Educational Intervention in Preventing Early Childhood Caries

Study Overview
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Brief Summary
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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.

Official Title
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A Cluster-randomized Trial of the Effectiveness of an Educational Intervention in Preventing Early Childhood Caries

Conditions
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Dental Caries

Intervention / Treatment
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* Behavioral: Education Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational Intervention<br>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 | Behavioral: Education Intervention<br>* 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.<br>|
| No Intervention: Control group<br>This group will receive no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dental plaque index | The oral health status will be recorded by visible dental plaque index. | after 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dentals caries, population, new populational caries prevention strategies., educational intervention