Dental CariesPhase 3NCT01623362
Evaluation of a Low Fluoride Dentifrice for Caries Control
A Phase 3 study testing Low-fluoride acidic dentifrice, conventional dentifrice and neutral pH and low-fluoride dentifrice in people with Dental Caries, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
The aim of this randomized clinical trial is to evaluate the effect of pH and fluoride concentration in liquid dentifrices in the control of dental caries in early childhood, in non-fluoridated area. Read more about this study
- Who is it for?
- Ages 2 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Low-fluoride acidic dentifrice, conventional dentifrice and neutral pH and low-fluoride dentifrice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2010to Feb 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 2 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 2 to 4 years;
- Not having participated in any other clinical study within 3 months prior to selection;
- Not having very large carious lesions or dentin sensitivity during the study;
- Signature of informed consent by the parents.
Who cannot join
- Using orthodontic appliances
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-fluoride Acidic Liquid Dentifrice in Non-fluoridated Communities: a Randomized Clinical Trial
The aim of this randomized clinical trial is to evaluate the effect of pH and fluoride concentration in liquid dentifrices in the control of dental caries in early childhood, in non-fluoridated area. This study also aims to assess the effect of the consistency of liquid dentifrices in the fluoride uptake in the plaque and the fluoride concentration in the toenails, to estimate the fluoride intake from these formulations.
Read the detailed description
The study was carried out with schoolchildren living in a non-fluoridated area, with (A) or without (I) active caries lesions, were randomly allocated into 3 groups according to the LD used over 12 months: Group 1 (n=39-A/38-I): 550µgF/g-pH4.5, Group 2 (n=33-A/35-I) 1100µgF/g-pH7.0, Group 3 (n=33-A/34-I): 550µgF/g-pH7.0.
- Conditions
- Dental Caries
- Being tested
- Low-fluoride acidic dentifrice, conventional dentifrice, neutral pH and low-fluoride dentifrice
- Keywords
- Dentifrices, Dental Caries, Fluorides, Nails, pH
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fluoride acidic dentifriceOther
Also called G1
550 ppm (mg/L) of sodium fluoride in pH 4,5; 12 months , 3 times a day.
conventional dentifriceOther
Also called G2
1100 ppm (mg/L) of sodium fluoride, pH 7 , 3 times a day for 12 months
neutral pH and low-fluoride dentifriceOther
Also called G3
500 ppm sodium fluoride, pH 7 , 3 times a day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Low-fluoride acidic dentifrice | Experimental | Not described Receives: Other: Low-fluoride acidic dentifrice |
| Conventional dentifrice | No intervention | 1100µgF/g-pH7.0 Receives: Other: conventional dentifrice |
| neutral pH and low-fluoride dentifrice | Experimental | 550 ppm pH 7 Receives: Other: neutral pH and low-fluoride dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the concentration of fluoride incorporated into the biofilm and nails 6 months after initiation of dentifrices use in non-fluoridated communities
Samples of plaque and nails were analysed for fluoride using an ion-specific electrode after diffuusion with hexamethyldisiloxane-facilitated (HMDS)
Measured: 6 months
Secondary outcomes (1)
New caries diagnostic criteria: caries progression/regression in caries-active children and caries progression in caries-inactive children after 12 months according to the type of dentifrice used in non-fluoridated communities
The caries progression/regression of active noncavited and progression of inactive noncavitated was evaluated by the date from the examinations at baseline and after 12 months using Nyvad, Machiulskienec, Baelum,1999: Score 0: Sound/ Score 1: Active caries (intact surface)/Score 2: Active caries (surface discontinuity)/Score 3: Active caries (cavity)/Score 4: Inactive caries(intact surface) /Score 5: Inactive caries (surface discontinuity) /Score 6: Inactive caries(cavity)/Score 7: Filling (sound surface)/Score 8: Filling + active caries/Score 9: Filling + inactive caries
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startSep 2010
- Primary completionJul 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Correia Sampaio, Federal University of Paraíba
- Investigators
- Fábio Sampaio, PhD, Principal investigator, Paraíba Federal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623362
- Sponsor's protocol ID
- LOWF-UFPB
- Status last verified
- May 2012
- First submitted
- 18 May 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-fluoride Acidic Liquid Dentifrice in Non-fluoridated Communities: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01623362
- Acronym / sponsor ID
- LOWF-UFPB
- Conditions
- Dental Caries
- Keywords
- Dentifrices, Dental Caries, Fluorides, Nails, pH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 20 Jun 2012 (estimated)
- Results
- Not posted in the source record
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 randomized clinical trial is to evaluate the effect of pH and fluoride concentration in liquid dentifrices in the control of dental caries in early childhood, in non-fluoridated area. This study also aims to assess the effect of the consistency of liquid dentifrices in the fluoride uptake in the plaque and the fluoride concentration in the toenails, to estimate the fluoride intake from these formulations.
Detailed description
The study was carried out with schoolchildren living in a non-fluoridated area, with (A) or without (I) active caries lesions, were randomly allocated into 3 groups according to the LD used over 12 months: Group 1 (n=39-A/38-I): 550µgF/g-pH4.5, Group 2 (n=33-A/35-I) 1100µgF/g-pH7.0, Group 3 (n=33-A/34-I): 550µgF/g-pH7.0.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-fluoride acidic dentifrice | Experimental | Other: Low-fluoride acidic dentifrice |
| Conventional dentifrice | No intervention | Other: conventional dentifrice1100µgF/g-pH7.0 |
| neutral pH and low-fluoride dentifrice | Experimental | Other: neutral pH and low-fluoride dentifrice550 ppm pH 7 |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 2 to 4 years;
- Not having participated in any other clinical study within 3 months prior to selection;
- Not having very large carious lesions or dentin sensitivity during the study;
- Signature of informed consent by the parents.
Key exclusion criteria (1 listed)
- Using orthodontic appliances
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 |
|---|---|---|
| Low-fluoride acidic dentifriceAlso: G1550 ppm (mg/L) of sodium fluoride in pH 4,5; 12 months , 3 times a day. | Other | Low-fluoride acidic dentifrice |
| conventional dentifriceAlso: G21100 ppm (mg/L) of sodium fluoride, pH 7 , 3 times a day for 12 months | Other | Conventional dentifrice |
| neutral pH and low-fluoride dentifriceAlso: G3500 ppm sodium fluoride, pH 7 , 3 times a day for 12 months | Other | neutral pH and low-fluoride dentifrice |
Primary outcome
Evaluation of the concentration of fluoride incorporated into the biofilm and nails 6 months after initiation of dentifrices use in non-fluoridated communities
Time frame: 6 months
Samples of plaque and nails were analysed for fluoride using an ion-specific electrode after diffuusion with hexamethyldisiloxane-facilitated (HMDS)
1 secondary outcome
New caries diagnostic criteria: caries progression/regression in caries-active children and caries progression in caries-inactive children after 12 months according to the type of dentifrice used in non-fluoridated communities
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
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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.
Fábio Sampaio, PhD principal investigator
Paraíba Federal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low-fluoride acidic dentifrice, conventional dentifrice and neutral pH and low-fluoride dentifrice 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 4 inclusion and 1 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 20 Jun 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of the concentration of fluoride incorporated into the biofilm and nails 6 months after initiation of dentifrices use in non-fluoridated communities (time frame: 6 months). 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 20 Jun 2012.