A comparative clinical study investigating the efficacy of a test dentifrice containing 8% strontium acetate and 1040 ppm sodium fluoride versus a marketed control dentifrice containing 8% arginine, calcium carbonate, and 1450 ppm sodium monofluorophosphate in reducing dentinal hypersensitivity.

The objective of this clinical study was to evaluate and compare the efficacy in reducing dentin hypersensitivity of an 8% strontium acetate, 1040 ppm sodium fluoride dentifrice to a marketed control 8% arginine, calcium carbonate, 1450 ppm sodium monofluorophosphate dentifrice after twice-daily brushing for two, four, and eight weeks. This was a randomized, examiner-blind, two-arm parallel group, eight-week longitudinal clinical study with seventy-nine subjects, stratified based on baseline tooth sensitivity (Schiff score, Yeaple). Subjects brushed with either an 8% strontium acetate-based dentifrice or a marketed 8% arginine calcium carbonate dentifrice twice daily for approximately one minute. At screening, baseline, weeks two, four, and eight, subjects' tooth sensitivity was determined through both evaporative (Schiff and Visual Analogue Scale [VAS]) and tactile stimuli (Yeaple probe). Subject assessments using each stimulus were performed by the same examiner throughout the study. Seventy-seven subjects completed this clinical study. Both subject groups exhibited significant cumulative reductions from baseline to Days 14, 28, and 56 in dentin hypersensitivity as measured by Schiff, Yeaple, and VAS (for the 8% strontium acetate group, p < or = 0.0001 for all time points; for the 8% arginine calcium carbonate group, p = 0.0031 for Yeaple at Day 14, p = 0.0015 for VAS at Day 14, and p < 0.0001 for all remaining measures and time points). No significant differences (p > 0.05) were observed between treatments for any of the time points and measures except for tactile sensitivity at Day 56, for which the 8% strontium acetate-based dentifrice was statistically superior (p = 0.0391) to the control 8% arginine calcium carbonate dentifrice. The 8% strontium acetate, 1040 ppm sodium fluoride dentifrice provided significant reductions in dentin hypersensitivity (p < 0.0001) after two, four, and eight weeks of product use. Comparisons to a control 8% arginine calcium carbonate dentifrice showed no significant differences (p > 0.05) apart from tactile (Yeaple) sensitivity at week 8, where the 8% strontium acetate-based dentifrice showed significant improvement over the control (p = 0.0391).