BACKGROUND: Dentinal hypersensitivity is a prevalent oral condition that can be treated with in-office application of potassium oxalate (KO), which has US Food and Drug Administration 510(k) clearance. In this study, the authors assessed a KO mouthrinse for home use. The authors evaluated clinically meaningful improvement by analyzing the proportions of participants who responded to treatment. METHODS: In this multicenter, double-blind, parallel-group controlled study, the authors randomly assigned 375 participants with dentinal hypersensitivity to 1 of 2 mouthrinse groups: KO (189 participants) and placebo (186 participants). Participants used their assigned mouthrinses for 4 weeks. Each participant's success (defined as a ≥ 30% reduction from baseline in mean cold air stimulus response) was the primary efficacy measurement. The authors further defined success, on the basis of 2012 criteria from the American Dental Association, as a statistically significant difference of 20% or more between experimental and placebo groups for 1 sensitivity index. RESULTS: KO mouthrinse had statistically significantly higher success rates (the primary efficacy measurement) than did placebo (69.3% versus 44.6%; estimated odds ratio [OR], 2.817; 95% confidence interval [CI], 1.843 to 4.307; P < .001). At week 4, KO had statistically significant improvements compared with placebo in cold air stimulus score (estimated difference, -14.27 millimeters; 95% CI, -18.68 to -9.87; 35.6% improvement; P < .001) and tactile sensitivity (estimated difference, 13.45 grams; 95% CI, 9.83 to 17.08; 88.0% improvement; P < .001). The authors also observed statistically significant improvements for KO at week 2. Cold air stimulus and tactile sensitivity scores at weeks 2 and 4 were secondary efficacy measurements. CONCLUSIONS: This study's results demonstrated that KO mouthrinse used as an adjunct to toothbrushing statistically and clinically significantly controlled and reduced dentinal hypersensitivity. PRACTICAL IMPLICATIONS: Clinicians can use these results when determining appropriate at-home care regimens for patients with hypersensitivity.
BACKGROUND: Dentinal hypersensitivity is a prevalent oral condition that can be treated with in-office application of potassium oxalate (KO), which has US Food and Drug Administration 510(k) clearance. In this study, the authors assessed a KO mouthrinse for home use. The authors evaluated clinically meaningful improvement by analyzing the proportions of participants who responded to treatment. METHODS: In this multicenter, double-blind, parallel-group controlled study, the authors randomly assigned 375 participants with dentinal hypersensitivity to 1 of 2 mouthrinse groups: KO (189 participants) and placebo (186 participants). Participants used their assigned mouthrinses for 4 weeks. Each participant's success (defined as a ≥ 30% reduction from baseline in mean cold air stimulus response) was the primary efficacy measurement. The authors further defined success, on the basis of 2012 criteria from the American Dental Association, as a statistically significant difference of 20% or more between experimental and placebo groups for 1 sensitivity index. RESULTS: KO mouthrinse had statistically significantly higher success rates (the primary efficacy measurement) than did placebo (69.3% versus 44.6%; estimated odds ratio [OR], 2.817; 95% confidence interval [CI], 1.843 to 4.307; P < .001). At week 4, KO had statistically significant improvements compared with placebo in cold air stimulus score (estimated difference, -14.27 millimeters; 95% CI, -18.68 to -9.87; 35.6% improvement; P < .001) and tactile sensitivity (estimated difference, 13.45 grams; 95% CI, 9.83 to 17.08; 88.0% improvement; P < .001). The authors also observed statistically significant improvements for KO at week 2. Cold air stimulus and tactile sensitivity scores at weeks 2 and 4 were secondary efficacy measurements. CONCLUSIONS: This study's results demonstrated that KO mouthrinse used as an adjunct to toothbrushing statistically and clinically significantly controlled and reduced dentinal hypersensitivity. PRACTICAL IMPLICATIONS: Clinicians can use these results when determining appropriate at-home care regimens for patients with hypersensitivity.