drugset / Trial / NCT01587950

The Effects of Potassium Nitrate in Reducing Dentinal Hypersensitivity

NCT01587950 ↗

Phase 1 Completed 12 enrolled GlaxoSmithKline
RandomizedCrossoverDouble-blindTreatment

Summary

A randomized, controlled, double blind exploratory study to explore the effects of two different potassium nitrate concentrations and water on exposed dentine in reducing dentinal hypersensitivity. Solutions will be applied for either 2, 5 or 10 minutes and assessed by visual analogue scale (VAS) scores following evaporative (air) stimulus.

Timeline

Start
2009-02
Primary completion
2009-04
Completion
2009-04

Outcome

Missed primary endpoint

registry analysis (superiority or other test); 5% KNO3 Solution (2 Minutes) vs Sterile Water (2 Minutes); p = 0.5718; Adjusted Mean Difference -3.89 (95% CI -17.59 to 9.80); ANCOVA NCT01587950 ↗

registry analysis (superiority or other test); 5% KNO3 Solution (10 Minutes) vs Sterile Water (10 Minutes); p = 0.4255; Adjusted Mean Difference -5.56 (95% CI -19.42 to 8.29); ANCOVA NCT01587950 ↗

registry analysis (superiority or other test); 5% KNO3 Solution (10 Minutes) vs Sterile Water (10 Minutes); p = 0.8703; Adjusted Mean Difference -1.07 (95% CI -14.11 to 11.97); ANCOVA NCT01587950 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Potassium Nitrate Other / unclassified 2.5 % —
Subject Potassium Nitrate Other / unclassified 5 % —