A Clinical Study Investigating the Effects of a Dentifrice Containing 67% Sodium Bicarbonate When Used Twice Daily for 12 Weeks on Gingivitis Treatment and Plaque Removal

Summary

The main goal of this study is to evaluate and compare the efficacy of an on-market dentifrice containing 67 percent (%) sodium bicarbonate and 0.31% sodium fluoride to a reference regular fluoride dentifrice on treating gingival bleeding and gingival inflammation as well as reducing plaque accumulation in population with gingivitis after 12 weeks use.

Timeline

Start

2023-02-20

Primary completion

2023-11-30

Completion

2023-11-30

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Test Product (Corsodyl Original Toothpaste): -4.3 (Standard Error 1.44) bleeding sites NCT05654662 ↗

registry analysis (superiority test); Test Product (Corsodyl Original Toothpaste); p = 0.0032; MMRM NCT05654662 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	sodium bicarbonate	Diagnostic / imaging agent	67 %	Topical
Subject	sodium fluoride	Unknown	0.1 %	Topical
Subject	sodium fluoride	Unknown	0.31 %	Topical
Comparator	sodium monofluorophosphate	Unknown	0.76 %	Topical

Indications