Confirmation of efficacy in providing relief from the pain of dentin hypersensitivity of an anhydrous dentifrice containing 0.454% with or without stannous fluoride in an 8-week randomized clinical trial.

PURPOSE: To compare the efficacy of an anhydrous dentifrice containing 0.454% w/w stannous fluoride and a negative control dentifrice containing 1,000 ppm fluoride, as sodium monofluorophosphate, at reducing dentin hypersensitivity over 8 weeks with twice-daily brushing. METHODS: This was a randomized, examiner-blind, parallel, two treatment group, stratified (by maximum baseline Schiff sensitivity score), 8-week clinical study carried out at a single site in 119 healthy subjects with at least two sensitive teeth, who met all study criteria at the screening and baseline visits. Clinical assessments of sensitivity to evaporative (air) [with Schiff sensitivity score and visual analogue scale (VAS)] and tactile (Yeaple probe) stimuli were employed to compare the efficacy of the test dentifrice containing 0.454% w/w stannous fluoride to the negative control dentifrice at reducing sensitivity after 4 and 8 weeks treatment. RESULTS: Of the 119 subjects randomized to study treatment, 113 completed the study. At 4 and 8 weeks, between treatment analyses found the test dentifrice to be significantly better than the negative control dentifrice in relieving dentin hypersensitivity for all measures (Schiff: P < 0.0001 at 4 and 8 weeks; VAS score: P = 0.0003 at 4 weeks, P < 0.0001 at 8 weeks; tactile threshold: P = 0.0138 at 4 weeks, P < 0.0001 at 8 weeks).