NCT00875212

Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH

Effect of a Dentifrice Containing Calcium Glycerophosphate and Fluoride on the pH of Dental Biofilm in Vivo

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Federal University of Paraíba · Academic / Other
• Sex: All
• Age: 19 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DRUG	calcium glycerophosphate	use of a dentifrice containing CaGP (0.13%) and no fluoride
DRUG	no active ingredient	dentifrice without calcium glycerophosphate and no fluoride
DRUG	fluoride	use of a dentifrice containing fluoride (1500ppm) only
DRUG	CAGP + fluoride	calcium glycerophosphate and fluoride dentifrice

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-12-01
• Completion: 2008-07-01
• First posted: 2009-04-03
• Last updated: 2009-10-15
• Results posted: 2009-10-12

Locations

1 site across 1 country: Brazil