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Completed

NCT Number: NCT07419737

Dental Plaque Prevention Efficacy 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.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stannous Fluoride Toothpaste (SnF)

Drug

Test toothpaste (0.454% SnF)

Sodium Fluoride Dentifrice

Drug

Comparator toothpaste (0.243% NaF)

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Whole-Mouth Dental Plaque Score at Day 1

    Time frame: Day 1 (12 hours post-brushing)

    Mean whole-mouth plaque index score assessed one day after initial supervised brushing.

Sponsors and collaborators

Lead sponsor

Church & Dwight Company, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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