PURPOSE: To assess the efficacy of a novel stannous-containing dentifrice in the reduction of dentin hypersensitivity when compared to a marketed positive control dentifrice. METHODS: An 8-week, single-center, randomized, parallel group, two-treatment, double-blind clinical study was conducted in a generally healthy adult population with moderate thermal and tactile dentin hypersensitivity. A total of 60 adults were enrolled into the study. Participants were stratified at baseline by age, gender, and cold air sensitivity scores, and randomly assigned to either an experimental stannous-containing sodium fluoride dentifrice or a marketed potassium nitrate positive control. Brushing was supervised on site after baseline and Week 4 examinations. All other product usage was unsupervised. Subjects brushed 2 minutes twice daily. At baseline, Week 4 and Week 8, efficacy outcomes were assessed for tactile sensitivity via the Yeaple Probe, and for thermal sensitivity with air-blast/SchiffAir Index. RESULTS: Fifty-eight subjects completed all evaluations. Both the experimental stannous-containing and positive control dentifrices provided significant (P< 0.05) reductions in both tactile and thermal dentin hypersensitivity compared to baseline at both Weeks 4 and 8. There were no significant differences in Yeaple Probe or Schiff Air Index results between the dentifrices with either efficacy measurement at Week 4 and Week 8 (P > or = 0.5375).
RCT Entities:
PURPOSE: To assess the efficacy of a novel stannous-containing dentifrice in the reduction of dentin hypersensitivity when compared to a marketed positive control dentifrice. METHODS: An 8-week, single-center, randomized, parallel group, two-treatment, double-blind clinical study was conducted in a generally healthy adult population with moderate thermal and tactile dentin hypersensitivity. A total of 60 adults were enrolled into the study. Participants were stratified at baseline by age, gender, and cold air sensitivity scores, and randomly assigned to either an experimental stannous-containing sodium fluoride dentifrice or a marketed potassium nitrate positive control. Brushing was supervised on site after baseline and Week 4 examinations. All other product usage was unsupervised. Subjects brushed 2 minutes twice daily. At baseline, Week 4 and Week 8, efficacy outcomes were assessed for tactile sensitivity via the Yeaple Probe, and for thermal sensitivity with air-blast/SchiffAir Index. RESULTS: Fifty-eight subjects completed all evaluations. Both the experimental stannous-containing and positive control dentifrices provided significant (P< 0.05) reductions in both tactile and thermal dentin hypersensitivity compared to baseline at both Weeks 4 and 8. There were no significant differences in Yeaple Probe or Schiff Air Index results between the dentifrices with either efficacy measurement at Week 4 and Week 8 (P > or = 0.5375).