Dual component oral composition for enhancing remineralization of teeth

Abstract

An dual oral composition is provided having a first peroxide-containing component and a second bicarbonate-containing component having exceptional anti-plaque and antibacterial action with re-mineralization properties.

Claims

1. A dual-component oral composition comprising: a first gel composition and a second paste composition mixed and used in conjunction in a 1:1 ratio wherein; the gel composition comprises: 7.5% by weight of the gel composition of a hydrogen peroxide cleansing agent; 10.5% by weight of the gel composition of a humectant sugar alcohol; and the paste composition comprises: 25% by weight of the paste composition of sodium bicarbonate; 1.1% by weight of the paste composition of pharmaceutical grade sodium fluoride; and 0.1% weight of the paste composition of Xylitol; and 25% by weight of a paste composition of a calcium phosphate re-mineralization agent, wherein the calcium phosphate re-mineralization agent and xylitol work in combination to reduce hypersensitivity or periodontal pocketing.

2. The dual-component oral composition of claim 1 wherein the humectant sugar alcohol is sorbitol.

3. The dual-component oral composition of claim 1 further comprising sweeteners.

4. The dual-component oral composition of claim 1 further comprising flavoring.

5. A method of reducing dental hypersensitivity comprising brushing with the dual-component oral composition of claim 1.

6. A method of reducing periodontal pocketing comprising brushing with the dual-component oral composition of claim 1.

Description

BRIEF DESCRIPTION OF DRAWINGS

(1) FIG. 1 illustrates a normal tooth;

(2) FIG. 2 illustrates a diseased tooth;

(3) FIG. 3 illustrates the results of several patients that used the formulation;

(4) FIG. 4 illustrates the formulation of the gel component of the composition;

(5) FIG. 5 shows the formulation of the paste component of the composition;

(6) FIG. 6 illustrates the hypersensitivity level of several patients that used the formulation; and

(7) FIG. 7 illustrates the tartar buildup of the patients.

DETAILED DESCRIPTIONS

(8) The present invention comprises a dual component oral composition for the prevention of tooth decay and periodontal disease. The dual composition comprises a first cleansing agent base gel and a second sodium bicarbonate paste. The dual composition is used in conjunction with one another in a 1:1 ratio. Beyond the first essential ingredient of hydrogen peroxide of the first component there will also be included a pharmaceutical acceptable carries including surfactant, humectants, thickening agent and sweeteners. The bicarbonate component contains xylitol and prescription strength neutral sodium fluoride. The xylitol is a non-fermentable sugar alcohol which has been shown to not only reduce dental decay significantly, but also has re-mineralization capability in combination with other ingredients in the bicarbonate component. Xylitol has an alkaline makeup which inhibits anaerobic bacteria. The neutral sodium fluoride also re-mineralizes the tooth surface and prevents decay. The peroxide component provides oxygen to be released when introduced to the bicarbonate component and water is introduced.

(9) The oxygen released inhibits the anaerobic bacteria that must live in an oxygen-free environment. Additionally, the bicarbonate component is basic in nature and neutralizes the harmful acidic environment, and once again the anaerobic bacteria cannot survive in a non-acidic environment. The salt or sodium chloride within the component reduces the inflammation of the gum tissue as well as inhibits the anaerobic bacteria during osmosis. These three properties provided by the formulation of the present invention oxygenation, neutralization and osmosis reverse the environment conducive to periodontal disease.

(10) The present invention comprises a dual component oral composition for the prevention of tooth decay. The dual composition comprises a first cleansing agent base gel and a second sodium bicarbonate paste. The dual composition is used in conjunction with one another in a 1:1 ratio.

(11) The cleansing agent of the first component is a peroxide compound, preferably hydrogen peroxide. Beyond the first essential ingredient of hydrogen peroxide of the first component there will also be included pharmaceutical acceptable carries including surfactant, humectants, thickening agent and sweeteners.

(12) Peroxide Gel Cleansing Agent

(13) A first essential component or cleansing agent of compositions according to the present invention is that of a peroxide compound. In this composition as shown in FIG. 3, hydrogen peroxide of approximately 7.5% by weight.

(14) Polysorbate 20 NF is the surfactant which can be incorporated to provide foaming properties. Sorbitol Solution USP 70% by weight is the humectant or wetting agent which prevents the water in the composition from evaporating.

(15) Sweetness and flavoring agents can be used to ensure good taste during tooth brushing or for a freshening aftertaste after toothbrushing. In this gel component, Saccharin Sodium USP Dihydrate is the sweetener and Methyl Salicylate NF and Peppermint Oil are the flavorings. Poloxamer 407 25% gel is the thickening agent. Hydrogen peroxide is the preferred essential cleansing agent which ranges about 7.5% by weight.

(16) Method of Preparation of Hydrogen Peroxide Gel

(17) In an appropriate container mix saccharin sodium and polysorbate 20 in sorbitol Solution until completely dissolved. Then add flavoring to the above mixture. Add hydrogen peroxide to the mixture and place in an ice bath until uniform mixture is formed. Transfer mixture to containers and let stand at room temperature.

(18) Method of Preparation of the Potassium Sorbate Gel

(19) Mix Potassium Sorbate and Poloxamer 407 25% gel in a container and bring to final volume with cold refrigerated purified water. Refrigerate resultant mixture when all granules of potassium sorbate are mixed thoroughly and it takes up to 12 to 24 hours within the refrigerator before the mixture becomes a clear solution. Once the mixture becomes a clear solution, the gel will solidify at room temperature.

(20) Second Component

(21) The second oral composition comprises the following essential compounds: Sodium Bicarbonate, Xylitol, and a re-mineralization agent including Calcium Carbonate or Calcium Phosphate or, Dibasic USP Anhydrous of equivalent percentage of weight. Along with these compounds, the composition will also include sodium chloride (salt), flavorings, and a thickening agent. Polysorbate 20 NF is the thickening agent and the flavorings include Spearmint oil or peppermint oil, citric acid USP monohydrate powder, marshmallow, stevioside 15% liquid extract, and spearmint powder. Sweetener is Xylitol in this component.

(22) A second essential component of compositions is that of sodium bicarbonate with a preferred weight of 25%.

(23) A third essential component of compositions according to the present invention is xylitol which is 0.1% by weight. Xylitol is a non-fermentable sugar alcohol which has dental health benefits in caries prevention. It has a plaque-reducing effect that attracts and starves harmful micro-organisms, allowing the mouth to re-mineralize damaged teeth with less interruption. Xylitol specifically inhibits the streptococci mutans group. It inhibits streptococci mutans in the presence of other sugars with the exception of fructose. Saliva containing xylitol is more alkaline than saliva which contains other sugar products. When saliva is alkaline, the calcium and phosphate salts in saliva start to precipitate into those parts of enamel where they are lacking thereby allowing the tooth to effectively remineralize.

(24) A fourth essential component of compositions is sodium fluoride that is 1.1% by weight. The humectant sugar alcohol solution is optimally 10.5% by weight. This is a remineralization agent.

(25) A fifth essential compound of the present invention is calcium carbonate which is preferably 25% by weight. This is a re-mineralization agent. An alternative re-mineralization agent is calcium phosphate, Dibasic USP Anhydrous.

(26) The oral composition of the present invention for the hydrogen peroxide gel can be prepared in the preferred embodiment as described below in FIG. 4.

(27) The oral composition of the present invention for the sodium bicarbonate paste can be prepared in the preferred embodiment as described below in FIG. 5.

(28) Method of Preparation of Sodium Bicarbonate Paste

(29) At room temperature, in a container, with a mortar and pestle, triturate Sodium Bicarbonate, Sodium Chloride and Calcium Carbonate together. Then wet with enough glycerin until a thick smooth paste is formed. Then add flavorings and levigate thoroughly.

(30) FIG. 1 depicts a cross-sectional view of a normal tooth. As shown, the gums (60) are attached by the gingival fibers to the surface of the enamel (45) and the space created by the side of the tooth and the gum tissue is the gingival crevice (55). Enamel (45) is a hard white substance covering the crown of the tooth. The pulp (65) is the central part of the tooth that includes the living blood vessels and sensory nerves (75) that extend into the root (80) of the tooth near the bone (85) and out into the surrounding bone and enables sensation within the tooth. The gingiva or the gum tissue (60) is the tissue that lies over the bone (85) around and between the teeth. Cementum (70) is the calcified substance covering the root (80) of the tooth. Dentin (50) is the calcified substance lying below the enamel (45) covering the pulp (65).

(31) FIG. 2 depicts a cross-sectional drawing of an illustration of a diseased tooth. Depicted in FIG. 2 the gingival fibers have detached from the surface of the enamel (45) of the diseased tooth forming gingival crevice (55). Plaque is present that has formed at the gumline and below the gumline. Caries, or decay, has formed within the enamel (45) of the tooth. An infection or abscess (30) is shown at the tip of the root and infection is shown within the root of the tooth.

(32) The applicant used the formulation in FIGS. 4 and 5 on various patients with the results shown in FIGS. 3, 6 and 7. Prior to using the formulation, several of the patients had diseased gums at various stages. After using the formulation, their gums, or periodontal condition, improved significantly and showed significant signs of re-mineralization. The level of detachment of the gums showed significant signs of re-attaching, improving to within normal limits with a gingival crevice (55) of 3 mm or less as shown in FIG. 3 and less tarter buildup as shown in FIG. 7. FIG. 6 show the decrease in hypersensitivity of the patients that used the formulation in FIGS. 4 and 5.