Efficacy of an experimental toothpaste containing 5% calcium sodium phosphosilicate in the relief of dentin hypersensitivity: An 8-week randomized study (Study 2).

PURPOSE: To compare the efficacy of an experimental toothpaste containing 5% (w/w) calcium sodium phosphosilicate (CSPS) in relieving dentin hypersensitivity (DH) with that of control toothpastes containing no known anti-sensitivity ingredients.

METHODS: This was the second of two exploratory, randomized, four-treatment, examiner-blind, parallel-design, single-site, 8-week studies in healthy subjects with self-reported and clinically diagnosed DH. After an initial lead-in period, subjects were randomized to one of four study treatments: the experimental toothpaste containing 5% CSPS with a modified surfactant system, developed to enhance its organoleptic properties; an abrasivity-matched placebo formulation (0% CSPS) with additional abrasive silica replacing the CSPS; or one of two commercially available fluoride toothpastes as controls. Subjects were instructed to brush twice daily for the next 8 weeks. DH was assessed at baseline and following 4 and 8 weeks of treatment by response to tactile and evaporative (air) stimuli, and using a Dentine Hypersensitivity Experience Questionnaire (DHEQ; a validated quality of life measure for DH).

RESULTS: A total of 137 subjects were included in the efficacy analysis. The experimental 5% CSPS toothpaste demonstrated statistically significant reductions from baseline in sensitivity at Week 4 and Week 8 for each clinical measure (all P< 0.01). It also demonstrated significantly greater improvements in DH compared with the two control toothpastes for the majority of clinical measures at Week 4 (P ≤ 0.01) and for all clinical measures at Week 8 (all P < 0.01). The abrasivity-matched 0% CSPS toothpaste was associated with similar outcomes to the 5% CSPS toothpaste. The DHEQ responses did not reveal any consistent statistically significant within-treatment changes from baseline or between-treatment differences. Strong correlations with DHEQ outcomes were only observed for the subjects' sensitivity rating in response to evaporative (air) stimuli at Week 8. Study treatments were well tolerated.