U.S. patent application number 15/097487 was filed with the patent office on 2016-09-29 for dental appliances and methods for their fabrication.
This patent application is currently assigned to EZ Tray, LLC. The applicant listed for this patent is EZ Tray, LLC, Lewis R. Morrison. Invention is credited to James V. Crivello, Lewis R. Morrison.
Application Number | 20160278904 15/097487 |
Document ID | / |
Family ID | 46753548 |
Filed Date | 2016-09-29 |
United States Patent
Application |
20160278904 |
Kind Code |
A1 |
Crivello; James V. ; et
al. |
September 29, 2016 |
DENTAL APPLIANCES AND METHODS FOR THEIR FABRICATION
Abstract
The invention consists of a rapidly crosslinkable, two-component
silicone elastomer together with a specially designed tray that
serves as a form for the silicone resin and forms an integral
portion of a dental appliance.
Inventors: |
Crivello; James V.; (Clifton
Park, NY) ; Morrison; Lewis R.; (Clifton Park,
NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Morrison; Lewis R.
EZ Tray, LLC |
Clifton Park
Clifton Park |
NY
NY |
US
US |
|
|
Assignee: |
EZ Tray, LLC
Clifton Park
NY
|
Family ID: |
46753548 |
Appl. No.: |
15/097487 |
Filed: |
April 13, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14263381 |
Apr 28, 2014 |
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15097487 |
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13407949 |
Feb 29, 2012 |
8747109 |
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14263381 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61C 5/90 20170201; A61F
2005/563 20130101; A61K 6/90 20200101; A61K 47/34 20130101; A61C
19/066 20130101; A61Q 11/00 20130101; C08G 77/12 20130101; C08L
83/04 20130101; C08K 3/36 20130101; A61F 5/566 20130101; A61K 6/00
20130101; A61C 9/0006 20130101; A61K 8/895 20130101; C08L 83/04
20130101; A61P 31/04 20180101; C08L 83/00 20130101; C08L 83/04
20130101; A63B 2071/088 20130101; C08L 83/04 20130101; A61K 6/90
20200101; C08G 77/20 20130101; A63B 71/085 20130101; A61K 6/90
20200101 |
International
Class: |
A61C 19/06 20060101
A61C019/06; A61F 5/56 20060101 A61F005/56; A61C 5/14 20060101
A61C005/14; A63B 71/08 20060101 A63B071/08 |
Claims
1. A cured resin wherein said cured resin is cured from a curable
resin substantially free of surfactant comprising: (a) a first
component comprising (i) a cross-linkable, vinyl-functional
poly(dimethylsiloxane) having a vinyl content between 0.02 and 0.08
mmol/g and an amount of polydisperse silica of particle size 5 to
50 nm sufficient to impart a viscosity between 250,000 cps and
1.5.times.10.sup.6 cps to said first component, said
cross-linkable, vinyl-functional poly(dimethylsiloxane)s being
substantially free of monomers containing quaternary silicon-oxygen
bonded repeat units including QM resins; and (ii) a platinum
catalyst; and (b) a second component comprising (i) a
cross-linkable, vinyl-functional poly(dimethylsiloxane) having a
vinyl content between 0.02 and 0.08 mmol/g and an amount of
polydisperse silica of particle size 5 to 50 nm sufficient to
impart a viscosity between 250,000 cps and 1.5.times.10.sup.6 cps
to said second component, said cross-linkable, vinyl-functional
poly(dimethylsiloxane)s being substantially free of monomers
containing quaternary silicon-oxygen bonded repeat units including
QM resins; and (ii) a linear, branched or cyclic hydrofunctional
poly(siloxane) having a Si--H content from 1.4 to 5.0 mmol/g and
viscosity of 40-300 cps; wherein the platinum catalyst is the only
catalyst in the resin; and wherein after the resin is cured, the
resulting product is flexible and contours to the mouth and teeth
of the patient for repeated withdrawal and reinsertion.
2. A cured resin according to claim 1 wherein said first component
and said second component are combined in a ratio by volume of
approximately 1:1.
3. A cured resin according to claim 1 further comprising a dental
medicament.
4. A cured resin according to claim 3, wherein said medicament is
selected from the group consisting of a tooth-whitening bleach,
fluoride, an anti-bacterial agent and an oxidizing agent.
5. A cured resin according to claim 1, wherein the first component
further comprises a linear, branched or cyclic vinyl-functional
poly(dimethylsiloxane) having from 2 to 5 vinyl groups per
molecule.
6. A cured resin according to claim 5, wherein the linear, branched
or cyclic vinyl functional poly(dimethylsiloxane) is present in the
range of 0.05%-5.0% by weight of the total prepolymer mixture.
7. (canceled)
8. (canceled)
9. (canceled)
10. (canceled)
11. (canceled)
12. (canceled)
13. (canceled)
14. (canceled)
15. (canceled)
16. (canceled)
17. (canceled)
18. (canceled)
19. (canceled)
20. (canceled)
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a divisional application of U.S. patent
application Ser. No. 14/283,381 filed Apr. 28, 2014 which is a
divisional application of U.S. patent application Ser. No.
13/407,949, filed Feb. 29, 2012, now U.S. Pat. No. 8,747,109, which
claims the benefit of U.S. provisional application Ser. No.
61/449,293, filed Mar. 4, 2011. The entire contents of each of the
prior applications are hereby incorporated herein by reference.
TECHNICAL FIELD
[0002] The present invention is directed towards new materials and
processes used in the fabrication of dental appliances such as
night guards for the mitigation of the effects of bruxism (teeth
grinding), mouth guards to prevent injury during sporting and other
athletic activities and trays for teeth whitening. Specifically,
the invention is intended to provide a dental appliance with a
material that will readily conform to the contours of the mouth and
teeth of patients and will set rapidly to give a durable,
well-fitting, comfortable elastomeric dental appliance that can be
repeatedly withdrawn and reinserted many times for extended use.
The invention further consists of a rapidly crosslinkable, two
component silicone elastomer together with a specially designed
tray that serves as a form for the silicone resin before and during
cure and, in addition, forms an integral portion of the completed
dental appliance.
BACKGROUND INFORMATION
[0003] There is a general need for dental appliances that can be
specifically tailored to an individual patient, that can be
fabricated within a short time during a single patient visit and
that are durable and comfortable to use even after repeated
insertion and removal from the oral cavity. A number of appliances
are in current use in dentistry, but none provide the combination
of characteristics described above. For example, commercially
available night guards are designed to be worn while sleeping. The
guards mitigate the effects of involuntary grinding on the teeth
and the associated oral tissues and structures. In addition, the
guards provide relief in some patients from headaches and jaw pain
that result from teeth grinding. Generally, these devices consist
of a low glass transition thermoplastic elastomer that is contained
within a molded thermoplastic tray. The tray may be rigid or
flexible but should have a higher glass transition temperature than
the thermoplastic elastomer that it holds. The patient places this
appliance briefly in boiling water and then inserts it into the
mouth, biting down to impress and conform the thermoplastic
elastomer to the teeth. On cooling, the impression is
preserved.
[0004] The results obtained using such technology leave much to be
desired. First, insertion of a hot device into the mouth always
carries considerable risk of injury. Second, the results and
utility of the appliance depend on upon many variables including
how well the patient positions the device and how much pressure is
applied during the bite down portion of the process. Further, the
flow of the thermoplastic material during the above process is very
limited, such that only portions of the teeth are encapsulated;
this results in a loose and ill-fitting appliance. These negative
factors result in poor patient use compliance and a corresponding
unsatisfactory relief of the symptoms of teeth grinding.
Considerably more expensive but better fitting night guards can be
fabricated by an impression-casting process as described below for
sporting mouth guards.
[0005] Two methods are used in the fabrication of mouth guards used
to protect teeth during sporting or other activities. They can be
made by the so-called "boil and bite" process described above for
night guards. In addition, these guards can be fabricated by taking
a dental impression by licensed dental personnel, followed by
making a cast model from the impression and then forming the final
mouth guard around this casting. This normally requires two visits
by the patient to a dental office as well as several days for
completion of the entire process. Further, the long, complicated,
multistep process required for the fabrication adds significantly
to the overall cost of the resulting appliance. There are some
modifications of this technique whereby sports mouth guards are
made by having the athlete take his own impression and then
fabricating the mouth guard in a laboratory. This reduces the cost
somewhat. A greatly simplified one-step, rapid, low cost process
would be highly desirable.
[0006] Bleaching agents are commonly used to whiten teeth. To
afford an even, cosmetically attractive whitening process over all
the targeted teeth, it is desirable to find some method in which
the bleaching agent can be applied uniformly. During the bleaching
process, it would be advantageous to isolate the teeth undergoing
whitening within the oral cavity since the process may require
several minutes to several hours for completion. In such instances,
it is further desirable to limit the potential ingestion of
bleaching agents by the patient as well as the exposure of dental
tissues to these agents. In some cases, the bleaching agents are
applied to the teeth and, thereafter, the bleaching action is aided
by the exposure to UV light.
[0007] Periodontal disease, popularly called gingivitis, is present
to varying degrees in approximately 85% of the population. In
severe cases this bacterial disease results in serious infections
of the gums with accompanying soreness and bleeding and may
eventually lead to erosion of the teeth below the gum line and
their subsequent loss. Treatments for periodontal disease include
antibacterial agents that kill bacteria responsible for periodontal
disease on contact and oxidizing agents that remove the protective
bacterial biofilm formed on teeth and gums that promotes bacterial
reinfection. The devices of this invention can be employed in two
ways to mitigate the effects of periodontal disease. Custom fit
trays can be readily, quickly and inexpensively constructed using
the technology described herein. These trays can be filled with
antibacterial and/or oxidizing agents.
[0008] Certain common requirements are necessary to successfully
address all of the above targeted dental appliances and other
applications. First, the materials employed must possess no
appreciable oral or dermal toxicity. They should be odorless and
tasteless and should provide no permanent bonding to oral tissues
or teeth. They should release easily and cleanly from those tissues
and teeth to preserve fine details and fit of the dental appliance.
The materials should be compatible with water and saliva as well as
other agents commonly found in oral fluids and should undergo no
appreciable degradation in the presence of those agents. Silicones,
i.e. poly(dimethylsiloxanes), possess all of these properties and
are, therefore, the favored materials of choice for such
applications. However, commercially available crosslinkable
silicones currently used in dentistry, specifically in dental
impressions, are not suitable for the above applications since they
both have unacceptably long cure times and possess poor mechanical
properties, especially poor tear strength. For the above described
applications, it is desirable to have cure times under fifteen
minutes and, ideally, under seven minutes at physiological
temperatures (approx. 37.degree. C.) and high tear strengths that
allow repeated removal and reinsertion of the dental appliance. In
addition, the silicone elastomer produced should be tough and
possess sufficient stiffness to resist bite-through by the patient
while at the same time being soft and compliant for comfortable
long-term wear. Prior to cure, the silicone should possess a
sufficiently high viscosity so that the resin does not flow
appreciably during application and cure.
[0009] Currently, the above described requirements are not met by
any existing material, silicone or otherwise. It is also recognized
that a crosslinkable silicone material by itself is not usually
sufficient for the fabrication of a workable dental appliance.
Commonly, the device will consist of a combination of a
crosslinkable silicone together with a silicone curing tray that
becomes an integral portion of the resulting finished dental
appliance.
SUMMARY OF THE INVENTION
[0010] The present invention addresses the requirements listed
above by satisfying the need for safe, reusable, comfortable,
easily applied dental appliances. In accordance with the above, it
is an object of the present invention to provide dental appliances
with these characteristics. This invention consists of 1) a novel,
two-component platinum-catalyzed crosslinkable silicone resin
together with 2) a specially designed tray.
[0011] One embodiment of the present invention relates to a kit for
preparing a dental appliance comprising: [0012] a. a tray
insertable into the mouth of a subject; and [0013] b. a two-part
prepolymer mixture, substantially free of surfactant, said mixture
comprising: [0014] (1) a first component comprising [0015] (i) a
cross-linkable, vinyl-functional poly(dimethylsiloxane) having a
vinyl content between 0.02 and 0.08 mmol/g and an amount of
polydisperse silica of particle size 5 to 50 nm sufficient to
impart a viscosity between 250,000 cps and 1.5.times.10.sup.6 cps
to said first component; and [0016] (ii) a platinum catalyst; and
[0017] (2) a second component comprising [0018] (i) a
cross-linkable, vinyl-functional poly(dimethylsiloxane) having a
vinyl content between 0.02 and 0.08 mmol/g and an amount of
polydisperse silica of particle size 5 to 50 nm sufficient to
impart a viscosity between 250,000 cps and 1.5.times.10.sup.6 cps
to said second component; and [0019] (ii) a linear, branched or
cyclic hydrofunctional poly(siloxane) having a Si--H content from
1.4 to 5.0 mmol/g and viscosity of 40-300 cps; [0020] said
cross-linkable, vinyl-functional poly(dimethylsiloxane)s being
substantially free of monomers containing quaternary silicon-oxygen
bonded repeat units.
[0021] The present invention provides, in a second aspect, a resin
substantially free of surfactant comprising: [0022] (a) a first
component comprising [0023] (i) a cross-linkable, vinyl-functional
poly(dimethylsiloxane) having a vinyl content between 0.02 and 0.08
mmol/g and an amount of polydisperse silica of particle size 5 to
50 nm sufficient to impart a viscosity between 250,000 cps and
1.5.times.10.sup.6 cps to said first component; and [0024] (ii) a
platinum catalyst; [0025] (b) a second component comprising [0026]
(i) a cross-linkable, vinyl-functional poly(dimethylsiloxane)
having a vinyl content between 0.02 and 0.08 mmol/g and an amount
of polydisperse silica of particle size 5 to 50 nm sufficient to
impart a viscosity between 250,000 cps and 1.5.times.10.sup.6 cps
to said second component; and [0027] (ii) a linear, branched or
cyclic hydrofunctional poly(siloxane) having a Si--H content from
1.4 to 5.0 mmol/g and viscosity of 40-300 cps; [0028] said
cross-linkable, vinyl-functional poly(dimethylsiloxane)s being
substantially free of monomers containing quaternary silicon-oxygen
bonded repeat units.
[0029] In a third aspect, the present invention provides a method
of making a dental appliance comprising: [0030] a. providing a tray
insertable into the mouth of a subject; and [0031] b. mixing a
two-part prepolymer mixture, substantially free of surfactant, said
mixture comprising: [0032] (1) a first component comprising [0033]
(i) a cross-linkable, vinyl-functional poly(dimethylsiloxane)
having a vinyl content between 0.02 and 0.08 mmol/g and an amount
of polydisperse silica of particle size 5 to 50 nm sufficient to
impart a viscosity between 250,000 cps and 1.5.times.10.sup.6 cps
to said first component; and [0034] (ii) a platinum catalyst;
[0035] (2) a second component comprising [0036] (i) a
cross-linkable, vinyl-functional poly(dimethylsiloxane) having a
vinyl content between 0.02 and 0.08 mmol/g and an amount of
polydisperse silica of particle size 5 to 50 nm sufficient to
impart a viscosity between 250,000 cps and 1.5.times.10.sup.6 cps
to said second component; and [0037] (ii) a linear, branched or
cyclic hydrofunctional poly(siloxane) having a Si--H content from
1.4 to 5.0 mmol/g and viscosity of 40-300 cps; [0038] said
cross-linkable, vinyl-functional poly(dimethylsiloxane)s being
substantially free of monomers containing quaternary silicon-oxygen
bonded repeat units, [0039] wherein said two-part prepolymer
mixture is either mixed in said tray or mixed separately and
introduced into said tray as a mixture.
[0040] In a fourth aspect, the present invention provides a dental
appliance comprising: [0041] (a) a tray; and [0042] (b) a polymer
formed by reacting a two-part prepolymer mixture, substantially
free of surfactant, said mixture comprising: [0043] (1) a first
component comprising [0044] (i) a cross-linkable, vinyl-functional
poly(dimethylsiloxane) having a vinyl content between 0.02 and 0.08
mmol/g and an amount of polydisperse silica of particle size 5 to
50 nm sufficient to impart a viscosity between 250,000 cps and
1.5.times.10.sup.6 cps to said first component; and [0045] (ii) a
platinum catalyst; and [0046] (2) a second component comprising
[0047] (i) a cross-linkable, vinyl-functional
poly(dimethylsiloxane) having a vinyl content between 0.02 and 0.08
mmol/g and an amount of polydisperse silica of particle size 5 to
50 nm sufficient to impart a viscosity between 250,000 cps and
1.5.times.10.sup.6 cps to said second component; and [0048] (ii) a
linear, branched or cyclic hydrofunctional poly(siloxane) having a
Si--H content from 1.4 to 5.0 mmol/g and viscosity of 40-300 cps;
[0049] said cross-linkable, vinyl-functional
poly(dimethylsiloxane)s being substantially free of monomers
containing quaternary silicon-oxygen bonded repeat units.
[0050] The present invention provides, in a fifth aspect, a
two-part resin kit comprising: [0051] (a) a first component
comprising [0052] (i) a cross-linkable, vinyl-functional
poly(dimethylsiloxane) having a vinyl content between 0.02 and 0.08
mmol/g and an amount of polydisperse silica of particle size 5 to
50 nm sufficient to impart a viscosity between 250,000 cps and
1.5.times.10.sup.6 cps to said first component; and [0053] (ii) a
platinum catalyst; [0054] (b) a second component comprising [0055]
(i) a cross-linkable, vinyl-functional poly(dimethylsiloxane)
having a vinyl content between 0.02 and 0.08 mmol/g and an amount
of polydisperse silica of particle size 5 to 50 nm sufficient to
impart a viscosity between 250,000 cps and 1.5.times.10.sup.6 cps
to said second component; and [0056] (ii) a linear, branched or
cyclic hydrofunctional poly(siloxane) having a Si--H content from
1.4 to 5.0 mmol/g and viscosity of 40-300 cps: [0057] said
cross-linkable, vinyl-functional poly(dimethylsiloxane)s being
substantially free of monomers containing quaternary silicon-oxygen
bonded repeat units, and [0058] said resin being substantially free
of surfactant.
[0059] These, and other objects, features and advantages of this
invention will become apparent from the following detailed
description of the various aspects of the invention taken in
conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0060] FIGS. 1A and 1B depict examples of a dental tray which is
utilized on either the upper teeth and jaw or the lower teeth and
jaw. FIG. 1A shows a tray without a tab for insertion and removal.
FIG. 1B shows a tray with tabs for insertion and removal.
[0061] FIGS. 2A and 2B depict examples of a dental tray which is
utilized on both the upper and lower teeth and jaw. FIG. 2A shows a
tray without a tab for insertion and removal. FIG. 2B shows a tray
with tabs for insertion and removal.
DETAILED DESCRIPTION OF THE INVENTION
[0062] It is important to draw a clear distinction between the
previous silicone resins employed for dental impressions and other
applications as described in U.S. Patent Application Publication
US2007/0134618 A1, European application EP 0 522 341 A1 and PCT
application WO 93/17654 and those of the present invention. The
aforementioned compositions differ from those of the present
invention in two important respects. First, the aforementioned
compositions contain surfactants that are necessary to modify the
wetting properties of the silicone resin for dental impressions.
These surfactants are not required in the present invention.
Secondly, and most significantly, the cured silicone resin
formulations of the present invention achieve the desired
mechanical properties of toughness and tear resistance without the
need for highly vinyl functional QM resins specified in the prior
art.
[0063] QM resins are well-known in the art and follow a recognized
nomenclature. The generally accepted definitions for M, D, T and Q
(found on page 3 of Chemistry and Technology of Silicones by Walter
Noll, Academic Press, New York, 1968) are the ones used herein.
They are described in the following Table 1:
TABLE-US-00001 TABLE 1 STRUCTURAL UNITS OF THE POLYORGANOSILOXANES
(Silicones) Structural formula Composition Functionality Symbol
##STR00001## R.sub.3SiO.sub.1/2 Monofunctional M ##STR00002##
R.sub.2SiO.sub.2/2 Difunctional D ##STR00003## RSiO.sub.3/2
Trifunctional T ##STR00004## SiO.sub.4/2 Tetrafunctional Q
[0064] The R groups are organo groups that are joined to silicon by
means of a carbon-silicon bond. Thus, the Q units, also known as
"quaternary" units are repeat units in the silicone polymer
structure that contain no carbon-silicon bonds. These units serve
as tetrafunctional groups that often are used to provide branches
and crosslinks in network silicone polymers. The monomers,
oligomers and polymers of the present invention do not contain Q
units except to the extent that they may exist as impurities in the
intended monomers, oligomers and polymers.
[0065] The term "dental", for purposes of this application, relates
to anything in or related to the oral cavity. This may include the
teeth, gums, tongue or interior surfaces of the lips. It may also
refer to the jaw as it relates to jaw positioning.
[0066] Unless the resin is further described or modified, the term
"resin", for purposes of this application, refers to the
prepolymerized mixture.
Silicone Resin
[0067] The silicone resin consists of two components. Component A
of the silicone resin consists of: [0068] 1. a nano-particulate
silica-filled vinyl-functional poly(dimethylsiloxane), [0069] 2. an
optional linear, branched or cyclic vinyl functional compound or
poly(dimethylsiloxane), and [0070] 3. a platinum catalyst.
Component B of the silicone resin consists of: [0071] 1. a
nano-particulate silica-filled vinyl-functional
poly(dimethylsiloxane) and [0072] 2. a linear, branched or cyclic
Si--H functional poly(dimethylsiloxane).
[0073] Part 1 in Component A is a nano-particulate silica filled
vinyl-functional poly(dimethylsiloxane) with a vinyl content
ranging from approximately 0.02 to 0.08 mmol/g. The density ranges
from approximately 0.95 to 1.2 g/cc. Part 1 in Component A may be
formulated by intensive high shear blending of a vinyl-functional
poly(dimethylsiloxane) resin with fume nano-particulate silica that
has been surface treated with cyclic dimethylsiloxanes or other
coupling agents known in the art. Sufficient polydisperse silica
with a particle size range between approximately 5 nm to 50 nm is
added to provide a viscosity of from about 250,000-1,500,000 cps to
the first component. Polydisperse silica is better able to impart
viscosity than is monodisperse silica, which is typically used in
applications in which increased viscosity is not desired.
Alternatively, commercially available preblended silica filled
vinyl-functional poly(dimethylsiloxane) is available and can be
used directly in this invention. In some embodiments, the silica
filled vinyl-functional poly(dimethylsiloxane) comprises 90-99.5%
by weight of Component A. In other embodiments, the silica filled
vinyl-functional poly(dimethylsiloxane) comprises approximately
91-99.4% by weight of Component A. In other embodiments, the silica
filled vinyl-functional poly(dimethylsiloxane) comprises 98-99.4%
by weight of Component A.
[0074] A stabilizer is often, but not always, required in
crosslinkable silicone resins that cure by means of a hydrosilation
reaction. The function of the stabilizer is to control the rate of
cure. Part 2 in Component A, when present, serves this purpose. In
some embodiments of the invention, the stabilizer is a linear,
branched or cyclic vinyl-functional poly(dimethylsiloxane) having
from 2 to 5 vinyl groups per molecule. The stabilizer may be
selected from the group including, but not limited to:
1,3-divinyltetramethyldisiloxane; 1,5-divinylhexamethyltrisiloxane;
1,3,5-trivinylpentamethyltrisiloxane;
1,3,5-trivinyicyclotrisiloxane;
1,3,5,7-tetravinylcyclotetrasiloxane and
1,3,5,7,9-pentavinylcyclopentasiloxane. In some embodiments of the
invention, the stabilizer is 1,3-divinyltetramethyldisiloxane. In
some embodiments of the invention in which stabilizer is present,
the amount of stabilizer required is from 0.05-5% of the total
prepolymer mixture. In other embodiments, the amount of stabilizer
present ranges from 0.1-1.0% of the total prepolymer mixture. In
still other embodiments, the amount of stabilizer present ranges
from 0.1-0.6% of the total prepolymer mixture. In yet other
embodiments, there is no stabilizer present. The cure time is
highly sensitive to the amount of stabilizer and small amounts can
be used to extend the handling time prior to insertion of the
dental appliance into the oral cavity.
[0075] In Component A, part 3 is a platinum-containing
hydrosilation catalyst. As noted below, a variety of different
platinum compounds and complexes can be used for this purpose. The
amount of complex required varies widely with their activity.
Generally, it has been found sufficient platinum compound or
complex is required to afford 0.001-0.01 g platinum metal per 20 g
of total silicone resin to provide a cure time under 7 minutes at
physiological temperature (approx. 37.degree. C.). In some
embodiments of the invention, the amount of platinum metal is
0.002-0.008 g per 20 g of total silicone resin. In other
embodiments, the amount of platinum metal is 0.002-0.004 g per 20 g
of total silicone resin. In still other embodiments, the amount of
platinum metal is 0.001-0.003 g per 20 g of total silicone
resin.
[0076] The nano-particulate silica filled vinyl-functional
poly(dimethylsiloxane) used in Part 4 of Component B may be the
same as in part 1 of Component A, but is not required to be. In
some embodiments of the invention, the amount of Part 4 comprises
74-97% by weight of Component B. In other embodiments, the amount
of Part 4 comprises 85-94% by weight of Component B.
[0077] Part 5 of Component B is a linear, branched or cyclic
organohydrofunctional polysiloxane (Si--H functional
poly(siloxane)) bearing pendant and terminal Si--H functional
groups with a viscosity of 40-300 cps and a Si--H content ranging
from 1.4-5.0 mmol/g. In one embodiment of the invention, part 5
consists of a linear or branched poly(dimethylsiloxane) with a
minimum Si--H functionality of 2 for a linear moiety and 3 or more
if it is branched. In another embodiment, part 5 is a cyclic Si--H
functional siloxane. Examples of part 5 include, but are not
necessarily limited to 1,3,5-trimethylcyclotrisiloxane,
1,3,5,7-tetramethylcyclotetrasiloxane,
1,3,5,7,9-pentamethylcyclopentasiloxane,
tetrakis(dimethylsiloxy)silane, tris(dimethylsiloxy)methylsilane,
UXlink 140 and UXlink 430 (both UXlink supplied by Momentive
Performance Materials). In some embodiments of the invention, part
5 comprises 3-26% by weight of Component B. In other embodiments of
the invention, part 5 comprises 6-15% by weight of Component B. In
still other embodiments of the invention, part 5 comprises 4-10% by
weight of Component B.
[0078] In the invention, the cross-linkable, vinyl-functional
poly(dimethylsiloxane)s of Component A and Component B are both
substantially free of vinyl functional silicone monomers, oligomers
or polymers containing quaternary silicon-oxygen bonded repeat
units. Additionally, as mentioned supra, the resin is substantially
free of surfactant. "Substantially free of" as used herein means
containing either none of the named component or so little as not
to affect the physical properties. Generally this will be less than
1%, preferably less than 0.1%, and more preferably less than
0.01%.
[0079] The above Components A and B are designed to be combined and
cured as 1:1 (by weight or volume) mixtures. As such they are
suitable for application using commercially available double
syringe packages. Mixing is provided by attachment of the double
syringe to a static mixing head. Typically, the double syringe
package and static mixing head are fabricated from various plastics
with a new static mixing head employed for each use.
[0080] The above classes of two-component crosslinkable silicone
resins are suitable for dental applications because they undergo
reaction without the formation of byproducts. This reaction
proceeds at room temperature and is not substantially affected by
the presence of water or other agents commonly encountered in the
oral cavity. Additional attributes that contribute to the
suitability of these resins in dental applications are their lack
of taste, smell and overall physiological inertness. Further, the
above described resin compositions are highly viscous and, due to
the presence of the nano-particulate filler, display a high degree
of thixotropy. This means that they can be dispensed as fluids but
behave as physical gels. Thus, they do not flow appreciably under
their own weight. In the present application, this means that the
resins can be dispensed into the aforementioned trays and will
remain in place within the trays prior to and during application.
The filled trays can subsequently be handled and conveniently used
by the dentist, dental technician or patient himself to fabricate
the final device by insertion into the oral cavity.
[0081] While the inventors do not wish to be limited by theory, it
is generally held that the hydrosilation reaction process described
above used in the two-component crosslinkable silicone resin is
mediated by a noble metal catalyst. Typical catalysts used in this
reaction are platinum compounds and platinum complexes although it
is well known in the art that a variety of other catalysts, for
example, rhodium and palladium complexes can also be employed.
Among the many platinum-containing catalysts that can be used in
this invention are the well known Speier (J. L. Speier, Advances in
Comprehensive Organometallic Chemistry, Vol. 2, eds. G. Wilkinson,
F. G. A. Stone and E. W. Abel, Pergamon, Oxford, 1982, pp.
117-120), Karstedt (U.S. Pat. No. 3,715,334), Ashby (U.S. Pat. No.
3,715,334) and Lamoreaux (U.S. Pat. No. 3,220,972) catalysts and
chloroplatinic acid (H.sub.2PtCl.sub.6),
Cl.sub.2(COD)Pt(II)].sub.2, [Cl(COD)Pt(I)].sub.2 and
Cl.sub.2[(C.sub.2H.sub.5).sub.2S].sub.2Pt(II). The hydrosilation
reaction and catalysts used in carrying it out are well known in
the art.
[0082] Each of the above described components that make up the
crosslinkable silicone resin is shelf stable under normal storage
conditions at room temperature. Cure commences on mixing the two
components together. This is most conveniently achieved within a
dental setting through the use of a specially designed double
barrel syringe that is mated with a detachable static mixing head.
Depression of the dual syringe (usually with the aid of dispensing
gun) delivers the two components in predetermined (herein 1:1)
proportions to the static mixing head. Forcing the liquid
components through the static mixing head provides an intimate,
homogeneously combined mixture while simultaneously initiating the
hydrosilation cure reaction. In most applications, the orifice end
of the static mixing head is positioned so that it fills the
applicator tray. Several alternative methods can also be employed
to combine the two components of the silicone resin. For example,
the two components can be simply combined in the proper proportions
by volume or weight and hand mixed. The mixture can subsequently be
conveyed to the tray by various means and the assembly inserted
into the oral cavity for cure.
[0083] As previously mentioned, a tough but compliant cured
silicone resin is required for all of the dental appliance
applications discussed herein. These mechanical properties are
largely determined by the character and proportions of the various
constituents present in Components A and B. A number of different
formulations will be described in the Examples that achieve this
objective. Although we do not wish to be limited by theory, we have
achieved the requisite mechanical characteristics by designing
silicone resins filled with nano-particulate silica and possessing
a specific crosslink density.
[0084] It is an objective of this invention to provide said
silicone resins with a cure time acceptable to both ordinary dental
practice and with consideration for dental patient comfort. An
acceptable length of time for curing may be different for each
patient: one patient may be willing to wait for 30 minutes for the
resin to cure, while another may only be comfortable for 10
minutes. A cure time of seven minutes or less at approximately
37.degree. C. is believed to be tolerable for most patients. The
cure time is controlled by both the concentration of vinyl and
Si--H (hydrosilane) groups present in the silicone precursors and
by the level of the platinum catalyst employed for cure. Examples
are provided that demonstrate control over this parameter of the
cure.
Tray Design and Materials
[0085] As previously indicated, an embodiment of this invention
includes the tray in which the curable silicone resin is placed.
The tray serves the function of providing a means for containing
the uncured silicone resin and conveying it to the oral cavity. It
is also designed to confine the resin to specific regions within
the oral cavity. Further, after cure the tray becomes an integral
part of the completed dental appliance. In most cases, the tray
will consist of a thin plastic shell [20] containing an arch-shaped
channel [30] that closely parallels the contour of the teeth in the
jaw. This channel is where the silicone resin is added. FIGS. 1A
and 1B show the configuration of one potential tray configuration.
In this case, the tray [10] is designed to fit the teeth (and,
depending on the application, the gums) of either the upper jaw or
the lower jaw. Two trays of the type shown in FIGS. 1A and 1B can
be used to fit the teeth (and optionally the gums) of both jaws. In
such a case, first one half of the jaw is fitted and cured with a
tray as shown in FIG. 1A, and then the second half is treated
similarly with another tray as shown in FIG. 1B. Alternatively, as
shown in FIGS. 2A and 2B, a double tray [60] can be employed in
which the teeth (and optionally the gums) of both the upper and
lower jaws can be fitted simultaneously. In this case, an optional
hinge [40] may be utilized in the tray to improve patient comfort
during tray placement.
[0086] The tray optionally may be fitted with specially designed
tabs [50] to assist in insertion and withdrawal from the oral
cavity before and after curing as well as during repeated use of
the dental appliance.
[0087] The tray may be constructed from rigid or flexible
thermoplastic resins by a number of conventional molding techniques
including but not limited to: injection molding, compression
molding or by vacuum sheet or pressure forming. Some typical
thermoplastic resins that can be used for this purpose include
poly(ethylene), poly(propylene), poly(methylmethacrylate),
poly(oxymethylene), poly(carbonate), poly(styrene), poly(butylene
terephthalate), poly(ethylene terephthalate),
poly(acrylonitrile)-poly(butadiene)-poly(styrene) copolymer, high
impact poly(styrene), nylon-6, nylon-6,6, nylon-6,12, among many
others.
[0088] The tray may be fabricated from clear (unfilled) or filled
thermoplastic resins and may also contain pigments, dyes, and/or
other processing aids.
[0089] In some embodiments, it is desirable that the cured silicone
resin adhere to the tray to provide an integrally bonded dental
appliance. In many cases, sufficient bond strength will be achieved
during curing of the silicone resin within the tray. However,
bonding may also be augmented by other means. For example, the
surface of the tray in contact with the silicone resin may be
textured during fabrication or roughened by abrasion or etching
afterwards. Alternatively or additionally, various coupling agents
may be used to treat the surface of the tray to promote bonding.
Examples of applicable coupling agents comprise but are not limited
to: alkyl trialkoxysilanes, dialkyl dialkoxysilanes, alkyl
triacetoxysilanes and titanium tetraalkoxides. It may be
advantageous to employ both techniques to ensure bonding of the
silicone resin to the tray. Another technique for improving bonding
is to employ flame or corona ionization of the surface of the tray.
In addition, the channel of the tray may be perforated to allow a
further avenue for attaching and integrating the cured silicone to
the tray.
[0090] The design of the tray configuration will be tailored to the
specific dental appliance application for which it is intended. For
example, night guard trays will have a different design than those
employed for sporting mouth guards and these will again be
differently configured from dental appliances designated for use as
temporal-mandibular jaw splints. It is envisioned that a number of
different tray sizes for each dental appliance application will be
required to accommodate the requirements of various adult and
juvenile patients.
[0091] The procedure for the fabrication of a dental appliance
consists of combining the Components A and B of the silicone resin
using either [0092] 1. manual dispensing and hand mixing; [0093] 2.
a double syringe coupled to a disposable static mixer; or [0094] 3.
a pressure activated automated dual delivery system equipped with a
static mixing head. Methods 2 and 3 are preferred since they do not
introduce excessive amounts of air which may become trapped during
cure of the silicone resin.
[0095] Once the silicone resin is delivered to the tray, the
assembly is then introduced into the oral cavity and positioned
both by the dental personnel and by the patient's opposing jaw. The
patient is then asked to bite down on the tray. With the patient
holding the bite, the resin sets or hardens. The finished dental
appliance is then removed from the oral cavity and examined for any
defects. Some trimming and/or polishing may be necessary to remove
any excess gelled resin and tray material. The result is a
well-adapted, economical, comfortable, long lasting dental
device.
[0096] In some embodiments, the invention may further comprise a
dental medicament. Such medicaments include, but are not limited
to, one or more of a tooth-whitening bleach, fluoride, an
anti-bacterial agent or an oxidizing agent. The conformal nature of
the crosslinkable silicone resin used in this technology ensures
that therapeutic agents (bleach, antibacterial agents, etc.) will
be held in close contact with the teeth and/or gums for extended
time periods to deliver their activity to the targeted teeth or
periodontal pockets. The chemically inert nature of the silicone
resin used in this technology ensures that neither the device nor
the potency of the therapeutic agent will be degraded during the
treatment; for instance, the present invention provides a conformal
tray that is inert to bleaching agent and that can hold a bleaching
agent in direct contact with the teeth. Further, the silicone
appliances described in this invention are transparent to UV light
and can be used in a photo-assisted bleaching process. In a similar
fashion, the custom-fit dental appliances can be used for other
therapeutic uses, such as to deliver fluoride or to protect
sensitive gums after dental surgery.
[0097] A second way in which the devices of this invention can be
used in the treatment of periodontal disease is to incorporate
dental medicaments, such as, but not limited to, active
anti-bacterial agents (for example, streptomycin), into the
silicone resin used to fabricate the device. When the patient wears
the device, the medicament will be slowly leached from the device
and will be delivered to the treatment sites within the oral
cavity.
[0098] In addition to periodontal disease, dental caries and
sensitivity, cure and prevention can also be carried out by the use
of oral trays of this invention filled with anti cavity chemicals,
particularly fluoride, to help decrease bacteria and strengthen
teeth. The new tray fabrication technique and materials described
herein will help keep all prevention medications in closer contact
with tooth surfaces than the trays in current use, thus enhancing
the effectiveness of all desensitizing and decay prevention
techniques.
[0099] The incorporation of dyes, pigments or other inert colorants
into one or both of the components of the silicone resin may be
desirable for esthetic purposes, for personal identification of the
dental appliance or for inspection purposes. Such agents are within
the scope and intent of the present invention.
[0100] While night guards, mouth guards, bleaching trays and trays
for treatment of periodontal disease constitute the prime
applications of the novel dental appliances described in this
invention, they are not the exclusive objectives. Additional
applications include but are not limited to: anti-snoring devices,
temporal-mandibular jaw splints and teeth positioning devices. In
the latter case, the highly conformal yet resilient nature of the
resin in the device can hold the alignment of teeth and prevent
their movement. The comfort provided by these devices makes them
highly suitable for use as dental retainers for night-time and
long-term wear. An additional application for the silicone resin
employed in this invention is as a temporary dental adhesive. The
adhesive can be used to bond crowns and bridges in temporary
restorations to existing and implanted dental structures and still
be easily removed when desired. The material is also suitable to be
used to provide a soft and comfortable lining in removable oral
prostheses, i.e., full and partial dentures.
EXAMPLES
[0101] The following examples are not construed as limiting and are
offered by way of illustration. The experiments described in these
examples were carried out at room temperature (approx. 25.degree.
C.). For this reason, gel times in the oral cavity (approx.
37.degree. C.) on actual dental appliances will be somewhat
shorter.
Example 1
[0102] The following two-component mixture was prepared.
Component A
[0103] 1. 10 g Base Compound P-300 Nano-particulate silica filled
vinyl functional silicone resin having a viscosity of 300,000 cps,
a density of 1.1 g/ml and a vinyl content of 0.04 mmol/g (supplied
by Momentive Performance Materials) [0104] 2. 0.067 g
Platinum-1,3-divinyltetramethyldisiloxane complex in vinyl
terminated silicone oil (Gelest 91P6830.3) with a platinum content
of 3.0-3.5%.
Component B
[0104] [0105] 1. 10 g Base Compound P-300 Nano-particulate silica
filled vinyl functional silicone resin having a viscosity of
300,000 cps, a density of 1.1 g/ml and a vinyl content of 0.04
mmol/g (supplied by Momentive Performance Materials) [0106] 2. 0.75
g UXlink 140 organohydrofunctional polysiloxane (Si--H functional
poly(siloxane), Si--H content 1.4 mmol/g; viscosity 300 cps)
(supplied by Momentive Performance Materials). The individual parts
of Components A and B were hand mixed together and then each
component was loaded into the separate barrel of a double barrel
syringe. The dual plunger of the syringe was inserted and the
assembly inverted to allow the entrapped air bubbles to escape. A
static mixing head was affixed to the syringe and this was used to
fill a transparent poly(methyl methacrylate) tray for a night
guard. Thereafter, the tray was inserted into the oral cavity of a
patient in such a manner that the teeth of the front portion of the
upper jaw were encapsulated by the patient biting down on the tray.
The time elapsed to this point in the process after dispensing the
mixed silicone resin into the tray was approximately 0.5-1 minutes.
After an additional 5 minutes, the silicone resin was set and was
removed from the patient's mouth. The completed night guard was
ready for immediate use.
Example 2
[0107] The following two-component mixture was prepared.
Component A
[0108] 1. 10 g Base Compound P-300 Nano-particulate silica filled
vinyl functional silicone resin having a viscosity of 300,000 cps,
a density of 1.1 g/ml and a vinyl content of 0.04 mmol/g [0109] 2.
0.055 g 1,3-divinyltetramethyldisiloxane (supplied by Gelest Co.)
[0110] 3. 0.067 g Platinum-1,3-divinyltetramethyldisiloxane complex
in vinyl terminated silicone oil (Gelest 91P6830.3) with a platinum
content of 3.0-3.5%)
Component B
[0110] [0111] 1. 10 g Base Compound P-300 Nano-particulate silica
filled vinyl functional silicone resin having a viscosity of
300,000 cps, a density of 1.1 g/ml and a vinyl content of 0.04
mmol/g. [0112] 2. 0.75 g 1,3,5,7,9-pentamethylcyclopentasiloxane
(supplied by PCR Inc.) The parts of each of components A and B were
separately mixed and then each part was loaded into a 12 mL
syringe. To measure the cure time, two gram aliquots of Components
A and B were weighed into a shallow dish and mixed. Gelation took
place after one minute. A soft elastomeric non-tacky elastomer was
obtained.
Example 3
[0113] The following two-component mixture was prepared.
Component A
[0114] 1. 10 g Base Compound P-300 Nano-particulate silica filled
vinyl functional silicone resin having a viscosity of 300,000 cps,
a density of 1.1 g/ml and a vinyl content of 0.04 mmol/g. [0115] 2.
0.055 g 1,3-divinyltetramethyldisiloxane (supplied by Gelest Co.)
[0116] 3. 0.067 g Platinum-1,3-divinyltetramethyldisiloxane complex
in vinyl terminated silicone oil (Gelest 91P6830.3) with a platinum
content of 3.0-3.5%)
Component B
[0117] 10 g Base Compound P-300 Nano-particulate silica filled
vinyl functional silicone resin having a viscosity of 300,000 cps,
a density of 1.1 g/ml and a vinyl content of 0.04 mmol/g. [0118] 1.
0.75 g UXlink 430 organohydrofunctional polysiloxane (Si--H
functional poly(siloxane)) (supplied by Momentive Performance
Materials) having a Si--H content of 4.3 mmol/g and a viscosity of
40 cps. The parts of each of components A and B were separately
mixed and then each part was loaded into a 12 mL syringe. To
measure the cure time, two gram aliquots of Components A and B were
weighed into a shallow dish and mixed. Gelation took place after 3
minutes. A tough gelled elastomeric elastomer was obtained after 10
minutes that became non-tacky after an additional 2 minutes.
Example 4
[0119] The following two-component mixture was prepared.
Component A
[0120] 1. 10 g Base Compound P-300 Nano-particulate silica filled
vinyl functional silicone resin having a viscosity of 300,000 cps,
a density of 1.1 g/ml and a vinyl content of 0.04 mmol/g (supplied
by Momentive Performance Materials) [0121] 2. 0.055 g
1,3-divinyltetramethyldisiloxane (supplied by Gelest Co.) [0122] 3.
0.067 g Platinum-1,3-divinyltetramethyldisiloxane complex in vinyl
terminated silicone oil (Gelest 91P6830.3) with a platinum content
of 3.0-3.5%)
Component B
[0122] [0123] 1. 10 g Base Compound P-300 Nano-particulate silica
filled vinyl functional silicone resin having a viscosity of
300,000 cps, a density of 1.1 g/ml and a vinyl content of 0.04
mmol/g. [0124] 2. 0.34 g UXlink 430 organohydrofunctional
polysiloxane (Si--H functional poly(siloxane)) (supplied by
Momentive Performance Materials) having a Si--H content of 4.3
mmol/g and a viscosity of 40 cps. The parts of each of components A
and B were separately mixed and then each part was loaded into a 12
mL syringe. To measure the cure time, two gram aliquots of
Components A and B were weighed into a shallow dish and mixed.
Gelation took place after 9 minutes. The formulation remained tacky
even after standing for 15 minutes.
Example 5
[0125] The following two-component mixture was prepared.
Component A
[0126] 1. 10 g Base Compound P-1300 Nano-particulate silica filled
vinyl functional silicone resin having a viscosity of 1,300,000
cps, a density of 1.15 g/ml and a vinyl content of 0.04 mmol/g
(supplied by Momentive Performance Materials). [0127] 2. 0.055 g
1,3-divinyltetramethyldisiloxane (supplied by Gelest Co.) [0128] 3.
0.067 g Platinum-1,3-divinyltetramethyldisiloxane complex in vinyl
terminated silicone oil (Gelest 91P6830.3) with a platinum content
of 3.0-3.5%)
Component B
[0128] [0129] 1. 10 g Base Compound P-1300 Nano-particulate silica
filled vinyl functional silicone resin having a viscosity of
1,300,000 cps, a density of 1.15 g/ml and a vinyl content of 0.04
mmol/g. [0130] 2. 0.75 g UXlink 140 organohydrofunctional
polysiloxane (Si--H functional poly(siloxane), Si--H content 1.4
mmol % g; viscosity 300 cps) (supplied by Momentive Performance
Materials) The parts of each of components A and B were separately
mixed and then each part was loaded into a 12 mL syringe. To
measure the cure time, two gram aliquots of Components A and B were
weighed into a shallow dish and mixed. Gelation required over 15
minutes.
Example 6
[0131] The following two-component mixture was prepared.
Component A
[0132] 1. 10 g Base Compound P-300 Nano-particulate silica filled
vinyl functional silicone resin having a viscosity of 300,000 cps,
a density of 1.1 g/ml and a vinyl content of 0.04 mmol/g (supplied
by Momentive Performance Materials) [0133] 2. 0.055 g
1,3-divinyltetramethyldisiloxane (supplied by Gelest Co.) [0134] 3.
0.067 g Platinum-1,3-divinyltetramethyldisiloxane complex in vinyl
terminated silicone oil (Gelest 91P6830.3) with a platinum content
of 3.0-3.5%)
Component B
[0134] [0135] 1. 10 g Base Compound P-300 Nano-particulate silica
filled vinyl functional silicone resin having a viscosity of
300,000 cps, a density of 1.1 g/ml and a vinyl content of 0.04
mmol/g (supplied by Momentive Performance Materials) [0136] 2. 1.5
g UXlink 140 organohydrofunctional polysiloxane (Si--H functional
poly(siloxane), Si--H content 1.4 mmol/g; viscosity 300 cps)
(supplied by Momentive Performance Materials) The parts of each of
components A and B were separately mixed and then each part was
loaded into a 12 mL syringe. To measure the cure time, two gram
aliquots of Components A and B were weighed into a shallow dish and
mixed. This formulation required 11 minutes for gelation.
Example 7
[0137] The following two-component mixture was prepared.
Component A
[0138] 1. 10 g Base Compound P-300 Nano-particulate silica filled
vinyl functional silicone resin having a viscosity of 300.000 cps,
a density of 1.1 g/ml and a vinyl content of 0.04 mmol/g. [0139] 2.
0.025 g 1,3-divinyltetramethyldisiloxane (supplied by Gelest Co.)
[0140] 3. 0.067 g Platinum-1,3-divinyltetramethyldisiloxane complex
in vinyl terminated silicone oil (Gelest 91P6830.3) with a platinum
content of 3.0-3.5%)
Component B
[0140] [0141] 1. 10 g Base Compound P-300 Nano-particulate silica
filled vinyl functional silicone resin having a viscosity of
300,000 cps, a density of 1.1 g/ml and a vinyl content of 0.04
mmol/g (supplied by Momentive Performance Materials) [0142] 2. 1.0
g UXlink 140 organohydrofunctional polysiloxane (Si--H functional
poly(siloxane), Si--H content 1.4 mmol/g; viscosity 300 cps). The
parts of each of components A and B were separately mixed and then
each part was loaded into a 12 mL syringe. To measure the cure
time, two gram aliquots of Components A and B were weighed into a
shallow dish and mixed. This formulation required 7 minutes for
gelation.
Example 8
[0143] The following two-component mixture was prepared.
Component A
[0144] 1. 10 g Base Compound P-300 Nano-particulate silica filled
vinyl functional silicone resin having a viscosity of 300,000 cps,
a density of 1.1 g/ml and a vinyl content of 0.04 mmol/g (supplied
by Momentive Performance Materials) [0145] 2. 0.025 g
1,3-divinyltetramethyldisiloxane. [0146] 3. 0.067 g
Platinum-1,3-divinyltetramethyldisiloxane complex in vinyl
terminated silicone oil (Gelest 91P6830.3) with a platinum content
of 3.0-3.5%)
Component B
[0146] [0147] 1. 10 g Base Compound P-300 Nano-particulate silica
filled vinyl functional silicone resin having a viscosity of
300,000 cps, a density of 1.1 g/ml and a vinyl content of 0.04
mmol/g. [0148] 2. 0.50 g UXlink 140 organohydrofunctional
polysiloxane (Si--H functional poly(siloxane), Si--H content 1.4
mmol/g; viscosity 300 cps). The parts of each of components A and B
were separately mixed and then each part was loaded into a 12 mL
syringe. To measure the cure time, two gram aliquots of Components
A and B were weighed into a shallow dish and mixed. This
formulation required 14 minutes for gelation.
Example 9
[0149] The following two-component mixture was prepared.
Component A
[0150] 1. 10 g Base Compound P-300 Nano-particulate silica filled
vinyl functional silicone resin having a viscosity of 300,000 cps,
a density of 1.1 g/ml and a vinyl content of 0.04 mmol/g (supplied
by Momentive Performance Materials) [0151] 2. 0.067 g
Platinum-1,3-divinyltetramethyldisiloxane complex in vinyl
terminated silicone oil (Gelest 91P6830.3) with a platinum content
of 3.0-3.5%)
Component B
[0151] [0152] 1. 10 g Base Compound P-300 Nano-particulate silica
filled vinyl functional silicone resin having a viscosity of
300,000 cps, a density of 1.1 g/ml and a vinyl content of 0.04
mmol/g. [0153] 2. 0.75 g UXlink 140 organohydrofunctional
polysiloxane (Si--H functional poly(siloxane), Si--H content 1.4
mmol/g; viscosity 300 cps). The parts of each of components A and B
were separately mixed and then each part was loaded into a 12 mL
syringe. To measure the cure time, two gram aliquots of Components
A and B were weighed into a shallow dish and mixed. This
formulation required 1.5 minutes for gelation.
Example 10
[0154] The following two-component mixture was prepared.
Component A
[0155] 1. 10 g Base Compound P-300 Nano-particulate silica filled
vinyl functional silicone resin having a viscosity of 300,000 cps,
a density of 1.1 g/ml and a vinyl content of 0.04 mmol/g (supplied
by Momentive Performance Materials) [0156] 2. 0.067 g
Platinum-1,3-divinyltetramethyldisiloxane complex in vinyl
terminated silicone oil (Gelest 91P6830.3) with a platinum content
of 3.0-3.5%)
Component B
[0156] [0157] 1. 10 g Base Compound P-300 Nano-particulate silica
filled vinyl functional silicone resin having a viscosity of
300,000 cps, a density of 1.1 g/ml and a vinyl content of 0.04
mmol/g (supplied by Momentive Performance Materials) [0158] 2. 1.5
g UXlink 140 organohydrofunctional polysiloxane (Si--H functional
poly(siloxane), Si--H content 1.4 mmol % g; viscosity 300 cps)
(supplied by Momentive Performance Materials) The parts of each of
components A and B were separately mixed and then each part was
loaded into a 12 mL syringe. To measure the cure time, two gram
aliquots of Components A and B were weighed into a shallow dish and
mixed. This formulation required 1.5 minutes for gelation and was
tack-free after 4 minutes. A tough, resilient silicone elastomer
was obtained.
Example 11
[0159] The following two-component mixture was prepared.
Component A
[0160] 1. 10 g Base Compound P-1300 Nano-particulate silica filled
vinyl functional silicone resin having a viscosity of 1,300,000
cps, a density of 1.15 g/ml and a vinyl content of 0.04 mmol/g
(supplied by Momentive Performance Materials). [0161] 2. 0.067 g
Platinum-1,3-divinyltetramethyldisiloxane complex in vinyl
terminated silicone oil (Gelest 91P6830.3) with a platinum content
of 3.0-3.5%)
Component B
[0161] [0162] 1. 10 g Base Compound P-1300 Nano-particulate silica
filled vinyl functional silicone resin having a viscosity of
1,300,000 cps, a density of 1.15 g/ml and a vinyl content of 0.04
mmol/g. [0163] 2. 0.75 g UXlink 140 organohydrofunctional
polysiloxane (Si--H functional poly(siloxane), Si--H content 1.4
mmol/g; viscosity 300 cps) (supplied by Momentive Performance
Materials) The parts of each of components A and B were separately
mixed and then each part was loaded into a 12 mL syringe. To
measure the cure time, two gram aliquots of Components A and B were
weighed into a shallow dish and mixed. Gelation required over 2.1
minutes and was tack-free after 6 minutes.
Example 12
[0164] The following two-component mixture was prepared.
Component A
[0165] 1. 10 g Base Compound P-1300 Nano-particulate silica filled
vinyl functional silicone resin having a viscosity of 1,300,000
cps, a density of 1.15 g/ml and a vinyl content of 0.04 mmol/g
(supplied by Momentive Performance Materials). [0166] 2. 0.013 g
1,3-divinyltetramethyldisiloxane. [0167] 3. 0.067 g
Platinum-1,3-divinyltetramethyldisiloxane complex in vinyl
terminated silicone oil (Gelest 91P6830.3) with a platinum content
of 3.0-3.5%)
Component B
[0167] [0168] 1. 10 g Base Compound P-1300 Nano-particulate silica
filled vinyl functional silicone resin having a viscosity of
1,300,000 cps, a density of 1.15 g/ml and a vinyl content of 0.04
mmol/g. [0169] 2. 0.75 g UXlink 140 organohydrofunctional
polysiloxane (Si--H functional poly(siloxane), Si--H content 1.4
mmol/g; viscosity 300 cps) (supplied by Momentive Performance
Materials) The parts of each of components A and B were separately
mixed and then each part was loaded into a 12 mL syringe. To
measure the cure time, two gram aliquots of Components A and B were
weighed into a shallow dish and mixed. Gelation required over 5
minutes and was tack-free after 11 minutes. A tough, resilient
elastomer was obtained.
[0170] A comparison of examples 1, 7 and 12 provides a comparison
of the effect of the 1,3-divinyltetramethylsiloxane on the cure
time of identical formulations. As can be seen, the cure time and
handling time can be adjusted by varying the concentration of this
component within the formulation.
[0171] The following process is one example of a method of
producing an embodiment of the invention. The occlusal plane of a
stone model (e.g., a fiber reinforced plaster of Paris) was built
up with wax to make it flat. An alginate impression is taken and
poured in stone. A variety of thermo-forming materials may be used,
such as a hard tray material and a soft bleaching tray material in
a range of thicknesses. When the appropriate material is chosen,
the tray material is molded around the new flat stone model, for
instance, by employing a pressure forming machine. The person of
skill will realize that alternative methods may be used for making
the tray. A high speed dental drill is then used to trim the flat
section off the model to create the actual tray. The tray can be
trimmed to extend as far back in the patient's mouth as desired; in
one instance, the tray is trimmed to extend from the left first
premolar to the right first premolar. The tray is then smoothed and
polished to be comfortable for the patient, and retention grooves
are drilled into the inside of the tray. The inside of the tray is
then lined with the prepolymer resin and inserted into the
patient's mouth. The patient is instructed to bite and stay biting
while the material hardens, for instance, for ten minutes. Once
fully hard, the tray is removed and the excess overflow of hard
material is trimmed, for instance, by using laboratory scissors.
The tray is then reinserted into the patient's mouth and the bite
is checked and adjusted. Once the patient feels comfortable, he/she
is sent home with instructions on when to wear their specific tray
and with cleaning instructions.
[0172] Eight patients filled out questionnaires about the process
of making and using the dental devices as described above. The
patients were asked to rate the overall experience with the device
and their experience with the making and fitting of the device (as
described above) on a scale of 1 to 10, with 1 being "poor" and 10
being "excellent." The results are shown in Table I.
TABLE-US-00002 TABLE I Patient Overall Experience Experience with
Making Number with Product and Fitting of Product 1 2 5 2 7 7 3 10
10 4 10 10 5 7 9 6 10 10 7 8 8 8 10 10 Average 8.00 8.63 Std. Dev.
2.60 1.73
[0173] While several aspects of the present invention have been
described and depicted herein, alternative aspects may be affected
by those skilled in the art to accomplish the same objectives.
Accordingly, it is intended by the appended claims to cover all
such alternative aspects as fall within the true spirit and scope
of the invention. Although this invention is susceptible to
embodiment in many different forms, some preferred embodiments of
the invention are shown. It should be understood, however, that the
present disclosure is to be considered as an exemplification of the
principles of this invention and is not intended to limit the
invention to the embodiments illustrated.
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