drugset / Trial / NCT05750745

A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population

NCT05750745 ↗

Completed 416 enrolled HALEON
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of the 0.454 percentage (%) weight/weight (w/w) stannous fluoride (SnF2) toothpastes for the relief of dentine hypersensitivity (DH) in China.

Timeline

Start
2023-05-08
Primary completion
2023-09-19
Completion
2023-09-19

Outcome

Missed primary endpoint

registry analysis (superiority test); Test Dentifrice (Sensodyne Sensitivity and Gum) vs Negative Control (Crest Cavity Protection Fresh Lime); p = 0.0871; Adjusted Mean Difference -0.17 (95% CI -0.36 to 0.02); Mixed Model with Repeated Measure (MMRM) NCT05750745 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator PHOSPHINE SILANE Other / unclassified 5 % Topical
Comparator sodium fluoride Unknown 1150 ppm Topical
Subject stannous fluoride Small molecule 0.454 % Topical

Indications