U.S. patent application number 13/074485 was filed with the patent office on 2011-07-14 for dental treatment devices.
This patent application is currently assigned to ULTRADENT PRODUCTS, INC.. Invention is credited to Peter M. Allred, Scot N. Andersen, Dan E. Fischer, Paul E. Lewis.
Application Number | 20110171606 13/074485 |
Document ID | / |
Family ID | 41608727 |
Filed Date | 2011-07-14 |
United States Patent
Application |
20110171606 |
Kind Code |
A1 |
Lewis; Paul E. ; et
al. |
July 14, 2011 |
DENTAL TREATMENT DEVICES
Abstract
Dental treatment trays or strips include a moisture-resistant
barrier layer that is flexible so as to conform to a plurality of
differently-sized and shaped dental arches during use. The
moisture-resistant barrier layer comprised of wax, paraffin wax
and/or polyolefin. The dental treatment device also includes a
substantially solid dental treatment composition adapted so as to
be initially substantially dry to the touch and so as to become
sticky and adhesive to dental tissue when moistened. The
substantially solid dental treatment composition includes at least
one adhesive agent and at least one active agent, such as a dental
bleaching agent.
Inventors: |
Lewis; Paul E.; (Midvale,
UT) ; Andersen; Scot N.; (Draper, UT) ;
Allred; Peter M.; (Riverton, UT) ; Fischer; Dan
E.; (Sandy, UT) |
Assignee: |
ULTRADENT PRODUCTS, INC.
South Jordan
UT
|
Family ID: |
41608727 |
Appl. No.: |
13/074485 |
Filed: |
March 29, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12183303 |
Jul 31, 2008 |
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13074485 |
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61190054 |
Aug 31, 2007 |
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Current U.S.
Class: |
433/217.1 |
Current CPC
Class: |
A61C 19/06 20130101;
A61C 19/066 20130101 |
Class at
Publication: |
433/217.1 |
International
Class: |
A61C 19/06 20060101
A61C019/06 |
Claims
1. A dental treatment device for use in applying a dental treatment
composition to a person's teeth and/or gums, comprising: a
moisture-resistant barrier layer comprised of a blend of wax and a
polymeric material; and a substantially solid dental treatment
composition disposed adjacent to the moisture-resistant barrier
layer and comprising at least one adhesive agent and at least one
active agent, the substantially solid dental treatment composition
being substantially dry to the touch or less adhesive prior to
being moistened with saliva or water adapted to become more sticky
and adhesive when moistened with saliva or water.
2. A dental treatment device as recited in claim 1, wherein the
moisture-resistant barrier layer is a strip.
3. A dental treatment device as recited in claim 2, wherein the
strip is flexible so as to wrap around a person's teeth and assume
a tray shape when worn over the person's teeth during use.
4. A dental treatment device as recited in claim 1, wherein the
moisture-resistant barrier layer is tray shaped.
5. A dental treatment device as recited in claim 1, wherein the
moisture-resistant barrier layer comprises a blend of paraffin wax
and a polyolefin.
6. A dental treatment device as recited in claim 5, wherein the
moisture-resistant barrier layer comprises a blend of paraffin wax
and polyethylene.
7. A dental treatment device as recited in claim 5, wherein the
moisture-resistant barrier layer comprises a blend of paraffin wax
and polypropylene.
8. A dental treatment device as recited in claim 1, wherein the
moisture-resistant barrier layer further comprises at least one
material selected from the group consisting of plasticizers, flow
additives, and fillers.
9. A dental treatment device as recited in claim 1, wherein the
dental treatment composition comprises a dental bleaching
agent.
10. A dental treatment device as recited in claim 1, wherein the at
least one adhesive agent is selected from the group consisting of
polyvinyl pyrrolidone and carboxymethylcellulose.
11. A dental treatment device as recited in claim 1, wherein the
moisture-resistant barrier layer further comprises a bleaching
agent destabilizer compounded with and/or disposed on the inner
treatment surface of the barrier layer.
12. A dental treatment device for use in applying a dental
treatment composition to a person's teeth and/or gums, comprising:
a moisture-resistant barrier layer comprised of a blend of paraffin
wax and a polymeric material, wherein the moisture-resistant
barrier layer is a flexible strip adapted as to wrap around a
person's teeth and assume a tray shape when worn over the person's
teeth during use; and a substantially solid dental treatment
composition disposed adjacent to the moisture-resistant barrier
layer and comprising at least one adhesive agent and at least one
active agent, the substantially solid dental treatment composition
being substantially dry to the touch or less adhesive prior to
being moistened with saliva or water adapted to become more sticky
and adhesive when moistened with saliva or water.
13. A dental treatment device as recited in claim 12, wherein the
polymeric material comprises a polyolefin.
14. A dental treatment device as recited in claim 13, wherein the
polyolefin comprises polyethylene.
15. A dental treatment device as recited in claim 13, wherein the
polyolefin comprises polypropylene.
16. A dental treatment device as recited in claim 12, wherein the
moisture-resistant barrier layer further comprises at least one
material selected from the group consisting of plasticizers, flow
additives, and fillers.
17. A dental treatment device as recited in claim 1, wherein the
dental treatment composition comprises a dental bleaching
agent.
18. A dental bleaching device for use in applying a dental
treatment composition to a person's teeth and/or gums, comprising:
a moisture-resistant barrier layer comprised of a blend of wax and
a polymeric material, wherein the moisture-resistant barrier layer
is a flexible tray-like body adapted so as to wrap around a
person's teeth when worn; and a substantially solid dental
treatment composition disposed adjacent to the moisture-resistant
barrier layer and comprising at least one adhesive agent and at
least one dental bleaching agent, the substantially solid dental
treatment composition being substantially dry to the touch or less
adhesive prior to being moistened with saliva or water adapted to
become more sticky and adhesive when moistened with saliva or
water.
19. A dental treatment device as recited in claim 18, wherein the
moisture-resistant barrier layer comprises a blend of paraffin wax
and a polyolefin.
20. A dental treatment device as recited in claim 19, wherein the
moisture-resistant barrier layer further comprises at least one
material selected from the group consisting of plasticizers, flow
additives, and fillers.
Description
RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 12/183,303, filed Jul. 31, 2008, which claims the benefit
of U.S. Provisional Application No. 61/190,054, filed Aug. 31,
2007. The disclosures of the foregoing applications are
incorporated herein in their entirety.
BACKGROUND OF THE INVENTION
[0002] 1. The Field of the Invention
[0003] The present invention is in the field of shaped, flexible
dental trays and strips used to deliver a dental bleaching
composition to a person's teeth. More particularly, the invention
relates to flexible dental trays and strips with enhanced user
comfort and tooth adhesion.
[0004] 2. The Relevant Technology
[0005] Virtually all people desire white or whiter teeth. A common
bleaching method involves the use of a dental tray that is
custom-fitted to a person's teeth and that is therefore relatively
comfortable to wear. One type of customized tray is made by vacuum
forming a sheet of moisture resistant thermoplastic polymer
material over a stone cast of a person's teeth, after which the
custom tray may be cut out. Another is customized directly using a
person's teeth as a template (e.g., "boil-and-bite" trays).
Non-customized trays that approximate the shapes and sizes of a
variety of users' dental arches have also been used. A dental
bleaching composition is placed into the tray and the tray placed
over the person's teeth for a desired period of time.
[0006] Another tooth bleaching method involves placing a flexible
bleaching strip over a user's tooth surfaces. Conventional
bleaching strips comprise a flexible plastic strip coated with a
dental bleaching gel of moderate viscosity and relatively low
stickiness on the side of the strip facing the user's teeth. To
install the bleaching strip, a portion of the bleaching strip is
placed over the front surfaces of the user's teeth, and the
remainder is folded around the occlusal edges of the teeth and
against a portion of the lingual surfaces.
[0007] Because of the generally poor adhesion of bleaching strips
to the user's teeth, coupled with their generally flimsy nature, it
is often difficult for the user to maintain the bleaching strip in
its proper position for the recommended time. Conventional
bleaching strips are prone to slip off the teeth as a result of
even minimal movement of the user's mouth, jaw or tongue. It is
recommended that the user not eat, drink, smoke or sleep while
wearing the bleaching strip. In some cases, the bleaching strip can
become so dislodged or mangled that it must be removed by the user
and replaced with a fresh bleaching strip to complete the
recommended bleaching time.
[0008] Ultimately, the main impediment to successful bleaching is
the failure of users to complete the prescribed bleaching regimen.
If the bleaching apparatus is difficult to install over a person's
teeth, requires numerous repetitions to achieve observable results,
and/or is uncomfortable to wear, the user may simply give up and
prematurely abort the prescribed bleaching regimen. Thus, even if
dental bleaching is possible using a particular bleaching apparatus
or method, it is less likely to occur if the inadequacies of the
bleaching apparatus or method cause a user to become discouraged
before desired results are attained.
BRIEF SUMMARY OF THE PREFERRED EMBODIMENTS
[0009] The present invention generally relates to improved dental
bleaching trays and strips used to deliver a dental bleaching
composition to a person's teeth. The inventive dental bleaching
trays and strips are formed from a moisture resistant (e.g.,
polymeric) material and include a bleaching agent destabilizer
disposed on an inner treatment surface of the barrier layer that is
oriented toward and adjacent to the person's teeth during use. The
bleaching agent destabilizer may be compounded with a polymeric or
other moisture resistant material from which the barrier layer is
formed so that at least some destabilizer is positioned on an inner
treatment surface of the tray or strip during use.
[0010] Bleaching agent destabilizers may include any known
bleaching agent destabilizer that is capable of destabilizing a
dental bleaching agent in order to accelerate bleaching. When
peroxides are destabilized they more rapidly release oxygen
radicals, which are believed to be responsible for the tooth
bleaching effect. The bleaching agent destabilizer is
advantageously retained on the surface and/or within the polymeric
or other moisture resistant barrier layer of the tray or strip
prior to use. Upon contact with a peroxide dental bleaching agent
in the presence of water, the destabilizer is able to activate or
destabilize the bleaching agent, resulting in the formation of free
radicals from the peroxide for increased bleaching effect.
[0011] One class of bleaching agent destabilizers includes
transition and/or alkaline earth metals or their ions. Non-limiting
examples of suitable metals and metal ions include magnesium, iron,
titanium, cobalt, nickel, copper, platinum, tin, zinc, manganese,
chromium, aluminum, silver, and combinations thereof. Magnesium
and/or iron ions are particularly preferred. Another class of
bleaching agent destabilizer includes enzymes, particularly
organo-metallic enzyme containing transition metals, such as iron.
Examples of organo-metallic enzymes include "peroxidase" and
"catalase".
[0012] One embodiment provides a tray or strip in which the
bleaching composition is prefilled within the tray or pre-applied
to the strip. In one manner, this is made possible by providing the
moisture-resistant barrier layer including the bleaching agent
destabilizer with a protective rupturable membrane disposed between
the barrier layer and the dental bleaching composition so as to
prevent premature contact between the dental bleaching agent and
the bleaching agent destabilizer on or within the barrier layer. In
another manner, this may be made possible by providing an anhydrous
dental bleaching composition. The anhydrous dental bleaching
composition may be disposed directly in contact with the barrier
layer, and will not react prematurely because of the anhydrous
nature of the bleaching composition. As soon as water is added to
the system (e.g., when contacted with saliva by placing the
pre-filled tray or strip onto the teeth), reaction between the
destabilizer and bleaching composition will begin. Embodiments
including an anhydrous dental bleaching composition and no
ruptureable membrane should preferably be sealed within a
protective package to prevent absorption of water from the
surrounding air during shipment and storage.
[0013] These and other advantages and features of the present
invention will become more fully apparent from the following
description and appended claims, or may be learned by the practice
of the invention as set forth hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] To further clarify the above and other advantages and
features of the present invention, a more particular description of
the invention will be rendered by references to specific
embodiments thereof, which are illustrated in the appended
drawings. It is appreciated that these drawings depict only typical
embodiments of the invention and are therefore not to be considered
limiting of its scope. The invention will be described and
explained with additional specificity and detail through the use of
the accompanying drawings in which:
[0015] FIG. 1 is a perspective view of an exemplary non-custom
dental bleaching tray according to the invention;
[0016] FIG. 2A is an exploded view of a dental bleaching tray
having anatomical features to improve fit and an optional
complementary outer support tray;
[0017] FIG. 2B is a perspective view showing the dental bleaching
tray nested within the outer support tray;
[0018] FIG. 3 is a perspective view of an exemplary dental
bleaching strip according to the present invention;
[0019] FIG. 4 illustrates a pair of pre-filled tray assemblies
similar to the assembly of FIG. 2B contained within a sealed
protective package having a peelable cover;
[0020] FIG. 5 is a cross-sectional view of a tray assembly
including a rupturable membrane between the barrier layer and the
bleaching composition;
[0021] FIG. 6A illustrates a person placing a dental bleaching tray
according to the invention over the person's upper dental arch;
and
[0022] FIG. 6B illustrates dental bleaching trays according to the
invention in place over both the upper and lower dental arches.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
I. Introduction
[0023] The present invention relates to dental bleaching trays and
strips used to deliver a dental bleaching composition to a person's
teeth. The trays and strips are formed from a moisture resistant
material and include a bleaching agent destabilizer compounded
within the moisture resistant material from which the barrier layer
body is formed and/or disposed on an inner treatment surface of the
barrier layer that is oriented toward and adjacent to the person's
teeth during use.
II. Exemplary Chemically Activated Dental Bleaching Trays and
Strips
[0024] FIG. 1 illustrates an exemplary non-custom dental bleaching
tray 100 which is formed from a moisture resistant material (e.g.,
a two-part silicone). Dental bleaching tray 100 includes a barrier
layer body 102 in the shape of a tray. The tray shaped body 102
includes a buccal-labial front side wall 104, a lingual rear side
wall 106, and a bottom wall 108 bridging the buccal-labial wall 104
and buccal-labial wall 106. Bottom wall 108 is adjacent to
buccal-labial wall 104 such that buccal-labial wall 104 extends
laterally from bottom wall 108 in a substantially vertical
direction. Buccal-labial wall 104 is shown as including an optional
v-shaped cut 105 formed along the top surface thereof, near the
center where the incisors reside during use. Such a cut helps wall
104 to stretch and flex so as to better accommodate the incisors.
Although not shown, such a similar cut or discontinuity may be
formed within lingual wall 106. Lingual wall 106 is disposed at the
opposite side of bottom wall 108, extending laterally upwardly and
outwardly therefrom. The buccal-labial wall 104, lingual wall 106,
and bottom wall 108 together form a tray shaped body 102 having an
approximate U-shaped cross section and a generally horseshoe-shaped
curvature.
[0025] The size, shape and curvature of the tray body 102 are
advantageously selected in order for the horseshoe-shaped curvature
to generally approximate the curvature of a person's dental arch.
The U-shaped cross section generally corresponds to and defines an
interior cavity of the tray body 102. The depth of the interior
cavity is selected in order for the buccal-labial and lingual walls
104 and 106 respectively to extend over a desired portion of a
person's teeth, and optionally, over a portion of the person's
gums.
[0026] Because of its non-custom nature (i.e., tray shaped body 102
is substantially devoid of structures corresponding to the size and
shape of a person's unique dentition), the tray shaped barrier
layer body 102 comfortably fits over a plurality of differently
sized and/or shaped teeth corresponding to different people.
Nevertheless, it is within the scope of the invention to provide
separate dental trays that are sized and configured to correspond
to either a person's upper or lower dental arch, as the lower
dental arch is typically smaller than the upper arch, with lower
teeth that are typically smaller than the upper teeth. It is also
within the scope of the invention to provide varyingly-sized
bleaching trays to account for variability among different people's
dental arches and/or teeth (e.g., adults versus children, larger
mouths versus average or smaller mouths, and larger teeth versus
average or smaller teeth).
[0027] The tray body 102 may be injection molded, vacuum formed,
cut and/or stamped from a sheet of polymeric material, although
injection molding is preferred over methods that involve cutting
and/or stamping because the outer edges 109 of each wall may be
injection molded so as to have a smooth, rounded edge surface as
opposed to the sharp, angled surfaces formed when a tray is cut or
stamped from a sheet of material. Such smooth edges also contribute
to the overall comfortable feel of the tray.
[0028] Tray 100 includes an inner treatment surface 103 that
includes the inwardly oriented surfaces of buccal-labial front side
wall 104, bottom wall 108, and lingual rear side wall 106 that will
be positioned against tooth tissue to be bleached during use. At
least a portion of inner surface 103 includes one or more bleaching
agent destabilizers. In one embodiment, the destabilizer may be
compounded with the moisture resistant (e.g., polymeric) material
from which the tray 100 is formed. In such an example, the
destabilizer is distributed substantially evenly throughout the
material from which tray 100 is formed, so that at least some
destabilizer is present on inner treatment surface 103. In another
embodiment, the destabilizer may be applied to at least a portion
of inner surface 103, for example, by spraying, brushing, or
otherwise applying the destabilizer onto the inner treatment
surface 103. Advantageously, the destabilizer may be present on at
least that portion of inner surface 103 corresponding to surfaces
of the teeth to be bleached. For example, the destabilizer may be
present on at least the lower portion of buccal-labial front side
wall 104 nearest bottom wall 108, which corresponds to the labial
surface of the teeth to be bleached. Destabilizers may
advantageously be absent from any portions of the tray designed to
contact gingival tissue, where no bleaching is to take place.
[0029] The one or more bleaching agent destabilizers act to
destabilize the peroxide dental bleaching agent during use. When
peroxides are destabilized they more rapidly release free radicals,
which cause tooth bleaching. For example, it is believed that
peroxide dental bleaching agents are destabilized to form
predominantly hydroxyl (HO.) free radicals, although peroxyl
(.OOH), super oxide (.O), and super dioxide (.OO) free radicals may
also be formed. Upon decomposition, which is accelerated by the
bleaching agent destabilizer, these free radicals are more easily
able to pass into the tooth enamel to the location of tooth stains
as compared to the larger peroxide (H.sub.2O.sub.2) molecules,
which may have increased difficulty passing through tight spaces of
the enamel to stain locations because of their larger size. The
bleaching agent destabilizer is advantageously retained on at least
inner treatment surface 103 of the tray or strip prior to use, and
upon contact with a peroxide dental bleaching agent in the presence
of water; the destabilizer becomes activated, resulting in
formation of free radicals from the peroxide for increased
bleaching effect.
[0030] One class of bleaching agent destabilizers includes
transition and/or alkaline earth metal ions. Non-limiting examples
of suitable metal ions include magnesium ions, iron ions, titanium
ions, cobalt ions, nickel ions, copper ions, platinum ions, tin
ions, zinc ions, manganese ions, chromium ions, silver ions,
aluminum ions, and combinations thereof. Magnesium and/or iron ions
are particularly preferred. Another class of bleaching agent
destabilizer includes enzymes, particularly organo-metallic enzymes
containing transition metals, such as iron. Examples include
"peroxidase" and "catalase", which is described more particularly
in U.S. Pat. No. 6,485,709 to Banerjee et al., herein incorporated
by reference with respect to its disclosure of organo-metallic
enzymes.
[0031] One or more bleaching agent destabilizers including the
above metal ions in available form and/or organo-metallic enzymes
are preferably collectively included in an amount in a range of
about 0.01% to about 20% by weight of the polymeric material, more
preferably in a range of about 0.05% to about 10% by weight, and
most preferably about 0.1% to about 5% by weight. Examples of
suitable metal compounds include iodides, nitrates, chlorates,
borates, perchlorates, and perborates of suitable metal cations.
Preferred specific compounds include MgO, ferric sulfate, ferric
chloride, MnO.sub.2, and TiO.sub.2. Less preferred bleaching agent
destabilizers include elemental metals (e.g., iron, silver,
platinum, copper, magnesium, titanium, cobalt, nickel, tin, zinc,
chromium, aluminum, and/or manganese in powder form). Of course,
any other metal ions mentioned herein may also be used in elemental
form. Another class of bleaching agent destabilizers that may be
used include iodine salts (e.g., potassium iodide and/or sodium
iodide).
[0032] Many of the metal ion containing compounds are believed to
react with the peroxide bleaching agent according to Fenton's
Reaction, for example, ferric Fe.sup.2+ ions react to form ferrous
Fe.sup.3+ ions in the presence of peroxide, releasing oxygen free
radicals. During the course of the reaction, the peroxide is
regenerated, allowing more ferric ions to react, resulting in
production of more oxygen free radicals.
[0033] FIG. 2A illustrates an alternative non-custom dental
bleaching tray 200 that includes anatomical structural features
that allow tray 200 to more closely conform to a person's teeth
during use. Body 202 includes a buccal-labial front side wall 204,
a bottom wall 208, and a lingual side wall 206 connected to bottom
wall 208 at an opposite side relative to buccal-labial wall 204. An
inner treatment surface 203 is defined by interior portions of
bottom wall 208, buccal-labial front side wall 204, and lingual
side wall 206. Illustrated tray 200 is sized and configured for
placement over a person's upper dental arch. As illustrated,
lingual wall 206 may advantageously include a notch 205, which
allows the non-custom tray 200 to more easily spread open or
compress in the area of the incisors. This is helpful in allowing
the lingual wall 206 of the non-custom tray 200 to more easily
conform to differently-sized dental arches. Bottom wall 204
includes an abrupt reduction in width positioned at locations 210
corresponding to a transition between posterior teeth (i.e.,
bicuspids and molars) and anterior teeth (i.e., canines and
incisors). Bottom wall 208 also advantageously includes two
v-shaped indentations 216 for insertion into the depression between
the occlusal peaks of the posterior teeth (i.e., the bicuspids and
molars).
[0034] Similar to tray 100, at least a portion of inner surface 203
of tray 200 includes one or more bleaching agent destabilizers. In
a preferred example, the one or more dental bleaching agent
destabilizers may be compounded with the moisture resistant
polymeric material from which the tray 200 is formed. In such an
example, the destabilizers may be distributed substantially evenly
throughout the material from which tray 200 is formed, so that at
least some destabilizer is present on inner treatment surface 203.
Alternatively, one or more bleaching agent destabilizers may be
applied (e.g., after molding or otherwise forming tray body 202) to
at least a portion of inner treatment surface 203 where dental
bleaching composition will be applied during use, and which
surfaces of the tray will be placed against tooth tissues to be
bleached during use.
[0035] FIG. 2A is an exploded view showing the dental bleaching
tray 200 in combination with a corresponding optional outer support
tray 250 that is complementarily shaped so as to be capable of
receiving the dental bleaching tray 200 in a nested configuration
(see FIG. 2B). The outer support tray 250 may include the same
anatomical features as tray 200 in order to provide a closer fit.
The outer support tray 250 advantageously includes a handle 252
extending outwardly from a central portion of the buccal-labial
front wall in order to facilitate gripping by the user during
placement of the dental bleaching tray 200 over the person's
teeth.
[0036] In FIG. 2B, dental bleaching tray 200 is nested within outer
support tray 250 so as to form a dental tray assembly 255. The
handle 252 extends beyond the buccal-labial wall of tray 200 in
order to facilitate placement and removal of the outer support tray
250 after placement of tray 200 over the person's teeth.
[0037] FIG. 3 illustrates an exemplary dental bleaching strip 400
which is formed from a polymeric material. Dental bleaching strip
400 is initially substantially rectangular and includes a planar
surface 402 which can be positioned adjacent the teeth to be
bleached and folded along the incisal edge of the teeth so as to
cover the labial and incisal tooth surfaces. Depending on the
position of the fold during placement, a portion (or substantially
all) of the lingual tooth surfaces may also be covered by the strip
400 once placed. At least a portion of planar surface 402 defines
an inner treatment surface corresponding to portions of surface 402
which are positioned adjacent to particularly the labial teeth
surfaces during use.
[0038] At least a portion of inner planar surface 402 oriented
toward a person's tooth surfaces includes one or more bleaching
agent destabilizers. In a preferred example, the one or more dental
bleaching agent destabilizers may be compounded with the moisture
resistant polymeric material from which the strip 400 is formed. In
such an example, the destabilizers may be distributed substantially
evenly throughout the material from which strip 400 is formed, so
that at least some destabilizer is present on planar treatment
surface 402. Alternatively, one or more bleaching agent
destabilizers may be applied (e.g., after forming of strip barrier
layer 400) to at least a portion of inner treatment planar surface
402 where dental bleaching composition will be applied during use
and which surfaces of the strip will be placed against tooth
tissues to be bleached during use.
[0039] Although conventional strips are less effective in bleaching
teeth relative to tray shaped barrier layers because strips tend to
readily slip off and/or become mangled before treatment is
complete, an improved dental bleaching strip can be provided
according to the present invention by providing a bleaching agent
destabilizer compounded within or otherwise disposed on an inner
treatment surface of the strip. Such strips may provide for
improved bleaching as the destabilizer acts to promote formation of
active bleaching free radicals from the peroxide bleaching agent,
which may be expected to result in faster bleaching, at least
partially counteracting the disadvantages (i.e., tendency to slip
off and/or mangle) of strips.
[0040] Any dental tray or strip according to the invention may be
provided separately from a dental bleaching composition, which is
introduced into the tray (e.g., adjacent the tray's inner treatment
surface) or applied onto the strip by the user immediately prior to
use so that there is no contact between the bleaching agent
destabilizer of the barrier layer and the bleaching composition
until treatment begins. In one alternative embodiment, it may be
possible to prefill a tray or preapply a dental bleaching
composition to a strip if the bleaching composition is anhydrous.
The anhydrous dental bleaching composition may be disposed directly
in contact with the barrier layer, and will not react prematurely
because of the anhydrous nature of the bleaching composition. As
soon as water is added to the system (e.g., when contacted by
saliva by placing the pre-filled tray or pre-applied strip on the
teeth), reaction between the destabilizer and bleaching agent will
begin. Embodiments including an anhydrous dental bleaching
composition may advantageously be sealed within a protective
package to prevent absorption of water from the surrounding air
during shipment and storage.
[0041] Another alternative embodiment may include an anhydrous
adhesive composition (e.g., including polyvinyl pyrollidone as an
adhesive agent) that also includes a bleaching agent destabilizer
(e.g., potassium iodide). The adhesive destabilizing composition
may be coated over the barrier layer (e.g., as a thin layer or
film). It is important to note that such a composition including
the bleaching agent destabilizer is applied to a region of the
barrier layer corresponding to the tooth surfaces to be bleached.
In other words, if the composition is not applied over
substantially the entire interior surface of the barrier layer tray
or strip, it is at least applied to that portion of the barrier
layer which in use is positioned against the tooth surfaces to be
bleached (e.g., at least the labial tooth surface). It is not
necessary to apply the bleaching agent destabilizer to regions of
the barrier layer which will be positioned against gum tissue
during use. In fact it may be preferable in some embodiments to
ensure that no bleaching agent destabilizer is present in regions
of the barrier layer which will be positioned against gingival
tissue so as to prevent reaction with peroxide bleaching agents
adjacent the gingival tissue, which may otherwise cause discomfort
and soreness. Of course, in embodiments where the destabilizer is
compounded within the material of the barrier layer this may be
impractical, although discomfort to gingival tissues may be
prevented by limiting application of the bleaching composition to
regions of the barrier layer corresponding to tooth surfaces to be
bleached.
[0042] In other words, it may be preferred to apply the bleaching
composition so that substantially no bleaching composition is
applied adjacent any part of the barrier layer that will be
positioned adjacent the gingival tissue, so that the bleaching
agent and the destabilizer are only present together at portions of
the tray corresponding to tooth surfaces to be bleached. In
embodiments where the destabilizer is applied as a film or
composition layer, it may be preferable to maintain any portions of
the barrier layer which will be positioned adjacent to gingival
tissue so that they are substantially free of the bleaching agent
destabilizers, and that the destabilizer film or layer is only
applied to those portions of the barrier layer corresponding to
tooth surfaces to be bleached (e.g., at least the labial tooth
surface). In other words, in any embodiment, the bleaching agent
and the destabilizer may be present together only at those portions
of the tray corresponding to tooth surfaces to be bleached. At
portions of the tray that will be positioned adjacent to gingival
tissue during use, only one or the other (or neither) of the
bleaching agent destabilizer and the bleaching agent are present so
as to prevent discomfort and soreness.
[0043] In embodiments where the adhesive destabilizer composition
is anhydrous, a peroxide bleaching agent may also be included, so
long as no water is present so as to prevent premature reaction
between the bleaching agent destabilizer and the peroxide bleaching
agent. Alternatively, a bleaching composition (e.g., an aqueous
gel) may be applied over the layer or film adhesive layer just
prior to use. The water within the bleaching composition and/or
saliva within the user's mouth causes the bleaching agent
destabilizer to be activated in the presence of the bleaching
agent.
[0044] In another alternative embodiment, a non-custom dental tray
or strip according to the invention may be preloaded with a dental
bleaching composition. In order to prevent premature contact
between the bleaching agent destabilizer and bleaching composition,
the tray or strip further includes a protective rupturable membrane
disposed between the barrier layer and the bleaching composition.
The membrane may be configured to be rupturable subsequent to
placement of the tray over the person's teeth. For example, a
rupturable membrane of a tray or strip bleaching device may be
configured to rupture upon biting, bending and/or folding of the
barrier layer and membrane. Such a rupturable membrane may comprise
any rupturable layer that is disposed between the bleaching
composition and the tray or strip including a bleaching agent
destabilizer. Examples of suitable materials include a protective
coating layer of high molecular weight polyethylene glycol, a
di-para-xylene coating layer, and/or a wax coating. Di-para-xylene
is available commercially as Parylene from Parylene Coating
Services, Inc., located in Katy, Tex. Such coatings may serve to
simply separate the bleaching composition from the barrier layer
during storage and shipment, and the coating membrane is ruptured
upon biting, bending, and/or flexing of the tray or strip. The
rupturable membrane layer may be water-degradable so as to
dissolve, degrade, or become dispersed upon contact with moisture
(e.g., saliva).
[0045] Such a tray or strip may be provided within a sealed
container or package to protect the tray or strip, the bleaching
composition, and rupturable membrane from contaminants and/or
premature rupture during storage, transport, and prior to use. FIG.
4 shows a first tray assembly 355 configured for placement over an
upper dental arch and a second tray assembly 355' configured for
placement over a lower dental arch sealed within protective package
356. Each tray 300 and 300' includes a bleaching composition 354
pre-loaded therein. Protective package 356 includes a rigid support
layer 358 and a peelable cover 360. Each tray assembly 355 and 355'
may optionally include an additional removable protective layer
(not shown) placed adjacent to the bleaching composition 354 for
additional protection. When it is desired to use the dental
bleaching tray devices, the peelable cover 360 is removed and the
tray assemblies 355 and 355' are removed or separated from support
layer 358.
[0046] FIG. 5 illustrates a cross-sectional view through tray
assembly 355 of FIG. 4, including tray 300 and outer support tray
350, perhaps best illustrating protective rupturable membrane 357
disposed adjacent to inner treatment surface 303 of tray 300.
[0047] Another embodiment may include a multi-use tray, for example
a custom dental tray formed by vacuum forming a sheet of moisture
resistant thermoplastic polymer material over a stone cast of a
person's teeth, after which the custom tray may be cut out. Such
custom trays can be very comfortable to wear as they provide an
excellent fit to the user's dentition. A bleaching agent
destabilizer (e.g., a ferric salt) may be compounded with the tray
material or otherwise provided so that the bleaching agent
destabilizer is present on the interior treatment surface of the
tray. During use, the user applies a bleaching composition into the
tray, and then places the tray over the teeth for bleaching
treatment. The bleaching agent destabilizer, for example, a ferric
salt, is oxidized during use so as to form ferrous ions. Because at
least some of the bleaching agent destabilizer will likely remain
after use, the custom tray may be used multiple times before all
the bleaching agent destabilizer has been consumed. Once all
bleaching agent destabilizer has been consumed, the custom tray may
still be used as a conventional custom bleaching tray, although it
will no longer provide the increased bleaching effect afforded by
the bleaching agent destabilizer.
[0048] The trays and strips may be used with any known dental
bleaching composition. Exemplary bleaching compositions include a
peroxide dental bleaching agent. The bleaching composition may
comprise a sticky viscous gel, a less viscous gel, a highly viscous
putty, or a substantially solid composition that is less adhesive
prior to being moistened with saliva or water but that becomes more
sticky and adhesive when moistened.
[0049] According to one embodiment, the barrier layer comprises a
thin (e.g., about 1 mm or less), flexible membrane formed from a
polymeric or other moisture-resistant material. Polymeric materials
are preferred. In one embodiment, the barrier layer comprises
silicone. In another, it comprises ethyl vinyl acetate and
polypropylene. According to another embodiment, it may be formed of
a polyolefin or similarly moisture-resistant material, such as wax,
paraffin, ethylene-vinyl acetate copolymer (EVA), ethylene-vinyl
alcohol copolymer (EVAL), polycaprolactone (PCL), polyvinyl
chloride (PVC), polyesters, polycarbonates, polyamides,
polyurethanes or polyesteramides. Examples of suitable polyolefins
for use in making the barrier layer include, but are not limited
to, polyethylene (PE), high density polyethylene (HDPE), low
density polyethylene (LDPE), ultra low density polyethylene
(ULDPE), polypropylene, and polytetrafluoroethylene (PTFE) (e.g.,
TEFLON). An example of a suitable polyester for use in making the
barrier layer includes, but is not limited to, polyethylene
terephthalate (PET), an example of which is MYLAR, sold by DuPont.
An example of a suitable polyurethane barrier material is a
polyurethane film manufactured by ArgoTech, which is located in
Greenfield, Mass. The barrier layer may comprise a polymeric blend
and/or multiple layers comprising two or more of the foregoing
materials. Plasticizers, flow additives, and fillers known in the
art can be used as desired to modify the properties of any of the
foregoing polymers used to form the barrier layer. The forgoing
listing of polymeric materials is not meant to be exhaustive, as
numerous other polymeric materials may be used.
[0050] Other materials that can act as a barrier layer include
metal foil, cellulosic ethers, cellulose acetate, polyvinyl
acetate, polyvinyl alcohol, shellac, and chemical or light-cure
materials (e.g., methacrylate or acrylate resins). Examples of
useful cellulosic ethers that can be used to form a barrier layer
include, but are not limited to, ethyl cellulose, propyl cellulose,
isopropyl cellulose, butyl cellulose, t-butyl cellulose, and the
like. Although non-polymeric moisture resistant materials, e.g.,
metal foil, may be used, polymeric materials are preferred.
[0051] Silicone and silicone like materials (i.e., materials
exhibiting similar physical characteristics) are one preferred
class of polymeric materials for forming the barrier layer because
of their excellent adaptability, flexibility, softness, elasticity,
and resiliency. Exemplary suitable two-part silicone materials are
available from Shin-Etsu Silicones of America, located in Akron,
Ohio. One preferred material is KEG2000-50A/B, the physical
properties of which are described in the table below. Various other
Shin-Etsu silicone products and silicone materials from other
suppliers can also be used.
TABLE-US-00001 Property Value Hardness - Shore-A 52 Tensile
Strength - MPa 11.1 Elongation - % 580 100% Modulus - Mpa 1.72 Tear
Strength - kN/m 40 Comp Set 22 h/302.degree. F.-1 h/302.degree. F.
31 Comp Set 22 h/302.degree. F.-4 h/392.degree. F. 8 Linear
Shrinkage 2.6 Specific Gravity 1.13 Viscosity - Part A-Pa s 1700
Viscosity - Part B-Pa s 1600
[0052] For example, a silicone material may initially comprise a
two-part composition including a first part comprising one or more
siloxanes and a second part including an activator. Upon mixing the
two liquid parts together, the siloxane molecules polymerize and
cross-link so as to form a polysiloxane. Heat may be applied (e.g.,
by heating the mold) to accelerate polymerization of the silicone
material. For example, part A and part B of the raw silicone
precursor material are mixed together, which causes the material to
begin to polymerize. For many exemplary silicone materials, this
reaction could take 2-6 weeks to completely cure at room
temperature. Heating the mixture significantly increases the rate
at which the material polymerizes. For example, according to one
method, the material is heated to 375.degree. F. so as to cause the
material to polymerize in a matter of seconds. Actual
polymerization time depends on the thickness of the tray or strip
being formed. Silicone trays and/or strips may also be formed by
other methods, for example with a two part silicone in which
polymerization is activated by mixing and/or by compression.
[0053] Silicone polymeric materials include a platinum and/or tin
catalyst within one or both parts of the composition to assist with
polymerization. Advantageously, residual catalyst is present within
the material after the tray or strip has been formed. Residual
platinum and/or tin catalyst disposed throughout the material,
including on the inner treatment surface of the tray or strip, can
also act as a bleaching agent destabilizer, acting to produce free
radicals from the peroxide bleaching agent upon contact of the
barrier layer with a peroxide bleaching composition. Although
platinum is a less preferred destabilizer because of its generally
higher cost, it is within the scope of the present invention to
utilize platinum when present. As the platinum and/or tin may be
included in small, silicone-catalyzing amounts (e.g., typically
less than 1000 ppm, more typically less than 100 ppm), it may be
advantageous to include an additional, more preferred destabilizer,
for example magnesium and/or iron in addition to the residual
platinum and/or tin, in order to boost the overall destabilizing
effect.
[0054] Styrene-ethylene-butylene-styrene (SEBS), and/or VERSAflex,
a proprietary thermoplastic elastomer alloy exhibiting elasticity
and other properties similar to silicone, are examples of
silicone-like materials. A suitable example of a SEBS material is
SEBS TPE 45A, available from various providers. Physical properties
for SEBS TPE 45A are summarized in the table below. Various other
SEBS products may also be used in forming a polymeric moisture
resistant barrier layer.
TABLE-US-00002 Property Value Density (g/cm.sup.3) 0.94 Surface
Hardness- Shore A 45 Tensile Strength (MPa) 6 Flexural Modulus
(GPa) 0.02 Notched Izod (kJ/m) 1.06+ Linear Expansion (/.degree. C.
.times. 10.sup.-5) 16 Elongation at Break (%) 800 Water Absorption
(%) 0.3 Oxygen Index (%) 19 Melting Temp. Range (.degree. C.)
200-240 Mold Shrinkage (%) 1.5 Mold Temp. Range (.degree. C.)
50-70
[0055] Several suitable VERSAFLEX TPE materials are available from
GLS Corporation, located in McHenry, Ill. Preferred VERSAFLEX
materials include VERSAFLEX CL30 and VERSAFLEX CL40, properties of
each of which are summarized in the table below. Various other
VERSAFLEX products from GLS Corporation can also be used.
TABLE-US-00003 Product Property CL30 CL40 Test Method Shore A
Hardness, 10 sec delay 30 43 ASTM D2240 Specific Gravity 0.89 0.89
ASTM D792, 23/23.degree. C. Tensile Strength 6619 kPa 5929 kPa ASTM
D412-Die C, 2 hrs, 23.degree. C. Elongation at Break 780% 690% ASTM
D412-Die C, 2 hrs, 23.degree. C. 100% Modulus 689 kPa 1379 kPa ASTM
D412-Die C, 2 hrs, 23.degree. C. 300% Modulus 1448 kPa 2413 kPa
ASTM D412-Die C, 2 hrs, 23.degree. C. Tear Strength 19 kN/m 23 kN/m
ASTM D624 Melt Flow Rate @ 190.degree. C., 2160 g 18 g/10 min 13
g/10 min ASTM D 1238 Melt Flow Rate @ 200.degree. C., 5000 g 108
g/10 min 38 g/10 min ASTM D 1238 Apparent Viscosity @ 200.degree.
C. 11170/sec 15 Pa-s 16 Pa-s ASTM D 3835 Compression Set, 22 hrs @
RT 11% 12% ASTM D 395B
[0056] Preferred dental bleaching trays are characterized by wall
thicknesses of no more than about 1 mm, more preferably between
about 0.03 mm and about 1 mm, and most preferably between about 0.1
mm and about 0.5 mm. Wall thicknesses greater than about 1 mm are
significantly less useful as a comfortable dental bleaching tray,
as the thickness of the tray begins to seriously interfere with the
normal relaxed position of the occlusal tooth surfaces when wearing
such a tray (i.e., the tray(s) get in the way between teeth of
opposite dental arches, preventing the user from completely closing
their jaw), making the tray significantly less comfortable than a
tray with wall thicknesses that are no more than about 1 mm. For
this same reason, existing mouth guards formed of silicone have
little or no use as a comfortable dental treatment tray as their
wall thickness is typically greater than 2 mm, and more typically
about 4 mm so as to provide a cushioning effect to the teeth when
accepting a blow to the mouth or jaw. Similarly, the inventive
dental bleaching trays would be unacceptable for use as a mouth
guard, as their thin walls provide little or no protection to the
teeth against such blows.
[0057] The dental bleaching trays according to the invention can be
designed to be worn for any desired time period. Due to the
extremely comfortable fit between the inventive dental bleaching
trays and the person's teeth, it is possible to wear such trays for
extended periods of time as desired. The dental bleaching trays can
be worn for as little as a few minutes or as long as several hours.
By way of example, not limitation, a typical bleaching session of
fast duration may last from about 10 to about 30 minutes; a
bleaching session of intermediate duration may last from about 30
minutes to about 2 hours; and a bleaching session of long duration,
including overnight bleaching while a person is sleeping, may last
from about 2 hours to about 12 hours.
[0058] When used in combination with a sticky bleaching
composition, dental bleaching trays may possibly be worn while
performing normal daily activities, such as talking, drinking,
smoking, coughing, smiling, frowning, grimacing, or while sleeping.
Dental bleaching trays according to the invention may be worn over
a person's upper dental arch, lower dental arch, or both
simultaneously. Although trays provide an improved fit as compared
to strips, it is of course within the scope of the invention to
provide dental bleaching strips which can also be used to provide
similar treatment. Such strips may be expected to be worn for
similar ranges of time as described above, and when used with an
initially dry bleaching composition that becomes very sticky upon
contact with water, may even be worn while engaging in the above
described activities as the bleaching composition (e.g., a
substantially dry bleaching composition) more effectively holds the
strip in place against the tooth tissues to be bleached.
[0059] FIG. 6A illustrates a person 375 placing a dental bleaching
assembly 355 over the person's upper dental arch. The outer support
tray helps in placing the inner bleaching tray over the teeth. FIG.
6B illustrates a dental bleaching tray 300 in place over the
person's upper dental arch and a dental bleaching tray 300' over
the lower dental arch, both outer support trays having been
removed.
[0060] To remove the dental bleaching tray after a desired time
period, the user simply grasps a corner or portion of the tray and
pulls it off the teeth. Any residual bleaching composition that
remains adhered to the person's teeth can be removed by washing or
flushing with water and/or by brushing.
EXAMPLES OF THE PREFERRED EMBODIMENTS
[0061] Following are examples of polymeric compositions that may be
used to manufacture dental bleaching trays according to the
invention. The exemplary formulations and manufacturing conditions
are given by way of example, and not by limitation. Unless
otherwise indicated, all percentages are by weight.
Example 1
[0062] A composition for injection molding a silicone dental
treatment tray was formed from Shin-Etsu's KEG2000-50A/B two part
thermoset silicone material. Part A containing the
activator/hardener had a viscosity of about 1700 Pa-s, while part B
containing the siloxane had a viscosity of about 1600 Pa-s. At
least one part included a platinum catalyst.
[0063] The two parts of the silicone composition were pumped out of
storage drums through hoses to a static mixing head where the two
parts were mixed together. The mixed silicone material exits the
static mixer and was forced into the screw and barrel of the
injection molding machine. The mixed silicone material was injected
into the heated mold (e.g., about 375.degree. F.), at which point
the material quickly polymerized. The tray was removed from the hot
mold after polymerization was substantially complete. Exemplary
formed trays exhibited excellent adaptability, flexibility,
elasticity, and softness, while also being resilient. The molded
trays were translucent, had a Shore A durometer hardness of about
50, an elasticity of about 580%. Trays having wall thicknesses of
about 0.004 inch (0.10 mm), 0.006 inch (0.15 mm), 0.008 inch (0.2
mm), 0.01 inch (0.25 mm) and 0.014 inch (0.36 mm), respectively,
were formed. It is believed that the residual platinum catalyst
content within the finished tray was less than 1000 ppm, more
likely less than 100 ppm. The presence of residual platinum
catalyst within the silicone material provided available platinum
ions to act as a bleaching agent destabilizer when contacted with a
peroxide dental bleaching agent.
Example 2
[0064] A composition for injection molding a dental treatment tray
was formed from SEBS TPE 45A material. The heated material was
pumped so as to be forced into the screw and barrel of the
injection molding machine. The material was injected into the mold.
The cooled tray was removed from the mold. Exemplary formed SEBS
trays exhibited excellent adaptability, flexibility, elasticity,
and softness, while also being resilient, similar to the silicone
tray of Example 1. The molded trays were translucent, had a Shore A
durometer hardness of about 45, an elasticity of about 800% and a
wall thickness of about 0.020 inch (0.5 mm). The trays were found
to be very comfortable when worn over a person's dental arch, with
excellent adaptability, flexibility, elasticity, softness, and
resiliency. A bleaching agent destabilizer (e.g., about 0.1 percent
to about 5 percent by weight) may be compounded with the SEBS
material prior to molding so that the finished trays include the
bleaching agent destabilizer on the inner surface of the tray.
Example 3
[0065] A composition for injection molding a dental treatment tray
is formed from VERSAFLEX CL30. The heated TPE material is pumped so
as to be forced into the screw and barrel of the injection molding
machine. The material is injected into the mold. The cooled tray is
removed from the mold. Exemplary formed VERSAFLEX CL30 trays
exhibit excellent adaptability, flexibility, elasticity, and
softness, while also being resilient, similar to the silicone tray
of Example 1. The molded trays are translucent, have a Shore A
durometer hardness of about 30, an elasticity of about 780% and a
wall thickness of about 0.020 inch (0.5 mm). The trays are very
comfortable when worn over a person's dental arch, with excellent
adaptability, flexibility, elasticity, softness, and resiliency A
bleaching agent destabilizer (e.g., about 0.1 percent to about 5
percent by weight) may be compounded with the VERSAFLEX material
prior to molding so that the finished trays include the bleaching
agent destabilizer on the inner surface of the tray.
Example 4
[0066] A composition for injection molding a dental treatment tray
is formed from VERSAFLEX CL40. The heated TPE material is pumped so
as to be forced into the screw and barrel of the injection molding
machine. The material is injected into the mold. The cooled tray is
removed from the mold. Exemplary formed VERSAFLEX CL40 trays
exhibit excellent adaptability, flexibility, elasticity, and
softness, while also being resilient, similar to the silicone tray
of Example 1. The molded trays are translucent, have a Shore A
durometer hardness of about 40, an elasticity of about 690% and a
wall thickness of about 0.020 inch (0.5 mm). The trays are very
comfortable when worn over a person's dental arch, with excellent
adaptability, flexibility, elasticity, softness, and resiliency A
bleaching agent destabilizer (e.g., about 0.1 percent to about 5
percent by weight) may be compounded with the VERSAFLEX material
prior to molding so that the finished trays include the bleaching
agent destabilizer on the inner surface of the tray.
Example 5
[0067] A composition for injection molding a dental treatment tray
was formed by combining and mixing the following materials:
TABLE-US-00004 ELVAX 450 98% Ferric sulfate 2%
[0068] All fractions are by weight. ELVAX 450 is an EVA polymeric
material available from Dupont. The heated material was pumped so
as to be forced into the screw and barrel of the injection molding
machine. The material was injected into the mold. The cooled tray
was removed from the mold. The finished trays included the ferric
sulfate bleaching agent destabilizer on the inner surface of the
tray.
Example 6
[0069] A composition for injection molding a dental treatment tray
was formed by combining and mixing the following materials:
TABLE-US-00005 ELVAX 450 98% Ferric chloride 2%
[0070] All fractions are by weight. ELVAX 450 is an EVA polymeric
material available from Dupont. The heated material was pumped so
as to be forced into the screw and barrel of the injection molding
machine. The material was injected into the mold. The cooled tray
was removed from the mold. The finished trays included the ferric
chloride bleaching agent destabilizer on the inner surface of the
tray.
Example 7
[0071] A composition for injection molding a dental treatment tray
was formed by combining and mixing the following materials:
TABLE-US-00006 ELVAX 450 98% Magnesium powder 2%
[0072] All fractions are by weight. ELVAX 450 is an EVA polymeric
material available from Dupont. The heated material was pumped so
as to be forced into the screw and barrel of the injection molding
machine. The material was injected into the mold. The cooled tray
was removed from the mold. The finished trays included the
elemental magnesium bleaching agent destabilizer on the inner
surface of the tray.
Example 8
[0073] A composition for injection molding a dental treatment tray
was formed by combining and mixing the following materials:
TABLE-US-00007 ELVAX 450 98% Iron powder 2%
[0074] All fractions are by weight. ELVAX 450 is an EVA polymeric
material available from Dupont. The heated material was pumped so
as to be forced into the screw and barrel of the injection molding
machine. The material was injected into the mold. The cooled tray
was removed from the mold. The finished trays included the
elemental iron bleaching agent destabilizer on the inner surface of
the tray.
Example 9
[0075] A composition for injection molding a dental treatment tray
was formed by combining and mixing the following materials:
TABLE-US-00008 ELVAX 450 98% Copper powder 2%
[0076] All fractions are by weight. ELVAX 450 is an EVA polymeric
material available from Dupont. The heated material was pumped so
as to be forced into the screw and barrel of the injection molding
machine. The material was injected into the mold. The cooled tray
was removed from the mold. The finished trays included the
elemental copper bleaching agent destabilizer on the inner surface
of the tray.
Example 10
[0077] A composition for injection molding a dental treatment tray
was formed by combining and mixing the following materials:
TABLE-US-00009 ELVAX 450 98% Nickel powder 2%
[0078] All fractions are by weight. ELVAX 450 is an EVA polymeric
material available from Dupont. The heated material was pumped so
as to be forced into the screw and barrel of the injection molding
machine. The material was injected into the mold. The cooled tray
was removed from the mold. The finished trays included the
elemental nickel bleaching agent destabilizer on the inner surface
of the tray.
Example 11
[0079] A composition for injection molding a dental treatment tray
was formed by combining and mixing the following materials:
TABLE-US-00010 ELVAX 450 98% Aluminum powder 2%
[0080] All fractions are by weight. ELVAX 450 is an EVA polymeric
material available from Dupont. The heated material was pumped so
as to be forced into the screw and barrel of the injection molding
machine. The material was injected into the mold. The cooled tray
was removed from the mold. The finished trays included the
elemental aluminum bleaching agent destabilizer on the inner
surface of the tray.
Example 12
[0081] A composition for injection molding a dental treatment tray
was formed by combining and mixing the following materials:
TABLE-US-00011 ELVAX 450 98% Chromium powder 2%
[0082] All fractions are by weight. ELVAX 450 is an EVA polymeric
material available from Dupont. The heated material was pumped so
as to be forced into the screw and barrel of the injection molding
machine. The material was injected into the mold. The cooled tray
was removed from the mold. The finished trays included the
elemental chromium bleaching agent destabilizer on the inner
surface of the tray.
Example 13
[0083] A composition for injection molding a dental treatment tray
was formed by combining and mixing the following materials:
TABLE-US-00012 ELVAX 450 98% Zinc powder 2%
[0084] All fractions are by weight. ELVAX 450 is an EVA polymeric
material available from Dupont. The heated material was pumped so
as to be forced into the screw and barrel of the injection molding
machine. The material was injected into the mold. The cooled tray
was removed from the mold. The finished trays included the
elemental zinc bleaching agent destabilizer on the inner surface of
the tray.
Example 14
[0085] A composition for injection molding a dental treatment tray
was formed by combining and mixing the following materials:
TABLE-US-00013 ELVAX 450 98% Titanium powder 2%
[0086] All fractions are by weight. ELVAX 450 is an EVA polymeric
material available from Dupont. The heated material was pumped so
as to be forced into the screw and barrel of the injection molding
machine. The material was injected into the mold. The cooled tray
was removed from the mold. The finished trays included the
elemental titanium bleaching agent destabilizer on the inner
surface of the tray.
Example 15
[0087] A composition for injection molding a dental treatment tray
was formed by combining and mixing the following materials:
TABLE-US-00014 ELVAX 250 98% Magnesium powder 2%
[0088] All fractions are by weight. ELVAX 250 is an EVA polymeric
material available from Dupont. The heated material was pumped so
as to be forced into the screw and barrel of the injection molding
machine. The material was injected into the mold. The cooled tray
was removed from the mold. The finished trays included the
elemental magnesium bleaching agent destabilizer on the inner
surface of the tray.
Example 16
[0089] A composition for injection molding a dental treatment tray
was formed by combining and mixing the following materials:
TABLE-US-00015 ELVAX 720 98% Magnesium powder 2%
[0090] All fractions are by weight. ELVAX 720 is an EVA polymeric
material available from Dupont. The heated material was pumped so
as to be forced into the screw and barrel of the injection molding
machine. The material was injected into the mold. The cooled tray
was removed from the mold. The finished trays included the
elemental magnesium bleaching agent destabilizer on the inner
surface of the tray.
[0091] Following is an example of a dental bleaching composition
that can be used in combination with dental bleaching trays or
strips including a bleaching agent destabilizer. The dental
bleaching composition may be pre-loaded in a tray or pre-applied to
a strip.
Example 17
[0092] A sticky, viscous dental bleaching composition was prepared
by mixing together the following components:
TABLE-US-00016 Water 22.5% EDTA Disodium 0.1% Carbamide Peroxide
18.5% Sucralose 25% solution 0.75% Glycerine 41.6% Carbopol 974
5.3% Sodium Hydroxide 50% solution 2.25% Polyvinyl Pyrrolidone
(M.W. = 1.3 million) 2% Carboxymethyl Cellulose 4% Watermelon
Flavor 3%
[0093] All fractions are by weight. A bite ruptureable membrane is
positioned adjacent the inner treatment surface of a tray shaped or
strip shaped barrier layer. A bead of dental bleaching composition
is then spread along the ruptureable barrier layer adjacent the
dental bleaching tray. The bleaching composition may be positioned
adjacent the labial-buccal wall of the tray, as illustrated in FIG.
5. In the case of a strip, the dental bleaching composition is
applied evenly over one side of the strip shaped barrier layer,
with the rupturable membrane between the composition and the
barrier layer. During placement and/or use the rupturable membrane
is broken, contacting the composition to the barrier layer. Upon
contact of the bleaching composition with the barrier layer, the
peroxide dental bleaching agent is destabilized so as to accelerate
production of free radicals. The trays and strips reliably adhere
to tooth tissue, and exhibit excellent comfort and
adhesiveness.
[0094] Additional exemplary dental bleaching compositions, and
methods for making such compositions, which may be used with
devices according to the invention are disclosed in U.S. Pat. No.
5,376,006; U.S. Pat. No. 5,785,527; U.S. Pat. No. 5,851,512; U.S.
Pat. No. 5,858,332; U.S. Pat. No. 5,985,249; U.S. Pat. No.
6,306,370; U.S. Pat. No. 6,309,625; U.S. Pat. No. 6,312,671; U.S.
Pat. No. 6,322,774; U.S. Pat. No. 6,368,576; U.S. Pat. No.
6,387,353; U.S. Pat. No. 6,500,408; U.S. Pat. No. 6,503,485 and
U.S. patent application Ser. No. 11/460,016 filed Jul. 26, 2006.
For purposes of disclosing dental bleaching compositions, and
methods of making such compositions, the foregoing patents and
application are incorporated herein by reference.
[0095] The present invention may be embodied in other specific
forms without departing from its spirit or essential
characteristics. The described embodiments are to be considered in
all respects only as illustrative and not restrictive. The scope of
the invention is, therefore, indicated by the appended claims
rather than by the foregoing description. All changes which come
within the meaning and range of equivalency of the claims are to be
embraced within their scope.
* * * * *