Educational Intervention in Preventing Early Childhood Caries

Federal University of Pelotas

Status and phase: Completed; Phase 3

Conditions: Dental Caries

Treatments: Behavioral: Education Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01502566

UFPEL-PPGO0011

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Ages: Under 12 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Educational Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Education Intervention

Control group

No Intervention group

Description:

This group will receive no intervention