Conditions: Dental Caries
Keywords: Calcium glycerophosphate Fluoride Dentifrice Biofilm Dental caries
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 12
Healthy volunteers: yes

Brief 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.

Detailed description:
Although the mechanisms of action of fluoride are reasonably understood, the mechanism of calcium phosphate and calcium glycerophosphate (CaGP) are still a matter of debate. It has been suggested that CaGP increases the phosphorus content in the biofilm and, as a result, the buffering capacity of the biofilm is intensified. The pH levels of the biofilm are maintained above the 5.0-5.5 range. This is above the critical range for enamel demineralization.

Arms:
arm 1: 4 types of dentifrices were used in 4 different periods in a crossover study design.

Interventions: intervention 1: calcium glycerophosphate intervention 2: no active ingredient intervention 3: fluoride intervention 4: CAGP + fluoride
Intervention descriptions: intervention 1: use of a dentifrice containing CaGP (0.13%) and no fluoride intervention 2: dentifrice without calcium glycerophosphate and no fluoride intervention 3: use of a dentifrice containing fluoride (1500ppm) only intervention 4: calcium glycerophosphate and fluoride dentifrice

Protocol document: