Last updated: 11/04/2018 10:25:59

Anti-caries potential of a sodium monofluorophosphate and Calcium sodium Phosphosilicate dentifrice

GSK study ID
RH01381
See study documents
Clinicaltrials.gov ID
NCT01657877
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: In Situ Study to Confirm the Anti-caries Potential of a 1.1365% w/w Sodium Monofluorophosphate (1500ppm F) Dentifrice
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

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.

Timeframe: Baseline to 21 days

Secondary outcomes:

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.

Timeframe: Baseline to 21 days

Enamel fluoride uptake (EFU)

Timeframe: Baseline to 21 days

Interventions:
  • Drug: Calcium sodium phosphosilicate
  • Drug: Sodium monoflurophosphate
  • Drug: Placebo
    • Enrollment:
    100
    Primary completion date:
    2013-30-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Caries
    Product
    Calcium sodium phosphosilicate, Sodium monofluorophosphate
    Collaborators
    Not applicable
    Study date(s)
    May 2012 to June 2013
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 80 years
    Accepts healthy volunteers
    Yes
    • 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)].
    Inclusion and exclusion criteria
    Inclusion 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 location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    Indiana University School of Dentistry
    Indianapolis, IN, United States, 46202
    Status
    Recruiting
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2013-30-06
    Actual study completion date
    2013-30-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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