OBJECTIVE: To evaluate the efficacy of a marketed stabilized stannous fluoride (SnF2) dentifrice in reducing dentinal hypersensitivity as compared to a marketed sodium fluoride (NaF)/triclosan dentifrice over an eight-week period. METHODS:Adults with confirmed dentinal hypersensitivity were enrolled in this randomized and controlled, parallel group, double blind, eight-week, single-center clinical trial. Random assignment to one of two dentifrice test groups via age, gender, and thermal sensitivity of enrolled test teeth was performed at baseline, with subjects assigned to twice-daily unsupervised brushing with either the marketed SnF2 dentifrice (Oral-B Pro-Expert, 0.454% SnF2 plus 0.077% NaF) or the marketed 0.32% NaF with 0.3% triclosan/copolymer dentifrice control (Colgate Total Advanced). Tactile sensitivity (Yeaple Probe) and thermal sensitivity (airblast/Schiff Air Index) evaluations of the selected test teeth were performed at baseline pre-treatment, and again at Weeks 2 and 8 of product use to compare the dentifrices' relative hypersensitivity protection effectiveness. RESULTS:Ninety-seven (97) of the 100 enrolled subjects completed the trial and were fully evaluable. At both Week 2 and Week 8, for both the thermal and tactile evaluation measurements, subjects brushing with the marketed SnF2 dentifrice experienced statistically significantly (p < 0.0001) superior average dentinal hypersensitivity improvement versus subjects assigned to the NaF/triclosan control dentifrice. Between groups, superior relative mean reduction in thermal Schiff Air Index favored SnF2 by 24% at Week 2 and 68% at Week 8, while greater relative mean tactile Yeaple Probe benefits were observed for SnF2 relative to the control by 114% after Week 2 and 184% at Week 8. The dentifrices were well-tolerated. CONCLUSION: Twice-daily brushing with a marketed SnF2 dentifrice provided superior dentinal hypersensitivity improvement versus a commercially available NaF/triclosan dentifrice, with significantly (p < 0.0001) greater relief after two weeks, and even larger relative benefits at eight weeks.
RCT Entities:
OBJECTIVE: To evaluate the efficacy of a marketed stabilized stannous fluoride (SnF2) dentifrice in reducing dentinal hypersensitivity as compared to a marketed sodium fluoride (NaF)/triclosan dentifrice over an eight-week period. METHODS: Adults with confirmed dentinal hypersensitivity were enrolled in this randomized and controlled, parallel group, double blind, eight-week, single-center clinical trial. Random assignment to one of two dentifrice test groups via age, gender, and thermal sensitivity of enrolled test teeth was performed at baseline, with subjects assigned to twice-daily unsupervised brushing with either the marketed SnF2 dentifrice (Oral-B Pro-Expert, 0.454% SnF2 plus 0.077% NaF) or the marketed 0.32% NaF with 0.3% triclosan/copolymer dentifrice control (Colgate Total Advanced). Tactile sensitivity (Yeaple Probe) and thermal sensitivity (airblast/Schiff Air Index) evaluations of the selected test teeth were performed at baseline pre-treatment, and again at Weeks 2 and 8 of product use to compare the dentifrices' relative hypersensitivity protection effectiveness. RESULTS: Ninety-seven (97) of the 100 enrolled subjects completed the trial and were fully evaluable. At both Week 2 and Week 8, for both the thermal and tactile evaluation measurements, subjects brushing with the marketed SnF2 dentifrice experienced statistically significantly (p < 0.0001) superior average dentinal hypersensitivity improvement versus subjects assigned to the NaF/triclosan control dentifrice. Between groups, superior relative mean reduction in thermal Schiff Air Index favored SnF2 by 24% at Week 2 and 68% at Week 8, while greater relative mean tactile Yeaple Probe benefits were observed for SnF2 relative to the control by 114% after Week 2 and 184% at Week 8. The dentifrices were well-tolerated. CONCLUSION: Twice-daily brushing with a marketed SnF2 dentifrice provided superior dentinal hypersensitivity improvement versus a commercially available NaF/triclosan dentifrice, with significantly (p < 0.0001) greater relief after two weeks, and even larger relative benefits at eight weeks.