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

October 13, 2009 updated by: Federal University of Paraíba

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Paraiba
      • Joao Pessoa, Paraiba, Brazil, 58051900
        • Health Science Centre at the Federal University of Paraiba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • CaGP
Drug: no active ingredient
dentifrice without calcium glycerophosphate and no fluoride
Other Names:
  • dentifrice only (placebo)
Drug: fluoride
use of a dentifrice containing fluoride (1500ppm) only
Other Names:
  • sodium fluoride
Drug: CAGP + fluoride
calcium glycerophosphate and fluoride dentifrice
Other Names:
  • Experimental dentifrice with CAGP + fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimum pH
Time Frame: at 1 minute (minimum fermenting pH) or at 7 minutes
The dental biofilm pH was measured in vivo with the microtouch method, using a palladium microelectrode + reference electrode. Data represents the mean values of the lowest pH observed each time after the use of sucrose.
at 1 minute (minimum fermenting pH) or at 7 minutes
Minimum pH After 14 Days of Use of Dentifrice
Time Frame: 14 days
measurement of pH obtained as described before. However, this time the biofilm was exposed to the dentifrices for a longer period (14 days).
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Paraíba

Collaborators

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 Paraíba
  • Study Chair: Thiago S Carvalho, Master, Federal University of Paraíba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

April 2, 2009

First Submitted That Met QC Criteria

April 2, 2009

First Posted (Estimate)

April 3, 2009

Study Record Updates

Last Update Posted (Estimate)

October 15, 2009

Last Update Submitted That Met QC Criteria

October 13, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFPB-CAPES_2005
  • CNPq?PIBIC?UFPB_2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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