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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00875212
Recruitment Status : Completed
First Posted : April 3, 2009
Results First Posted : October 12, 2009
Last Update Posted : October 15, 2009
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordination for the Improvement of Higher Education Personnel
Information provided by:
Federal University of Paraíba

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of a Dentifrice Containing Calcium Glycerophosphate and Fluoride on the pH of Dental Biofilm in Vivo
Study Start Date : January 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Tooth Decay

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Minimum pH [ Time Frame: at 1 minute (minimum fermenting pH) or at 7 minutes ]
  2. Minimum pH After 14 Days of Use of Dentifrice [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00875212

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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
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Principal Investigator: Fabio C Sampaio, PhD Federal University of Paraiba
Study Chair: Thiago S Carvalho, Master Federal University of Paraiba

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Responsible Party: CAPES, Coordination for the Improvement of Higher Education Personnel Identifier: NCT00875212     History of Changes
Other Study ID Numbers: UFPB-CAPES_2005
First Posted: April 3, 2009    Key Record Dates
Results First Posted: October 12, 2009
Last Update Posted: October 15, 2009
Last Verified: October 2009
Keywords provided by Federal University of Paraíba:
Calcium glycerophosphate
Dental caries
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Calcium, Dietary
Sodium Fluoride
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Cariostatic Agents
Protective Agents