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

Federal University of Paraíba

Status and phase: Completed; Phase 1

Conditions: Dental Caries

Treatments: Drug: CAGP + fluoride; Drug: no active ingredient; Drug: fluoride; Drug: calcium glycerophosphate

Study type: Interventional

Funder types: Other

Identifiers

NCT00875212

CNPq?PIBIC?UFPB_2005

UFPB-CAPES_2005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 19 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 1 patient group

dentifrice intervention

Experimental group

Description:

4 types of dentifrices were used in 4 different periods in a crossover study design.

Treatment:

Drug: calcium glycerophosphate

Drug: fluoride

Drug: no active ingredient

Drug: CAGP + fluoride