Method: This was a single centre, examiner-blinded, randomized, stratified (by maximum baseline Schiff Sensitivity Score), parallel, two treatment group, 8-week clinical study in healthy volunteers with at least two sensitive teeth. At baseline, subjects underwent tooth sensitivity assessments consisting of evaporative air sensitivity (Schiff Sensitivity Score and visual analogue scale (VAS)) and tactile sensitivity (Yeaple probe). Eligible subjects, who met all inclusion/exclusion criteria were stratified by maximum baseline Schiff Sensitivity Score of the two selected test teeth and randomized to treatment. Treatment consisted of either 0.454% w/w stannous fluoride dentifrice or a regular sodium fluoride dentifrice with no indication for dentine hypersensitivity (Colgate Cavity Protection). After 4 and 8 weeks of twice daily brushing with their allocated treatment, subjects returned to the site for tooth sensitivity assessments. All efficacy endpoints (Schiff Sensitivity Score, tactile threshold and VAS) were calculated as the subject level mean change (on the two test teeth) from baseline. One hundred and fifty seven subjects were screened, 119 subjects were randomized and 113 subjects completed the study.
Result: Statistically significant between-treatment differences were observed for all efficacy measures (tactile threshold, Schiff Sensitivity Score and VAS) at all time points (primary time point - 8 weeks; secondary time point - 4 weeks), in favour of the 0.454% stannous fluoride dentifrice compared to the control dentifrice.
Conclusion: A dentifrice containing 0.454% w/w stannous fluoride was shown to be superior to a control dentifrice in reducing dentine hypersensitivity over an 8 week period. The reductions in dentine hypersensitivity (compared to baseline) observed at 4 and 8 weeks, and the magnitude of the between-treatment differences, are considered clinically relevant.