NCT01502566

Educational Intervention in Preventing Early Childhood Caries

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Federal University of Pelotas · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-07-01
• Completion: 2012-12-01
• First posted: 2011-12-30
• Last updated: 2013-07-22

Locations

1 site across 1 country: Brazil