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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: calcium glycerophosphate
* Drug: no active ingredient
* Drug: fluoride
* Drug: CAGP + fluoride


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dentifrice intervention<br>4 types of dentifrices were used in 4 different periods in a crossover study design. | Drug: calcium glycerophosphate<br>* use of a dentifrice containing CaGP (0.13%) and no fluoride<br>* Other names: CaGP;Drug: no active ingredient<br>* dentifrice without calcium glycerophosphate and no fluoride<br>* Other names: dentifrice only (placebo);Drug: fluoride<br>* use of a dentifrice containing fluoride (1500ppm) only<br>* Other names: sodium fluoride;Drug: CAGP + fluoride<br>* calcium glycerophosphate and fluoride dentifrice<br>* Other names: Experimental dentifrice with CAGP + fluoride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum pH | 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. | at 1 minute (minimum fermenting pH) or at 7 minutes | 
| Minimum pH After 14 Days of Use of Dentifrice | measurement of pH obtained as described before. However, this time the biofilm was exposed to the dentifrices for a longer period (14 days). | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcium glycerophosphate, Fluoride, Dentifrice, Biofilm, Dental caries