Educational Intervention in Preventing Early Childhood Caries

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01502566

Enrollment

500

Registered

2011-12-30

Start date

2010-06-30

Completion date

2012-12-31

Last updated

2013-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

educational intervention, dentals caries, population, new populational caries prevention strategies.

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.

Interventions

BEHAVIORALEducation 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 12 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
dental plaque index	after 12 months	The oral health status will be recorded by visible dental plaque index.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026