At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of a Dentifrice Containing Calcium Glycerophosphate and Fluoride on the pH of Dental Biofilm in Vivo
In Brief
A Phase 1 clinical trial evaluating calcium glycerophosphate, no active ingredient, and 2 other interventions for Dental Caries. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
use of a dentifrice containing CaGP (0.13%) and no fluoride
dentifrice without calcium glycerophosphate and no fluoride
use of a dentifrice containing fluoride (1500ppm) only
calcium glycerophosphate and fluoride dentifrice