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Completed

NCT Number: NCT01502566

Educational Intervention in Preventing Early Childhood Caries

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Federal University of Pelotas - School of Dentistry

Pelotas, Rio Grande do Sul, 96015560, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education Intervention

Behavioral

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.

Primary outcomes

  1. 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

  1. dental plaque index

    Time frame: after 12 months

    The oral health status will be recorded by visible dental plaque index.

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Sponsors and collaborators

Lead sponsor

Federal University of Pelotas

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Dec 30, 2011
Registry last updated
Jul 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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