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Educational Intervention in Preventing Early Childhood Caries

Primary Purpose

Dental Caries

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Education Intervention

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring educational intervention, dentals caries, population, new populational caries prevention strategies.

Eligibility Criteria

undefined - 12 Months (Child)All SexesAccepts 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

Sites / Locations

Federal University of Pelotas - School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Educational Intervention

Control group

Arm 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

This group will receive no intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

dental plaque index

The oral health status will be recorded by visible dental plaque index.

Full Information

NCT ID

NCT01502566

First Posted

December 29, 2011

Last Updated

July 19, 2013

Sponsor

Federal University of Pelotas

1. Study Identification

Unique Protocol Identification Number

NCT01502566

Brief Title

Educational Intervention in Preventing Early Childhood Caries

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Pelotas

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Educational Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

This group will receive no intervention

Intervention Type

Behavioral

Intervention Name(s)

Education Intervention

Intervention 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.

Primary Outcome Measure Information:

Title

Caries status (dmfs)

Description

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

Time Frame

after 12 months

Secondary Outcome Measure Information:

Title

dental plaque index

Description

The oral health status will be recorded by visible dental plaque index.

Time Frame

after 12 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

12 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maximiliano S Cenci, PhD

Organizational Affiliation

Federal University of Pelotas

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marina S Azevedo, MSc

Organizational Affiliation

Federal University of Pelotas

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ana R Romano, PhD

Organizational Affiliation

Federal University of Pelotas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Federal University of Pelotas - School of Dentistry

City

Pelotas

State/Province

ZIP/Postal Code

96015560

Country

Brazil

12. IPD Sharing Statement

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed?term=mohebbi%202009%20caries

Description

Related Info

Learn more about this trial

Educational Intervention in Preventing Early Childhood Caries

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