A Randomized Clinical Study to Evaluate the Efficacy of an Experimental 3.75% (w/w) Potassium Chloride Dentifrice for the Relief of Dentin Hypersensitivity.

OBJECTIVES: To evaluate the clinical efficacy of an experimental "Test" dentifrice containing 3.75% (w/w) potassium chloride (KCl) in reducing dentin hypersensitivity (DH) compared with that of a standard fluoride "Reference" dentifrice after eight weeks' twice-daily brushing.

METHODS: This was a randomized, controlled, examiner-blind, stratified, parallel-group, single-center study in healthy subjects with selfreported and clinically diagnosed DH. After an initial lead-in period, subjects were randomized to either the Test (n = 67) or the Reference dentifrice (n = 66) and instructed to brush twice daily for the next eight weeks. DH was assessed at baseline and following two, four, and eight weeks of dentifrice use by response to an evaporative air stimulus (as evaluated by Schiff sensitivity score and 100 mm visual analog scale [VAS]) and by response to a tactile stimulus (tactile threshold).

RESULTS: Both dentifrices were associated with statistically significant reductions in DH from baseline after two, four, and eight weeks' use, as determined by all efficacy measures (all p < 0.0001). The reduction in Schiff sensitivity score was significantly greater in the Test dentifrice group compared with the Reference dentifrice group at all time points (p < 0.0001). There was a statistically significantly greater increase in tactile threshold in the Reference dentifrice group compared with the Test dentifrice group after eight weeks (p < 0.05); however, reductions in DH as determined by VAS were not significantly different between the treatment groups at any time point. Both dentifrices were generally well tolerated.

CONCLUSIONS: Throughout eight weeks of use, the experimental 3.75% (w/w) KCl dentifrice was more effective than the Reference fluoride dentifrice in reducing DH, as determined by the primary endpoint of Schiff sensitivity score. Secondary assessment measures of change in DH (VAS score and tactile threshold) were not consistent with this finding.