Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH (CAGP-F)
Primary Purpose
Dental Caries
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
calcium glycerophosphate
no active ingredient
fluoride
CAGP + fluoride
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring Calcium glycerophosphate, Fluoride, Dentifrice, Biofilm, Dental caries
Eligibility 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.
Sites / Locations
- Health Science Centre at the Federal University of Paraiba
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
dentifrice intervention
Arm Description
4 types of dentifrices were used in 4 different periods in a crossover study design.
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT00875212
First Posted
April 2, 2009
Last Updated
October 13, 2009
Sponsor
Federal University of Paraíba
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordination for the Improvement of Higher Education Personnel
1. Study Identification
Unique Protocol Identification Number
NCT00875212
Brief Title
Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH
Acronym
CAGP-F
Official Title
Effect of a Dentifrice Containing Calcium Glycerophosphate and Fluoride on the pH of Dental Biofilm in Vivo
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of Paraíba
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordination for the Improvement of Higher Education Personnel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Calcium glycerophosphate, Fluoride, Dentifrice, Biofilm, Dental caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dentifrice intervention
Arm Type
Experimental
Arm Description
4 types of dentifrices were used in 4 different periods in a crossover study design.
Intervention Type
Drug
Intervention Name(s)
calcium glycerophosphate
Other Intervention Name(s)
CaGP
Intervention Description
use of a dentifrice containing CaGP (0.13%) and no fluoride
Intervention Type
Drug
Intervention Name(s)
no active ingredient
Other Intervention Name(s)
dentifrice only (placebo)
Intervention Description
dentifrice without calcium glycerophosphate and no fluoride
Intervention Type
Drug
Intervention Name(s)
fluoride
Other Intervention Name(s)
sodium fluoride
Intervention Description
use of a dentifrice containing fluoride (1500ppm) only
Intervention Type
Drug
Intervention Name(s)
CAGP + fluoride
Other Intervention Name(s)
Experimental dentifrice with CAGP + fluoride
Intervention Description
calcium glycerophosphate and fluoride dentifrice
Primary Outcome Measure Information:
Title
Minimum pH
Description
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
at 1 minute (minimum fermenting pH) or at 7 minutes
Title
Minimum pH After 14 Days of Use of Dentifrice
Description
measurement of pH obtained as described before. However, this time the biofilm was exposed to the dentifrices for a longer period (14 days).
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio C Sampaio, PhD
Organizational Affiliation
Federal University of Paraiba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thiago S Carvalho, Master
Organizational Affiliation
Federal University of Paraiba
Official's Role
Study Chair
Facility Information:
Facility Name
Health Science Centre at the Federal University of Paraiba
City
Joao Pessoa
State/Province
Paraiba
ZIP/Postal Code
58051900
Country
Brazil
12. IPD Sharing Statement
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Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH
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