A Bleeding-Model Clinical Study

Completed 90 enrolled Procter and Gamble

RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.

Timeline

Start: 2020-10-19
Primary completion: 2020-11-20
Completion: 2020-11-20

Outcome

Met primary endpoint

paper At 1 mo, the positive control produced 45.1% (study 1) and 45.8% (study 2) fewer bleeding sites versus the negative control (P < 0.001 for both), PMID 39118360 ↗

Publications

He T, Zou Y, Grender J, Amini P, Kaminski M, Biesbrock AR. Randomized Controlled Trials Assessing Exposure Frequency Effects of Stannous Fluoride on Gingivitis. JDR Clin Trans Res. 2025 Apr;10(2):124-134. doi: 10.1177/23800844241263031. Epub 2024 Aug 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	sodium monofluorophosphate	Unknown	0.76 %	Topical
Subject	stannous fluoride	Small molecule	0.454 %	Topical