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

NCT01657877 | Completed Phase 2 Results

• 1 other identifier: RH01381
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline to 21 days

Secondary Outcomes (2)

• 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

Study Arms (5)

CSP/SMFP Dentifrice

EXPERIMENTAL

Dentifrice containing high fluoride content as SMFP and CSP

Drug: Calcium sodium phosphosilicate; Drug: Sodium monoflurophosphate

SMFP Dentifrice Prototype 1

ACTIVE COMPARATOR

Dentifrice containing high fluoride content as SMFP and no CSP

Drug: Sodium monoflurophosphate

SMFP Dentifrice Prototype 2

ACTIVE COMPARATOR

Dentifrice containing low fluoride content as SMFP and no CSP

Drug: Sodium monoflurophosphate

CSP Dentifrice

ACTIVE COMPARATOR

Dentifrice containing CSP but no fluoride

Drug: Calcium sodium phosphosilicate

Placebo Dentifrice

PLACEBO COMPARATOR

Dentifrice containing no CSP and no fluoride

Drug: Placebo

Interventions

Calcium sodium phosphosilicate DRUG

CSP high percentage weight by weight

CSP Dentifrice; CSP/SMFP Dentifrice

Sodium monoflurophosphate DRUG

500 to 1500 parts per million (ppm) of fluoride

CSP/SMFP Dentifrice; SMFP Dentifrice Prototype 1; SMFP Dentifrice Prototype 2

Placebo DRUG

No CSP and no fluoride

Placebo Dentifrice

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[required dimensions 12 x 7 millimeters (mm)\].

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 6, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 1, 2014
• Results First Posted: July 24, 2014

Record last verified: 2014-09

Locations

US (1)