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

Danying Tao, Martin R Ling, Xi-Ping Feng, John Gallob, Audrey Souverain, Wenjie Yang, Anousheh Alavi, Danying Tao, Martin R Ling, Xi-Ping Feng, John Gallob, Audrey Souverain, Wenjie Yang, Anousheh Alavi

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 randomized, 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 < .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 = .0476; 12.57% difference). Difference in tactile threshold was -7.20 g (95% CI -16.376, 1.975), and this was not statistically significant (p = .3715; -21.83% difference). Test group showed no significant difference versus Positive control for either measure. Toothpastes were generally well tolerated.

Conclusion: While 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.

Keywords: Stannous fluoride; dentifrice; dentine sensitivity; pain; toothpaste.

Conflict of interest statement

ML, AS and AA are employees of GSK Consumer Healthcare, who provided funding for this study. DT, XF and WY are employees of Shanghai Jiao Tong University, and JG is an employee of Consumer Research Consulting, both of which received funding from the study sponsor.

© 2020 The Authors. Journal of Clinical Periodontology published by John Wiley & Sons Ltd.

Figures

FIGURE 1
FIGURE 1
Study flow
FIGURE 2
FIGURE 2
Raw mean (±SE) Schiff sensitivity scores at baseline, Week 4 and Week 8 according to treatment group (mITT population)
FIGURE 3
FIGURE 3
Raw mean (±SE) tactile threshold at baseline, Week 4 and Week 8 according to treatment group (mITT population)

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