Drug – bio-affecting and body treating compositions – Dentifrices – Fluorine or fluorine compound containing
Reexamination Certificate
1999-01-21
2001-01-30
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Fluorine or fluorine compound containing
C424S049000
Reexamination Certificate
active
06180089
ABSTRACT:
BACKGROUND OF TIME INVENTION
1. Field of the Invention
The present invention relates to a desensitizing dentifrice composition which eliminates or reduces the discomfort and pain associated with dentinal hypersensitivity and more particularly to a two-component desensitizing dental composition containing potassium salt desensitizing agents.
2. The Prior Art
Dentinal hypersensitivity is defined as acute, localized tooth pain in response to physical stimulation of the dentine surface as by thermal (hot or cold) osmotic, tactile combination of thermal, osmotic and tactile stimulation of the exposed dentin.
Exposure of the dentine, which is generally due to recession of the gums, or loss of enamel, frequently leads to hypersensitivity. The art has determined that dentine tubules open to the surface have a high correlation with dentine hypersensitivity, Abs, J. Clin. Periodontal. 14,280-4 (1987). Dentinal tubules lead from the pulp to the cementum. When the surface cementum of the tooth root is eroded, the dentinal tubules become exposed to the external environment. The exposed dentinal tubules provide a pathway for transmission of fluid flow to the pulpal nerves, the transmission induced by changes in temperature, pressure and ionic gradients.
It is known to the art that potassium salts are effective in the treatment of dentinal hypersensitivity. For example, U.S. Pat. No. 3,863,006 discloses that toothpastes containing potassium salts such as potassium nitrate desensitize the teeth after tooth brushing for several weeks. It is believed by those skilled in the art that an elevation in the extracellular potassium concentration in the vicinity of pulpal nerves underlying sensitive dentin is responsible for the therapeutic desensitizing effect of topically applied oral products which contain potassium nitrate. Due to passive diffusion of potassium ion into and out of the open dentine tubules, repeated application of the active ingredient is necessary to build up the necessary concentration in the vicinity of the pulpal nerves.
It is believed that the improved pain relief is obtained from the use of potassium salts in combination with gradual mineralization on the dentin surface which can either totally or partially occlude dentin tubules. Total occlusion will dramatically reduce fluid flow within the tubules which stimulates pain. Partial occlusion of the dentin tubules is believed to increase delivery of potassium ion inside the tooth because the inward diffusive flux is less dependent upon tubule radius than outward fluid flow (due to positive pulpal pressures) (See D H Pashley and W G Mathews, Archs. Oral Biol. (1993) 38, 577-582). Therefore, this enhanced delivery of potassium should enhance relief.
Although potassium salts such as potassium nitrate are highly effective in the treatment of dentine hypersensitivity, the art continuously seeks means to improve the efficacy of such treatment.
SUMMARY OF THE INVENTION
The present invention is based upon the discovery that when a dual component dentifrice comprised of separately housed dentifrice components of acidic and alkaline pH at least one component containing a potassium salt are combined before use, the combined composition exhibits unexpected improved effectiveness when applied to the teeth in obturating dentinal tubules with concomitant desensitization of teeth as compared to single component compositions of neutral pH.
In accordance with the present invention there is provided a method for the treatment of dentinal hypersensitivity using a multicomponent dentifrice comprised of two separately housed, semi-solid aqueous components; the first component containing a fluoride salt as the source of fluoride ions, in an orally acceptable vehicle having an alkaline pH of at least about 8.0 and preferably about 9.0 to about 10.5 and, the second component containing an acid to provide an acid pH from about 1.0 to about 6.0 preferably about 1.0 to about 3.0 in an orally acceptable vehicle, at least one component containing a fluoride ion releasing compound such as a water soluble, potassium ion releasable compound whereby upon mixing and combination of the components, a mixture having a pH of from about 6.5 to about 9.0, preferably about 7.0 to about 8.5, is formed whereby upon repeated application of the mixture to the teeth increased relief from dentinal hypersensitivity is experienced by the user.
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Fisher Steven W.
Gambogi Robert J.
Joziak Marilou T.
Masters James G.
Tavss Edward A.
Colgate-Palmolive Company
Rose Shep K.
Shapiro Paul
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