PURPOSE: To evaluate the efficacy of a dentifrice containing 0.454% stannous fluoride (SnF2) in the reduction of dentin hypersensitivity immediately after use, after 3 days and after a 2-week use period as compared to a positive control dentifrice containing 8.0% arginine, calcium carbonate and 1450 ppm fluoride as sodium monofluorophosphate. METHODS:80 healthy adult subjects with moderate dentin hypersensitivity were enrolled in this clinical study, which had a controlled, randomized, examiner-blind, two-treatment (40 subjects per treatment group), parallel group design. For each subject, two sensitive bicuspid or cuspid teeth in different quadrants demonstrating reproducible sensitivity to thermal stimuli (Schiff air sensitivity score of > 1) were chosen for evaluation. Subjects were randomized to treatment with either the SnF2 dentifrice or the positive control dentifrice. At the baseline visit, subjects were assessed for sensitivity to thermal stimuli, received an oral soft tissue examination, and were instructed to brush with their assigned dentifrice according to manufacturers' usage instructions. Immediately after brushing, sensitivity to thermal stimuli for each enrolled tooth was assessed by an experienced dental examiner using the Schiff air sensitivity index and by study subjects based on air visual analog scale (VAS). After using their assigned dentifrice for 3 days and for 2 weeks, thermal sensitivity was re-assessed by both examiner and subject, and each subject received an oral soft tissue examination. RESULTS:40 subjects in the SnF2 dentifrice group and 38 subjects in the control group completed all study procedures. Both dentifrice groups showed significant sensitivity relief relative to baseline (P < 0.01). The SnF2 dentifrice provided a statistically significant (P = 0.005) 7.4% reduction in sensitivity relative to the positive control dentifrice immediately after first use and an even more significant (P = 0.001) 20% reduction at Week 2 based on the Schiff air sensitivity scale. Based on the VAS, the SnF2 dentifrice provided statistically significant (P < 0.0001) reduction in sensitivity relative to the positive control dentifrice immediately after first use, at Day 3, and Week 2, with percent reductions of 7.2%, 15.8% and 28.2%, respectively. No adverse events were reported with either dentifrice.
RCT Entities:
PURPOSE: To evaluate the efficacy of a dentifrice containing 0.454% stannous fluoride (SnF2) in the reduction of dentin hypersensitivity immediately after use, after 3 days and after a 2-week use period as compared to a positive control dentifrice containing 8.0% arginine, calcium carbonate and 1450 ppm fluoride as sodium monofluorophosphate. METHODS: 80 healthy adult subjects with moderate dentin hypersensitivity were enrolled in this clinical study, which had a controlled, randomized, examiner-blind, two-treatment (40 subjects per treatment group), parallel group design. For each subject, two sensitive bicuspid or cuspid teeth in different quadrants demonstrating reproducible sensitivity to thermal stimuli (Schiff air sensitivity score of > 1) were chosen for evaluation. Subjects were randomized to treatment with either the SnF2 dentifrice or the positive control dentifrice. At the baseline visit, subjects were assessed for sensitivity to thermal stimuli, received an oral soft tissue examination, and were instructed to brush with their assigned dentifrice according to manufacturers' usage instructions. Immediately after brushing, sensitivity to thermal stimuli for each enrolled tooth was assessed by an experienced dental examiner using the Schiff air sensitivity index and by study subjects based on air visual analog scale (VAS). After using their assigned dentifrice for 3 days and for 2 weeks, thermal sensitivity was re-assessed by both examiner and subject, and each subject received an oral soft tissue examination. RESULTS: 40 subjects in the SnF2 dentifrice group and 38 subjects in the control group completed all study procedures. Both dentifrice groups showed significant sensitivity relief relative to baseline (P < 0.01). The SnF2 dentifrice provided a statistically significant (P = 0.005) 7.4% reduction in sensitivity relative to the positive control dentifrice immediately after first use and an even more significant (P = 0.001) 20% reduction at Week 2 based on the Schiff air sensitivity scale. Based on the VAS, the SnF2 dentifrice provided statistically significant (P < 0.0001) reduction in sensitivity relative to the positive control dentifrice immediately after first use, at Day 3, and Week 2, with percent reductions of 7.2%, 15.8% and 28.2%, respectively. No adverse events were reported with either dentifrice.