Educational Intervention in Preventing Early Childhood Caries

Phase 3

Completed

• Conditions: Dental Caries
• Interventions: Behavioral: Education Intervention

• Registration Number: NCT01502566
• Lead Sponsor: Federal University of Pelotas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2011-07
• Study First Submitted: 2011-12-29
• Study First Submitted QC: 2011-12-29
• Study First Posted: 2011-12-30
• Study Completion: 2012-12
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-19
• Last Update Posted: 2013-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational Intervention	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. This intervention will be applied at the Brazilian National Vaccination Day

Primary Outcome Measures

Name	Time	Method
Caries status (dmfs)	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 Outcome Measures

Name	Time	Method
dental plaque index	after 12 months	The oral health status will be recorded by visible dental plaque index.

Trial Locations

Locations (1)

Federal University of Pelotas - School of Dentistry; 🇧🇷 Pelotas, RS, Brazil