NCT07425509

Evaluation of a Stannous Fluoride Dentifrice for Control of Oral Malodor

A Randomized Crossover Clinical Evaluation of a Stannous Fluoride Containing Dentifrice on Oral Malodor

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Church & Dwight Company, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This single-center, randomized, double-blind, two-treatment crossover clinical study evaluated the safety and efficacy of a stannous fluoride-containing dentifrice compared with a sodium fluoride control dentifrice for the control of intrinsic oral malodor. Adult subjects brushed twice daily with each product during separate treatment periods following standardized wash-out periods. Oral malodor was assessed using trained organoleptic judges applying a validated Odor Intensity (OI) scale at baseline and multiple post-treatment time points.

Detailed description

This four-week, randomized, double-blind crossover study enrolled generally healthy adult subjects with qualifying intrinsic oral malodor. Following screening and an acclimation wash-out period using an ADA-accepted sodium fluoride dentifrice, subjects were randomized to one of two treatment sequences: TheraBreath® Healthy Gums Toothpaste or Crest® Cavity Protection Toothpaste. Each treatment period included supervised and at-home twice-daily brushing without tongue brushing or use of non-study oral hygiene products. Oral malodor was evaluated at baseline, 12-hour overnight, and 4- and 8-hour post-brushing time points on Day 1 and Day 7 using standardized organoleptic assessments performed by three trained judges. Safety was monitored through oral examinations and subject interviews. Treatment comparisons were analyzed using ANCOVA models appropriate for crossover designs.

Conditions

• Oral Malodor (Halitosis)

Interventions

Type	Name	Description
DRUG	Sodium Fluoride Dentifrice	Comparator toothpaste (0.243% NaF)
DRUG	Stannous Fluoride Toothpaste (SnF)	Test toothpaste (0.454% SnF)

Timeline

• Start date: 2024-09-09
• Primary completion: 2024-11-04
• Completion: 2024-11-04
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States