Last updated: 11/04/2018 10:25:59
Anti-caries potential of a sodium monofluorophosphate and Calcium sodium Phosphosilicate dentifrice
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2013-30-06
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
Indiana University School of Dentistry
Indianapolis, IN, United States, 46202
Status
Recruiting
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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