Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice

Phase 2

Completed

• Conditions: Caries
• Interventions: Drug: Calcium sodium phosphosilicate; Drug: Placebo; Drug: Sodium monoflurophosphate

• Registration Number: NCT01657877
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-02
• Study First Posted: 2012-08-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2014-06-19
• Results First Submitted QC: 2014-06-26
• Results First Posted: 2014-07-24
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-18
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CSP/SMFP Dentifrice	Calcium sodium phosphosilicate	Dentifrice containing high fluoride content as SMFP and CSP
CSP/SMFP Dentifrice	Sodium monoflurophosphate	Dentifrice containing high fluoride content as SMFP and CSP
SMFP Dentifrice Prototype 1	Sodium monoflurophosphate	Dentifrice containing high fluoride content as SMFP and no CSP
SMFP Dentifrice Prototype 2	Sodium monoflurophosphate	Dentifrice containing low fluoride content as SMFP and no CSP
CSP Dentifrice	Calcium sodium phosphosilicate	Dentifrice containing CSP but no fluoride
Placebo Dentifrice	Placebo	Dentifrice containing no CSP and no fluoride

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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	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.
Enamel Fluoride Uptake (EFU)	Baseline to 21 days	Change to EFU was determine using a microdrill enamel biopsy of the in situ enamel specimens.

Trial Locations

Locations (1)

Indiana University School of Dentistry; 🇺🇸 Indianapolis, Indiana, United States