Abstract

BackgroundStudies of dentifrices containing strontium chloride or potassium nitrate have documented the clinical efficacy of these formulations for dentin hypersensitivity (DH), but few studies have evaluated dentifrices containing both active ingredients. ObjectiveThe objective of this study was to compare the effects on DH of a dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (experimental dentifrice) with those of a dentifrice containing the same silica base without any active ingredient (control dentifrice). MethodsMale and female patients aged 20 to 65 years with DH were eligible to participate in this randomized, double-blind, placebo-controlled study in China. Patients were assigned to receive the experimental or control dentifrice. At baseline, immediately after topical dentifrice use, and after 3 days, patients received an oral examination of their hard and soft tissues, followed by an evaluation of DH that used the Yeaple Probe to measure tactile hypersensitivity and the Schiff Cold Air Scale to measure the perception of pain from an air blast stimulus. Adverse events (in particular, discomfort while brushing or alteration in taste) in the oral hard or soft tissues were monitored throughout the study. ResultsA total of 81 patients were enrolled (40 in the experimental group; 41 in the control group), of whom 79 (55 women; 24 men) completed the study. After topical use, the experimental group had a significantly higher mean (SD) tactile hypersensitivity score (19.47 [14.69] vs 14.27 [5.76]; P = 0.047) and a significantly lower mean air blast hypersensitivity score (1.93 [0.51] vs 2.22 [0.60]; P = 0.026) than did the control group. After 3 days, the experimental group had a significantly higher mean tactile hypersensitivity score (19.87 [14.95] vs 14.51 [6.00]; P = 0.045) and a significantly lower air blast hypersensitivity score (1.80 [0.56] and 2.13 [0.60]; P = 0.014) than the control group. After topical use and after 3 days, the experimental group had increases from baseline in tactile scores of 54.04% and 56.67%, respectively (both, P = 0.001) and reductions from baseline in air blast scores of 18.51% and 24.21% (both, P < 0.001); the control group had increases in tactile scores of 21.14% and 21.54% (P = 0.022 and P = 0.007) and reductions in air blast scores of 10.24% and 13.41% (P = 0.001 and P < 0.001). No adverse events were reported throughout the study. ConclusionIn these patients with DH in China, the dentifrice containing 2% strontium chloride and 5% potassium nitrate was efficacious in reducing DH when used instantly after topical dentifrice use and after 3 days of use. Clinicaltrials.gov identifier: NCT01426360.

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