A randomized controlled clinical trial to assess the desensitizing effect of a stannous fluoride dentifrice.

PURPOSE: To assess the dentin hypersensitivity-reducing effectiveness of a 0.454% stannous-containing dentifrice as compared to a marketed negative control dentifrice after the first brushing as well as after 3 days and 2 weeks of twice daily use. METHODS: This was a 2-week, randomized, double-blind, parallel group, single-center clinical investigation in confirmed dentin hypersensitivity adult sufferers. At baseline, subjects were stratified by age, gender, and thermal sensitivity scores, and randomly assigned to a marketed 0.454% stannous fluoride (SnF2) dentifrice or a marketed sodium fluoride (NaF) dentifrice negative control. Following baseline assessment of tactile and thermal sensitivity via the Yeaple Probe and air-blast/Schiff Air Index evaluations, respectively, subjects brushed once on-site with their assigned test product following the same usage instructions. Post-brushing tactile and thermal sensitivity were then assessed ('Immediate' evaluation). Subjects subsequently brushed twice daily at home for a 2-week period, with the same tactile and thermal efficacy evaluations repeated at Day 3 and Week 2 post-baseline. RESULTS: All 116 enrolled subjects completed all evaluations. The stannous fluoride dentifrice provided significantly (P < 0.0001) superior dentin hypersensitivity reduction compared to the negative control dentifrice at each time point and by both evaluation measures: superior mean relative Yeaple Probe (tactile) benefits were 124.5% after one use, 203.8% after 3 days, and 222.5% after 2 weeks; and superior mean relative Schiff Air Index (thermal) benefits were 27.6% after a single use, 44.6% at Day 3, and 74.2% at Week 2. Both dentifrices were well-tolerated.