Clinical Desensitizing Effect of Bioavailable SnF₂ Dentifrice

Objectives: To evaluate the clinical efficacy of a 0.454% bioavailable stannous fluoride (SnF₂) dentifrice in the reduction of dentinal hypersensitivity relative to a negative control.
Methods: This was a 30-day, parallel-group, double-blind, randomized, and controlled clinical trial. A total of 91 healthy adults with at least two teeth demonstrating moderate hypersensitivity were enrolled and 90 subjects were randomly assigned to one of the two test products: a 0.454% bioavailable SnF₂ dentifrice or a negative control dentifrice (Colgate Cavity Protection dentifrice: 0.76% sodium monofluorophosphate). Safety (Oral hard and soft tissue) and efficacy (thermal evaluations based on Schiff Air Index and tactile examinations via Yeaple Probe) measurements were taken at Baseline, Day 3, and Day 30. Study subjects were instructed to use their test product twice daily over the 30-day period. All statistical comparisons were two-sided at the 0.05 level of significance.
Results: Ninety subjects completed the study. Treatment groups were balanced (p≥0.299) on age, race and gender. Baseline mean Schiff Air Index and Yeaple Proble scores were balanced between the two treatment groups (p≥0.876). The SnF₂ dentifrice exhibited statistically significantly better (p<0.001) sensitivity protection relative to the negative control for Schiff Air Index by 34.9% at Day 3 and 81.7% at Day 30. The SnF₂ dentifrice provided statistically significantly better (p<0.001) sensitivity protection for tactile measurement by 79.9% at Day 3 and 199.0% at Day 30 relative to the negative control. All test products were well tolerated.
Conclusions: The research demonstrated fast and long term hypersensitivity relief benefit of the 0.454% bioavailable SnF₂ dentifrice relative to the negative control as assessed by both the cold air and the tactile measurements.