Method: This study was a randomized, parallel group, controlled, 8-week clinical trial. Subjects reporting moderate dentinal hypersensitivity on 2 teeth (Schiff Index of 2 or 3 and Yeaple Probe 10g) were enrolled and randomized to one of the treatment dentifrices: a 0.454% stannous fluoride dentifrice (Oral-B® PRO EXPERT), or a marketed control dentifrice (Colgate® Total Advanced, UK). Subjects used the test product twice daily, 1 minute each time, for 8 weeks. Tactile Yeaple probe and thermal Schiff cold air assessments were performed at baseline, week 2, and week 8. Treatments were compared using ANOVA (Yeaple) or ANCOVA (Cold air) statistical analysis.
Result: One hundred subjects were randomized to treatment and 97 subjects completed the study with a mean age of 45.5 years. Treatment groups were balanced on Baseline mean Schiff air index (p=0.74) and Baseline Yeaple scores were 10.00 for all subjects. Relative to the control, the 0.454% stannous fluoride dentifrice demonstrated significantly superior sensitivity protection (p<0.0001) for mean Yeaple scores by 113.6% at week 2, and 183.8% at week 8. For Schiff cold air assessment, the 0.454% stannous fluoride dentifrice exhibited significantly superior sensitivity protection (p<0.0001) by 24.2% at week 2, and 67.7% at week 8. No adverse events were reported with either dentifrice.
Conclusion: The 0.454% stannous fluoride dentifrice provided superior rapid and long lasting dentinal hypersensitivity relief benefit when compared to the marketed desensitizing dentifrice control.