Educational Intervention in Preventing Early Childhood Caries

NCT01502566 | Completed Phase 3

• 1 other identifier: UFPEL-PPGO0011
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Caries status (dmfs)

  Number of carious lesions, including intial lesions (white spot), per surface teeth. Also missed and filled surfaces due to caries will be included.

  after 12 months

Secondary Outcomes (1)

• dental plaque index

  after 12 months

Study Arms (2)

Educational Intervention

EXPERIMENTAL

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

Behavioral: Education Intervention

Control group

NO INTERVENTION

This group will receive no intervention

Interventions

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.

Educational Intervention

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children with 0 to 12 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Federal University of Pelotas - School of Dentistry

Pelotas, Rio Grande do Sul, 96015560, Brazil

Location

Related Links

• Related Info

MeSH Terms

Conditions

Dental Caries

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Maximiliano S Cenci, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

• Marina S Azevedo, MSc

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

• Ana R Romano, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Associate Professor

Study Record Dates

• First Submitted: December 29, 2011
• First Posted: December 30, 2011
• Study Start: June 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2012
• Last Updated: July 22, 2013

Record last verified: 2013-07

Locations

BR (1)