A Cluster-randomized Trial of the Effectiveness of an Educational Intervention in Preventing Early Childhood Caries
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Dental Caries
- Sponsor
- Federal University of Pelotas
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Caries status (dmfs)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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. 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.
Investigators
Maximiliano Sergio Cenci
PhD, Associate Professor
Federal University of Pelotas
Eligibility Criteria
Inclusion Criteria
- •Children with 0 to 12 months
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- dental plaque index(after 12 months)