WO1992018090A2

WO1992018090A2 - Antimicrobial oral compositions

Info

Publication number: WO1992018090A2
Application number: PCT/US1992/002358
Authority: WO
Inventors: Michael Frederick Lukacovic; Satyanarayana Majeti; David Allen Weber
Original assignee: The Procter & Gamble Company
Priority date: 1991-04-19
Filing date: 1992-03-25
Publication date: 1992-10-29
Also published as: AU1987292A; WO1992018090A3

Abstract

Disclosed are methods for treating and/or preventing microbial infections of the oral cavity, including an overgrowth of yeast, comprising administering to humans and/or lower animals in need of such treatment an oral composition comprising a monoperphthalic acid compound and an anionic surfactant.

Description

ANTIMICROBIAL ORAL COMPOSITIONS

BACKGROUND OF THE INVENTION

Many microbial infections arise endogenously. Bacteria and yeast are a part of the normal flora of the skin. They also exist prevalently on all mucous membrane surfaces as indigenous flora. Given the proper circumstances and opportunity to penetrate tissues, bacteria from the indigenous flora can set up infections, such as gas gangrene, vulvovaginal abscess, chronic sinusitis, and Vincent's disease.

While good oral hygiene, as achieved by brushing the teeth with a cleansing dentifrice, may help reduce the incidence of periodontal disease, it does not necessarily prevent or eliminate its occurrence. This is because microorganisms contribute to both the initiation and progress of periodontal disease. Thus, in order to prevent or treat periodontal disease, these micoorganisms must be suppressed by some means other than simple mechanical scrubbing. Towards this end, there has been a great deal of research aimed at developing therapeutic dentifrices, mouthwashes, and methods of treating periodontal disease which are effective in suppressing these microorganisms. Treatment with monoperoxy acid compounds has been suggested in treating bacterial infections of the oral cavity. However, there is still a need for safe and effective methods for treating and preventing yeast overgrowth which occurs with the use of such monoperoxy acids in some patients susceptible to such overgrowth.

Monoperoxy acids are known for treating microbial diseases of the oral cavity. U.S. Patent 4,990,329, issued February 5, 1991 to Sampathkumar discloses an oral hygiene composition comprising a onoperphthal ic acid compound or its pharmaceutically-acceptable salts or esters. These compositions are used to treat or prevent anaerobic infections in humans and lower animals. U.S. Patent 4,886,658, issued December 12, 1989 to Charbonneau discloses methods for treating or preventing dental plaque, caries, or gingival or periodontal diseases of the oral cavity in humans or lower animals, with reduced staining of teeth or dentures. Compositions suitable for use in this invention comprise a monoperoxyphthalate compound and an anti-plaque bis-biguanide compound.

U.S. Patent 4,716,035, issued December 29, 1987 to Sampathkumar discloses oral compositions comprising certain organic peroxy acid agents and a source of fluoride ions. These compositions are used as anticaries and antigingivitis agents. Monoperoxy acids are also used for other disinfecting/cleansing purposes. European Patent Application No. 0,133,354 published February 20, 1985 by Interox Chemicals Limited, discloses denture cleansing compositions comprising an organic peroxygen compound, especially in effervescent tablet form.

Great Britain Patent Specification No. 2,137,822A, published October 17, 1984 by Interox Chemicals Limited, discloses an alkanolic solution of a magnesium salt of an aryl, cycloal phatic, or conjugated aliphatic carboxyl c acid (substituted by one or more peroxycarboxylic acid groups). This invention is said to be useful as a broad spectrum disinfectant/sterilizing agent for hard surfaces.

U.S. Patent 4,917,815, issued April 17, 1990 to Beilfuss et al., discloses aqueous solutions of aromatic percarboxylic acids. Uses for this invention include acidic or neutral liquid disinfectants for surfaces with low to medium loading of dirt for the skin, the mucous membranes or the hands.

U.S. Patent 4,490,269 issued December 25, 1984 to Gallopo discloses a denture cleansing composition comprising an effervescent agent, and as a bleaching agent, a monoperphthal te or a potassium monopersulfate and a monoperphthalate.

U.S. Patent 4,221,660, issued September 9, 1980 to

Eggensperger et al., discloses a method for disinfecting an aqueous system with a solid aromatic percarboxylic acid having solubility in water. Percarboxylic acids which may be employed in this invention include monoperphthalic acid. U.S. Patent 3,988,433, issued October 26, 1976 to Benedict discloses compositions containing alkyl and aryl peroxy acids. These compositions are stated to be used to remove stains from teeth. Baldry, M.G. "The Antimicrobial Properties of Magnesium Monoperoxyphthalate Hexahydrate," Journal of Applied Bacteriology, Vol. 57, pages 499-503 (1984), investigated the antimicrobial properties of magnesium monoperoxyphthalate hexahydrate (hereinafter referred to as "MMPP hexahydrate") against yeasts, vegetative bacteria and bacterial endospores. The results of this investigation suggest that 1-2% MMPP hexahydrate produces a total kill of C__s. albicans when used for at least 10 minutes.

In spite of such disclosures, it has been observed that when monoperphthalic acid is used as an antimicrobial agent in oral compositions, some humans and lower animals exhibit an overgrowth of yeast. A possible explanation for such yeast overgrowth is that oral compositions containing monoperphthalic acids are not present in the oral cavity for a period of time necessary to kill the yeast flora. Therefore, it is necessary to reduce the number of viable yeast in the oral cavity during the limited contact time available with the use of these oral monoperphthalic acid compositions. Surprisingly, it has been discovered that incorporation of certain anionic surfactants into the oral monoperphthalate compositions lessens the amount of time necessary to reduce the viable yeast flora in the oral cavity.

Sodium lauryl sulfate, an anionic surfactant useful in the present invention, is known to have some antibacterial properties. U.S. Patent 4,150,151 issued April 17, 1979 to Pader et al., discloses an antibacterial liquid mouthwash comprising water, ethanol, an essential oil flavor mixture, and about 0.1% to about 0.6% of an alkyl sulfate. There are also sodium lauryl sulfate-containing mouthrinse products currently on the market including Close-Up® Antiplaque Rinse and Signal^® Mouthwash sold by Cheeseborough Ponds, and Listermint^® Mouthwash with Fluoride, sold by Warner-Lambert Co. It is the object of the present invention to provide methods for treating or preventing microbial infections of the oral cavity by administering to humans or lower animals in need of such treatment an oral composition comprising a monoperphthalic acid and a anionic surfactant. An additional object of this invention is to provide such treatment without causing an overgrowth of yeast in the oral cavity in those subjects susceptible to such overgrowth.

These and other objects of the present invention will be apparent from the detailed description of the invention contained hereinafter.

All percentages and ratios herein are by weight and all measurements are made at 25°C unless otherwise specified.

SUMMARY OF THE INVENTION The present invention provides methods for treating or preventing microbial infection of the oral cavity, including the overgrowth of yeast, said method comprising administering to a human or lower animal in need of such treatment an oral composition comprising: (a) a safe and effective amount of a monoperphthalic acid compound;

(b) a safe and effective amount of an anionic surfactant; and

(c) a suitable carrier, wherein said composition is retained in the oral cavity for from about one second to about

300 seconds. A detailed description of the essential and optional components of the present invention are detailed below.

ΠFTAΓLED DESCRIPTION OF THE INVENTION Monoperphthalic Acid Compounds:

The present invention relates to methods for treating or preventing microbial diseases of the oral cavity, including an overgrowth of yeast, by administering to humans or lower animals a composition comprising a safe and effective amount of a monoperphthalic acid and an anionic surfactant. By "diseases of the oral cavity", as used herein, is meant diseases which are initrated and/or perpetuated by bacteria in the oral cavity, and includes such diseases as, for example, periodontal disease, gingivitis, periodontitis, gingivosis, periodontosis, periodontitis complex, and other inflammatory and/or degenerative conditions of the tissues within the oral cavity, plus caries, Vincent's disease, trench mouth, malodor, and yeast overgrowth. Also specifically included are dentoalveolar infectious, dental abscesses (e.g., cellulitis of the jaw; osteomyelitis of the jaw), acute necrotizing ulcerative gingivitis (i.e., Vincent's infection), infectious stomatitis (i.e., acute inflammation of the buccal mucosa), and Noma (i.e., gangrenous stomatitis or cancrum oris). Oral and dental infections are more fully disclosed in Fingold, Anaerobic Bacteria in Human Diseases, chapter 4, pp 78-104, and chapter 6, pp 115-154 (Academic Press, Inc., NY, 1977), the disclosures of which are incorporated herein by reference. The method of treatment of the present invention is particularly effective for treating or preventing periodontal disease, gingivitis and/or periodontitis, while lessening the potential for an overgrowth of yeast to occur in the oral cavity. By "safe and effective amount" as used herein is meant an amount of a monoperphthalic acid compound, or its pharmaceutically-acceptable salt or ester, high enough to significantly positively modify the infection to be treated, but low enough to avoid serious side effects (at a reasonable benefit/risk ratio), within the scope of sound medical judgment. The safe and effective amount of a monoperphthalic acid compound or its pharmaceutically-acceptable salt or ester will vary with the particular infection (e.g., disease of the oral cavity) being treated, the age and physical condition of the patient being treated, the severity of the infection, the duration of treatment, the nature of concurrent therapy, the specific form (i.e., acid, salt, and/or ester) of the monoperphthalic acid employed, and the particular vehicle from which the monoperphthalic acid is applied.

The monoperphthalic acid compounds, useful in this invention are substituted monoperphthalic acids having the general structure:

or its pharmaceutically acceptable salts or esters, wherein R may be one or more substituents compatible with the peroxy acid functionality of the aromatic ring.

By "substituents compatible with the peroxy acid function^¬ ality of the aromatic ring", as used herein, is meant substituents on the ring which do not react with peroxy acids thereby reducing the stability and effectiveness of the compounds to treat diseases of the oral cavity. Non-limiting examples of R groups include hydrogen, substituted and unsubstituted saturated alkyl having from 1 to about 20 carbon atoms (e.g., methyl, ethyl), substituted and unsubstituted aryl (e.g., phenyl, naphthyl), substituted and unsubstituted benzyl, chloro, fluoro, nitro, sulphonate. tri- fluoromethyl, trialkylammonium (e.g., tri ethylammonium; trethyl - ammonium), cyano, carboxy, carboxylate (e.g. ,--0C0CH₃) , percar- boxylate (e.g.,--C03H), and alkoxy (e.g., methoxy, ethoxy) . Preferred R groups are hydrogen, saturated alkyl having from 1 to about 20 carbon atoms, aryl, benzyl, chloro, fluoro, carbox , and alkoxy. Particularly preferred for use in the above method for treating or preventing diseases of the oral cavity is monoper- phthalic acid (i.e., R«H), or its phamaceutically-acceptable salts or esters. R may also be an iodo, bromo, substituted or unsub^¬ stituted amino, or amido group, but such groups are generally not desirable since they can react with peroxy acid groups. Selection of substituents compatible with the peroxy acid functionality of the aromatic ring can easily be made by one skilled in the art. By "pharmaceutically-acceptable salts or esters", as used herein, is meant esters and salts of the substituted or unsub¬ stituted monoperphthal ic acid compounds which have the same general antibacterial properties as the preferred magnesium salt of monoperphthal ic acid, and which are acceptable from a toxicity viewpoint. Nonlimiting examples of pharmaceutically-acceptable salts include alkali metal (e.g., sodium, potassium), alkaline earth metal (e.g., calcium, magnesium), non-toxic heavy metal, and trialkyl ammonomium (e.g., trimethylammonium). Preferred compounds for treating or preventing diseases of the oral cavity are pharmaceutically-acceptable salts of the substituted or unsubstituted monoperphthalic acid compounds, with the pharmaceu¬ tically-acceptable salts of divalent cations more preferred (e.g., magnesium, calcium) and the magnesium salt being the most preferred.

Most preferred for use in the above method of treating or preventing surface tissue infections caused by or involving microbial organisms, and particularly preferred for diseases of the oral cavity, is the magnesium salt of monoperphthal ic acid. This magnesium salt is the salt of the carboxylic acid group only, having the formula:

as disclosed in European Patent Application No. 27,693, published Apr. 29, 1981, filed by Interox Chemicals, Ltd., the disclosures of which are incorporated herein by reference. This compound is a hexahydrate when in its solid form. Synthesis of substituted and unsubstituted monoperphthalic acid compounds can be achieved by those skilled in the art using methods disclosed in, for example, European Patent Application No. 27,693, published Apr. 29, 1981, filed by Interox Chemicals Limited; European Patent Appl cation 66,992, to Interox Chemicals Limited; U.S. Pat. No. 3,075,921, to Brockelhurst et al.; "Organic Peroxides", Daniel Swern, Editor, published 1970 by John Wiley & Sons, Inc.; and in British Patent Specification No. 1,378,671; the disclosures of all of which being incorporated herein by reference. Synthesis of the magnesium salt of monoperphthalic acid is disclosed in the European Patent Application No. 27,693, cited above. This compound is also commercially available from Interox Chemicals Limited.

For the method of treatment and prevention of diseases of the oral cavity, including overgrowth of yeast, as defined by the present invention hereinabove, the amount of monoperphthalic acid or its pharmaceutically-acceptable salts or esters in the compo¬ sitions used is from about 0.1% to about 55%; a more preferred amount is from about 0.25% to about 22.1%. The most preferred amount of a monoperphthalic acid compound or its pharmaceuti¬ cally-acceptable salts or esters useful in the present invention is from about 0.5% to about 17.7%. Anionic Surfactants

Anionic surfactants are necessary in the oral compositions used in the methods of the present invention to extend the anti¬ microbial spectrum of the monoperphthalic acid. These surfactants aid in reducing the viable yeast in the oral cavity, thereby decreasing the potential for an overgrowth of yeast to occur with the use of monoperphthalic acid. Non-limiting examples of anionic surfactants that are suitable for use in the present invention include water soluble salts of alkyl sulfates and alkoyl sarco- sinates having from 10 to 18 carbon atoms in the alkyl radical. The preferred anionic surfactant useful in the present invention is sodium N-lauroyl sarcosinate (also known as N-lauroyl sarcosine, sodium salt), available commercially from Sigma Chemical Company, Saint Louis, Missouri, and especially preferred is sodium lauryl sulfate, which is available commercially from Sigma Chemical Company, Saint Louis, Missouri and Fisher Scientific, Pittsburgh, Pennsylvania.

In the oral compositions used in the methods of the present invention, the anionic surfactant compound is present in an amount of from about 0.01% to about 8.84%, and more preferably from about 0.025% to about 3.54%; and most preferably from about 0.05% to about 2.65%. Suitable Carrier Materials: Suitable carrier materials for the oral compositions useful in the present invention are preferably in the form of any of a number of conventional oral care products, for example, a solution (e.g., mouthrinse), a dentifrice (e.g., toothpaste, gel or tooth powder), chewing gum, chewable tablets, lozenge or sachet. Preferred compositions useful in the methods of the present invention are in the form of a solution and a dentifrice.

These suitable carrier materials should be compatible with the monoperphthalic acid and anionic surfactants present in the oral compositions of the present invention. By "compatible", as used herein, is meant that the components of the composition are capable of being commingled without interaction in a manner which would substantially reduce the compositions efficacy for treating or preventing microbial diseases of the oral cavity, according to the method of the present invention. Examples of suitable carrier materials useful in the oral care formulations of the present method of treatment or prevention invention include, but are not limited to the group consisting of flavoring agents, sweetening agents (e.g. saccharin, magnasweet), coloring agents, humectants, emulsifying agents, buffering agents, suitable aqueous carriers and mixtures thereof. The term "suitable aqueous carriers" as used herein, means water or a mixture of water and an alcohol that is proven to be safe for human use.

A buffering agent is useful in this invention to maintain a desirable pH of the monoperphthalic acid/anionic surfactant- containing composition of from about 5 to about 7, and preferably from about 5 to about 5.5. Examples of suitable buffering agents for the present invention include sodium bicarbonate, citric acid, malic acid, tartaric acid, gluconic acid and monosodium phosphate. Preferred buffering agents for the present invention are sodium bicarbonate, citric acid, and monosodium phosphate.

Optionally, the oral compositions of the present invention may contain a water-soluble fluoride compound in an amount sufficient to give a fluoride concentration of from about 0.0025% to about 5.0% by weight, preferably from about 0.005% to about 2.0% by weight, to provide anticaries effectiveness. The fluoride compounds are believed to provide protection against deminerali- zation as well as aid in remineralization of dental enamel. Preferred fluorides are sodium fluoride, stannous fluoride, indium fluoride, and sodium monofluorophosphate. Norris et al., U.S. Patent 2,946,725, issued July 26, 1960 and Widder et al . , U.S. Patent 3,678,154, issued July 18, 1972 disclose such salts as well as others.

The pharmaceutically-acceptable carrier materials in the monoperphthal c acid/anionic surfactant-containing compositions useful in the method of the present invention are present in a range of from about 36.16% to about 99.89%; more preferably from about 74.36% to about 99.725%; and most preferably from about 79.65% to about 99.45%.

Dentifrice compositions are preferred compositions for use in the methods of the present invention for treating or preventing microbial infections, including overgrowth of yeast, in the oral cavity comprise a monoperphthalic acid or its pharmaceu¬ tically-acceptable salts or esters in an amount of from about 0.1% to about 10%; more preferably from about 1% to about 7.5%; most preferably from about 2.5% to about 5%. An anionic surfactant, as described in detail hereinbefore will be present in the dentifrice compositions in an amount of from about 0.1% to about 5.0%; more preferably from about 0.25% to about 2.0%; and most preferably from about 0.5% to about 1.5%. The remaining portion of the dentifrice compositions is made up of suitable carrier materials in an amount of from about 85% to about 99.8%; more preferably from about 90.5% to about 98.75%; most preferably from about 93.5% to about 97.0%. Other preferred compositions useful in the methods of the present invention are in the form of a granule which may then be dissolved in a suitable aqueous carrier for use as a mouthrinse or mouth spray. Granular compositions useful in the methods of the present invention comprise a monoperphthalic acid or its pharmaceutically-acceptable salts or esters in an amount of from about 1.76% to about 55%; more preferably from about 4.4% to about 22.1%; most preferably from about 8.8% to about 17.7%; and an anionic surfactant in an amount of from about 0.17% to about 8.84%; more preferably from about 0.44% to about 3.54%; most preferably from about 0.88% to about 2.65%; and suitable carrier materials in an amount of from about 36.16% to about 98.07%; more preferably from about 74.36% to about 95.16%; most preferably from about 79.65% to about 90.32%. Method of Treatment: The method of this invention to treat or prevent microbial diseases of the oral cavity, including yeast overgrowth, said method comprising administering to humans or lower animals in need of such treatment or prevention an oral composition comprising a monoperphthalic acid compound and an anionic surfactant as described in detail hereinabove.

In the methods of the present invention, these oral composi¬ tions are preferably used from about once to about four times daily, more preferably once or twice daily; most preferably twice daily. The oral compositions in the methods of the present invention are administered by contacting them with the dental surfaces in the oral cavity for from about one second to about 300 seconds during each use, more preferably from about 10 seconds to about 120 seconds during each use, most preferably from about 30 seconds to about 60 seconds during each use. The granular compositions useful in the methods of the present invention, as described in detail hereinabove may be used in preparing aqueous compositions that may then be used to treat or prevent microbial infections of the oral cavity, including an overgrowth of yeast, in humans or lower animals in need of such treatment. An aqueous solution of monoperphthalic acid or its pharmaceutically-acceptable salts or esters and anionic surfactant are prepared by dissolving the granular compositions, as described in detail hereinabove, in a suitable aqueous carrier such that the resulting solutions provide monoperphthalic acid or its pharmaceu¬ tically-acceptable salts or esters in a range of from about 0.10% to about 5%; more preferably from about 0.25% to about 1.25%; most preferably from about 0.5% to about 1%; and an anionic surfactant in a range of from about 0.01% to about 0.5%; more preferably from about 0.025% to about 0.2%; most preferably from about 0.05% to about 0.15%. These monoperphthalic acid/anionic surfactant-containing solutions are used in the methods of the present invention to treat or prevent microbial infections in the oral cavity including an overgrowth of yeast, said methods comprising having a human or lower animal in need of such treatment retain in the oral cavity from about 5 ml to about 30 ml ; more preferably from about 10 ml to about 20 ml ; most preferably from about 12 ml to about 18 ml of said solutions.

The monoperphthalic acid/anionic surfactant-containing dentifrice compositions are used in the methods of the present invention to treat or prevent microbial infections in the oral cavity including an overgrowth of yeast, said methods comprising by having a human or lower animal in need of such treatment brush their teeth or have their teeth brushed with preferably 0.2 g s to about 2.5 gms; more preferably 0.5 gms to about 2.0 gms; most preferably 1.0 gms to about 1.5 gms of said dentifrice composi¬ tions.

The following examples further describe and demonstrate preferred embodiments within the scope of the present invention. The examples are given solely for illustration and are not to be construed as limitations of this invention, as many variations thereof are possible without departing from the spirit and scope thereof.

Total 0.9000 100.0%

^a)PAM used in this formulation contains 87% magnesium monoperphthalate and 13% magnesium bis(hydrogen phthalate), sold by Interox Chemicals, Ltd., Warrington, Cheshire, England. b)sodium lauryl sulfate is sold by Fisher Scientific of Pittsburgh, Pennsylvania. A human or lower animal in need of a method of treatment of prevention of microbial diseases of the oral cavity places the above powder mixture in 15 ml of water, thereby providing a composition containing 1.0% monoperphthalic acid and 0.1% sodium lauryl sulfate. The human or lower animal then retains and/or swishes the aqueous composition around in the oral cavity for 30-60 seconds.

Example II

Sodium lauryl sulfate^) 0.0158 1.98%

Saccharin 0.0284 3.56%

Magnasweet 100 0.0095 1.18%

FD&C Blue Dye 0.0002 0.02%

Total 0.8000 100.0%

^a)PAM used in this formulation contains 87% magnesium monoperphthalate and 13% magnesium bis(hydrogen phthalate), sold by Interox Chemicals, Ltd., Warrington, Cheshire, England. b)sodium lauryl sulfate is sold by Fisher Scientific of

Pittsburgh, Pennsylvania.

A human or lower animal in need of a method of treatment or prevention of microbial diseases of the oral cavity places or has placed the above powder mixture in 15 ml of water, thereby providing a composition containing 0.5% monoperphthalic acid and

0.1% sodium lauryl sulfate. The human or lower animal then retains and/or swishes the aqueous composition around in the oral cavity for 30-60 seconds.

Example III A toothpaste is made using the procedure taught in U.S. Patent No. 3,988,433 issued to Benedict on October 26, 1976, which is incorporated by reference herein. AQUEOUS PHASE

Material Wei^ght %

1. Sodium Fl ouride 0.27

2. Sorbitol 26.52

3. SASSa) 6.00

4. Pepermint Flavor 1.56

5. Titanium Dioxide 0.50

6. Saccharin 0.89

7. PEG 12 2.00

8. FD&C Blue Dye 0.10

9. Carbopol 0.35 10. Xanthan Gum 0.70

1. Mineral Oil 25.15 2. Petrolatum 16.65

3. Magnasweet 100 0.40

4. PAMb) 57.80

100.00 This dentifrice is a combination product consisting of 90% aqueous phase and 10% nonaqueous phase. ^a)SASS is a 28% aqueous solution of sodium alkyl sulfate, sold by Sigma Chemical Company, St. Louis, Missouri b)PAM used in this formulation contains 87% magnesium monoperphthalate and 13% magnesium bis(hydrogen phthalate), sold by Interox Chemicals, Ltd., Warrington, Cheshire, England.

WHAT IS CLAIMED IS:

Claims

1. The use of a monoperphthalic acid for the manufacture of a composition for treating or preventing microbial infections of the oral cavity, including an overgrowth of yeast, said treatment of prevention comprising administering to humans and/or lower animals in need of such treatment an oral composition comprising:

(a) a safe and effective amount of a monoperphthalic acid compound;

(b) a safe and effective amount of an anionic surfactant; and

(c) a suitable carrier, wherein said treatment time is from about one to about 300 seconds.

2. The use of a monoperphthalic acid according to Claim 1 wherein the monoperphthalic acid compound is the magnesium salt of monoperphthal c acid.

3. The use of a monoperphthalic acid according to either of Claims 1 or 2 wherein the anionic surfactant is selected from the group consisting of water soluble salts of alkyl sulfate and N-alkoyl sarcosinates having from 10 to 18 carbon atoms in the alkyl radical .

4. The use of monoperphthalic acid according to any of Claims 1-3 wherein the anionic surfactant is sodium lauryl sulfate.

5. The use of monoperphthalic acid according to any of Claims 1-4 wherein the suitable carrier is selected from the group consisting of flavoring agents, sweetening agents, coloring agents, humectants, emulsifying agents, buffering agents, suitable aqueous carriers, and mixtures thereof.

6. The use of monoperphthalic acid according to any of Claims 1-5 wherein the aqueous composition has a pH range of from about 5 to about 7.

7. The use of monoperphthalic acid according to any of Claims 1-6 wherein said oral composition comprises:

(a) from about 0.01% to about 55% of a monoperphthalic acid compound; and (b) from about 0.025% to about 8.84% of an anionic surfactant; and

(c) a suitable carrier, wherein said treatment time is from about 10 seconds to about 120 seconds.

8. The use of monoperphthalic acid according to Claim 7, wherein the monoperphthalic acid compound is the magnesium salt of monoperphthalic acid.

9. The use of monoperphthalic acid according to either of Claims 7 or 8 wherein the anionic surfactant is selected from the group consisting of water soluble salts of alkyl sulfate and N-alkoyl sarcosinates having from about 10 to 18 carbon atoms in the alkyl radical .

10. The use of monoperphthalic acid according to any of Claims 1-7 wherein the anionic surfactant is sodium lauryl sulfate.