Title

Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH
Effect of a Dentifrice Containing Calcium Glycerophosphate and Fluoride on the pH of Dental Biofilm in Vivo
  • Phase

    Phase 1
  • Study Type

    Interventional
  • Study Participants

    12
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.
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.
Study Started
Jan 31
2006
Primary Completion
Dec 31
2007
Study Completion
Jul 31
2008
Results Posted
Oct 12
2009
Estimate
Last Update
Oct 15
2009
Estimate

Drug calcium glycerophosphate

use of a dentifrice containing CaGP (0.13%) and no fluoride

  • Other names: CaGP

Drug no active ingredient

dentifrice without calcium glycerophosphate and no fluoride

  • Other names: dentifrice only (placebo)

Drug fluoride

use of a dentifrice containing fluoride (1500ppm) only

  • Other names: sodium fluoride

Drug CAGP + fluoride

calcium glycerophosphate and fluoride dentifrice

  • Other names: Experimental dentifrice with CAGP + fluoride

dentifrice intervention Experimental

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

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.

Summary

Toothbrushing

All Events

Event Type Organ System Event Term

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.

Control

5.4
pH (Mean)
Standard Deviation: 0.60

Calcium Glycerophosphate

5.48
pH (Mean)
Standard Deviation: 0.65

Fluoride

5.25
pH (Mean)
Standard Deviation: 0.77

Calcium Glycerophosphate and Fluoride

5.7
pH (Mean)
Standard Deviation: 0.43

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).

Control

4.78
pH (Mean)
Standard Deviation: 0.67

Calcium Glycerophosphate

5.24
pH (Mean)
Standard Deviation: 0.83

Fluoride

5.25
pH (Mean)
Standard Deviation: 0.71

Calcium Glycerophosphate and Fluoride

5.44
pH (Mean)
Standard Deviation: 0.59

Age Continuous

26
years (Mean)
Standard Deviation: 3

Age, Categorical

Region of Enrollment

Sex: Female, Male

Placebo Dentifrice

Toothbrushing

CaGP Only Dentifrice

Toothbrushing

Fluoride Only Dentifrice

Toothbrushing

CaGP and Fluoride Dentifrice

Toothbrushing