Phase 1
N=12
Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT00875212 ↗Enrolled (actual)
12
Serious AEs
—
Results posted
Oct 2009
Primary outcome: Primary: Minimum pH — 5.40; 5.48; 5.25; 5.70 pH — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- calcium glycerophosphate (Drug); no active ingredient (Drug); fluoride (Drug); CAGP + fluoride (Drug)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- Federal University of Paraíba
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minimum pH |
5.40; 5.48; 5.25; 5.70 | 0.001 sig |
| PRIMARY Minimum pH After 14 Days of Use of Dentifrice |
4.78; 5.24; 5.25; 5.44 | 0.01 sig |
Summary
The aim of this study was to investigate the buffering effect of a calcium glycerophosphate-fluoride (CaGP-F) dentifrice on in vivo dental biofilm after a cariogenic challenge and evaluate its probable 12-hour protective effect. Twelve young adults took part in this randomized, double blind, 14-day 4-phase crossover study. Between each phase, the volunteers had a 1-week wash-out period. Coded dentifrices were randomly assigned to the volunteers: A) no F and no CaGP; B) CaGP-only (0.13%); C) F-only (1500 ppm (ppm= parts per million of fluoride which is equivalent to mg/kg)); D) CaGP-F (0.13%, 1500 ppm, respectively). The pH measurements were taken from a single-site using a microelectrode, with salt bridge established by a 1M KCl (one molar potassium chloride) solution with a reference electrode. pH measurements were taken at 0 (baseline), 1, 7, 14 and 21 min (minutes) after a cariogenic challenge (10% w/v sucrose solution, %w/v = percent weight per volume). Four sets of measurements were carried out: (D0BS) before test dentifrice usage; (D01min) 1-min after test dentifrice usage; and (D712h) 7 days and (D1412h) 14 days using the test dentifrice, 12 hours (h)after brushing. Stephen curves and mean AUC (area under the curve) were obtained.
Eligibility Criteria
Inclusion Criteria
- to live in a non-fluoridated area
- to have at least 20 natural teeth
- signed a consent form agreeing to carefully follow the research instructions
Exclusion Criteria
- presence of active caries lesions
- periodontal disease
- use of antibiotics/medication.
Data sourced from ClinicalTrials.gov (NCT00875212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.