Dental CariesPhase 1CAGP-FNCT00875212
Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH
A Phase 1 study testing calcium glycerophosphate, no active ingredient and fluoride in people with Dental Caries, run by Federal University of Paraíba at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- calcium glycerophosphate, no active ingredient and fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2006to Jul 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- presence of active caries lesions
- periodontal disease
- use of antibiotics/medication.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Health Science Centre at the Federal University of Paraiba
João Pessoa, Paraíba, 58051900
About this study
Official title: Effect of a Dentifrice Containing Calcium Glycerophosphate and Fluoride on the pH of Dental Biofilm in Vivo
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.
Read the 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.
- Conditions
- Dental Caries
- Being tested
- calcium glycerophosphate, no active ingredient, fluoride, CAGP + fluoride
- Keywords
- Calcium glycerophosphate, Fluoride, Dentifrice, Biofilm, Dental caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium glycerophosphateDrug
Also called CaGP
use of a dentifrice containing CaGP (0.13%) and no fluoride
no active ingredientDrug
Also called dentifrice only (placebo)
dentifrice without calcium glycerophosphate and no fluoride
fluorideDrug
Also called sodium fluoride
use of a dentifrice containing fluoride (1500ppm) only
CAGP + fluorideDrug
Also called Experimental dentifrice with CAGP + fluoride
calcium glycerophosphate and fluoride dentifrice
| Study group | Role | What they receive |
|---|---|---|
| dentifrice intervention | Experimental | 4 types of dentifrices were used in 4 different periods in a crossover study design. Receives: Drug: calcium glycerophosphate; Drug: no active ingredient; Drug: fluoride; Drug: CAGP + fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startJan 2006
- Primary completionDec 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordination for the Improvement of Higher Education Personnel
- Investigators
- Fabio C Sampaio, PhD, Principal investigator, Federal University of ParaibaThiago S Carvalho, Master, Study chair, Federal University of Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875212
- Sponsor's protocol ID
- UFPB-CAPES_2005
- Other IDs
- CNPq?PIBIC?UFPB_2005
- Acronym
- CAGP-F
- Status last verified
- Oct 2009
- First submitted
- 2 Apr 2009
- Last updated
- 15 Oct 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Dentifrice Containing Calcium Glycerophosphate and Fluoride on the pH of Dental Biofilm in Vivo
- ClinicalTrials.gov ID
- NCT00875212
- Acronym / sponsor ID
- CAGP-F / UFPB-CAPES_2005
- Conditions
- Dental Caries
- Keywords
- Calcium glycerophosphate, Fluoride, Dentifrice, Biofilm, Dental caries
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordination for the Improvement of Higher Education Personnel
- Study start
- Jan 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 3 Apr 2009 (estimated)
- Results
- Posted 12 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dentifrice intervention | Experimental | Drug: calcium glycerophosphate, Drug: no active ingredient, Drug: fluoride, Drug: CAGP + fluoride4 types of dentifrices were used in 4 different periods in a crossover study design. |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- presence of active caries lesions
- periodontal disease
- use of antibiotics/medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calcium glycerophosphateAlso: CaGPuse of a dentifrice containing CaGP (0.13%) and no fluoride | Drug | dentifrice intervention |
| no active ingredientAlso: dentifrice only (placebo)dentifrice without calcium glycerophosphate and no fluoride | Drug | dentifrice intervention |
| fluorideAlso: sodium fluorideuse of a dentifrice containing fluoride (1500ppm) only | Drug | dentifrice intervention |
| CAGP + fluorideAlso: Experimental dentifrice with CAGP + fluoridecalcium glycerophosphate and fluoride dentifrice | Drug | dentifrice intervention |
Primary outcome
Minimum pH
Time frame: at 1 minute (minimum fermenting pH) or at 7 minutes
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
Time frame: 14 days
measurement of pH obtained as described before. However, this time the biofilm was exposed to the dentifrices for a longer period (14 days).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio C Sampaio, PhD principal investigator
Federal University of Paraiba
Thiago S Carvalho, Master study chair
Federal University of Paraiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing calcium glycerophosphate, no active ingredient and fluoride in people with Dental Caries, run by Federal University of Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum pH (time frame: at 1 minute (minimum fermenting pH) or at 7 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2009.