Clinical trial NCT00875212: Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH
Official title: Effect of a Dentifrice Containing Calcium Glycerophosphate and Fluoride on the pH of Dental Biofilm in Vivo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Caries
Keywords: Calcium glycerophosphate
Fluoride
Dentifrice
Biofilm
Dental caries
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Coordination for the Improvement of Higher Education Personnel
First posted: 2009-04-03
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Minimum pH
timeFrame: at 1 minute (minimum fermenting pH) or at 7 minutes
measure: Minimum pH After 14 Days of Use of Dentifrice
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Joao Pessoa
country: Brazil
facility: Health Science Centre at the Federal University of Paraiba
state: Paraiba
Study officials:
affiliation: Federal University of Paraiba
name: Fabio C Sampaio, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Paraiba
name: Thiago S Carvalho, Master
role: STUDY_CHAIR
References: