U.S. patent application number 11/293497 was filed with the patent office on 2006-06-29 for method and apparatus for tooth whitening.
Invention is credited to Damon J. Brown, Tim Diasti, Graham JR. K. Philp.
Application Number | 20060141422 11/293497 |
Document ID | / |
Family ID | 36612063 |
Filed Date | 2006-06-29 |
United States Patent
Application |
20060141422 |
Kind Code |
A1 |
K. Philp; Graham JR. ; et
al. |
June 29, 2006 |
Method and apparatus for tooth whitening
Abstract
Preconditioning mouth rinse, which pre-treats the teeth to
better receive a whitening formula containing a photosensitive
compound, and a hand-held consumer light source for tooth
whitening, which provides rapid tooth whitening, are disclosed. The
light source may use a specific range of visible light and also
emit heat sufficient to raise the temperature of the teeth a
desired amount at a depth up to about 2 mm in the range of about
from 1-5.degree. Celsius over a predetermined period of time. The
specified wavelengths of the hand-held consumer operable light will
activate the photosensitive substance in the whitening formula. The
oxidizing compounds may be transparent to light enabling light
energy to activate the oxidizing compounds directly on the tooth
surface, or to activate a photosensitizing or photosensitive
compound added to produce the desired temperature increase.
Inventors: |
K. Philp; Graham JR.;
(Naples, FL) ; Brown; Damon J.; (Boston, MA)
; Diasti; Tim; (Clearwater, FL) |
Correspondence
Address: |
SHLESINGER, ARKWRIGHT & GARVEY LLP
1420 KING STREET
SUITE 600
ALEXANDRIA
VA
22314
US
|
Family ID: |
36612063 |
Appl. No.: |
11/293497 |
Filed: |
December 5, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
PCT/US04/10953 |
Apr 20, 2004 |
|
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|
11293497 |
Dec 5, 2005 |
|
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Current U.S.
Class: |
433/215 ;
433/29 |
Current CPC
Class: |
A61C 19/066 20130101;
A61C 19/063 20130101; A61N 2005/0644 20130101; A61N 2005/0606
20130101; A61C 2204/002 20130101 |
Class at
Publication: |
433/215 ;
433/029 |
International
Class: |
A61C 1/00 20060101
A61C001/00; A61C 5/00 20060101 A61C005/00; A61C 3/00 20060101
A61C003/00 |
Claims
1. A tooth whitening system, comprising: a) a portable,
self-contained, hand-held light source; b) the hand-held light
source including: i) a housing; ii) the housing including a handle
configured for being manipulated by a user; iii) a head; iv) a lens
provided on the head of the housing at a distance from the handle;
v) a self-contained light element provided in the housing and
located for emitting light through the lens, the light element, in
use, emitting light of a wavelength suitable for activating a
light-activated tooth whitener, in use, when a tooth whitener is
provided on a user's teeth; and vi) a power source provided in the
housing, the power source being electrically connected with the
light element; and c) the head of the housing being disposed
relative to the handle at a predetermined angle so that, in use, a
user may direct light emitted by the light element at the user's
own teeth;
2. A tooth whitening system as in claim 1, wherein: a) the handle
extends at an angle of about 45.degree.-135.degree. relative to a
direction of extension of the head of the housing.
3. A tooth whitening system as in claim 1, wherein: a) the light
element includes a halogen light.
4. A tooth whitening system as in claim 1, wherein: a) the light
element includes a tungsten light.
5. A tooth whitening system as in claim 1, wherein: a) the light
element includes a xenon light.
6. A tooth whitening system as in claim 1, wherein: a) a switch is
provided, the switch being electrically connected with the power
element for switching the light element on and off.
7. A tooth whitening method, comprising: a) providing a portable,
self-contained, hand-held light source the hand-held light source
including: i) a housing; ii) the housing including a handle
configured for being manipulated by a user; iii) a self-contained
light element provided in the housing and located for emitting
light of a wavelength suitable for activating a light-activated
tooth whitener, in use, when a tooth whitener is provided on a
user's teeth; iv) a power source provided in the housing, the power
source being electrically connected with the light element; and v)
the light element being disposed relative to the handle for
emitting light at a predetermined angle so that, in use, a user may
direct light emitted by the light element at the user's own teeth;
and b) providing a tooth whitener on a user's teeth.
8. A tooth whitening method as in claim 7, wherein: a) the light
element includes a halogen light.
9. A tooth whitening method as in claim 7, wherein: a) a mouth
rinse is provided, the mouth rinse being selected for
preconditioning a user's teeth for receiving a whitening
compound.
10. A tooth whitening method as in claim 7, wherein: a) the tooth
whitener includes a light-activated tooth whitener provided on a
user's teeth.
11. A tooth whitening method as in claim 7, wherein: a) the tooth
whitener includes a heat-activated tooth whitener provided on a
user's teeth.
12. A tooth whitening method as in claim 7, wherein: a) a
preconditioning rinse is provided, the preconditioning rinse being
formulated to pretreat the environment of the user's teeth to be in
a pH range of about 7.9-9.0.
13. A tooth whitening method as in claim 7, wherein: a) a blue
light filter which filters out undesirable wavelengths of light is
provided, the blue light filter thus enabling a blue wavelength to
be emitted to penetrate the tooth.
14. A tooth whitening method as in claim 12, wherein: a) the
preconditioning rinse is formulated to kill bacteria which produce
peroxidase enzymes.
15. A tooth whitening method as in claim 9, wherein: a) the mouth
rinse includes a mouth rinse having a formula: TABLE-US-00009
Ingredient Concentration NP-9, ethoxylated 0.65 mls nonyphenol, 9
molar EO. Peppermint Oil 1.4 mls Nutrasweet .RTM. 0.75 grams
Granular 100 Glycerin 99.5% 30 mls Kosher food grade Sodium
Bicarbonate 2 grams food grade Sodium Carbonate 0.1 grams food
grade Benzethonium 0.15 grams Chloride Purified Water Balance to 1
gallon (i.e., 3.785 liter) Ethanol 75% or .about.10 mls greater
16. A tooth whitening method as in claim 7, wherein: a) the tooth
whitener includes a tooth whitener having a formula: TABLE-US-00010
% by COMPOUND Weight RANGE % Ethyl Alcohol 73.75 Hydrogenated Ester
of 13.87 0.001-35.00 Rosin Urea (Carbamide) 11.10 0.001-25.00
Hydrogen Peroxide Hydroxypropylcellulose 0.55 0.001-10.00 1500 cps
Flavoring- Menthol 0.22 0.001-15.00 Flavoring- Peppermint 0.20
0.001-15.00 Oil Zinc Oxide (micro 0.15 0.001-5.00 particles)
Flavoring- Aspartame 0.15 0.001-5.00
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of Application No.
PCT/US2004/010953 to Philp, Jr. et al., filed 20 Apr. 2004, which
claims the priority of Application No. PCT/US2003/017631 to Brown,
Jr. et al., filed 5 Jun. 2003, and this application claims the
priority of U.S. patent application No. 60/524,861 to Philp, Jr. et
al., filed 26 Nov. 2003, and each of which is incorporated herein
by reference.
[0002] This application relates to applicant's concurrently filed
Application No. [applicant's ref. 7273-US], entitled "Method for
Whitening Teeth", filed Dec. 5, 2005, and which is incorporated
herein by reference.
FIELD OF INVENTION
[0003] The invention relates to a method and apparatus for
achieving rapid tooth whitening, which is usable by a consumer. In
particular, the invention relates to a preconditioning mouth rinse,
which prepares teeth to receive the whitening formula, a whitening
compound, which is directly applied onto teeth and which contains a
photoactive substance, which responds to a safe wavelength of
visible light. Also included in the invention is a hand held
consumer light, which emits a biologically safe wavelength of light
to assist in the whitening of teeth, such as by activating the
tooth-whitening photoactive substance.
BACKGROUND OF THE INVENTION
[0004] Teeth become discolored with age, blood, amalgam
restorations, antibiotics such as tetracycline, and substances in
food, beverages, tobacco and salivary fluid. Tooth structures which
are responsible for a stained appearance are enamel, dentin, and
the acquired pellicle.
[0005] Tooth enamel is predominately formed from an inorganic
substance, hydroxyapatite crystals, along with approximately 5%
organic materials, predominantly collagen. The dentin is composed
of about 20% protein including collagen; the balance of inorganic
materials including hydroxyapatite crystals. The acquired pellicle
is a proteinaceous layer on the surface of tooth enamel, and that
may be removed after an intensive tooth cleaning.
[0006] Tooth stains are generally classified as either extrinsic or
intrinsic, depending on whether the stain is on the surface of the
tooth within the acquired pellicle or within the tooth structure
itself within the enamel or dentin. For example, extrinsic staining
of the acquired pellicle can occur from foods or compounds, which
contain tannins and other polyphenolic compounds which become
trapped in the lightly bound proteinaceous layer on the surfaces of
the teeth.
[0007] Intrinsic staining, on the other hand, occurs when
chromogens and pre-chromogens penetrate the enamel and dentin and
become tightly bound to the tooth structure. Intrinsic staining can
occur when blood or amalgam products leach into the enamel and
dentin. Intrinsic staining likewise can occur systemically from
excess fluoride intake during enamel development leading to a
mottled yellow or brown stain of fluoresce staining. Intrinsic
staining is not removable by mechanical methods of tooth cleaning
and generally requires the use of chemicals, for example strong
oxidizing agents such as hydrogen peroxide which can penetrate into
the tooth structure to effect a change in the light absorbtivity of
the stain chromogen and/or the solubility of the chromogens.
[0008] The desire for whiter, lighter teeth is considered to be
cosmetic and desirable in today's cosmetically-orientated society.
Tooth bleaching is generally accomplished by gels, pastes, or
liquids which contain an oxidizing agent such as hydrogen peroxide
that attack (i.e., chemically react with) the chromogen molecules,
making them colorless and/or water soluble, making the tooth appear
lighter and brighter, thus resulting in lighter brighter teeth.
[0009] The most commonly used oxidizing agent is hydrogen peroxide
(H.sub.2O.sub.2), such as from carbamide peroxide, which is mixed
with an anhydrous viscous carrier containing glycerin and/or
propylene glycol and/or polyethylene glycol. When in contact with
water, carbamide peroxide dissociates into urea and hydrogen
peroxide. The hydrogen peroxide in the presence of water then
disassociates into water and a nascent oxygen anion species. It is
these highly-nascent oxygen species, which react with the stain
making them more water soluble, transparent, or both.
[0010] There are several known delivery systems to deliver
carbamide peroxide to the surfaces of the teeth.
[0011] A common approach is to have a dental professional construct
a custom-made tray from an impression of the patient's teeth. The
oxidizing gel is dispensed into the tray by the patient and the
tray is worn over the teeth intermittently for a period of two
weeks to several months, depending on the severity of the staining.
This approach can cause tooth sensitivity in over 50% of the
patients, and it can be uncomfortable for the patients to wear the
tooth bleaching trays. Tooth sensitivity is believed to result from
the movement of fluid through the dentinal tubules, which is sensed
by nerve endings within the tooth. The carriers, glycerin propylene
glycol and polyethylene glycol, draw fluids toward them and
therefore contribute to the tooth sensitivity often experienced by
wearing a bleaching tray.
[0012] Another approach is to incorporate the oxidizing agent in a
strip and have the patient wear the strip intermittently over a
period of two weeks. This approach also has the disadvantage of
being awkward for patients to wear, and many patients wearing the
strips, also experience tooth sensitivity. Further, the strips have
an inherent problem of contacting the teeth only on the facial
surfaces and most of the staining occurs in between the teeth in
the interproximal areas where in can be difficult to place the
strip, having it in contact with the tooth.
[0013] Another recent approach is to simply paint on the oxidizing
agent, carbamide peroxide or hydrogen peroxide, directly on the
teeth. In products, which are gels containing glycerin and/or
propylene glycol or polyethylene glycol, tooth sensitivity can be
experienced, and the gels can easily be removed by the lips and
tongue, thereby decreasing their effectiveness.
[0014] One approach involves dissolving carbamide peroxide in
alcohol, and a resin. The resultant compound is applied directly
onto the teeth, and the alcohol evaporates, leaving a sticky resin
film or precipitate remaining on the surface, of the teeth. When
saliva contacts the teeth, the peroxide is released in a relatively
strong concentration for a period of up to 20 minutes. This product
contains no glycerin, propylene glycol, or polyethylene glycol and
tooth sensitivity is lessened with some resultant whitening. These
products take approximately two weeks of use several times a day to
achieve a desired result.
[0015] To address the problem of taking excessive time to whiten
teeth, manufacturers developed systems used by a dentist and only
available in a dental office (with and without a light source), to
whiten teeth in approximately one hour. These systems generally use
oxidizing compositions (hydrogen peroxide up to 35%), which are
applied directly on the surfaces of the teeth in a dental office
under the supervision of a dentist or dental hygienist. Owing to
the high concentration of oxidizing agents contained in these
in-office products, they can be hazardous to the patient if not
handled carefully. The patient's soft tissues--gingiva, lips and
tissues--must be isolated from potential exposure to a
concentration of oxidizing agent by the use of a rubber dam or by
covering the soft tissues with a polymerizable resin that is shaped
to conform to the gingival contours and subsequently cured by a
high intensity light source operable only by a dentist. These
dentist in-office whitening systems are expensive to the
patient.
[0016] Known patents directed to these various tooth whitening
systems include:
[0017] U.S. Pat No. 4,952,143 to Becker et al.; and
[0018] U.S. Pat. No. 5,032,178 to Cornell.
[0019] These known systems have drawbacks.
[0020] A commercial product, called Opalescence, from Attica Dental
Products, Inc., South Jordan, Utah is known.
[0021] Further known systems are set forth in:
[0022] U.S. Pat. No. 5,785,527 to Jensen et al.; and
[0023] U.S. Pat. No. 6,517,350 to Diasti et al.
[0024] One commercially available illuminating system is from Union
Broach, a Health/Claim Company, New York, N.Y.
[0025] Other known United States patent documents include:
[0026] U.S. Pat. No. 4,450,139 Bussiere et al.;
[0027] U.S. Pat. No. 5,457,611 Verderber;
[0028] U.S. Pat. No. 6,331,111 Cao;
[0029] U.S. Pat. No. 6,343,933 Montgomery;
[0030] U.S. Pat. No. 6,416,319 Cipolla;
[0031] U.S. Pub. No. 2003/0017435 Ibsen et al.;
[0032] U.S. Pub. No. 2003/0036037 Zavitsanos et al.; and
[0033] U.S. Pat. No. 4,661,070 to Friedman.
[0034] There is a need for improved compositions and devices for
whitening teeth that are capable of whitening the teeth rapidly and
inexpensively by consumers without damaging the tooth enamel,
dentin, or the pulp, and that are able to be used at a lower
concentration of peroxide, thus enabling the patient to use the
product at home without harming the tissues, or causing tissue
irritation, or causing tooth sensitivity.
OBJECTS AND SUMMARY OF THE INVENTION
[0035] It is an object of the invention to provide a tooth
whitening method, system, and device that overcome the drawbacks of
prior art methods, systems, and devices.
[0036] It is a further object of the invention to provide a tooth
whitening system, which provides a more even whitening of the teeth
than known systems.
[0037] It is yet another object of the invention to provide a tooth
whitening system, which is self-regulating and avoids overheating
of the user's teeth being whitened, for example.
[0038] Another object of the invention is to provide a tooth
whitening system, which may be performed without the use of a
dental dam or without protecting the oral tissues by covering them
with a polymerizable resin.
[0039] It is an object of this invention to provide a tooth
whitening system, the action of which is accelerated by
light-and-heat energy, which the consumer can use at home, thereby
being more cost-effective than in-office teeth whitening
regimes.
[0040] It is a further object of this invention to provide a tooth
whitening system, which shortens the treatment time to obtain a
given level of whitening using at-home paint-on whitening products
or bleaching tray regimes.
[0041] Another object of this invention is to use a solution or gel
which temporarily adheres to the teeth, and which can be directly
applied to the teeth by consumers at their home or elsewhere.
[0042] It is yet another object of this invention to use a solution
or gel with a concentration of peroxide which will reduce or
eliminate irritation of the patient's tissues making it better and
more comfortable for the patient.
[0043] A further object of the invention is to provide a
preconditioning mouth rinse formulated to prepare teeth for a tooth
whitening agent.
[0044] It is yet another object of this invention to use a
hand-held light source which uses batteries or a rechargeable power
source, and that can provide an even illumination of visible- and
light-heat in the range of 1.degree. to 5.degree. C. against the
surfaces of the front anterior teeth.
[0045] It is a further object of this invention that the light/heat
source of light be controlled so as not to exceed a 5.degree. C.
increase in temperature no matter how long the consumer applies the
light/heat source to the surfaces of the anterior teeth.
[0046] It is a further object of this invention to use a liquid
solution or gel which is relatively transparent and allows the
transmission of heat into the enamel or dentin to achieve a
temperature increase of about 1.degree. to 5.degree. C. for
approximately 1-2 minutes to effect a biologically-compatible and
effective level of tooth whitening.
[0047] Another object is to provide a tooth whitening device
including a hand-held light source used by the consumer that
produces a slight increase in temperature of from
1.degree.-5.degree. C. either on the surface of the tooth directly
or within the tooth structure at a depth of 1-2 mm from the surface
with the use of photosensitive compounds for producing the slight
increase in temperature.
[0048] A further object is to provide a tooth whitening device with
an attachment which is curved to simulate the natural curvature of
the arch of the teeth, and which is provided in several sizes;
e.g., small, medium, and large.
[0049] A further object is to provide a tooth whitening device with
a timer which automatically turns the light source off at the
desired time along with a device for indicating the light source is
on.
BRIEF DESCRIPTION OF DRAWINGS
[0050] FIG. 1 shows a left side view of an embodiment of a
hand-held consumer light for use with a tooth whitening system
according to the invention;
[0051] FIG. 2 shows a front view of the hand-held consumer light of
FIG. 1 for use with the tooth whitening system according to the
invention;
[0052] FIG. 3 shows a bottom view of the hand-held consumer light
of FIG. 1 for use with the tooth whitening system according to the
invention;
[0053] FIG. 4 shows a top view of the hand-held consumer light of
FIG. 1 for use with the tooth whitening system according to the
invention;
[0054] FIG. 5 shows a right, partially broken away side view of the
hand-held consumer light of FIG. 1 in use; and
[0055] FIG. 6 shows a perspective view of the hand-held consumer
light for use with the tooth whitening system according to the
invention in an optional recharger base.
DETAILED DESCRIPTION OF THE INVENTION
[0056] These embodiments are set forth to describe and illustrate
the invention, but are not intended to be limiting. The invention
may achieve rapid tooth whitening by using a preconditioning rinse
and hand held consumer light for emitting optical energy and a safe
amount of heat to penetrate an oxidizing compound placed directly
on the tooth surface to be whitened.
[0057] There are known compositions that include light (or heat),
which can be added to an oxidizing compound (e.g. gel or solution)
and dispersed directly in and homogenously throughout the oxidizing
compound. Some references and text are noted: for example
Kirk-Othmer Encyclopedia of Chemical Technology, 4th edition,
volumes 4 (1992), 13 (1995), 18 (1996), John Wiley & Sons,
N.Y.; Goldstein and Garber, Complete Dental Bleaching, Quintessence
Publishing Co. 1995; and the Journal of the American Dental
Association, Vol. 128, Special Supplement, April 1997.
[0058] For tooth whitening the greatest oxidizing activity is
required in the first few millimeters of enamel and in the dentin
at the tooth surface.
[0059] The present invention is more effective at removing teeth
stains at lower levels of active oxidizing agents and lower levels
of heat than known devices, thereby resulting in a better whitening
system which can be used safely by a consumer and which can result
in more rapid tooth whitening. To better understand the tooth
whitening process in the present invention some background
information is desirable.
[0060] The oxidizing agent, in the present invention, may be
carbamide peroxide (urea hydrogen peroxide). This agent is broken
down in the presence of water to urea and hydrogen peroxide
(H.sub.2O.sub.2). The hydrogen peroxide is unstable and in the
presence of light or moisture it decomposes into water H.sub.2O and
an Oxygen free radical (i.e., O.sup.- or nascent oxygen species or
oxygen free radicals). It is these oxygen free radicals, which
attack the stain molecules and make them water-soluble,
transparent, or both, resulting in the lighter brighter teeth.
[0061] The oxygen free radicals which are formed are highly
reactive and will react with each other to produce O.sub.2 (Oxygen)
rapidly. It is the ability and quantity of the free radical oxygen
anions to reach the stain molecules and react with them, which
determines the efficacy of the whitening process. The speed of the
whitening process can be significantly enhanced with the addition
of a slight amount of heat in that solution (dissolving) occurs
more rapidly in a warmer environment than a cooler one, for
example.
Detailed Description of the Mouth Rinse
[0062] The invention achieves rapid tooth whitening by using a
preconditioning mouth rinse, which prepares the tooth surface to
receive the whitening compound alone with a photosensitive compound
in the whitening compound followed by using optical energy which
penetrates through the existing formulation, which is placed on the
tooth surface to be whitened.
[0063] To enhance tooth whitening at the surface of and within the
first few millimeters of enamel below the surface, the present
invention includes a preconditioner, such as a preconditioning
mouth rinse, which prepares the teeth to receive the whitening
compound. The mouth rinse is formulated to kill bacteria which
produce peroxidase enzymes, create an environment on the tooth
surface which has a slightly basic pH, and contains a surfactant
thereby improving wetting of the tooth surface by the whitening
compound and allowing deeper penetration. The surfactant will also
help the oxygen free radicals react with the tooth stain (chromogen
molecules) and within the tooth surface; the mouth rinse may also
contain substances which destroy and prevent oral malodors and
flavoring compounds.
[0064] The mouth contains peroxide enzymes including salivary
peroxidase, catalases and bacteria, which produce peroxidases,
which are enzymes which destroy peroxide. It would be desirable to
have in the preconditioning or activator mouth rinse a disinfectant
which would kill the bacteria which produce peroxidases thereby
increasing the quantity of hydrogen peroxide, which produces the
oxygen free radicals.
[0065] Common disinfectants in known mouthwash preparations may be
used.
[0066] If the pH in the environment of the oxidizing compound,
hydrogen peroxide, for example, is increased, the oxidizing
compound will degrade and generate free radicals more readily.
Furthermore, most peroxidase enzymes (including salivary peroxides
and catalases) have low activities above a pH of 8.
[0067] It is therefore desirable to have an alkaline pH in the
activator rinse to pre-treat the environment agent to have a pH of
about 8. Sodium bicarbonate, which is safe and commonly used in
dental toothpastes and rinses, has a pH of 8.2. The ideal pH to
break down hydrogen peroxide is between a pH range of 7.9-9.0, a
higher pH can become caustic to the oral tissues.
[0068] pH Adjusting Chemicals
[0069] Sodium carbonate, potassium carbonate, sodium hydroxide,
ammonium hydroxide, potassium hydroxide, sodium phosphate di- and
tri-basic, potassium phosphate di- and tri-basic, sodium
tripolyphosphate, tris(hydroxymethyl)aminomethane,
polyethylenaimine, triethanolamine, and other alkaline agents.
Acidic pH adjusting agents, such as citric acid, phosphoric acid,
and others may also be used alone or in conjunction with an
alkaline pH adjusting agent to obtain the desired pH and to provide
buffering capacity.
[0070] The performance enhancing adjuvant may include at least one
of a buffer, a surfactant, a thickener, a film forming ingredient,
a penetration enhancer, and desensitizing agent.
[0071] Surfactants (Surface Active Agents)
[0072] Surfactants may be used to lower the surface tension of the
compositions. Lowering of the surface tension allows for better
wetting and spreading of the composition on the tooth surface. Some
surfactants, such as zwitterionic and fluorinated surfactants, have
been seen to increase the penetration of the present inventive
compositions into the tooth structure.
[0073] Useful surfactants may include those identified in U.S. Pat.
No. 5,279,816 to Church et al. and U.S. Pat. No. 5,302,375 to
Viscio, each of which is incorporated herein by reference in its
entirety.
[0074] Zwitterionic surfactants have positive and negative charges
that significantly improve penetration of peroxide into the tooth.
It is to be understood that additional useful surfactants will
become apparent to those skilled in the art based upon the
disclosure herein. The level of surfactant, when present, may be
from about 0.001% to about 10.0% by weight of the accelerator
composition, and may be from about 0.1% to about 1% by weight of
the accelerator composition.
[0075] Thickeners
[0076] A thickener may also be added to the accelerator composition
as a performance enhancing adjuvant to increase the contact time of
the accelerator on the tooth surface.
[0077] In one embodiment, the thickener provides coating properties
for the accelerator by forming a film when applied to the
teeth.
[0078] Thickeners such as neutralized carboxypolymethylene and
other polyacrylic acid polymers and copolymers,
hydroxypropylcellulose and other cellulose ethers, salts of
poly(methyl vinyl ether-co-maleic anhydride), polyvinyl pyrrolidone
(PVP), poly(vinylpyrrolidone-co-vinyl acetate), silicon dioxide,
fumed silica, stearic acid esters, and others are found to have
utility in the formulation of the oxidizing compositions and tooth
whitening accelerator compositions.
[0079] Polymers utilized as thickeners may also serve as
film-forming agents that provide for even distribution of the
accelerator composition over the tooth surface. It is to be
understood that additional useful thickeners will become apparent
to those skilled in the art based upon the disclosure herein.
[0080] The level of thickener, when present, is highly dependent
upon the type chosen, but in general may be included in the
composition at a concentration of from about 0.1% to about 20.0% by
weight of the composition, and may be at a concentration of from
about 0.1% to about 5% by weight of the accelerator
composition.
[0081] Flavorants
[0082] Flavorants may also be included in the accelerator
composition in order to improve palatability and acceptance by the
user or the patient. Flavorants are generally known in the art and
include, among others, spearmint, peppermint, anethole, menthol,
stevia, citrus flavors, and vanilla.
[0083] It may be desirable to provide within the composition an
artificial sweetener selected from the group including sodium
saccharin and potassium acesulfame. Sugars and sugar alcohols, such
as sucrose, fructose, glucose, xylitol, maltitol, mannitol,
sorbitol, and other mono-, di-, tri-, and higher monosaccharides
may be used as sweeteners. For example, glycine may also serve as a
sweetener and has the ability to mellow saltiness and bitterness of
the pH adjusting agent.
[0084] Both flavorants and sweeteners, when present, may each be
included at a level of from about 0.01% to about 5.0% by weight of
the composition.
[0085] Other artificial sweeteners are contemplated to have utility
in the practice of the present invention, limited only by their
solubility and stability in the compositions.
EXAMPLE OF FORMULA FOR MOUTH RINSE
[0086] TABLE-US-00001 Supplier and miscellaneous Ingredient
Concentration information NP-9, ethoxylated 0.65 mls Brenntag,
Univar nonyphenol, 9 molar EO. Peppermint Oil 1.4 mls Lebermuth
Nutrasweet .RTM. 0.75 grams The Nutrasweet Company Granular 100
Glycerin 99.5% 30 mls Brenntag, Univar Kosher food grade Sodium
Bicarbonate 2 grams Brenntag, Univar food grade Sodium Carbonate
0.1 grams Brenntag, Univar food grade Benzethonium 0.15 grams Lonza
Inc Chloride Purified Water Balance to 1 Distilled or deionized
gallon (i.e., 3.785 liter) or reverse osmosis grade Ethanol 75% or
.about.10 mls Food Grade greater
Detailed Description of the Directly Applied Tooth Whitening
Formula
[0087] Along with a safe concentration of an oxidizing agent of
approximately 8-12% carbamide peroxide by weight the oxidizing
solution or gel can be incorporated with light-activated
photosensitizing agents, which can include any compounds capable of
absorbing light energy at biologically acceptable wavelengths for
use in the oral cavity.
[0088] Examples of compounds which may convert light energy to heat
or chemical energy include readily available compounds, such as
semiconductor particles, e.g., titanium oxide and/or zinc oxide. If
photosensitizers are used, such may be allowed to penetrate into
the enamel or dentin prior to the application of the light,
depending on the intended use and the chemical composition of the
whitener used. Therefore the particle size should enable
penetration of the photoactive substance.
EXAMPLE OF TOOTH WHITENING FORMULA
[0089] TABLE-US-00002 % by COMPOUND Weight RANGE % Ethyl Alcohol
73.75 Hydrogenated Ester of 13.87 0.001-35.00 Rosin Urea
(Carbamide) 11.10 0.001-25.00 Hydrogen Peroxide
Hydroxypropylcellulose 0.55 0.001-10.00 1500 cps Flavoring- Menthol
0.22 0.001-15.00 Flavoring- Peppermint 0.20 0.001-15.00 Oil Zinc
Oxide (micro 0.15 0.001-5.00 particles) Flavoring- Aspartame 0.15
0.001-5.00
[0090] A supplier of the zinc oxide (micro particles) is B.F.
Goodrich.
EXAMPLE OF ALTERNATIVE FORMULA
[0091] TABLE-US-00003 COMPOUND %/w RANGE Anhydrous Propylene Glycol
54.3% 0.001-75.00 Fumed Silica 20% 0.001-40.00 Sodium Perborate
Monohydrate 25% 0.001-40.00 Sodium Saccharine 0.7% 0.001-5.00
[0092] Viscous whitening agent which may be painted on the teeth
may be as follows.
[0093] The viscosity of one or more of whitening agents may be
varied depending on the intended use, as described in detail
below.
[0094] The whitening agent may be a "paint-on" whitening agent
which can be applied to the teeth, adheres to the teeth, and
requires no protective tape, film, or cover when on the teeth to
avoid being wiped off by the user's gums or saliva. Please see
Applicant's co-pending application no. PCT/US03/17631, filed 5 Jun.
2003, and which is incorporated herein by reference.
[0095] It is contemplated that in any of the embodiments of any
suitable viscous, solid or semi-solid whitening agent may be used
that can whiten without irritating the mouth tissues.
[0096] In an embodiment of the invention, the whitening agent may
have the following range of compositions.
Whitening Agent Composition A2
(To Yield 100 ml of Composition)
[0097] TABLE-US-00004 Ethanol (ethyl alcohol) balance ml Urea
Peroxide .001-40 g Resin .001-30 g Hydroxyl propyl cellulose
.001-20 g total 100 ml
[0098] A further embodiment of the whitening agent follows.
Whitening Agent Composition A4
(Total Yield 100 ml of Composition)
[0099] TABLE-US-00005 Ethanol (ethyl alcohol) balance ml Urea
Peroxide 8 g Resin 10 g Hydroxyl propyl cellulose .5 g total 100
ml
[0100] Whitening agent of composition A3 may be made with 100% pure
undenatured ethyl alcohol and 98% pure urea peroxide.
[0101] Rosin may be substituted for resin in all formulas.
[0102] Urea hydrogen peroxide may be substituted for urea peroxide
in all formulas.
[0103] Whitening agents may be formulated as follows:
Whitening Agent Composition A5
(Total Yield 100 ml of Composition)
[0104] TABLE-US-00006 Rosin .001-30 g Urea hydrogen peroxide
.001-40 g Hydroxypropyl cellulose 1500 cps .001-20 g Ethyl alcohol
(95%) balance ml Total Volume 100 ml
[0105] The following is an example of a tooth whitening compound
that has been formulated in accordance with the invention.
[0106] The following is the formulation of a procedure for making
100 ml of a Solution No. 16.
[0107] In the following formula, the resin, the urea hydrogen
peroxide USP, and the hydroxypropyl cellulose 1500 cps are all
expressed as a weight per volume (w/v; i.e., g/100 ml) and the
ethanol 95 was added in a quantity as needed (q.s.) to yield the
desired 100 ml of whitening agent.
Whitening Agent Composition of Solution No. 16
(Total Yield 100 ml of Composition)
[0108] TABLE-US-00007 Rosin 12.5 g Urea hydrogen peroxide 8.0 g
Hydroxypropyl cellulose 1500 cps 0.5 g Ethyl alcohol (95%) balance
ml Total Volume 100 ml
[0109] Solution No. 16 was formulated as follows to yield 100 ml of
product: [0110] 1. Dissolve 12.5 g of resin in 75 ml of the ethanol
in a beaker having a spin bar therein; [0111] 2. The spin bar was
spun using the spinning device (stirrer) of an unheated hot plate
of the type having a magnetic stirrer disposed therein, the
spinning was continued until the unheated rosin and ethanol
solution was clear; [0112] 3. 8 g of the urea hydrogen peroxide
were weighed out and ground into a fine powder using a mortar and
pestle, added to the rosin and ethanol solution, and then stirred
on the spinning device. A cloudy solution resulted. [0113] 4. As
the rosin and ethanol solution was spinning, the 0.5 g of
hydroxypropyl cellulose was added gradually (sprinkled into the
vortex of the spinning solution resulting from the magnetic stir
bar) in small amounts at a time. The spinning was continued for
about an hour until the solution began to gel. Enough ethyl alcohol
(95%) was added q.s. to bring the volume up to 100 ml, and the
spinning was continued. [0114] 5. The mixed solution was put in a
refrigerator (at about 40.degree. F.) and left overnight (i.e.,
about 19-20 hours) to allow the solution to completely hydrolyze.
[0115] 6. The refrigerated solution was removed from the
refrigerator and again spun at room temperature at about 70.degree.
F.) for about 30 minutes to throughly mix the solution. [0116] The
prepared solution was then put into the desired containers.
[0117] It should be noted that in Step 4 of spinning the solution
having the rosin, the urea hydrogen peroxide 1500 cps, and the
hydroxypropyl cellulose, the added materials may not throughly
dissolve. It appears that the step of allowing the solution to sit
overnight in the refrigerator for a period of time, and then
remixing the solution succeeds in yielding a homogeneous solution
with the added materials dissolved and dispersed throughout.
[0118] The following is the formulation of a Solution No. 18 that
has been made.
Whitening Agent Composition Of Solution No. 18
(Total Yield 60 ml (i.e., 51.43 g) of Composition)
[0119] TABLE-US-00008 Rosin 7.5 g Urea hydrogen peroxide 3.6 g
Hydroxypropyl cellulose 1500 cps 0.3 g Ethyl alcohol (95%) 40.0 g
Spearmint Extract (1 drop) 0.03 g Total Weight 51.43 g
[0120] Thus, Solution No. 18 can be expressed on a weight per
weight (w/w) basis of about 14.6% rosin; 7.0% urea hydrogen
peroxide; 0.6% hydroxypropyl cellulose 1500 cps; 77.8% ethyl
alcohol; and 0.06% spearmint extract; the total is not exactly 100%
owing to the rounding of the percentages to one(1) significant
digit.
[0121] Solution No. 18 was prepared in a manner analogous to that
as described above in connection with the preparation of Solution
No. 16.
Detailed Description of the Hand Held Consumer Light
[0122] The present invention provides a light source for tooth
whitening which uses a battery or a rechargeable power supply and,
which may be held by the consumer (i.e., the patient) outside the
patient's mouth in a manner to provide a uniform illumination of
the patient's anterior teeth to produce a uniform increase in
temperature of the anterior surfaces of the anterior teeth from
about 1.degree. C. to a maximum of 5.degree. C. over a period of
application of a maximum of 10 minutes. Also the light emits a
biologically safe wavelength of visible light between 350-700
nanometers, which can penetrate the tooth and react with the
photoactivator substance speeding the release of the oxidizing
compound.
[0123] As described in the literature, an unexpected benefit of
utilizing a transparent solution or gel containing the oxidizing
compound is that certain visible wavelengths of light seem to be
absorbed by tooth chromogens (stains) in a manner that promotes
their oxidation to a non-chromogenic state. Reflectance studies
demonstrate that enamel and dentin transmit green light, reflect
yellow and red light, and absorb blue light. Light can be absorbed
by the molecules responsible for tooth discoloration, thus the
chromogens may, in effect, act as photosensitizers. In theory,
light of a visible wavelength may utilize a tooth chromogen
molecule as a photosensitizer in order to improve the efficiency of
the oxidizing agent to remove the chromogen (stain). Yet, prior to
the present invention no one had previously reduced light intensity
levels--to levels which could be used by a consumer with effective
tooth whitening results.
[0124] The device illustrated in FIGS. 1-6 is a consumer hand-held
light source according to the invention that is capable of
generating a desired amount of heat of approximately
1.degree.-5.degree. C. within 2 mm of the tooth surface. This may
be considered a desired temperature increase. The desired
temperature increase may be administered up to about 10 minutes. An
example of a known light source that meets these requirements is a
Xenon light. Other light sources may be Quartz or Halogen light
sources or other sources not limited to the ones described, as will
be readily apparent to a person having ordinary skill in the
art.
[0125] The power source shown in the FIGS. 1-6 is battery power for
convenience; however, direct current may also be considered
enabling the device to be free-standing. FIG. 6 shows the power
source may include a rechargeable battery.
[0126] Attachment(s) which may be used with above-described
inventive hand-held consumer light containing the illuminating
bulb(s) will be shaped to follow the natural curvature of the upper
arch enabling an even disbursement of light and heat to all the
anterior teeth to provide even whitening results. Attachments may
be provided in various sizes to facilitate different size
arches--large, medium and small.
[0127] Another attribute of the attachment is that it may be
enclosed, completely or partially, by an encompassing soft material
which will act as a cheek and lip retractor keeping the light
source a given required distance from the tooth surface to produce
the temperature range required and to isolate the teeth while the
light is activated. The light sources capable of causing a desired
increase in temperature are considered to be included in this
invention. The desired temperature increase may be as described
above. Infrared light more readily penetrates the tooth structure
and may cause an excessive temperature rise in the pulp. Suitable
bulbs which can produce heat are linear flash lamps, tungsten,
halogen, metal halides, xenon short arc and, mercury short arc, as
well as others which achieve the desired results.
[0128] FIGS. 1-6 illustrate an embodiment of a hand-held light
source 10 for use with a tooth whitening system according to the
invention.
[0129] Light source 10 may include a handle 20 and an upper part or
head 30. A blue lens 32 may be provided. Blue lens 32 filters out
certain wavelengths of light, which wavelengths may be undesirable
wavelengths of light, depending on the methodology consistent with
the invention. Lens 32 allows the desired wavelengths of light to
pass through. Lens 32 may be provided on head 30 and be configured
in the desired shape to assist in causing light rays to be directed
at and strike the whitening compound applied to a user's teeth 33
in the desired amount and intensity for causing the predetermined
chemical reaction effecting the whitening of the teeth, along the
lines described above.
[0130] In order to provide the desired light and/or heat source,
one or more light sources or elements or bulbs may be provided,
such as the illustrated light bulbs 44 and 46.
[0131] Light rays 48 of the desired wavelength and intensity are
schematically shown in FIG. 5.
[0132] A power source 50, such as a battery, alternating or direct
current, as desired, may likewise be provided. Also, rechargeable
batteries may be utilized.
[0133] It will be appreciated that the configuration and the
location of light sources 44 and 46, as shown in the illustrated
array, will effect the desired consistent, uniform chemical
reaction of the tooth whitening agent provided on the user's teeth,
in use.
[0134] Light source 10 may further be provided with an on-off
switch 54 for controlling the administering of light from the light
source. A timer may be provided for controlling the length of time
the light source may be used within a given period of time,
regardless of the number of times the user actuates switch 54.
Alternatively, light bulbs 44 and 46 may be activated (i.e. ON)
only when switch 54 is actuated.
[0135] One or more attachments 56 may be provided to accommodate
different sizes, widths, and arch sizes of the user's mouth.
Attachment 56 may be provided with one or more extensions 58 and
60, as well as with a predetermined curvature 62, dependent on the
size requirements of the user's mouth, as outlined above. In
addition, a height 64 and a width 66, as well as other
configuration considerations will be taken into account, dependent
on the user's mouth contour, and the type of light source 44 and 46
provided, for example.
[0136] In use, thanks to the configuration of attachment 56 and its
associated configured extensions, size, and shapes, attachment 56
will contact the lips and mouth tissue in a region 70, as shown in
FIG. 5. This contact region 70 establishes a predetermined distance
72 between attachment 56 and teeth 33. Thus, a desired offset or
spacing 74 between lens 32 and light sources 44 and 46 and teeth 33
is established. In that manner, the intensity of light rays 48 is
governed and predetermined so that the predetermined degree of
temperature increase within the outer 2 mm of the tooth surface is
established, as described above.
[0137] Still further, thanks to the establishment of a
predetermined angle 76 between head 30 and body 20 of light source
10, the user is able to comfortably and accurately direct light
rays 48 at teeth 33 in the desired manner. Thus, the goal of home
use by a person whose teeth 33 are to be whitened is achieved.
[0138] FIG. 6 illustrates a recharger 80 which may be provided for
recharging rechargeable battery 50.
[0139] Recharger 80 may be provided with an electrical cord and a
plug 84, as will be readily understood by a person having ordinary
skill in the art. In the case where the recharger is powered by
alternating current, such as typical AC household electrical
outlets, an AC to DC convert/transformer or a microchip to convert
AC effectively into DC may be provided in the recharger base 86, as
will be readily understood. Base 86 may be configured for being
freestanding and sized and weighted so that light source 10 may be
placed on a countertop for recharging, as shown.
[0140] In use, it will have been appreciated that the user may bare
his or her teeth 33, such as by smiling, and face lens 32 at the
same level and orientation as lens 32 of FIG. 5, with light source
10 disposed substantially adjacent the teeth, as shown, and as
described above.
[0141] There may be a fiber optic strand or cable or device to
guide and direct light from the light source to a desired
location.
[0142] The location may be selected so as to illuminate and whiten
one or more of the user's teeth.
[0143] While this invention has been described as having a
preferred design, it is understood that it is capable of further
modifications, and uses and/or adaptations of the invention and
following in general the principle of the invention and including
such departures from the present disclosure as come within the
known or customary practice in the art to which the invention
pertains, and as may be applied to the central features
hereinbefore set forth, and fall within the scope of the invention
or limits of the claims appended hereto.
* * * * *