Educational Intervention in Preventing Early Childhood Caries

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502566
• Other study ID #: UFPEL-PPGO0011
• Status: Completed
• Phase: Phase 3
• First received: December 29, 2011
• Last updated: July 19, 2013
• Start date: June 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Pelotas - School of Dentistry	Pelotas	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	dental plaque index	The oral health status will be recorded by visible dental plaque index.	after 12 months	No

External Links

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