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Educational Intervention in Preventing Early Childhood Caries

NCT01502566 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2013-07-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Federal University of Pelotas

    lead OTHER

Principal Investigators

  • Maximiliano S Cenci, PhD · Federal University of Pelotas

  • Marina S Azevedo, MSc · Federal University of Pelotas

  • Ana R Romano, PhD · Federal University of Pelotas

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-07-31
Completion
2012-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01502566 on ClinicalTrials.gov