Phase 2 N=79 Randomized Double-blind Treatment

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

Caries

Bottom Line

View on ClinicalTrials.gov: NCT01657877 ↗

Enrolled (actual)

Serious AEs

0.8%

Results posted

Jul 2014

Primary outcome: Primary: 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. — 30.15; 32.32 Percentage SMHR — p=0.2601

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Calcium sodium phosphosilicate (Drug); Sodium monoflurophosphate (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	30.15; 32.32	0.2601
SECONDARY 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.	18.72; 14.74; 14.01	—
SECONDARY Enamel Fluoride Uptake (EFU)	15.58; 14.85; 9.23; 4.17; 4.54	—

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.

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)].

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Data sourced from ClinicalTrials.gov (NCT01657877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.