Instant and Rapid Sensitivity Relief of a Stannous fluoride Dentifrice

Objectives: To evaluate the effect of an experimental 0.454% stannous fluoride dentifrice in the reduction of dentinal hypersensitivity relative to a positive control. Methods: This was a two-week, parallel-group, examiner-blind, randomized and controlled clinical trial. A total of 80 healthy adults with at least two teeth demonstrating moderate hypersensitivity were enrolled and randomly assigned to one of the two test products: an experimental 0.454% stannous fluoride dentifrice or a positive control dentifrice (Colgate® Sensitive Pro-relief dentifrice: 8.0% Arginine, 1450ppm sodium monofluorophosphate ®). Following baseline examinations, subjects performed their first product use on site and then used the product according to the manufacturer's usage instruction over the two-week period. Subjects in the experimental dentifrice group brushed the sensitive tooth first for 30 seconds. Safety (Oral soft tissue) and efficacy (thermal evaluations based on Schiff Air Index by an experienced dental examiner and Visual Analog Scale -VAS by the study subjects) measurements were made at Baseline, immediately after the first product application, Day 3, and Week 2. All statistical comparisons were two-sided at the 0.05 level of significance. Results: The Baseline mean sensitivity scores were balanced between the two treatment groups (p=0.096 for VAS, p=0.265 for Schiff Air Index). The experimental stannous fluoride dentifrice provided statistically significantly better sensitivity protection relative to the positive control immediately after the first use (p=0.005) and at Week 2 (p<0.001) based on Schiff Air Index. The experimental stannous fluoride dentifrice resulted in statistically significantly lower VAS scores relative to the positive control across all post-treatment measurement points (p<0.0001). All test products were well tolerated. Conclusions: The research demonstrated the instant and rapid hypersensitivity relief benefit of the 0.454% Stannous fluoride dentifrice relative to the 8% Arginine positive control dentifrice as assessed by the dental examiner and the study subjects.