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

Dental Caries Clinical Trial

— CAGP-F  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875212
• Other study ID #: UFPB-CAPES_2005
• Secondary ID: CNPq?PIBIC?UFPB_
• Status: Completed
• Phase: Phase 1
• First received: April 2, 2009
• Last updated: October 13, 2009
• Start date: January 2006
• Est. completion date: July 2008

Study information

• Verified date: October 2009
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• calcium glycerophosphate
use of a dentifrice containing CaGP (0.13%) and no fluoride
• no active ingredient
dentifrice without calcium glycerophosphate and no fluoride
• fluoride
use of a dentifrice containing fluoride (1500ppm) only
• CAGP + fluoride
calcium glycerophosphate and fluoride dentifrice

Locations

Country	Name	City	State
Brazil	Health Science Centre at the Federal University of Paraiba	Joao Pessoa	Paraiba

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Paraíba	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordination for the Improvement of Higher Education Personnel

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum pH		at 1 minute (minimum fermenting pH) or at 7 minutes	Yes
Primary	Minimum pH After 14 Days of Use of Dentifrice		14 days	Yes