Drug – bio-affecting and body treating compositions – Dentifrices
Reexamination Certificate
1999-09-14
2002-11-05
Gitomer, Ralph (Department: 1627)
Drug, bio-affecting and body treating compositions
Dentifrices
C424S401000
Reexamination Certificate
active
06475469
ABSTRACT:
TECHNICAL FIELD
The present invention relates to oral care compositions, and more particularly, to oral care compositions for removing tooth stains.
BACKGROUND ART
Within the past decade, there has been an increase in interests for oral care products which can effectively improve the appearance of teeth, and more particularly, in oral care products which can remove tooth stains and whiten teeth. In general, tooth staining results from accumulated interactions of tooth components, such as, enamel, dentin, proteinaceous acquired pellicle, plaque, and tartar with external chromogens (e.g., chromogen-containing foodstuffs, beverages, tobacco, etc.) and internal chromogens (e.g., tetracycline, blood, etc.). The ability of each of the above tooth components to absorb and retain the external and/or internal chromogens is dependent upon the chemical and physical nature of both the tooth component and the associated chromogen.
In response to the interests in oral care products which can effectively improve the appearance of teeth, oral care companies have offered a variety of approaches to improving the appearance of teeth, including dentist-supervised in-office procedures, such as the use of high concentrations of peroxide and/or lasers, dentist-supervised take-home products, such as peroxide-containing gels and pastes administered to the patient in a custom made dental tray, and a multitude of over-the-counter (OTC) gel, paste, rinse, and spray products. Currently, the safety and/or effectiveness of over-the-counter gels and pastes which contain peroxides (often formulated at an acidic pH to improve stability) or other oxidizing agents intended to whiten teeth is still being debated, regardless of the manner in which the gels or pastes are being administered, for instance, by way of a dental tray or toothbrushing.
The removal of tooth stains may also be accomplished by utilizing an abrasive dentifrice or prophylaxis paste or gel to scrape off, for instance, a film of proteinaceous acquired pellicle and its associated chromogens through toothbrushing and/or dental prophylaxis. In general, the higher the level of abrasivity of a composition, the greater the extent to which the stained acquired pellicle may be removed. Highly abrasive compositions, however, have been known to remove layers of mineralized tissue from tooth enamel and dentin, in addition to the layer of acquired pellicle. As a result, both consumers and dental practitioners have expressed concerns over the possibility of damage to the enamel and dentin from highly abrasive toothpastes and gels.
A number of oral care compositions have been developed to address the above concerns. These compositions, however, have not always provided satisfying results. Specifically, when using pastes or gels, in order to obtain a visible difference in tooth whitening, those compositions which contain a relatively low level of oxidizing agents and/or acidic pH, may still employ highly abrasive materials. As the use of highly abrasive materials can damage the tooth enamel, those compositions may not always be used on a daily basis. For those oral care compositions which contain a relatively low level of abrasive materials, and for those compositions which contain a relatively low level of oxidizing agents, as well as a low level of abrasive materials, the degree to which a visible difference in tooth whiteness is noticeable has been disappointing.
It would thus be desirable to provide an effective composition for removing tooth stains without the use of oxidizing agents and/or an unduly high amount of highly abrasive components, so that the composition may be used on a daily basis without concern for damage to the oral mucosa, tooth enamel or dentin.
SUMMARY OF THE INVENTION
The present invention, in a preferred embodiment, is directed to removing tooth stains caused by the binding of chromogenic substances (referred to below as “tannins” or “phenolic compounds”)to the proteinaceous acquired pellicle on the tooth.
To remove such tooth stains, the present invention provides, in one embodiment, a novel oral care composition which includes (i) a destabilizing agent to disassociate and solubilize the chromogen from the layer of proteinaceous acquired pellicle, and (ii) a complexing agent having affinity for the disassociated chromogen to prevent its reassociation with the layer of proteinaceous acquired pellicle. The oral care composition of the present invention is preferably formulated to provide an oral pH equal to or above a pH for destabilizing the chromogen from its bond to the proteinaceous acquired pellicle, but less than a pH which can destabilize the chromogen from its bond to the complexing agent. In a preferred embodiment, the oral pH to be achieved by the composition is between approximately 7.0 and approximately 10.5. The composition may be in the form of a dentifrice, mouthrinse, chewing gum, or any other oral care delivery system providing sufficient oral contact time to permit destabilization of the bond between the chromogen and proteinaceous acquired pellicle and to allow for the complexing of the phenolic compound with the complexing agent.
In another embodiment, the present invention provides a process for manufacturing an oral care composition for removing tooth stains. The process includes first providing a water-soluble alkaline compound capable of disassociating a chromogen from a layer of proteinaceous acquired pellicle and obtaining a polymeric substance having affinity for the disassociated chromogen to prevent the chromogen from reassociating with the pellicle. A mixture of the polymeric substance and the alkaline compound is then created, so that when in use, an oral pH that is at least equal to a pH for destabilizing the chromogen from its bond to the proteinaceous pellicle, but less than a pH which can destabilize the chromogen from its bond to the polymeric substance. Once the mixture is created, the oral care composition is formulated from the mixture.
In a further embodiment of the invention, a method is provided for removing tooth stains. The method includes the steps of disassociating a chromogen from a layer of proteinaceous acquired pellicle on a tooth surface, and forming a complex between the disassociated chromogen and a polymeric substance having affinity for the chromogen to prevent reassociation of the chromogen with the proteinaceous acquired pellicle. In one embodiment of the method of the present invention, a composition may be provided which can disassociate the chromogen from the layer of acquired pellicle and which can form a complex between the chromogen and a polymeric substance.
DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS
The term “acquired pellicle” or “proteinaceous acquired pellicle” refers to a non-mineralized protein film, which tends to form when saliva contacts a clean tooth surface.
The term “tannin” refers to chromogenic substances and encompasses compounds known as phenolics which form tooth stains when complexed with the acquired pellicle on a surface of a tooth.
“Phenolic compound”, as used hereinafter, refers to a compound having one or more benzene rings with at least one hydroxyl group attached directly to a benzene ring. Examples of phenolic compounds in foods and beverages include phenolic acids, coumarins, flavonoids, and polyphenolics.
Generally, after a tooth surface has been aggressively cleaned, such as that occurring during a dental prophylaxis with a pumice paste, the negatively-charged enamel surface on the tooth is exposed and is almost immediately contacted by saliva. Saliva contains components such as calcium ions and proline-rich proteins (PRP), which readily interact with amino acid side chains on the newly exposed negatively-charged enamel surface to form a proteinaceous film. This proteinaceous film tends to resist solubilization, even in highly acidic media, and may not dislodge, even by the constant salivary flow through the oral cavity. The strong interactions between the calcium ions and the amino acid side chains of the proteinaceous film, in addition to
Applied Dental Sciences, Inc.
Banner & Witcoff , Ltd.
Gitomer Ralph
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