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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Caries

Treatments: Drug: Sodium monoflurophosphate; Drug: Calcium sodium phosphosilicate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01657877

RH01381

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)].

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

100 participants in 5 patient groups, including a placebo group

CSP/SMFP Dentifrice

Experimental group

Description:

Dentifrice containing high fluoride content as SMFP and CSP

Treatment:

Drug: Sodium monoflurophosphate

Drug: Calcium sodium phosphosilicate

SMFP Dentifrice Prototype 1

Active Comparator group

Description:

Dentifrice containing high fluoride content as SMFP and no CSP

Treatment:

Drug: Sodium monoflurophosphate

SMFP Dentifrice Prototype 2

Active Comparator group

Description:

Dentifrice containing low fluoride content as SMFP and no CSP

Treatment:

Drug: Sodium monoflurophosphate

CSP Dentifrice

Active Comparator group

Description:

Dentifrice containing CSP but no fluoride

Treatment:

Drug: Calcium sodium phosphosilicate

Placebo Dentifrice

Placebo Comparator group

Description:

Dentifrice containing no CSP and no fluoride

Treatment:

Drug: Placebo