Health Science Centre at the Federal University of Paraiba
João Pessoa, Paraíba, 58051900, Brazil
NCT Number: NCT00875212
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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Notify Me19 year–30 year
All sexes
Interventional
Phase 1
João Pessoa, Paraíba, 58051900, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
use of a dentifrice containing CaGP (0.13%) and no fluoride
Other names: CaGP
dentifrice without calcium glycerophosphate and no fluoride
Other names: dentifrice only (placebo)
use of a dentifrice containing fluoride (1500ppm) only
Other names: sodium fluoride
calcium glycerophosphate and fluoride dentifrice
Other names: Experimental dentifrice with CAGP + fluoride
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.
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).
Federal University of Paraíba
Other
Effect of a Dentifrice Containing Calcium Glycerophosphate and Fluoride on the pH of Dental Biofilm in Vivo
Acronym: CAGP-F
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