In Situ Study to Confirm the Anti-caries Potential of a 1.1365% w/w Sodium Monofluorophosphate (1500ppm F) Dentifrice
Overview
- Phase
- Phase 2
- Intervention
- Calcium sodium phosphosilicate
- Conditions
- Caries
- Sponsor
- GlaxoSmithKline
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
In situ study to compare treatment effect on enamel remineralization potential, measured by surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice containing calcium sodium phosphosilicate (CSP) in comparison to an experimental SMFP only dentifrice.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Wears a removable bilateral mandibular partial denture that has good stability and support, with sufficient room on each side in the posterior buccal flange area to accommodate two enamel specimens \[required dimensions 12 x 7 millimeters (mm)\].
Exclusion Criteria
- Not provided
Arms & Interventions
CSP/SMFP Dentifrice
Dentifrice containing high fluoride content as SMFP and CSP
Intervention: Calcium sodium phosphosilicate
CSP/SMFP Dentifrice
Dentifrice containing high fluoride content as SMFP and CSP
Intervention: Sodium monoflurophosphate
SMFP Dentifrice Prototype 1
Dentifrice containing high fluoride content as SMFP and no CSP
Intervention: Sodium monoflurophosphate
SMFP Dentifrice Prototype 2
Dentifrice containing low fluoride content as SMFP and no CSP
Intervention: Sodium monoflurophosphate
CSP Dentifrice
Dentifrice containing CSP but no fluoride
Intervention: Calcium sodium phosphosilicate
Placebo Dentifrice
Dentifrice containing no CSP and no fluoride
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice.
Time Frame: Baseline to 21 days
Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: \[(D1-R)/ (D1-B)\]\*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.
Secondary Outcomes
- Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP.(Baseline to 21 days)
- Enamel Fluoride Uptake (EFU)(Baseline to 21 days)