Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH (CAGP-F)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Caries |
Drug: calcium glycerophosphate Drug: no active ingredient Drug: fluoride Drug: CAGP + fluoride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Effect of a Dentifrice Containing Calcium Glycerophosphate and Fluoride on the pH of Dental Biofilm in Vivo |
- Minimum pH [ Time Frame: at 1 minute (minimum fermenting pH) or at 7 minutes ] [ Designated as safety issue: Yes ]
- Minimum pH After 14 Days of Use of Dentifrice [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 12 |
| Study Start Date: | January 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: dentifrice intervention
4 types of dentifrices were used in 4 different periods in a crossover study design.
|
Drug: calcium glycerophosphate
use of a dentifrice containing CaGP (0.13%) and no fluoride
Other Name: CaGP
Drug: no active ingredient
dentifrice without calcium glycerophosphate and no fluoride
Other Name: dentifrice only (placebo)
Drug: fluoride
use of a dentifrice containing fluoride (1500ppm) only
Other Name: sodium fluoride
Drug: CAGP + fluoride
calcium glycerophosphate and fluoride dentifrice
Other Name: Experimental dentifrice with CAGP + fluoride
|
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| Ages Eligible for Study: | 19 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Brazil | |
| Health Science Centre at the Federal University of Paraiba | |
| Joao Pessoa, Paraiba, Brazil, 58051900 | |
| Principal Investigator: | Fabio C Sampaio, PhD | Federal University of Paraiba |
| Study Chair: | Thiago S Carvalho, Master | Federal University of Paraiba |
More Information
No publications provided
| Responsible Party: | CAPES, Coordination for the Improvement of Higher Education Personnel |
| ClinicalTrials.gov Identifier: | NCT00875212 History of Changes |
| Other Study ID Numbers: | UFPB-CAPES_2005, CNPq?PIBIC?UFPB_2005 |
| Study First Received: | April 2, 2009 |
| Results First Received: | April 2, 2009 |
| Last Updated: | October 13, 2009 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of Paraíba:
|
Calcium glycerophosphate Fluoride Dentifrice Biofilm Dental caries |
Additional relevant MeSH terms:
|
Dental Caries Tooth Demineralization Tooth Diseases Stomatognathic Diseases Calcium, Dietary Fluorides |
Sodium Fluoride Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Cariostatic Agents Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013