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

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ClinicalTrials.gov Identifier: NCT00875212
Recruitment Status : Completed
First Posted : April 3, 2009
Results First Posted : October 12, 2009
Last Update Posted : October 15, 2009
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordination for the Improvement of Higher Education Personnel
Information provided by:
Federal University of Paraíba

April 2, 2009
April 3, 2009
April 2, 2009
October 12, 2009
October 15, 2009
January 2006
December 2007   (Final data collection date for primary outcome measure)
  • Minimum pH [ Time Frame: at 1 minute (minimum fermenting pH) or at 7 minutes ]
  • Minimum pH After 14 Days of Use of Dentifrice [ Time Frame: 14 days ]
pH [ Time Frame: 1, 7, 14, 21 minutes after use ]
Complete list of historical versions of study NCT00875212 on ClinicalTrials.gov Archive Site
Not Provided
minimal pH [ Time Frame: 14 days ]
Not Provided
Not Provided
 
Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Dental Caries
  • 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
Experimental: dentifrice intervention
4 types of dentifrices were used in 4 different periods in a crossover study design.
Interventions:
  • Drug: calcium glycerophosphate
  • Drug: no active ingredient
  • Drug: fluoride
  • Drug: CAGP + fluoride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Same as current
July 2008
December 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
19 Years to 30 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00875212
UFPB-CAPES_2005
CNPq?PIBIC?UFPB_2005
No
Not Provided
Not Provided
CAPES, Coordination for the Improvement of Higher Education Personnel
Federal University of Paraíba
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordination for the Improvement of Higher Education Personnel
Principal Investigator: Fabio C Sampaio, PhD Federal University of Paraiba
Study Chair: Thiago S Carvalho, Master Federal University of Paraiba
Federal University of Paraíba
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP