Dental Plaque Prevention Efficacy of a Stannous Fluoride Toothpaste

NCT07419737 | Completed

• 1 other identifier: ST-24-U50
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, stratified, double-blind, two-cell parallel clinical study evaluated the dental plaque prevention efficacy of a stannous fluoride toothpaste compared to a sodium fluoride control toothpaste following a professional dental prophylaxis. Adult subjects brushed twice daily for 14 days with their assigned dentifrice. Plaque was assessed using the Lobene-Soparkar modification of the Turesky Modification of the Quigley-Hein Plaque Index at baseline, Day 1, and Day 14 following periods of oral hygiene abstention.

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (1)

• Whole-Mouth Dental Plaque Score (Turesky Modified Quigley-Hein Index)

  Mean whole-mouth plaque index score assessed using the Lobene-Soparkar modification of the Turesky Modification of the Quigley-Hein Plaque Index. Treatment comparisons performed using ANCOVA with baseline plaque score as a covariate.

  Day 14 (12 hours post-brushing following 14 days of twice-daily use)

Secondary Outcomes (1)

• Whole-Mouth Dental Plaque Score at Day 1

  Day 1 (12 hours post-brushing)

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 plaque prevention compared to sodium fluoride control.

Drug: Stannous Fluoride Toothpaste (SnF)

Interventions

Stannous Fluoride Toothpaste (SnF) DRUG

Test toothpaste (0.454% SnF)

Stannous Fluoride Toothpaste

Sodium Fluoride Dentifrice DRUG

Comparator toothpaste (0.243% NaF)

Sodium Fluoride Control Dentifrice

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Good general health based on medical history
• Minimum of 18 natural teeth with scorable surfaces
• Baseline mean plaque score ≥2.0
• Willing to refrain from non-study oral hygiene products
• Willing to abstain from oral hygiene prior to study visits
• Able and willing to comply with study procedures

You may not qualify if:

• Known allergy to oral care products
• Conditions limiting normal brushing
• Significant medical conditions affecting study participation
• Pregnant or nursing females
• Severe periodontal disease
• Recent dental prophylaxis
• Recent participation in another dental study

Sponsors & Collaborators

• Church & Dwight Company, Inc.: lead

Study Sites (1)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: October 16, 2024
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)