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

This study has been completed.
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordination for the Improvement of Higher Education Personnel
Information provided by:
Federal University of Paraíba
ClinicalTrials.gov Identifier:
NCT00875212
First received: April 2, 2009
Last updated: October 13, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Dental Caries
Drug: calcium glycerophosphate
Drug: no active ingredient
Drug: fluoride
Drug: CAGP + fluoride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Effect of a Dentifrice Containing Calcium Glycerophosphate and Fluoride on the pH of Dental Biofilm in Vivo

Resource links provided by NLM:


Further study details as provided by Federal University of Paraíba:

Primary Outcome Measures:
  • Minimum pH [ Time Frame: at 1 minute (minimum fermenting pH) or at 7 minutes ] [ Designated as safety issue: Yes ]
  • Minimum pH After 14 Days of Use of Dentifrice [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: January 2006
Study Completion Date: July 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dentifrice intervention
4 types of dentifrices were used in 4 different periods in a crossover study design.
Drug: calcium glycerophosphate
use of a dentifrice containing CaGP (0.13%) and no fluoride
Other Name: CaGP
Drug: no active ingredient
dentifrice without calcium glycerophosphate and no fluoride
Other Name: dentifrice only (placebo)
Drug: fluoride
use of a dentifrice containing fluoride (1500ppm) only
Other Name: sodium fluoride
Drug: CAGP + fluoride
calcium glycerophosphate and fluoride dentifrice
Other Name: Experimental dentifrice with CAGP + fluoride

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.

  Eligibility

Ages Eligible for Study:   19 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • to live in a non-fluoridated area
  • to have at least 20 natural teeth
  • signed a consent form agreeing to carefully follow the research instructions

Exclusion Criteria:

  • presence of active caries lesions
  • periodontal disease
  • use of antibiotics/medication.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875212

Locations
Brazil
Health Science Centre at the Federal University of Paraiba
Joao Pessoa, Paraiba, Brazil, 58051900
Sponsors and Collaborators
Federal University of Paraíba
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordination for the Improvement of Higher Education Personnel
Investigators
Principal Investigator: Fabio C Sampaio, PhD Federal University of Paraiba
Study Chair: Thiago S Carvalho, Master Federal University of Paraiba
  More Information

No publications provided

Responsible Party: CAPES, Coordination for the Improvement of Higher Education Personnel
ClinicalTrials.gov Identifier: NCT00875212     History of Changes
Other Study ID Numbers: UFPB-CAPES_2005, CNPq?PIBIC?UFPB_2005
Study First Received: April 2, 2009
Results First Received: April 2, 2009
Last Updated: October 13, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Paraíba:
Calcium glycerophosphate
Fluoride
Dentifrice
Biofilm
Dental caries

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Calcium, Dietary
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014