Dental Plaque Prevention Efficacy of a Stannous Fluoride Toothpaste

Dental Plaque Prevention Efficacy Evaluation and Comparison of a Stannous Fluoride Toothpaste

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.

Study Overview

• Status: Completed
• Conditions: Dental Plaque
• Intervention / Treatment: Drug: Sodium Fluoride Dentifrice; Drug: Stannous Fluoride Toothpaste (SnF)

Detailed Description

This two-week, randomized, double-blind, parallel-group study evaluated plaque prevention following dental cleaning. Subjects meeting plaque qualification criteria underwent a complete prophylaxis and were randomized to either a stannous fluoride test dentifrice or a sodium fluoride control dentifrice. Subjects brushed twice daily for two minutes with the assigned product. Plaque accumulation was assessed at baseline, after one day of use, and after 14 days of use following overnight abstention from oral hygiene. Plaque was disclosed and scored on facial and lingual tooth surfaces using the Lobene-Soparkar modified Turesky Plaque Index. Treatment comparisons were performed using ANCOVA with baseline plaque as a covariate.

• Study Type: Interventional
• Enrollment (Actual): 91
• 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:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel 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 plaque prevention 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	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole-Mouth Dental Plaque Score at Day 1	Mean whole-mouth plaque index score assessed one day after initial supervised brushing.	Day 1 (12 hours post-brushing)

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): October 16, 2024
• Primary Completion (Actual): December 4, 2024
• Study Completion (Actual): December 4, 2024

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: ST-24-U50

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