drugset / Trial / NCT04050722

A Clinical Study Investigating the Efficacy of a Stannous Fluoride Dentifrice in Improving Gingival Health After Twice Daily Use for 3 Weeks

NCT04050722 ↗

Phase 4 Completed 130 enrolled GlaxoSmithKline
RandomizedParallel-groupSingle-blindTreatment

Summary

The aim of this study is to investigate the impact of a stannous fluoride containing toothpaste in reducing gingivitis when used twice daily for a maximum for 3 weeks, when compared to a standard sodium fluoride toothpaste (negative control).

Timeline

Start
2019-10-07
Primary completion
2019-11-13
Completion
2019-11-13

Outcome

Met primary endpoint

registry analysis (superiority test); Sensodyne Repair and Protect (Test Dentifrice) vs Colgate Cavity Protection (Negative Control Dentifrice); p <0.0001; Adjusted Mean Difference -0.06 NCT04050722 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject sodium fluoride Unknown — Topical
Subject stannous fluoride Small molecule 0.454 % Topical

Indications