303), thereby hoping to speed up
the brightening process while lowering the time the user had to use
the splint of Munro or later modified and improved versions of
same. However, the increased concentration and/or viscosity of the
brightening agent--frequently a peroxide derivative--resulted in an
accompanying increase in deleterious side effects for the user. To
avoid tissue damage from the increased concentration of the
brightening agent, the user had to frequently shorten his exposure
to same with intervening periods of no exposure--with the result
that the overall bleaching time (time to achieve
whitened/brightened teeth) has remained more or less similar.
[0014] There have been additional techniques and devices developed
over the years in an effort to improve the methods for brightening
or whitening teeth. One such effort was the application of heat to
dental and/or periodontal structures and the whitening agents, such
as peroxides, being applied thereto. It is widely known in the art
that heat activates peroxide solutions, increasing their
effectiveness as whitening agents. Under the "Q10 Rule," it is well
known in the art that an increase of 10.degree. C. in temperature
of whitening agents/solutions--such as peroxides and peroxide
derivatives--doubles the speed of the whitening action/process. In
other words, the time to achieve whitening results is effectively
halved. Thus, whitening time can be reduced by 50% by application
of a sufficient supra-body heat temperature to the whitening
agent.
[0015] For this reason, the application of heat to dental and/or
periodontal structures and the whitening agents has long been a
desired treatment parameter, but the lack of control of the amount
of heat or the difficulty associated with the delivery of a
therapeutic quantity of heat for sufficient time to be useful along
with the degree of discomfort to the patient has limited the use of
heat in various dental/periodontal treatments. For example, in an
article entitled "Bleaching Tetracycline-Stained Vital Teeth"
published in Oral Surg., March 1970, a method was introduced to
bleach certain stained teeth by the application of 30% hydrogen
peroxide (Super oxol) to individual teeth warmed or heated by a
modified soldering iron (bleaching tool) to the individual's limit
for pain (pain threshold), for a period of 30 minutes over
treatments, spanning a two-month period. All treatments had to be
conducted in the dentist's office, with follow-up visits to
maintain bleaching monthly thereafter. The inventors noted that
this bleaching technique would be contra indicated for any tooth
bearing a silicate/resin restoration. Interestingly, the pulp
temperature remained constant and unchanged during treatment.
[0016] With the advent of Munro, the slight advantages offered by
the prior art heating source method--and its progeny--were
overcome, as the tray technology of Munro and its progeny achieved
equivalent teeth whitening results by longer exposure times to
peroxide activated by body heat. The art tried to counter the Munro
progeny trays with better sources of heat and peroxides to counter
the relative ease of the Munro trays with better whitening results.
Photo flood lights, hot irons (soldering irons), hot water baths
and lasers have all been recorded in the art as methods of
activating, and heating, peroxide compounds for teeth whitening
procedures. With the exception of some of the hot water bath
techniques, all of these heating methods must be practiced by a
dentist or other medical professional in the office due to the
cumbersome and non-portable natures of these heat sources; these
methods are not at home techniques. As a result, office procedures
are costly on a per hour basis, especially when many hours of
treatment may be necessary over an extended number of days. Thus,
in an effort to maximize results within short time periods,
therefore decreasing "chair time" at the dental office, high
concentrations of whitening solutions (peroxide compounds) have
been required in addition to uncomfortably high levels of heat.
[0017] In a typical tray-type whitening method utilizing Munro and
its progeny, a tray is loaded with carbamide peroxide, or other
similar bleaching/whitening agent, and placed over the teeth to be
whitened. The tray is then left in contact with the teeth for a
prescribed period of time, during which time some whitening or
bleaching of the tooth/teeth occurs. Repeated applications are
necessary as whitening of the tooth/teeth occurs in small
increments over a period of several weeks. The degree of whitening
is dependent, in part, on the amount and concentration of the
whitening solution and the time in which said solution remains in
contact with the teeth, as well as the susceptibility of the tooth
to this whitening procedure.
[0018] The only remaining variable is the temperature under which
the bleaching/whitening action takes place. Currently, in all
tray-type whitening methods, the bleaching/whitening takes place at
body temperature (inside of the mouth), though some methods perform
a preliminary step of warming the whitening agent (by immersing
same into a bowl of warm water) to obtain a temporary body-like or
greater temperature before the placement of the whitening agent
within the tray. However, no current tray-type method utilizes
sustained supra-body heat temperature, and the constant maintenance
of same, on the whitening agent during the whitening/bleaching
process. This problem is further exemplified and exacerbated due to
the user's/patient's mouth being open during use of the tray; the
inhale/exhale process brings room temperature air over the teeth
constantly. Thus, simple breathing thereby lowers the temperature
of the whitening agent and thus lowers the reaction speed, thereby
increasing the total time needed for the user to obtain whitened
teeth.
[0019] Therefore, there is a need in the art for a simplified and
less costly process of tooth brightening that the user can do,
either at home or during a single trip or two to the
dentist/doctor's office, without the serious side effects
associated with an increase in the concentration of the whitening
agent. A further need exists in the art for a simplified process of
tooth brightening associated with a maintenance system for the now
whitened/brightened teeth, said process being within the total
control and ability of the user.
SUMMARY OF THE INVENTION
[0020] It is an object of the present invention to provide an
improved method and apparatus for treating a tooth or teeth with an
active agent which produces results which are superior to the
results heretofore known to the art. This is accomplished by use of
a dental device comprising a splint, a heating element attached to
the splint, and a means for increasing the temperature of the
heating element. In another embodiment of the present invention, an
active whitening agent is placed in the splint to assist in
whitening the teeth.
[0021] Another object of the present invention is to provide an
improved method and apparatus for treating a tooth or teeth with an
active agent wherein said active agent is retained in a
custom-fitted splint and catalyzed by a heating element used in
conjunction with said custom-fitted splint.
[0022] In multiple embodiments of the present invention, the means
for increasing the temperature of the heating element include a
battery connection, with a standard rechargeable battery, or some
other external power source.
[0023] The foregoing has outlined some, not all, of the more
pertinent objects of the present invention. Said objects should not
be construed to be illustrative of all pertinent features and
applications of the present invention, but merely illustrative of
some of the more pertinent features and applications of the
invention. Many other beneficial results can be obtained through
the use of the disclosed invention--whether same is applied in a
different manner or otherwise modified within the scope of this
disclosure. Therefore, a more full understanding of the present
invention may be obtained by referring to the drawings, the summary
of the invention and the detailed description describing the
preferred embodiment of same, with the scope of the invention being
defined by the claims and illustrated by said attached drawings
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] FIG. 1 is a depiction of the heating element wire bent and
formed over a mold of a set of upper teeth in a manner as to cover
a maximum surface per tooth to provide even heat displacement.
[0025] FIG. 2 is a depiction of the heating element wire attached
via solder to an insulated power supply wire.
[0026] FIG. 3 is a depiction of a mold of a set of upper teeth and
the splint therefore constructed following standard dental
procedures. The heating element wire is encased in the splint and
the insulated power supply wire protrudes from the splint and is
attached to a power source.
[0027] FIG. 4 is a depiction of the heating element wire encased in
a heat dispensing pad bent and formed over a mold of a set of upper
teeth.
[0028] FIG. 5 is a depiction of the splint with the heating element
wire encased in the splint and the insulated supply wire protruding
from the splint. The insulated power supply wire is connected to a
potentiometer or other voltage regulator which is connected to the
power source, a battery.
DETAILED DESCRIPTION OF THE INVENTION
[0029] It has been discovered that the bleaching/whitening agents
currently being utilized within the liquid splints/trays of Munro
and progeny in the prior art can be further activated by the
constant application of heat on said bleaching/whitening agent by
means of a heating element within said liquid splint/tray, and
adjacent to the whitening agent, thereby activating and
accelerating the bleaching/whitening process of stained or
otherwise discolored teeth, while remaining in the control of the
user. The present invention provides a method and process for
placing a heated element within a liquid splint or tray, with said
heated element connected to a power source, such as a typical
D-cell battery, thereby providing an increase in the temperature of
the bleaching/whitening agent above normal body temperature
(98.6.degree. F.) with a subsequential and consequential increase
in the bleaching/whitening reaction, pursuant to the Q10 Rule. This
permits the whitening procedure to be accomplished in a shorter
period of time than current conventional tray whitening techniques
allow. A further benefit of the invention is that, due to the
increased reaction rate of the whitening agent, a user with
sensitive teeth/gums can still undergo the whitening process in the
same amount of time as the current conventional techniques, but
with a lesser concentration of whitening agent, thereby lowering
the risk of pain, discomfort, and damage a user faces with higher
concentrations of said whitening agent. Together, the invention
would thus achieve greater whitening efficiency and in a faster
time, retain control of the procedure with the user, and provide
results at a fraction of the costs of professional whitening.
[0030] Specifically, this invention pertains to the technique of
mouth guard, night guard or tray-type teeth whitening whereby a
custom or non-custom fitted splint is used in conjunction with a
heated element to increase the effectiveness of a bleaching agent
contained within said splint to whiten teeth. The heated splint is
offered to the art as a simple, economical and novel method of
applying heat to a single tooth or plurality of teeth and whitening
agent within a patient's/user's mouth. This heat application is
utilized to increase efficiency and uniformity of the bleaching or
whitening process over all state-of-the-art modalities. This method
allows precise control over the amount of heat delivered to the
tooth structures, as heat is focused via this heated tray method
within a specific area and has minimal, if any, affect on
surrounding structures.
[0031] Due to the predictable heat level produced by the heated
tray for sustained time periods (0unlimited time, dependent on
power sources), and also due to the simple and portable nature of
its design, lower concentrations of whitening solution can be used
to obtain similar results to said prior art heat source methods
used in office procedures. Lower temperatures can also be employed
to obtain similar results because the time of treatment can be
easily extended without consuming expensive office treatment time;
the patient/user can utilize the technique at home.
[0032] Because lower concentrations of whitening solution can be
utilized, there will be a lower incidence of side effects related
to the concentration and/or components of the whitening solution.
Furthermore, due to the lower levels of heat which can be used,
there will also be less side effects related to the high levels of
heat previously used in the art. It has been shown in many studies
that teeth are resilient to moderate levels of heat and are not
permanently adversely effected by application of said moderate
levels of heat, up to approximately 160.degree. F.
[0033] Therefore, the heated tray technique will allow the use of
the most conservative components of a teeth whitening regimen while
still obtaining the greatest possible whitening effect in the
shortest period of time. The heated tray technique and invention as
disclosed herein constitutes the new state-of-the-art of teeth
whitening, since all the variables of time, whitening agent
concentration, and temperature can be controlled by the user at
home. Any of the custom trays derived from Munro (U.S. Pat. No. RE
34,196), its progeny, Darnell (U.S. Pat. No. 4,968,251) and Darnell
(U.S. Pat. No. 5,575,655) may be utilized in connection with the
heated tray technique, along with the over the counter non-custom
trays and the "boil and bite" semi-custom trays. Specifically, the
invention utilizes all the embodiments referred to in Munro U.S.
Pat. No. RE 34,196, Darnell U.S. Pat. No. 4,968,251, and Darnell
U.S. Pat. No. 5,575,655 and all such embodiments in said patents
are hereby incorporated by reference into this application.
[0034] The heated tray whitening method now allows the patient
total control over the whitening process. The patient can control
the level of heat to the desired level of comfort via a
potentiometer (voltage regulator or rheostat) or by simply
activating and deactivating the battery/power source. The patient
also controls the concentration of the whitening solution according
to each individual's sensitivity to the concentration of the
whitening agent. Furthermore, and perhaps most importantly to the
user, the patient can control the time regimen for utilizing the
heated tray whitening method that fits their own schedule. For
example, a patient can use the heated tray one hour per day or only
twenty minutes per day. Due to this level of control over the
whitening method, the patients can whiten their teeth until they
are satisfied that their teeth are as white as each particular
patient desires.
[0035] FIG. 1 illustrates the heating element wire 1 formed over a
mold of a set of upper teeth. The heating element wire 1 preferably
consists of a 3-4 inch length of nickel-chromium alloy (or other
similarly electrically conductive) wire bent or formed in such a
manner as to cover a maximum width per tooth 6 to provide even heat
displacement over a greater width than the thickness of the wire 1
itself. Other materials may be used for the heating element, such
as, for example, polyimide/FEP, etched foil, mica, ceramics,
carbon-based conducting materials, or a combination thereof An
insulated power supply wire 4 is attached via solder 2 or clip, or
some other electromechanical attaching means, to each end of said
heating element wire 1, as depicted in FIG. 2. There are many
possible and potential configurations for the heating element wire
1. The nichrome, or other similarly conductive, wire 1 is
preferably 27 gauge with no cover or padding and approximately 3-5
inches in length. A longer length of heating element wire 1 may
require a higher gauge. For example, seven inches of heating
element wire 1 would preferably be about 35 gauge, while a lesser
length of heating element wire 1 would preferably use a lower
gauge. For example, 2.5 inches of heating element wire 1 may be 25
gauge, in order to maintain similar therapeutic temperatures of
approximately 110.degree. using identical power sources 8 (i.e. a
1.5 volt D-cell battery). The heating element wire 1 may be encased
in a heat dispensing pad 9 such as cotton felt or acrylic, or some
other electrically insulated/inert material, as depicted in FIG. 4.
A power supply wire 4 is again attached to the two ends of the
heating element via wire 1 solder or other means. This resulting
unit, i.e., the heating element wire 1 and the solder 2 or other
attaching means is the portion that will be bonded, molded or
otherwise attached into the whitening tray. The heating element
wire 1 cannot be allowed to form a cross-circuit, i.e. cross
itself, since if uninsulated, the wire 1 could in effect "short
out," thus changing the effective length of the heating element
wire 1, and the resultant temperature/heat delivered to the
tooth/teeth surface(s) 6. The other end insulated power supply wire
is connected to the power supply, as depicted in FIG. 3.
[0036] In one embodiment, the heating element wire 1 is bonded
within the facial wall 13 of a "custom" tray 12, i.e., the inner
aspect of the tray or splint which contacts the front surface of
the teeth. In this manner, the heating element provides heat
directly to the front surface of the teeth and the whitening agent
is heated at the front surface of the teeth. The "custom" tray 12
is fabricated by means common to the art; herein the "custom" tray
12 may be fabricated by molding the tray with the heating element
wire 1 over a stone (or plaster) model 5 of the specific
user's/patient's teeth to be whitened utilizing a dental vacumform
machine. The stone or plaster model 5 may be formed from an
alginate impression of the patient's/user's upper or lower arch of
teeth, with the impression then being used to fabricate the stone
or plaster model 5. The stone model 5 is fabricated and trimmed
through the palatal/lingual surface until the maxillary and
mandibular models have a horseshoe appearance. A die spacer or some
other suitable material is placed on the surface (buccal and/or
lingual) of the teeth to be preferentially treated. The heating
element wire 1 would actually be placed on, and attached to the
stone model 5, said attachment being preferentially accomplished
through small drops of a superglue being applied to the desired
location on the maxillary and/or mandibular model, and the heating
element wire 1 then glued/tacked to said location. Selected tray
material, typically 0.040 EVA material or a polycarbonate
composition, is then heated in the vacumform unit, while the
patient's/user's model 5 with attached/affixed heating element wire
1 is placed on the vacumform stage or some other similar flat work
space. The heated tray material, after being heated in the
vacumform machine to a molten temperature, is then pulled down and
forced over the model 5 and the heating element wire 1. The sealing
of the heating element wire 1, save for the protrusions of the two
power supply wires 4, within the tray 12 by the vacumform tray
material also prevents any excess leakage of the whitening agent
from the incisal section of the tray at the point the power supply
wire 4 protrudes from the tray (i.e. where the heating element wire
1 connects to, and with, the power source or power source supply
wire 4). The nichrome wire portion of the heating element wire 1 is
generally sealed, away from the teeth surface, by the vacumformed
tray material, though it may be only partially sealed, and has a
resultant location on the inner aspect of the tray 12, which
contacts the front surface of the teeth. The tray 12 is then
trimmed in the standard manner, according to the prior art,
slightly to the tooth side and away from the gingival tissue 7
side. As is known in the prior art, the tray 12 should not overlie
gingival tissue 7, i.e. no tray material should touch the gingivae
at the neck areas of the teeth when the tray is in use with the
peroxide agent/solutions, so as to reduce possible injury or
irritation to the gingival tissue 7.
[0037] The heating element wire 1 may also be bonded into a generic
or universal tray, such as a commercially available
over-the-counter tray or splint as described above, i.e., the
heating element is located within the inner aspect of the splint
which contacts the front surface of the teeth. This unit is not
"custom-formed" for each particular user, or "patient," and thus
would be suitable for "over-the-counter" applications for at home
teeth whitening by the user. By way of example, and not by
limitation, a standard "thin" football or other sport
mouthpiece/mouth guard is utilized and the heating element wire 1
is either made or molded into the inner aspect of said mouth guard,
which contacts the front surface of the teeth. If the heating
element wire 1 is desired to be encased in said mouth guard, such
could be performed using the techniques outlined above, i.e.,
forming the heating element wire 1, attaching the power supply wire
4 by solder 2 or other means, and placing same into the generic or
universal mold before the tray material is deposited. As an
alternative to encasing the heating element wire 1 in the
mouthpiece, the heating element wire 1 can be molded and attached
to the tray, after the tray material is deposited into the mold.
The increments on the mouth guard can then be trimmed off to avoid
contact with the gingival tissue 7, such that the level of the
whitening solution/bleaching agent 11 is visible. The whitening
treatment would then proceed by activating the tray with a power
source 8, ideally in this incarnation a portable battery, such as a
D or C-cell battery.
[0038] The non-custom tray or splint with heating element contained
therein can also be heat-fitted, such as a known art technique of a
mouth guard which is boiled or heated until it becomes soft, and
the user then forms an impression of his teeth by biting into the
new soft mouth guard and letting same cool for a specified period
of time. The non-custom tray would then be "semi-custom," as the
user could buy a conventional mouth guard, then mold it to fit only
his/her teeth in the usual "boil and bite" mouth guard method.
[0039] Due to the lesser periods of time needed for the user to
obtain whitened teeth by this procedure, some of the "comfort"
normally required by the user for use of a bleaching/whitening tray
can be sacrificed. Less time in the non-custom but heated tray
would mean less time being uncomfortable, but with the same or
similar results as those currently obtained by custom-tray
techniques that do not utilize a heating element. The user who
could withstand a temporary sacrifice in comfort would save money
over the more costly conventional custom-tray techniques which
utilize dental impressions, stone or plastic models of same, etc.
Accordingly, for some users, the non-custom heated tray can be a
viable and cost-effective alternative to more costly
techniques.
[0040] The non-custom or "over-the-counter" heated tray may be best
used with the lower concentrations of carbamide peroxide, or
similar bleaching agents/whitening solutions 11, due to less
potential side effects, i.e. burned gingival tissue 7 caused by
lesser control over the peroxide solutions in the non-custom trays
as compared to higher levels of control over said solutions when a
user utilizes custom trays. The lower level or concentration of the
peroxide solutions are also recommended in this technique due to
the sole control by the user over the process; the process is
generally unsupervised by a dental or professional doctor. Due to
lower concentrations of the whitening solution and lower levels of
heat this method could be effective but take more time than the
dentist supervised custom tray incarnation described above.
[0041] The heating element wire 1 may also be bonded to either the
custom tray or generic tray in such a manner so that the felt (or
cotton or acrylic) surface of the heat dispensing pad 9 of the
heating element wire 1 is in direct contact with the teeth 6, or
may instead be bonded or attached in such a manner that the heating
element wire 1 and heat dispensing pad 9 are entirely bonded and
enclosed by the tray material. The layers of the tray material
would in effect "sandwich" the heating element and would be in
direct contact with the front surface of the teeth. In either
method, the two power supply wires 4 connected to the heating
element wire 1 can protrude through or over the tray material. The
power supply wire 4 can be routed in any convenient manner as long
as the power source is connected to the heating element wire 1.
[0042] In another embodiment, the device can be made by placing a
spacer on the surface of a tooth mold, forming a splint over the
mold, removing the formed splint and spacer from the mold, removing
the spacer from the splint, placing a heating element within the
splint, and connecting the heating element to a power source to
increase the temperature of the heating element.
[0043] The steps of a) placing a heating element on the surface of
the mold, b) connecting the power supply wires to each end of
heating element, and then c) forming the splint are equivalent to
the steps of a) attaching the power supply wires to each end of the
heating element b) placing the heating element on the surface of
the mold, and then c) forming the splint, which is also equivalent
to the steps of a) placing a heating element on the surface of the
mold, b) forming the splint, and then c) attaching the power supply
wires to each end of the heating element.
[0044] Regardless of the incarnation selected, the heating element
wire 1 is then activated by a power supply 8 by means of a power
supply wire 4 between said power supply 8 and heating element wire
1, as depicted in FIG. 3. The power supply 8 used to activate the
heating element wire 1 could be one or more D-cell alkaline
batteries. Almost any size battery 14 will enable the heating
element wire 1 to obtain the desired temperature and include
D-cell, C-cell sizes, as well as multiples of A and AA-cell size
batteries. The battery 14, which in one incarnation may be encased
in a battery case 16, may be replaced after each treatment,
depending on the size of the battery 14 initially used and the
length of treatment. A typical D-size battery will provide
approximately 4-5 hours worth of treatment time, or approximately
3-5 individual treatments. The power supply 8 may have a variable
potentiometer 15, or voltage regulator/rheostat device, to allow
the patient, or doctor/dentist if treated within an office, to vary
the temperature of the heated tray and utilize/achieve a more
comfortable temperature setting consistent with each patient's
desire. It may also alternatively utilize a cap on the battery
casing 16 which upon closure onto the battery case 16 would
activate the heating element wire 1. A "dead man" switch may also
be incorporated into an incarnation of the invention, such that the
power supply 8 to the heating element wire 1 is turned off should
the user let go of said switch, such as by falling asleep. The
switch would be attached in one incarnation of the invention to the
battery casing 16. The temperature range of the heating element
wire 1, activated once the battery 14 is installed, or in other
incarnations turned on via the cap on the battery casing 16 or via
a dead man's switch will be between 90-160.degree. F., preferably
100-125.degree. F., more preferably 105-110.degree. F.
[0045] The heated tray may also be fabricated wherein both the
heating element wire and the power supply 8 are located within the
heated tray. In this incarnation of the invention, a small 1.5 volt
camera battery, for example, is attached by means of a clip,
solders or other electrical attaching means known to the art to the
heating element wire 1 prior to the sealing of the heating element
wire 1 and the battery 14 by the vacumform tray material. The
internal power source 8, such as a camera or watch battery, would
be attached to the stone model 5 by means similar to the attachment
of the heating element wire 1 to said stone model 5, or by other
attaching means. A "dead-man's" switch, to enable or disconnect the
electrical circuit/heating element wire 1 as discussed below, is
attached to the outside (labial) surface of the heated tray.
Alternatively, the battery 14 could be placed inside yet another
(second) tray which would be placed over the first tray, so-called
double vacumforming, which would seal both the battery 14 and the
heating element wire 1 within the tray material so that the danger
of a patient/user swallowing the battery 14 would be drastically
lessened. The expected life of such a power source 8 within said
heated tray incarnation should extend beyond a 2-hour treatment
time for most normal cases. For serious cases, multiple heated
trays of this incarnation would have to be fabricated and later
utilized by the patient/user. The battery in this self-contained
tray can most conveniently be located in a "handle" attached to the
tray which protrudes form the patient's mouth, and said battery can
be, preferably, rechargeable.
[0046] Once the power supply 8 is activated, standard 5-44%,
preferably 10-22% carbamide peroxide solution, peroxide
formulations including peroxide gel solution, fluoride composition
or other similar whitening/bleaching agent 11, is loaded into the
tray. The tray is then placed over the teeth 6 to be whitened for a
prescribed period of time or "dosage." The tray is left in place
and the whitening agent/solution is replaced at necessary intervals
for normal tray use. If trays such as those disclosed in U.S. Pat.
Nos. 4,968,251 or 5,575,655 are utilized, there may be no need to
add additional whitening solution 11, due to the indentations,
reservoirs and baffles within said trays as per said
inventions.
[0047] As with conventional tray-type tooth whitening, the
frequency of use and the duration of such use is dependent on how
white the patient desires his teeth, how amenable the teeth are to
the whitening procedure, and the degree and type of stain present.
Depending on these factors, it would not be unlikely that certain
patients may need to repeat applications using this process for
several times a day, an hour per treatment, over a one or two week
period. For such serious cases however, the bleaching/whitening
tray-techniques utilizing the heated tray will still be faster than
conventional tray-type whitening techniques and cheaper than the
conventional laser/light/heat bleaching techniques, pursuant to the
application of the Q10 Rule.
[0048] The heated tray can be applied by the user for selected
times, for example varying from 10 minutes up to 2 hours or more at
steady and consistent heat levels, or applied with steady and
consistent heat levels for alternating intervals of heat and
non-heat (i.e. cooling) periods, such as 5 minutes heat on
alternating with 5 minutes heat off for a period of one or two
hours. The tray can also be applied using rising or changing heat
levels up to a maximum tolerance or comfort level, depending on
each such user, for example a 15 minute to 2 hour time frame, or
alternatively for intervals of heat on and increasing for a
specified time frame, followed by a cooling off interval. Such uses
can be directed by the doctor/dentist, or by the individual desires
of the user. These uses have been accomplished through utilization
of a "C" or "D" cell batteries (one or more per heating element,
one heating element per heated tray), a 4.5" 27 gauge nichrome wire
and a "dead man's" switch (said switch being held to activate the
circuit/heating element; loss of hold on the switch deactivates
said circuit/heating element).
[0049] Since each and every individual user will have a different
tolerance for the amount of heat supplied, and the concentration of
the whitening agent, a visit to a dentist/doctor to evaluate each
patient's/user's sensitivities to both temperature and the
concentration of the whitening agent/solution is recommended.
Variances in temperature to meet each patient's/user's need can be
met through the use of the variable potentiometer/voltage
regulator/rheostat mentioned above. Sensitivities to the strength
(concentration) of the whitening agent/solution used can be
overcome by using less concentrated agents which, given the
invention's decrease in whitening time through the application of
constant measured heat to the teeth, may still permit the subject
teeth to be whitened within the same period of time with no loss of
efficiency over the prior art. Alternatively, various agents can be
applied to the gums (gingival tissues) to decrease exposure to the
whitening agents. Some of the more common agents include the
petrolatum compounds, such as petroleum jelly or Vaseline, which
can be applied either to the gum tissues prior to the loading and
placement of the tray within the mouth and/or applied to the
exposed gum tissues after the heated tray is placed over the teeth
to be treated. Other agents to protect the gingival tissues include
"paint on rubber dams" and equivalents, which can likewise be
applied in a manner similar to the application of the petrolatum
compounds.
[0050] In a preferred embodiment of the invention, the heating
element wire 1 is composed of a 27 gauge nichrome wire of 4"
length, which is looped and attached within the vacumformed custom
fitted tray 12, and connected to a battery case containing two
C-cell batteries regulated by a 25 ohm variable wound rheostat,
connected to a 24 inch length of 24 gauge wire, soldered to the
nichrome wire. The nichrome wire is vacuformed and encased in
0.040" thickness EVA dental tray material. The unit can be
controlled by an on/off switch within the rheostat. In this
embodiment, batteries 14 produce a sustained temperature of
approximately 110.degree. F. for the duration of the
bleaching/whitening application process. The vacumformed tray, as
noted above, can contain indentations for excess
bleaching/whitening agent--in this case 16% carbamide peroxide,
pursuant to incorporated U.S. Pat. No. 5,575,655.
[0051] The amount of heat generated is dependent upon the length of
nichrome wire, the gauge of nichrome wire, the power level applied,
and the thickness and composition of said heat dispensing pad, if
such a pad is used. The following examples outline the amount of
heat generated by various combinations of wire length, wire gauge,
and battery type.
1EXAMPLE 1 4" 27 Gauge Thermometer Insulated New Length Nichrome
Wire Wrapped D-Cell Battery Time Element Temperature (.degree. F.)
0 77.5 30 sec 82.4 1 min 93.9 1 min 30 sec 104.0 2 min 112.2 2 min
30 sec 117.7 3 min 122.0 3 min 30 sec 125.0 4 min 127.0 4 min 30
sec 128.1 5 min 128.5 5 min 30 sec 129.5 6 min 129.2 6 min 30 sec
128.3 7 min 127.9 7 min 30 sec 127.1 8 min 126.5 8 min 30 sec 126.1
9 min 126.1 9 min 30 sec 126.0 10 min 125.3 10 min 30 sec 123.8 11
min 124.1 12 min 122.3 13 min 121.6 14 min 122.6 15 min 122.9 16
min 124.0 17 min 124.2 18 min 125.2 19 min 124.5 20 min 124.3
[0052]
2EXAMPLE 2 4" 27 Gauge New Length Nichrome Wire Wrapped D-Cell
Battery Time Element Temperature (.degree. F.) 0 78.2 30 sec 79.4 1
min 85.1 1 min 30 sec 90.1 2 min 94.5 2 min 30 sec 98.6 3 min 103.3
3 min 30 sec 103.8 4 min 105.3 4 min 30 sec 106.1 5 min 107.1 5 min
30 sec 107.4 6 min 107.8 6 min 30 sec 108.0 7 min 108.2 7 min 30
sec 108.3 8 min 108.3 8 min 30 sec 108.2 9 min 107.9 9 min 30 sec
107.8 10 min 108.1 11 min 108.5 12 min 108.2 13 min 107.6 14 min
107.5 15 min 107.3 16 min 107.0 17 min 106.9 18 min 106.9 19 min
106.7 20 min 106.5 21 min 106.7 22 min 106.8 23 min 106.1 24 min
106.0 25 min 106.0 26 min 106.1 27 min 105.6 28 min 105.4 29 min
105.4 30 min 105.3 31 min 105.1 32 min 105.1 33 min 105.2 34 min
105.0 35 min 105.1 36 min 104.9 37 min 105.0 38 min 105.0 39 min
105.4 40 min 105.8 41 min 105.2 42 min 105.2 43 min 105.0 44 min
104.7 45 min 104.2 46 min 104.0 47 min 103.9 48 min 103.6 49 min
103.8 50 min 103.6 60 min 104.2 65 min 103.5 70 min 103.2 75 min
102.6 80 min 102.2 85 min 102.1 90 min 102.2 95 min 101.3 100 min
102.4 105 min 102.2
[0053]
3EXAMPLE 3 3 1/8" 27 Gauge New Length Nichrome Wrapped* D-Cell
Battery Time Element Temperature (.degree. F.) 0 sec 73.4 30 sec
82.0 1 min 97.0 1 min 30 sec 190.2 2 min 118.0 2 min 30 sec 122.3 3
min 121.1 3 min 30 sec 128.3 4 min 130.6 4 min 30 sec 131.0 5 min
129.6 5 min 30 sec 128.9 6 min 128.1 6 min 30 sec 130.1 7 min 130.3
7 min 30 sec 131.4 8 min 130.6 5 min 30 sec 129.4 9 min 129.4 9 min
30 sec 129.0 10 min 128.4 11 min 126.7 12 min 128.0 13 min 125.7 14
min 128.5 15 min 129.6 16 min 130.0 17 min 130.1 18 min 130.3 19
min 130.6 20 min 129.2 *Wrapped around sensor with tape insulation
to avoid "shorting" the Nichrome
[0054]
4EXAMPLE 4 3" 27 Gauge 2 D-Cell Length Nichrome Wrapped** Batteries
Time Element Temperature (.degree. F.) 30 sec 125.0 45 sec 138.0 1
min 151.3 1 min 30 sec 169.2 2 min 186.0 2 min 30 sec 191.0
**Nichrome wire wrapped around sensor of thermometer
[0055] 2 D-cell batteries quickly heated past 191.degree. F. which
is too hot for this invention's use. Use of a variable
resistor--such as a rheostat--would increase the circuit's
resistance to the power source and thereby lower the temperature of
the heating element.
5EXAMPLE 5 4" 27 Gauge Length Nichrome Wire Temperature Battery
Type Time (.degree. F.) Duracel P .times. 28A 6 volt 1 min 83.0
(Photo/Electronic) 2 min 83.8 Miniature Battery 3 min 84.4 4 min
87.8 5 min 87.8 Catalog No.: 23-266A Radio Shack 6 volt 0 sec 84.0
Lithium 160 milli amps 30 sec 89.4 1 min 90.4 2 min 91.3 3 min 91.0
4 min 89.2 5 min 88.2 1.5 v Size N 0 sec 82.0 Radio Shack 30 sec
98.5 2/23-023 340 milli amps 1 min 113.2 1 min 30 sec 120.2 2 min
123.5 2 min 30 sec 126.3 3 min 124.7 3 min 30 sec 125.6 4 min 125.6
4 min 30 sec 126.5 5 min 126.7 5 min 30 sec 128.8 6 min 126.5 6 min
30 sec 125.6 7 min 124.0 7 min 30 sec 124.0 8 min 123.0 8 min 30
sec 123.1 9 min 122.6 9 min 30 sec 122.0 10 min 121.6 11 min 119.9
12 min 117.0 13 min 113.6 14 min 113.0 15 min 113.9 16 min 111.7 20
min 113.5 25 min 112.3 30 min 88.2 0.05 (milli amps) Length
Solution Temperature Gauge Nichrome (Inches) Power .degree. F. in
the Tray 27 ga. 3.0 1.5 v D-cell battery .about. 112.6 27 ga. 3.5
1.5 v D-cell battery .about. 110.1 27 ga. 4.0 1.5 v D-cell battery
.about. 108.2 27 ga. 4.5 1.5 v D-cell Battery .about. 106.6
[0056] These temperatures are for solution temperature in the tray
at room temperature on table top.
6EXAMPLE 7 Wire temperature using variable rheostat with 1 D-cell
1.5 v battery Variable resistor used in this test allows 0-94 MA 4"
27 gauge Wire 1.5 v D-cell Eveready Classic 71.4 room temperature
for 30 seconds 12 MA - no temperature change Time Element
Temperature (.degree. F.) 1 min 72.0 1 min 30 sec 75.0 2 min 78.2 2
min 30 sec 81.8 3 min 84.0 3 min 30 sec 85.3 4 min 86.9 4 min 30
sec 87.8 5 min 88.2 5 min 30 sec 88.5 6 min 89.1 6 min 30 sec 89.8
7 min 90.5 7 min 30 sec 90.6 8 min 90.9 8 min 30 sec 91.0 9 min
91.6 9 min 30 sec 91.6 10 min 91.7 11 min 92.0 12 min 91.0 13 min
91.0 14 min 91.3 15 min 91.0 16 min 91.2 17 min 91.6 18 min 91.8 19
min 91.9 20 min 92.1 30 min 92.6 45 min 93.3 60 min 93.0
[0057] Analysis of the above results, and application to the
present invention, depends upon the understanding of the Q10
Rule.
[0058] The Q10 Rule states: "For every 10.degree. C. (18.degree.
F.) in temperature, the reaction rate doubles."
[0059] Since:
[0060] Our heated tray temperature=10.degree. F. (for example)
[0061] Body temperature=98.6.degree. F. Actual mouth
temperature=<90.degree. F.
[0062] Using this data, which is conservative, the heated tray
produces an approximate 20.degree. F. increase in actual bleaching
temperature over the regular method.
[0063] Actual tooth temperature is less than bleaching surface
temperature due to the fact that enamel and dentin are excellent
insulators. Hence, pulpal temperatures are only minimally effected.
Surface temperatures of 124.degree. F. have been used for years and
are well known to the art for teeth bleaching. Pulpal trauma has
proven not to be a problem with even this high level of heat.
Anesthetic is never used in any heat bleaching technique in order
that the individual patient may control the bleaching process
(i.e., the level of heat being applied by the heated tray) and
prevent any discomfort (by varying or discontinuing treatment). All
teeth are different and have differing sensitivities to heat,
therefore, tray temperature should be adjusted on a personal basis.
A pulpal temperature rise is maintained below 8.degree. F. at all
times. Whitening concentration is similarly adjusted on a personal
basis with the availability of 10%, 16%, 20% and 44% carbamide
peroxide solutions.
[0064] Also, current state of the art treatment regimens vary with
personal preferences, such as one hour per day for 21 days or 18
hours per day regimens. The current state of the art allows a
selection of whitening agents viscosities and concentrations as
well as time regimens. The current state of the art allows no
control of the susceptibility of any particular tooth to the
whitening process. However, experience proves that most teeth are
susceptible to teeth whitening procedures--illustrated by the fact
that 95% of general dentists dispense take home teeth whitening
kits.
[0065] The heated tray allows an individual desiring whiter teeth
to control the last remaining variable, temperature, proven in the
art to increase efficacy. Heat is proven to activate peroxide based
whitening solutions, causing them to whiten teeth faster than the
same solution would whiten teeth without the addition of heat.
[0066] The very fact that teeth whitening occurs with peroxide
based solutions retained by a dental tray as well as it does
without heat activation is a factor of the current long time
periods of treatment required for successful, retained results.
This is why the heated tray has such value. It can increase the
whitening rate from 2 to 4 times the state of the art. Therefore,
the patient can obtain the same whitening in half of the time or
less! The physics of reaction rates required that any tooth that
would whiten by 4 vita shades in 10 hours of treatment, using the
state of the art method, would whiten 4 vita shades in 5 hours or
less of treatment using the heating tray.
EXAMPLE 8
[0067] Clinical results show 3-4 vita shade changes observed after
one hour of treatment. A vita shade change of A.sub.4 to A.sub.1
was observed following one hour of treatment with 20% carbamide
peroxide in viscous solution using 4.5" length of nichrome wire as
a heating element prepared in a custom tray powered by a fresh 1.5
v D-cell extra strength battery. Tray temperatures remained well
within the comport level of the patient. Effective teeth whitening
was visibly appreciated by the patient immediately upon removing
the heating tray. As with all teeth whitening treatments, repeated
exposures to the whitening solution increase the permanence of the
whitening effect.
EXAMPLE 9
[0068] Another clinical test demonstrated excellent results of a
vita shade change of B.sub.3 to a B.sub.1 was observed using 4
separate one hour treatments over a two day period. The heated tray
was constructed with a heating element wire consisting of a 4.0
inch length of 27 gauge nichrome wire, powered by a fresh 1.5 v
D-cell extra strength battery. A viscous solution of 16% carbamide
peroxide was placed into the heated tray, at the beginning of
treatment and again after 30 minutes of treatment. (The energy from
the heated tray activates the carbamide peroxide whitening solution
and therefore exhausts its whitening effect two to four times
faster than regular tray-type whitening. Accordingly, the whitening
solution must be replenished more frequently). The whitening
procedure was followed for one hour, at which time the tray was
removed and the teeth were brushed with water to remove the viscous
whitening solution that remained on the teeth (teeth were visibly
whiter). After a one hour rest period, the heated tray whitening
was begun again with a fresh 1.5 v D-cell extra strength battery
and a viscous solution of 16% carbamide peroxide. The solution was
replenished after 30 minutes of treatment. After the hour was
complete, the tray was removed and the teeth brushed with water to
remove retained carbamide peroxide. At this point, the teeth were
observed to be a vita shade B.sub.1 in effect, the whitest shade
for these particular teeth. No whiter tooth shade was available on
the guide for comparison.
[0069] The following day treatment with the heated tray was
commenced again. The same heated tray was used with a fresh same
type of 1.5 v D-cell battery. It was noted that some reversion to
original shade was observed--to approximately a vita shade B.sub.2.
The treated teeth were still visibly whiter than the untreated
teeth of the lower area. Treatment was identical to the previous
day. After the first one hour session (replenished solution after
30 minutes) the teeth were completely white, vita shade B.sub.1.
The teeth were brushed with water and a period of one hour elapsed
at which point treatment began with fresh solution and a fresh
battery. The whitening solution was replenished after 30 minutes.
The whitening procedure ended after one hour and teeth were
determined to have whitened as much as was possible. The teeth were
brushed with water to remove excess carbamide peroxide from all
surfaces. The patient observed that it felt like the teeth were
still bleaching even though the treatment was finished and the tray
was removed. Thus it appears that part of the success of this
technique is that with the heating of the solution, penetration of
the tooth structure by the whitening solution is increased,
therefore, the whitening effect still occurs for a short time even
after treatment has been discontinued. This would help explain the
results that are obtained in such a short period of time.
EXAMPLE 10
[0070] A commercially available battery on/off variable resistor
was obtained.
[0071] This device used two AA size (1.5 v each) 1.5 batteries and
was found to deliver 0 MA at the off position. The device delivered
74 MA at the lowest setting and 208 MA at the highest setting.
[0072] The following wire temperature results were obtained
utilizing nichrome wire of 27 gauge 4" length with a room
temperature of 66.8.degree. F.
7 Time Element Temperature (.degree. F.) On Low 30 sec 74.6 1 min
79.1 1 min 30 sec 83.3 2 min 86.1 2 min 30 sec 87.9 3 min 89.2 3
min 30 sec 89.6 4 min 89.8 4 min 30 sec 89.8 Dialed to High 30 sec
94.1 1 min 104.8 1 min 30 sec 112.4 2 min 115.5 2 min 30 sec 117.1
3 min 113.4 3 min 30 sec 114.5 4 min 117.2 4 min 30 sec 119.8 5 min
121.3 5 min 30 sec 121.8 6 min 121.8 6 min 30 sec 121.2 7 min 120.2
8 min 119.3 9 min 117.9 10 min 114.8 11 min 112.5 12 min 111.2 13
min 110.0 14 min 109.0 15 min 107.9 20 min 106.9
[0073] Teeth whitening procedures with the heated tray showed
dramatic results after the first treatment. This is very
encouraging to patients who undergo teeth whitening treatment. The
fact that they see quick results will generally motivate them to
continue the procedure. It encourages them to repeat the treatment
enough to obtain and maintain the color teeth they desire.
[0074] The heated tray technology allows the individual greater
control of the teeth whitening process. Not only can the patient
control the concentration of the whitening solution, as in the
prior art, but they can also control the time to a greater degree,
by controlling the temperature of the whitening process. This
allows for better and faster results than have ever been possible;
using moderate concentrations of whitening solutions, with moderate
levels of heat, over greater time periods, than was possible
sitting in a dentist chair. The heated tray will quickly become the
state of the art when used either by itself as the whole whitening
procedure or in alternation with standard non-heated tray type
tooth whitening, whereby an individual may use the heated tray at
home and a conventional tray between heated tray treatments. In any
case, heated tray technology will revolutionize teeth
whitening.
[0075] The heated tray/splint of the present invention has several
other uses in addition to whitening of the teeth. Because heat is
applied directly to the front surface of the teeth by the present
invention relatively selectively, a significant amount of heat can
be applied to the teeth without heating other structures of the
mouth or making the user uncomfortable. This feature allows the
present invention to be useful in the treatment of mouth odor,
dentin sensitivity, tooth demineralization, tooth decay, and
periodontal disease.
[0076] Bad breath is a major concern to the general population and
treatment is a source of an important profit industry worldwide.
This condition affects about 50 to 60 percent of the population.
The most common cause of bad breath is elevated levels of volatile
sulfur compounds, primarily hydrogen sulfide and methylmercaptan,
arising from the metabolism of protein by anerobic gram-negative
bacteria retained in periodontal pockets. These compounds, besides
producing odor, are highly toxic to tissues and may play a role in
the pathogenesis of inflammatory conditions such as periodontitis.
Heat applied to the teeth by the present invention can help destroy
bacteria, especially when used with other treatments added to the
tray, such as, for example, hydrogen peroxide, carbamide peroxide,
fluoride solutions, Peridex.RTM., conventional mouthwash solutions,
or a combination thereof.
[0077] Treatment of dentin hypersensitivity is of increasing
importance in the daily practice of dentistry. Dentin
hypersensitivity affects nearly 40 million Americans at one time or
another. Dentin hypersensitivity is caused by a change in fluid
flow in the dentinal tubules, which excites nerve endings located
in the dentinal tubules and at the pulp-dentine border area.
Traumatic oral hygiene procedures, excessive use of acid containing
dietary fluids, and certain dental treatments have been important
in the occurrence of dentine hypersensitivity. Several
desensitizing treatments applied to the teeth are known to reduce
pain associated with dentin hypersensitivity, such as, for example,
solutions of potassium nitrate, fluoride, strontium chloride,
sodium citrate, gutaraldehyde, or combinations thereof. Treating
the teeth with the tray/splint of the present invention will
substantially improve the efficacy of these agents, individually,
or in combiantion, by increasing the rate and extent of uptake and
penetration of these agents into dentinal tubules, protecting the
nerve endings. These agents can be added to the tray while heating
the teeth so that the heat and desensitizing treatment can be
applied simultaneously.
[0078] The heated tray/splint of the present invention may be used
to prevent and treat tooth decay and periodontal disease. Heating
the teeth with the tray/splint can destroy bacteria such as S.
Mutans and gram negative bacteria that cause tooth decay and
periodontal disease. The tray/splint can also be used in
combination with antibacterial agents, such as, for example,
Peridex.RTM. and Perioguard.RTM..
[0079] Demineralization and remineralization control the
progression and reversal of carious lesions in teeth, respectively.
Tooth demineralization and remineralization can be described as
naturally occurring dynamic processes in the oral enviornment.
Ions, such as calcium and phosphate are dissolved from the tooth
mineral into saliva and are precipitated back from saliva into the
teeth. Under normal physiologic conditions, the rates of
demineralization and remineralization are equivalent, resulting in
no net loss of tooth mineral. It is only when the balance between
these two processes is disturbed that destruction of mineralized
tissue occurs. A localized decrease in pH, such as that produced by
bacterial plaque, can change the dynamics in favor of
demineralization and result in a carious lesion. More generalized
changes in pH, such as those caused by frequent intake of acidic
foods or beverages, can also result in the generalized
demineralization associated with tooth erosion or root surface
sensitivity. Although many conditions associated with loss of tooth
mineral have multiple causes, the basic mechanism is
demineralization. The formation of a cavity will be prevented if
the average amount of demineralization that occurs is equal to or
exceeded by the average amount of remineralization.
[0080] Saliva provides a natural source of calcium and phosphate
ions for remineralization. However, in the absence of fluoride,
saliva is not a very effective remineralizing medium. Increasing
the fluoride content of saliva has been correlated with increased
rates of remineralizaiton and decreased caries incidence. It has
been shown that even trace concentrations of fluoride ions are
effective in promoting calcium hydroxyapatite (tooth mineral)
formation from supersaturated solutions of calcium and phosphate.
For this reason, fluoride is added to toothpastes, mouthrinses, and
drinking water as an anticaries agent. One of fluoride's primary
modes of action is to increase the uptake of calcium and phosphate
ions--the building blocks of tooth mineral--from saliva into
demineralized lesions in tooth enamel to promote remineralization.
A likely reason why fluoride is not more effective in preventing
decay is that the remineralization process is limited by the
availability of calcium and phosphate ions in saliva. If
supplemental concentrations of calcium and phosphate ions could be
supplied to saliva without insolubilizing the fluoride, the
effectiveness of fluoride could be increased.
[0081] The tray/splint of the present invention overcomes this
problem by providing heat to the teeth and to solutions within the
tray/splint containing fluoride, calcium, and phosphate. The heat
applied by the tray/splint to the front surface of the tooth
increases the solubility and concentration of calcium, phosphate,
and fluoride ions in the solution and further increases the rate
and extent of penetration and uptake of these ions into the tooth,
thereby providing an improved remineralization procedure. In this
manner, the present invention can be used to prevent, arrest, or
reverse tooth decay in carious areas.
[0082] From the foregoing description of the preferred embodiments
of the invention it will be apparent that many modifications may be
made therein. It should be understood, however, that these
embodiments are intended merely as an exemplification of the
invention and that the invention is not limited thereto. It should
be understood, therefore, that it is intended that in the appended
claims to cover all such modifications in the true spirit and scope
of the invention.
* * * * *