A Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks

Summary

The purpose of this clinical study is to investigate the efficacy of a dentifrice containing 0.454 percent (%) weight by weight (w/w) stannous fluoride (SnF2), on gingivitis treatment and plaque reduction, compared to a regular fluoride dentifrice after 12 weeks twice daily brushing in a population of clinically diagnosed gingivitis without undergoing dental prophylaxis.

Timeline

Start

2023-11-29

Primary completion

2024-03-12

Completion

2024-03-12

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Test Product: -14.6 (Standard Error 0.99) bleeding sites NCT06143670 ↗

registry analysis (superiority test); Test Product; p <0.0001; Mixed Model with Repeated Measures NCT06143670 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	sodium fluoride	Unknown	0.243 %	—
Subject	stannous fluoride	Small molecule	0.454 %	—

Indications