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Completed

NCT Number: NCT00875212

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

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.

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Key information

Age range

19 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Health Science Centre at the Federal University of Paraiba

João Pessoa, Paraíba, 58051900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

calcium glycerophosphate

Drug

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

Other names: CaGP

no active ingredient

Drug

dentifrice without calcium glycerophosphate and no fluoride

Other names: dentifrice only (placebo)

Fluoride

Drug

use of a dentifrice containing fluoride (1500ppm) only

Other names: sodium fluoride

CAGP + fluoride

Drug

calcium glycerophosphate and fluoride dentifrice

Other names: Experimental dentifrice with CAGP + fluoride

Primary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Federal University of Paraíba

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordination for the Improvement of Higher Education Personnel

Registry information

Official study title

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

Acronym: CAGP-F

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Apr 3, 2009
Registry last updated
Oct 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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