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

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.

Study Overview

• Status: Completed
• Conditions: Oral Malodor (Halitosis)
• Intervention / Treatment: Drug: Sodium Fluoride Dentifrice; Drug: Stannous Fluoride Toothpaste (SnF)

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • Salus Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults ≥18 years of age in good general health
• Baseline odor intensity score ≥2 after approximately 12 hours of oral hygiene abstention
• Intra-oral source of oral malodor
• At least 18 natural teeth
• Willing to comply with oral hygiene, dietary, and behavioral restrictions
• Able to provide informed consent

Exclusion Criteria:

• Allergy to oral hygiene products
• Pregnant or nursing
• Serious medical conditions affecting oral malodor
• Recent antibiotic or anti-inflammatory medication use
• Smoker or user of smokeless tobacco
• Advanced periodontal disease, frank caries, or significant oral pathology
• Participation in another oral care study within 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sodium Fluoride Control Dentifrice; Dentifrice containing sodium fluoride, serving as the control comparator.	Drug: Sodium Fluoride Dentifrice; Comparator toothpaste (0.243% NaF)
Experimental: Stannous Fluoride Toothpaste; Dentifrice containing stannous fluoride evaluated for malodor reduction compared to sodium fluoride control.	Drug: Stannous Fluoride Toothpaste (SnF); Test toothpaste (0.454% SnF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Odor Intensity Score (OI	Baseline to 12-hour overnight assessment after 7 days of product use

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Odor Intensity Score at Day 1	Mean change in Odor Intensity Scores from baseline to Day 1 overnight assessment.

Other Outcome Measures

Outcome Measure	Time Frame
Daytime Odor Intensity Scores	4 and 8 hours post-brushing on Day 1 and Day

Collaborators and Investigators

• Sponsor: Church & Dwight Company, Inc.
• Investigators: Study Director: Annahita Ghassemi, PhD, Church & Dwight, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2024
• Primary Completion (Actual): November 4, 2024
• Study Completion (Actual): November 4, 2024

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Halitosis
• Other Study ID Numbers: ST-24-U47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The sponsor does not plan to share individual participant data. Summary results will be provided as required, but no de-identified datasets will be made publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No