WO1991007162A1 - A composition for treatment of teeth and method of use - Google Patents

A composition for treatment of teeth and method of use Download PDF

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Publication number
WO1991007162A1
WO1991007162A1 PCT/US1990/005080 US9005080W WO9107162A1 WO 1991007162 A1 WO1991007162 A1 WO 1991007162A1 US 9005080 W US9005080 W US 9005080W WO 9107162 A1 WO9107162 A1 WO 9107162A1
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Prior art keywords
mucoprotectant
weight
composition
hydrogen peroxide
matter
Prior art date
Application number
PCT/US1990/005080
Other languages
French (fr)
Inventor
David K. Yarborough
Original Assignee
Yarborough David K
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Yarborough David K filed Critical Yarborough David K
Priority to AU65353/90A priority Critical patent/AU6535390A/en
Publication of WO1991007162A1 publication Critical patent/WO1991007162A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C19/00—Dental auxiliary appliances
    • A61C19/06—Implements for therapeutic treatment
    • A61C19/063—Medicament applicators for teeth or gums, e.g. treatment with fluorides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C19/00—Dental auxiliary appliances
    • A61C19/06—Implements for therapeutic treatment
    • A61C19/063—Medicament applicators for teeth or gums, e.g. treatment with fluorides
    • A61C19/066—Bleaching devices; Whitening agent applicators for teeth, e.g. trays or strips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/40—Peroxides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/04—Dispersions; Emulsions
    • A61K8/042—Gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/20—Halogens; Compounds thereof
    • A61K8/21—Fluorides; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/22—Peroxides; Oxygen; Ozone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/36—Carboxylic acids; Salts or anhydrides thereof
    • A61K8/361—Carboxylic acids having more than seven carbon atoms in an unbroken chain; Salts or anhydrides thereof

Definitions

  • the present invention relates generally to oral hygiene and more specifically to the area of cosmetic oral hygiene.
  • the present invention relates to bleaching the teeth and to protecting the gingival tissues while doing so.
  • the present invention may be described as a mucoprotectant gel used with hydrogen peroxide to bleach the teeth and protect the mucous membranes.
  • the cosmetic whitening of the teeth has been a prevalent concern of the modern consumer.
  • abrasives and bleaches have been used to effectuate the desired whitening.
  • One of the agents used by dentists for in-office cosmetic bleaching has been hydrogen peroxide.
  • Disclosure of Invention It is an object of the present invention to provide an effective means to protect the gums from the caustic action of relatively concentrated hydrogen peroxide without deterring the effectiveness of the hydrogen peroxide bleaching agent for the teeth.
  • Yet another object of the invention is to provide a means for the patient to safely bleach his teeth at home yet under the dentist's supervision. Still another object of the invention is to provide a means for bleaching of vital and non-vital teeth as well as bonded surfaces using a mouthpiece.
  • a further object of the invention is to provide a fluoride treatment to the teeth which may also be bleached.
  • my invention is advantageously accomplished using a vacuformed mouthpiece and a concentrated hydrogen peroxide oxidizer and a gelatinous mucoprotectant which forms a hydrophobic coating on the mucous membranes of the mouth to prevent the hydrogen peroxide from attacking these surfaces, yet which does not form such a protective coating on the teeth.
  • My gelatinous mucoprotectant comprises sodium stearate USP, a gelling agent, glycerine, and water with the amount of water or glycerin included varying in an inverse relationship.
  • the sodium stearate USP combines with the hydrogen peroxide to form stearic and palmitic acids which are readily deposited on the mucous membranes to form a protective barrier.
  • FIG. 1 is a perspective view of a vacuformed mouth guard and a dispenser container for my combined composition
  • FIG. 2 is a sectional view of the mouth guard in situ about the teeth with my composition in contact therewith;
  • FIG. 3 is a pictorial representation of my composition in its storage containers.
  • hydrogen peroxide is an effective whitener of teeth and bonded dental material, yet it is caustic to the adjacent tissues. Therefore, to enable the long-term use of hydrogen peroxide in a loosely supervised, at home, treatment regime requires the use of a mucoprotectant, i.e. a protective coating on the mucous membranes, which will prevent damage to the gum tissues.
  • a mucoprotectant i.e. a protective coating on the mucous membranes, which will prevent damage to the gum tissues.
  • the ingredient which appears to function as the mucoprotectant is sodium stearate USP.
  • Sodium stearate USP is actually a mixture of sodium stearate (oxtadeconoic acid, sodium salt) and sodium palmitate (hexodecanoic acid, sodium salt) wherein the sodium stearate content is at least 40% by weight.
  • Both sodium stearate and sodium palmitate are water soluble and aqueous solutions of these salts are alkaline. Alcoholic solutions are neutral due to hydrolysis. Stearic acid and palmitic acid, in contrast, are not water soluble.
  • a gelatinous carrier including water, glycerine, and a gelling agent.
  • a gelatinous mucoprotectant is formed which contains by weight: about 39% glycerine; about 55% water; about 1% sodium stearate USP; and about 5% gelling agent or binder.
  • I may use a small amount of fluoride such as sodium fluoride USP.
  • the binder material is a cellulose type binder and although many may be suitable, the binders which have been experimentally verified are listed in tables 1 and 2.
  • the gelatinous mucoprotectant made in accordance with the above formula can be a stand-alone treatment for the teeth if the fluoride is included, however the fluoride does not enhance whitening the teeth.
  • the whitening agent is an aqueous solution of hydrogen peroxide having an hydrogen peroxide concentration of between about 10% to 35% by weight.
  • the aqueous hydrogen peroxide solution and the gelatinous mucoprotectant can be stored in containers 11 and 12 of FIG. 3 for an indeterminate amount of time. Note, that hydrogen peroxide in this concentration cannot be introduced directly into the oral cavity without deleterious results.
  • the aqueous hydrogen peroxide solutions and the gelatinous mucoprotectant are combined in a dispensing container 13, shown in FIG. 1, at a ratio of about 1 part aqueous hydrogen peroxide solution to from about 2 to 5 or more parts gelatinous mucoprotectant. It may be seen that the hydrogen peroxide content will thus vary from about 2% by weight to about 15% by weight of the combination, with e concentration to be used to be selected by the dentist j ⁇ c each patient. Although the exact modality is not clearly understood, when the combination in dispenser 13 is placed in a mouthpiece 14 and inserted in the mouth about the teeth 16 and adjacent gums 17, as shown in FIG.
  • a protective coating having an affinity for the mucous membranes underlying the membranes attaches to these membranes but does not attach to the teeth.
  • This coating has a hydrophobic characteristic in that it does not permit the hydrogen peroxide to reach the gum tissue, thus no caustic effects of the hydrogen peroxide occur on these gingival tissues. It is believed that the addition of the acidic hydrogen peroxide to the gelatinous mucoprotectant form stearic acid and palmitic acid in situ. In this state they are readily deposited on the mucous membranes to block the hydrogen peroxide.
  • the dentist maintains a quantity of gelatinous mucoprotectant and aqueous hydrogen peroxide solution in bulk as in containers 11 and 12.
  • the dentist mixes the mucoprotectant and hydrogen peroxide in the desired ratio in dispensing container 13 and makes a vacuformed mold 14 of the patient's teeth.
  • the resulting slurry 18 has a shelf-life of about three days, thus the patient is instructed to place the slurry in the mouthpiece 14 and position it over the teeth.
  • the mouthpiece 14 with the slurry 18 may normally be retained in the mouth for as little as twenty minutes or as long as several hours without adverse effects.

Abstract

A composition of matter used to bleach the teeth and to protect the gingival tissues while bleaching the teeth. The composition is hydrogen peroxide in a concentration of 10 % to 35 % by weight in a solution and a mucoprotectant gel. The mucoprotectant gel is a composition of sodium stearate, cellulose emulsifier and water in varying proportions depending on the desired final composition. The composition of matter protects the mucous membranes of the mouth and more particularly the gingival tissues while bleaching the teeth with a concentration of hydrogen peroxide which would be caustic to the gingival tissues and mucous membranes if used without mucoprotectant.

Description

A COMPOSITION FOR TREATMENT OF TEETH
AND METHOD OF USE Technical Field The present invention relates generally to oral hygiene and more specifically to the area of cosmetic oral hygiene. In even greater particularity the present invention relates to bleaching the teeth and to protecting the gingival tissues while doing so. Still more particularly the present invention may be described as a mucoprotectant gel used with hydrogen peroxide to bleach the teeth and protect the mucous membranes.
Background Art
The cosmetic whitening of the teeth has been a prevalent concern of the modern consumer. Traditionally abrasives and bleaches have been used to effectuate the desired whitening. One of the agents used by dentists for in-office cosmetic bleaching has been hydrogen peroxide.
While hydrogen peroxide is a very safe chemical in dilute quantities it is very caustic and will cause sev -re tissue damage at higher concentrations. Thus, its use has heretofore been limited to controlled use in the dentist's office. Recently, dentists have attempted to bleach teeth using a vacuformed mouthpiece which fits over the teeth and adjacent tissue with a dilute hydrogen peroxide gel (1-1/2% hydrogen peroxide) . While the technique is laudable, the continued exposure of the mucous membranes of the mouth to hydrogen peroxide often seems to result in oral irritation which necessitates discontinuation of the treatment.
Therefore a need exists for a means for protecting the gum tissues while permitting hydrogen peroxide to contact the teeth.
Disclosure of Invention It is an object of the present invention to provide an effective means to protect the gums from the caustic action of relatively concentrated hydrogen peroxide without deterring the effectiveness of the hydrogen peroxide bleaching agent for the teeth.
Yet another object of the invention is to provide a means for the patient to safely bleach his teeth at home yet under the dentist's supervision. Still another object of the invention is to provide a means for bleaching of vital and non-vital teeth as well as bonded surfaces using a mouthpiece.
A further object of the invention is to provide a fluoride treatment to the teeth which may also be bleached. These and other objects and advantages of my invention are advantageously accomplished using a vacuformed mouthpiece and a concentrated hydrogen peroxide oxidizer and a gelatinous mucoprotectant which forms a hydrophobic coating on the mucous membranes of the mouth to prevent the hydrogen peroxide from attacking these surfaces, yet which does not form such a protective coating on the teeth. My gelatinous mucoprotectant comprises sodium stearate USP, a gelling agent, glycerine, and water with the amount of water or glycerin included varying in an inverse relationship. The sodium stearate USP combines with the hydrogen peroxide to form stearic and palmitic acids which are readily deposited on the mucous membranes to form a protective barrier.
Brief Description of the Drawings The appended drawings are illustrative of the use of my compound and form a portion of this disclosure, wherein:
FIG. 1 is a perspective view of a vacuformed mouth guard and a dispenser container for my combined composition;
FIG. 2 is a sectional view of the mouth guard in situ about the teeth with my composition in contact therewith; and
FIG. 3 is a pictorial representation of my composition in its storage containers.
Best Mode for Carrying Out the Invention
As noted hereinabove hydrogen peroxide is an effective whitener of teeth and bonded dental material, yet it is caustic to the adjacent tissues. Therefore, to enable the long-term use of hydrogen peroxide in a loosely supervised, at home, treatment regime requires the use of a mucoprotectant, i.e. a protective coating on the mucous membranes, which will prevent damage to the gum tissues. In my composition, the ingredient which appears to function as the mucoprotectant is sodium stearate USP.
Sodium stearate USP is actually a mixture of sodium stearate (oxtadeconoic acid, sodium salt) and sodium palmitate (hexodecanoic acid, sodium salt) wherein the sodium stearate content is at least 40% by weight. Both sodium stearate and sodium palmitate are water soluble and aqueous solutions of these salts are alkaline. Alcoholic solutions are neutral due to hydrolysis. Stearic acid and palmitic acid, in contrast, are not water soluble.
In my composition I use sodium stearate USP in a gelatinous carrier including water, glycerine, and a gelling agent. Thus a gelatinous mucoprotectant is formed which contains by weight: about 39% glycerine; about 55% water; about 1% sodium stearate USP; and about 5% gelling agent or binder. Additionally, I may use a small amount of fluoride such as sodium fluoride USP. The binder material is a cellulose type binder and although many may be suitable, the binders which have been experimentally verified are listed in tables 1 and 2.
Glycerine (99%)
Water
Sodium stearate USP
Sodium fluoride USP
Hydroxyethylcellulose
Methylcellulose
Figure imgf000006_0001
Glycerine (99%)
Water
Sodium stearate USP
Sodium fluoride USP
Carboxymethylcellulose
Powdered gelatin
Pectin
Figure imgf000007_0001
The gelatinous mucoprotectant made in accordance with the above formula can be a stand-alone treatment for the teeth if the fluoride is included, however the fluoride does not enhance whitening the teeth. The whitening agent is an aqueous solution of hydrogen peroxide having an hydrogen peroxide concentration of between about 10% to 35% by weight. Separately the aqueous hydrogen peroxide solution and the gelatinous mucoprotectant can be stored in containers 11 and 12 of FIG. 3 for an indeterminate amount of time. Note, that hydrogen peroxide in this concentration cannot be introduced directly into the oral cavity without deleterious results.
Rather, the aqueous hydrogen peroxide solutions and the gelatinous mucoprotectant are combined in a dispensing container 13, shown in FIG. 1, at a ratio of about 1 part aqueous hydrogen peroxide solution to from about 2 to 5 or more parts gelatinous mucoprotectant. It may be seen that the hydrogen peroxide content will thus vary from about 2% by weight to about 15% by weight of the combination, with e concentration to be used to be selected by the dentist j~c each patient. Although the exact modality is not clearly understood, when the combination in dispenser 13 is placed in a mouthpiece 14 and inserted in the mouth about the teeth 16 and adjacent gums 17, as shown in FIG. 2, a protective coating having an affinity for the mucous membranes underlying the membranes attaches to these membranes but does not attach to the teeth. This coating has a hydrophobic characteristic in that it does not permit the hydrogen peroxide to reach the gum tissue, thus no caustic effects of the hydrogen peroxide occur on these gingival tissues. It is believed that the addition of the acidic hydrogen peroxide to the gelatinous mucoprotectant form stearic acid and palmitic acid in situ. In this state they are readily deposited on the mucous membranes to block the hydrogen peroxide.
In actual practice, the dentist maintains a quantity of gelatinous mucoprotectant and aqueous hydrogen peroxide solution in bulk as in containers 11 and 12. When a patient desires a whitening treatment, the dentist mixes the mucoprotectant and hydrogen peroxide in the desired ratio in dispensing container 13 and makes a vacuformed mold 14 of the patient's teeth. When the mucoprotectant and the hydrogen peroxide are mixed, the resulting slurry 18 has a shelf-life of about three days, thus the patient is instructed to place the slurry in the mouthpiece 14 and position it over the teeth. The mouthpiece 14 with the slurry 18 may normally be retained in the mouth for as little as twenty minutes or as long as several hours without adverse effects.
It is also noteworthy to mention that hydrogen peroxide bleaching oftentimes increase the porosity of the tooth thus making the tooth somewhat more sensitive. This may be remedied to some extent by including fluoride in the gelatinous mucoprotectant as shown in the above tables so that the fluoride aids in re ineralization of the tooth as the tooth is bleached. The mucoprotectant with the fluoride additive may also be used in the absence of the hydrogen peroxide solution as a fluoride treatment for the teeth. Thus, beneficial results may be obtained using my mucoprotectant gel with either a hydrogen peroxide bleaching solution or a fluoride remineralization solution. Of course, it may also be desirable to add a flavoring in small percentages, however such additives would not constitute a part of this invention.
While I have shown my invention in various forms, it will be obvious to those skilled in the art that it is not so limited but is susceptible of various changes and modifications without departing from the spirit thereof.

Claims

What I claim is:
1. A composition of matter for oral application to the teeth and adjacent gingival tissues characterized by:
(a) a predetermined amount of an active ingredient for the beneficial treatment of the teeth selected from the group of hydrogen peroxide and fluoride; and
(b) a gelatinous mucoprotectant means for preventing irritation of the mucous membranes of the mouth by forming a hydrophobic coating thereon.
2. A composition of matter as defined in claim 1 wherein said active ingredient is hydrogen peroxide solution having a hydrogen peroxide concentration between 10% to 35% by weight.
3. A composition of matter as defined in claim 2 wherein said gelatinous mucoprotectant means comprises sodium stearate, a cellulose emulsifier, and water.
4. A composition of matter as defined in claim 3 wherein said sodium stearate comprises about 0.50% to about
1.5% by weight of said mucoprotectant means.
5. A composition of matter as defined in claim 4 wherein said cellulose emulsifier comprises hydroxyethylcellulose of about 2.5% to about 5% by weight of said mucoprotectant means and methylcellulose of about 0.75% to about 2.00% by weight of said mucoprotectant means.
6. A composition as defined in claim 5 further comprising water of about 41% to about 71% by weight of said mucoprotectant means and glycerine of about 25% to about 50% by weight of said mucoprotectant means said glycerin and water having inverse relation in the quantity contained in said mucoprotectant means.
7. A composition of matter as defined in claim 4 wherein said cellulose emulsifier comprises carboxymethylcellulose of about 3% to about 6% by weight of said mucoprotectant means, powdered gelatin and pectin, each of about 0.10% to 1.00% by weight of said mucoprotectant means.
8. A composition as defined in claim 7 further comprising water of about 41% to about 71% by weight of said mucoprotectant means and glycerine of about 25% to about 50% by weight of said mucoprotectant means said glycerin and water having inverse relation in the quantity contained in said mucoprotectant means.
9. A composition of matter as defined in claim 2 wherein said mucoprotectant means comprises sodium stearate, a gelling agent, water, and glycerine.
10. A composition of matter as defined in claim 2 wherein said mucoprotectant means comprises sodium stearate of about 0.50% to about 1.5% by weight; a gelling agent of about 3.2% to about 8.0% by weight; water of about 41% to a )out 71% by weight; and the balance glycerine. f o
11. A composition of matter as defined in claim 10 wherein said hydrogen peroxide is contained in an aqueous solution of about 10% to 30% hydrogen peroxide.
12. A composition of matter as defined in claim 11 wherein said hydrogen peroxide makes up between about 2.0% to about 15% by weight of said composition.
13. A composition as defined in claim 11 wherein said aqueous solution is combined with said gelatinous mucoprotectant means at a ratio of between about 1:2 to about 1:5 by weight.
14. A composition of matter as defined in claim 10 further comprising sodium fluoride in an amount of about 0.08% to about 0.10% by weight of said mucoprotectant means.
15. A composition of matter as defined in claim 1 wherein said active ingredient comprises sodium fluoride.
16. A composition of matter as defined in claim 15 wherein said mucoprotectant means comprises sodium stearate of about 0.50% to about 1.5% by weight; a gelling agent of about 3.2% to about 8.0% by weight; water of about 41% to about 71% by weight; and the balance glycerine.
17. A mucoprotectant gel for preventing irritation of oral mucous membranes during the application of an aqueous hydrogen peroxide solution having a hydrogen peroxide concentration between 10% to 35% by weight to the teeth comprising sodium stearate, a gelling agent, water, and glycerine.
18. A mucoprotectant gel as defined in claim 17 wherein said mucoprotectant comprises sodium stearate of about 0.50% to about 1.5% by weight; a gelling agent of about 3.2% to about 8.0% by weight; water of about 41% to about 71% by weight; and the balance glycerine.
19. A mucoprotectant gel as defined in claim 18 further comprising sodium fluoride in an amount of about 0.08% to about 0.10% by weight of said mucoprotectant.
20. A method of protecting the mucous membranes of the mouth while using a hydrogen peroxide solution to whiten the teeth characterized by the steps of:
(a) forming a reusable mold of the teeth and adjacent gingival area of a patient's mouth;
(b) combining an aqueous hydrogen peroxide solution with a gelatinous mucoprotectant to form an emulsion;
(c) placing said emulsion in said mold in a quantity sufficient to coat the teeth when placed thereabout; and (d) positioning said teeth in said mold for a predetermined period of time.
21. The method as defined in claim 20 wherein said combining step characterized by:
(a) providing said aqueous hydrogen peroxide solution in a first storable container;
(b) providing said gelatinous mucoprotectant in a second storable container; and (c) combining said aqueous hydrogen peroxide solution and said gelatinous mucoprotectant in a dispensing container at a ratio of between 1:2 and 1:5 solution to
-> mucoprotectant.
22. The method as defined in claim 22 wherein said mucoprotectant provided comprises glycerine of about 25% to about 50% by weight; sodium stearate of about 0.5% to 1.5% by weight; a gelling agent of about 3.2% to about 8.0% by 0 weight; and the balance water.
PCT/US1990/005080 1989-09-11 1990-09-07 A composition for treatment of teeth and method of use WO1991007162A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU65353/90A AU6535390A (en) 1989-09-11 1990-09-07 A composition for treatment of teeth and method of use

Applications Claiming Priority (2)

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US07/406,418 US4983380A (en) 1989-09-11 1989-09-11 Composition for treatment of teeth and method of use
US406,418 1989-11-11

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