CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
calcium glycerophosphate +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00875212
NCT00875212Phase 1Completed

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

Federal University of Paraíba·interventional·Posted Apr 3, 2009·Updated Oct 15, 2009

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesBrazil

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 3, 2009
Enrollment StartJan 1, 2006
Primary CompletionDec 1, 2007
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.2 years ago

Interventions

calcium glycerophosphatedrug

use of a dentifrice containing CaGP (0.13%) and no fluoride

no active ingredientdrug

dentifrice without calcium glycerophosphate and no fluoride

fluoridedrug

use of a dentifrice containing fluoride (1500ppm) only

CAGP + fluoridedrug

calcium glycerophosphate and fluoride dentifrice