Dental CariesPhase 3NCT01502566
Educational Intervention in Preventing Early Childhood Caries
A Phase 3 study testing Education Intervention in people with Dental Caries, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
Objective: The aim of this study is to assess the effectiveness of an oral health educative intervention in preventing early childhood caries (ECC). Methods: The trial targets 0- to 12-month-old children and their mothers in Pelotas, Brazil. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Education Intervention
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2010to Dec 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 Up to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with 0 to 12 months
Who cannot join
- Children with teeth in mouth at the time of enrollment
- Children not living in Pelotas
- No sufficient information provided by the mother at the time of enrollment
- Systemic diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Pelotas - School of Dentistry
Pelotas, Rio Grande do Sul, 96015560
About this study
Official title: A Cluster-randomized Trial of the Effectiveness of an Educational Intervention in Preventing Early Childhood Caries
Objective:
The aim of this study is to assess the effectiveness of an oral health educative intervention in preventing early childhood caries (ECC).
Read more
Methods:
The trial targets 0- to 12-month-old children and their mothers in Pelotas, Brazil. Twenty-four public health centres (clusters) were randomly selected and assigned to intervention or control group (12 clusters per intervention group). In each center, up to 30 children/mothers were selected and invited to participate in the trial. Each mother was interviewed in order to collect socio-economic and demographic variables. The intervention group received by means of a pamphlet the oral health instructions, which were emphasized with verbal instructions. Dental examination will be carried out after 1 year for all teeth surfaces to determine caries status.
- Conditions
- Dental Caries
- Being tested
- Education Intervention
- Keywords
- educational intervention, dentals caries, population, new populational caries prevention strategies.
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education InterventionBehavioural
Children/mothers allocated to this arm will receive an pamphlet with key information on dental caries prevention, together with oral instructions about how to avoid dental caries.
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention | Experimental | Children/mothers allocated to this arm will receive an pamphlet with key information on dental caries prevention, together with oral instructions about how to avoid dental caries. This intervention will be applied at the Brazilian National Vaccination Day Receives: Behavioral: Education Intervention |
| Control group | No intervention | This group will receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries status (dmfs)
Number of carious lesions, including intial lesions (white spot), per surface teeth. Also missed and filled surfaces due to caries will be included.
Measured: after 12 months
Secondary outcomes (1)
dental plaque index
The oral health status will be recorded by visible dental plaque index.
Measured: after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startJun 2010
- Primary completionJul 2011
- Study completionDec 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
- Investigators
- Maximiliano S Cenci, PhD, Principal investigator, Federal University of PelotasMarina S Azevedo, MSc, Principal investigator, Federal University of PelotasAna R Romano, PhD, Principal investigator, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502566
- Sponsor's protocol ID
- UFPEL-PPGO0011
- Status last verified
- Jul 2013
- First submitted
- 29 Dec 2011
- Last updated
- 22 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-randomized Trial of the Effectiveness of an Educational Intervention in Preventing Early Childhood Caries
- ClinicalTrials.gov ID
- NCT01502566
- Acronym / sponsor ID
- UFPEL-PPGO0011
- Conditions
- Dental Caries
- Keywords
- educational intervention, dentals caries, population, new populational caries prevention strategies.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Dec 2011 (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.
Objective:
The aim of this study is to assess the effectiveness of an oral health educative intervention in preventing early childhood caries (ECC).
Methods:
The trial targets 0- to 12-month-old children and their mothers in Pelotas, Brazil. Twenty-four public health centres (clusters) were randomly selected and assigned to intervention or control group (12 clusters per intervention group). In each center, up to 30 children/mothers were selected and invited to participate in the trial. Each mother was interviewed in order to collect socio-economic and demographic variables. The intervention group received by means of a pamphlet the oral health instructions, which were emphasized with verbal instructions. Dental examination will be carried out after 1 year for all teeth surfaces to determine caries status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention | Experimental | Behavioral: Education InterventionChildren/mothers allocated to this arm will receive an pamphlet with key information on dental caries prevention, together with oral instructions about how to avoid dental caries. This intervention will be applied at the Brazilian National Vaccination Day |
| Control group | No intervention | –This group will receive no intervention |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with 0 to 12 months
Key exclusion criteria (4 listed)
- Children with teeth in mouth at the time of enrollment
- Children not living in Pelotas
- No sufficient information provided by the mother at the time of enrollment
- Systemic diseases
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 |
|---|---|---|
| Education InterventionChildren/mothers allocated to this arm will receive an pamphlet with key information on dental caries prevention, together with oral instructions about how to avoid dental caries. | Behavioural | Educational Intervention |
Primary outcome
Caries status (dmfs)
Time frame: after 12 months
Number of carious lesions, including intial lesions (white spot), per surface teeth. Also missed and filled surfaces due to caries will be included.
1 secondary outcome
dental plaque index
Time frame: after 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 22 Jul 2013.
- Related InfoLink provided by the sponsor.
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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.
Maximiliano S Cenci, PhD principal investigator
Federal University of Pelotas
Marina S Azevedo, MSc principal investigator
Federal University of Pelotas
Ana R Romano, PhD principal investigator
Federal University of Pelotas
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 Education Intervention in people with Dental Caries, run by Federal University of Pelotas 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 1 inclusion and 4 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 22 Jul 2013. 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?
Caries status (dmfs) (time frame: after 12 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 22 Jul 2013; AzTrials last refreshed its copy on 1 Nov 2026.