Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH
NCT00875212 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2009-10-15
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.
Conditions
- Dental Caries
Interventions
- 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
Sponsors & Collaborators
-
Conselho Nacional de Desenvolvimento Científico e Tecnológico
collaborator OTHER_GOV -
Coordination for the Improvement of Higher Education Personnel
collaborator OTHER -
Federal University of Paraíba
lead OTHER
Principal Investigators
-
Fabio C Sampaio, PhD · Federal University of Paraiba
-
Thiago S Carvalho, Master · Federal University of Paraiba
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 19 Years
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2006-01-31
- Primary Completion
- 2007-12-31
- Completion
- 2008-07-31
Countries
- Brazil
Study Locations
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