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

NCT00875212 | Completed Phase 1 Results

• 2 other identifiers: UFPB-CAPES_2005CNPq?PIBIC?UFPB_2005
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Keywords

Calcium glycerophosphate; Fluoride; Dentifrice; Biofilm; Dental caries

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

dentifrice intervention

EXPERIMENTAL

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

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

Interventions

calcium glycerophosphate DRUG

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

Also known as: CaGP

dentifrice intervention

no active ingredient DRUG

dentifrice without calcium glycerophosphate and no fluoride

Also known as: dentifrice only (placebo)

dentifrice intervention

fluoride DRUG

use of a dentifrice containing fluoride (1500ppm) only

Also known as: sodium fluoride

dentifrice intervention

CAGP + fluoride DRUG

calcium glycerophosphate and fluoride dentifrice

Also known as: Experimental dentifrice with CAGP + fluoride

dentifrice intervention

Eligibility Criteria

• Age: 19 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• presence of active caries lesions
• periodontal disease
• use of antibiotics/medication.

Sponsors & Collaborators

• Federal University of Paraíba: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Coordination for the Improvement of Higher Education Personnel: collaborator

Study Sites (1)

Health Science Centre at the Federal University of Paraiba

João Pessoa, Paraíba, 58051900, Brazil

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Glycerophosphates; Fluorides; Sodium Fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Sugar Phosphates; Phospholipids; Membrane Lipids; Lipids; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

pH measurements of dental biofilms were difficult after continuous use of dentifrice because of reduced biofilm mass in contrast to baseline measurements.

Results Point of Contact

• Title: Fabio Correia Sampaio (research leader)
• Organization: Federal University of Paraiba

fabios@ccs.ufpb.br

+55 83 3216 7795

Study Officials

• Fabio C Sampaio, PhD

  Federal University of Paraiba

  PRINCIPAL INVESTIGATOR

• Thiago S Carvalho, Master

  Federal University of Paraiba

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: January 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: July 1, 2008
• Last Updated: October 15, 2009
• Results First Posted: October 12, 2009

Record last verified: 2009-10

Locations

BR (1)