Efficacy of an anhydrous stannous fluoride toothpaste for relief of dentine hypersensitivity: A randomized clinical study

Abstract

Aim To compare efficacy of an anhydrous 0.454% w/w stannous fluoride/sodium fluoride toothpaste (Test) versus a sodium monofluorophosphate toothpaste (Negative control) and a stannous chloride/sodium fluoride toothpaste (Positive control) for dentine hypersensitivity relief after 8 weeks’ twice‐daily use. Materials and methods In this randomised, examiner‐blind, stratified, parallel study, primary and secondary efficacy variables were mean changes in Schiff score (evaporative [air] sensitivity) and tactile threshold (Yeaple probe), respectively, from baseline to Week 8 between Test (n=62) and Negative control (n=62). Test and Positive control (n=61) comparisons were exploratory objectives. Results All groups significantly improved from baseline on both dentine hypersensitivity measures (p<0.0001). Difference between adjusted mean changes from baseline in Schiff sensitivity scores at Week 8 for Test versus Negative control groups was 0.19 (95% CI 0.002, 0.374), in favour of the Negative control (p=0.0476; 12.57% difference). Difference in tactile threshold was ‐7.20g (95% CI ‐16.376, 1.975), this was not statistically significant (p=0.3715; ‐21.83% difference). Test group showed no significant difference versus Positive Control for either measure. Toothpastes were generally well tolerated. Conclusion Whilst twice daily use of Test toothpaste significantly reduced dentine hypersensitivity from baseline, there was no significant advantage over negative or positive controls. Study registration: Clinicaltrials.gov; NCT03310268.