Educational Intervention in Preventing Early Childhood Caries

NCT ID: NCT01502566

Last Updated: 2013-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-12-31

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.

Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Educational 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

Group Type EXPERIMENTAL

Education Intervention

Intervention Type 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.

Control group

This group will receive no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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
Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Pelotas

OTHER

Sponsor Role lead

Responsible Party

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Maximiliano Sergio Cenci

PhD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maximiliano S Cenci, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Pelotas

Marina S Azevedo, MSc

Role: PRINCIPAL_INVESTIGATOR

Federal University of Pelotas

Ana R Romano, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Pelotas

Locations

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Federal University of Pelotas - School of Dentistry

Pelotas, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Related Links

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Other Identifiers

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UFPEL-PPGO0011

Identifier Type: -

Identifier Source: org_study_id

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