Dental Plaque
Conditions
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.
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.
Interventions
Test toothpaste (0.454% SnF)
Comparator toothpaste (0.243% NaF)
Sponsors
Church & Dwight Company, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Whole-Mouth Dental Plaque Score (Turesky Modified Quigley-Hein Index) | 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
| Measure | Time frame | Description |
|---|---|---|
| Whole-Mouth Dental Plaque Score at Day 1 | Day 1 (12 hours post-brushing) | Mean whole-mouth plaque index score assessed one day after initial supervised brushing. |
Countries
United States
Contacts
STUDY_DIRECTORAnnahita Ghassemi, PhD
Church & Dwight, Inc.
Outcome results
None listed