A randomized controlled clinical evaluation of desensitization efficacy of a newly developed toothpaste with highly stabilized SnF₂

Abstract

Purpose: To assess the relief of dentin hypersensitivity of the new toothpaste with stabilized stannous fluoride (SnF₂) versus a marketed standard fluoride toothpaste as a negative control and a marketed anhydrous SnF₂ toothpaste as a positive control.

Methods: This was a single-centered, randomized, controlled, double blind, clinical trial. 96 participants with hypersensitivity were enrolled in this 4-week clinical study. Electrical stimulation and evaporative air tests were performed to evaluate the desensitization efficacy. Clinical assessments were made at baseline, and after 3 days, 1 week, 2 weeks and 4 weeks of twice-daily brushing. Additionally, the influence of Sn² ⁺ species on desensitization was evaluated using bovine dentin specimens treated with toothpaste.

Results: All 96 enrolled participants were randomized. 96 participants completed all evaluations. Participants had an average age (SD) of 47.0 (10.5) years; 45% of participants were female. Both SnF₂ toothpastes showed superior desensitization efficacy compared to the negative control toothpaste, the conventional sodium monofluorophosphate (SMFP) toothpaste, after a week. The new stabilized SnF₂ toothpaste demonstrated improved electrical stimulation benefits compared to the negative control toothpaste, with increases of 15.1% after 3 days, 34.2% after 1 week, 66.3% after 2 weeks, and 111.6% after 4 weeks. Additionally, it showed relative verbal evaluation scale (VES) benefits of 14.2% after 3 days, 37.6% after 1 week, 28.9% after 2 weeks, and 37.4% after 4 weeks. The stabilized SnF₂ toothpaste exhibited desensitization properties comparable to those of a commercial anhydrous SnF₂ toothpaste, which typically produces undesirable side effects in the mouth. Toothpastes containing 0.454 % SnF₂ exhibited perfect occlusion of dentin tubules.

Clinical significance: The stabilized 0.454% SnF₂ toothpaste exhibited significantly greater dentin hypersensitivity relief within only a week and comparable property to commercial anhydrous SnF₂ toothpaste.