Efficacy of an Experimental Occlusion Technology Toothpaste in the Relief of Dentinal Hypersensitivity: An 8-week Randomised Controlled Trial

Abstract

Purpose: A novel anhydrous toothpaste formulation has been developed containing the anti-dentinal hypersensitivity (DH) ingredient stannous fluoride (SnF2).

Materials and methods: This randomised, controlled, examiner-blind, parallel-group, stratified (by baseline Schiff sensitivity score) study compared efficacy of an experimental 'Test' toothpaste (n = 67) containing 0.454% SnF2, 0.072% sodium fluoride and 5% sodium tripolyphosphate (all percentages w/w) with a negative 'Control' 0.76% sodium monofluorophosphate toothpaste (n = 68) in relieving DH in healthy Chinese adults. After 4-6 weeks acclimatisation, DH was assessed at baseline and following 4 and 8 weeks' twice-daily brushing by response to evaporative (air) (Schiff sensitivity score) and tactile (Yeaple probe) stimuli. An analysis of covariance model was used (factor: treatment group; covariate: baseline Schiff sensitivity score).

Results: Both Test and Control toothpastes statistically significantly reduced Schiff sensitivity score from baseline after 8 weeks' use; the Test toothpaste also statistically significantly reduced the score after 4 weeks' use (all p < 0.001). The Test toothpaste reduction was statistically significantly superior to the Control toothpaste reduction at both timepoints (p < 0.001). Percentage differences in treatment effects between Test and Control groups were 24.1% at 4 weeks and 31.7% at 8 weeks. Tactile threshold scores for both treatments statistically significantly increased from baseline at both timepoints (all p < 0.001); however, there were no statistically significant differences between Test and Control groups. Both toothpastes were well-tolerated with no adverse events reported.

Conclusion: The Test toothpaste containing 0.454% SnF2 reduced DH statistically significantly more than the Control as evaluated by the Schiff sensitivity score, but not by tactile threshold.

Keywords: dentifrices; dentin hypersensitivity; randomised controlled trial; tin fluorides.

Fig 1

Participant disposition. mITT: modified intent-to-treat; N,n: number; PP: per protocol.

Fig 2

Schiff sensitivity score by treatment group and visit (modified intent-to-treat population). Data shown are raw means ± standard errors and are offset for clarity; a low score is favourable. Week 0 = baseline.

Fig 3

Tactile threshold by treatment group and visit (modified intent-to-treat population). Data shown are raw means ± standard errors and are offset for clarity; a high value is favourable. Tactile threshold range 0–80 g. Week 0 = baseline.