Evaluation of a Stannous Fluoride Dentifrice for Control of Oral Malodor

NCT07425509 | Completed

• 1 other identifier: ST-24-U47
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Malodor (Halitosis)

Outcome Measures

Primary Outcomes (1)

• Change in Odor Intensity Score (OI

  Baseline to 12-hour overnight assessment after 7 days of product use

Secondary Outcomes (1)

• Change in Odor Intensity Score at Day 1

  Mean change in Odor Intensity Scores from baseline to Day 1 overnight assessment.

Other Outcomes (1)

• Daytime Odor Intensity Scores

  4 and 8 hours post-brushing on Day 1 and Day

Study Arms (2)

Sodium Fluoride Control Dentifrice

OTHER

Dentifrice containing sodium fluoride, serving as the control comparator.

Drug: Sodium Fluoride Dentifrice

Stannous Fluoride Toothpaste

EXPERIMENTAL

Dentifrice containing stannous fluoride evaluated for malodor reduction compared to sodium fluoride control.

Drug: Stannous Fluoride Toothpaste (SnF)

Interventions

Sodium Fluoride Dentifrice DRUG

Comparator toothpaste (0.243% NaF)

Sodium Fluoride Control Dentifrice

Stannous Fluoride Toothpaste (SnF) DRUG

Test toothpaste (0.454% SnF)

Stannous Fluoride Toothpaste

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead

Study Sites (1)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Annahita Ghassemi, PhD

  Church & Dwight, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: September 9, 2024
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)