Dental Plaque Prevention Efficacy of a Stannous Fluoride Toothpaste

N/ACompletedNCT07419737

Church & Dwight Company, Inc.91 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Dental Plaque

Interventions

Stannous Fluoride Toothpaste (SnF)DRUG

Test toothpaste (0.454% SnF)

Sodium Fluoride DentifriceDRUG

Comparator toothpaste (0.243% NaF)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Salus Research, Inc.

Fort Wayne, Indiana, United States

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Whole-Mouth Dental Plaque Score at Day 1

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

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

Data from ClinicalTrials.gov

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