The scientific rationale and development of an optimized dentifrice for the treatment of dentin hypersensitivity.

PURPOSE: To describe the development of a new dentin hypersensitivity treatment, Colgate Sensitive Maximum Strength dentifrice, containing 5% potassium nitrate as the anti-hypersensitivity active agent. The objective was to develop a home-use hypersensitivity dentifrice that would be superior to the market leader, improving on what is available, which also contains 5% potassium nitrate as the anti-hypersensitivity active agent. METHODS: In vivo (clinicals, taste evaluation and rat caries), in vitro (potassium flux) and analytical (rheology, dispensed volume, scanning electron microscopy, electron scanning chemical analysis and radioactive dentin abrasion) methods were performed. RESULTS: The objective was accomplished with the development of a new activated silica technology that resulted in enhanced potassium ion activity. In vitro documentation, supported by clinical studies, demonstrated that the resulting formula is more effective than the market leader for relief of hypersensitivity pain. Fast pain relief in less than 2 weeks and long-lasting protection against pain with regular use have also been clinically documented. Furthermore, FDA-required in vivo and in vitro studies indicate that this formula, which contains 0.45% stannous fluoride (1100 ppm fluoride) as the anti-caries active agent, is effective against caries. Good taste, acceptable rheology, acceptable abrasivity, and cosmetic and chemical stability have all been engineered into this unique dentin hypersensitivity treatment. In summary, a highly efficacious consumer friendly treatment for dentin hypersensitivity has been developed.

Anticaries efficacy of a new dentifrice for hypersensitivity.

PURPOSE: To evaluate the expected anticaries efficacy of a new dentifrice containing stannous fluoride as the anticaries agent and potassium nitrate as the antihypersensitivity agent using a series of laboratory and animal studies. METHODS: Four surrogate studies were performed in this assessment including fluoride uptake in sound enamel, enamel solubility reduction, fluoride bioavailability and animal caries. RESULTS: Each of these studies indicated the new dentifrice for hypersensitivity (Colgate Sensitive Maximum Strength) was effective in inhibiting the caries process. The data demonstrate that this new dentifrice is predicted to be highly effective against caries and equivalent to a positive control dentifrice.

Relationship between dentifrice fluoride concentration and clinical caries reduction.

PURPOSE: To review the published literature on clinical caries trials of fluoride dentifrices and to combine their results in order to evaluate the correlation between fluoride concentration in dentifrice formulations and their anticaries efficacy, i.e., the dose-response relationship. METHODS: All available dentifrice caries clinical trials reported in the literature of products having at least two fluoride concentrations greater than 0 ppm were reviewed, graphed and statistically analyzed. RESULTS: The evaluation supported a linear correlation between the fluoride concentration of dentifrices between 0 and 5000 ppm F and clinical caries efficacy.