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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01657877
First received: August 2, 2012
Last updated: April 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Caries
Drug: Calcium sodium phosphosilicate
Drug: Sodium monoflurophosphate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: In Situ Study to Confirm the Anti-caries Potential of a 1.1365% w/w Sodium Monofluorophosphate (1500ppm F) Dentifrice

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage surface microhardness recovery (SMHR) of test dentrifice relative to reference dentrifice [ Time Frame: Baseline to 21 days ] [ Designated as safety issue: No ]
    Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation 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.


Secondary Outcome Measures:
  • Percentage SMHR of treatment dentrifices [ Time Frame: Baseline to 21 days ] [ Designated as safety issue: No ]
    Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation 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.

  • Percentage enamel fluoride uptake (EFU) [ Time Frame: Baseline to 21 days ] [ Designated as safety issue: No ]
    Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.


Enrollment: 100
Study Start Date: May 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CSP/SMFP Dentifrice
Dentifrice containing high fluoride content as SMFP and CSP
Drug: Calcium sodium phosphosilicate
CSP high percentage weight by weight
Drug: Sodium monoflurophosphate
500 to 1500 parts per million (ppm) of fluoride
Active Comparator: SMFP Dentifrice Prototype 1
Dentifrice containing high fluoride content as SMFP and no CSP
Drug: Sodium monoflurophosphate
500 to 1500 parts per million (ppm) of fluoride
Active Comparator: SMFP Dentifrice Prototype 2
Dentifrice containing low fluoride content as SMFP and no CSP
Drug: Sodium monoflurophosphate
500 to 1500 parts per million (ppm) of fluoride
Active Comparator: CSP Dentifrice
Dentifrice containing CSP but no fluoride
Drug: Calcium sodium phosphosilicate
CSP high percentage weight by weight
Placebo Comparator: Placebo Dentifrice
Dentifrice containing no CSP and no fluoride
Drug: Placebo
No CSP and no fluoride

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)].
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657877

Locations
United States, Indiana
Indiana University School of Dentistry
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01657877     History of Changes
Other Study ID Numbers: RH01381
Study First Received: August 2, 2012
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fluorophosphate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014