Educational Intervention in Preventing Early Childhood Caries
NCT ID: NCT01502566
Last Updated: 2013-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2010-06-30
2012-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Educational Intervention
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
Education Intervention
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.
Control group
This group will receive no intervention
No interventions assigned to this group
Interventions
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Education Intervention
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Children not living in Pelotas
* No sufficient information provided by the mother at the time of enrollment
* Systemic diseases
12 Months
ALL
Yes
Sponsors
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Federal University of Pelotas
OTHER
Responsible Party
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Maximiliano Sergio Cenci
PhD, Associate Professor
Principal Investigators
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Maximiliano S Cenci, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Pelotas
Marina S Azevedo, MSc
Role: PRINCIPAL_INVESTIGATOR
Federal University of Pelotas
Ana R Romano, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Pelotas
Locations
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Federal University of Pelotas - School of Dentistry
Pelotas, Rio Grande do Sul, Brazil
Countries
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Related Links
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Other Identifiers
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UFPEL-PPGO0011
Identifier Type: -
Identifier Source: org_study_id
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