Method: This was a two-week, parallel-group, double-blind, randomized and controlled clinical trial. A total of 116 healthy adults with at least two teeth demonstrating moderate hypersensitivity were enrolled and randomly assigned to one of the two test products: a 0.454% stannous fluoride dentifrice or a negative control dentifrice (Colgate® cavity protection dentifrice: 0.76% sodium monofluorophosphate). Safety (Oral soft tissue) and efficacy (thermal evaluations based on Schiff Air Index and tactile examinations via Yeaple Probe) measurements were taken at Baseline, immediately after the first product application, Day 3, and Week 2. Study subjects were instructed to use their test product twice daily over the two-week period. All statistical comparisons were two-sided at the 0.05 level of significance.
Result: All subjects completed the study. Treatment groups were balanced (p>0.797) on age, ethnicity, and gender. Baseline mean Schiff Air Index was balanced between the two treatment groups (p=0.872). Baseline Yeaple Probe scores were 10.00 for all subjects. The stannous fluoride dentifrice exhibited statistically significantly better (p<0.0001) sensitivity protection relative to the negative control for Schiff Air Index by 27.6% after the first use, 44.6% at Day 3, and 74.2% at Week 2. The stannous fluoride dentifrice provided significantly superior (p<0.0001) sensitivity protection for tactile measurement by 124.5% after the first use, 203.8% at Day 3, and 222.5% at Week 2 relative to the negative control. All test products were well tolerated.
Conclusion:
The research demonstrated the instant and rapid hypersensitivity relief benefit of the 0.454% Stannous fluoride dentifrice relative to the negative control as assessed by both the cold air and the tactile measurements.