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Educational Intervention in Preventing Early Childhood Caries

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ClinicalTrials.gov Identifier: NCT01502566
Recruitment Status : Completed
First Posted : December 30, 2011
Last Update Posted : July 22, 2013
Sponsor:
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, Federal University of Pelotas

Tracking Information
First Submitted Date  ICMJE December 29, 2011
First Posted Date  ICMJE December 30, 2011
Last Update Posted Date July 22, 2013
Study Start Date  ICMJE June 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2011)
Caries status (dmfs) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2011)
dental plaque index [ Time Frame: after 12 months ]
The oral health status will be recorded by visible dental plaque index.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Educational Intervention in Preventing Early Childhood Caries
Official Title  ICMJE A Cluster-randomized Trial of the Effectiveness of an Educational Intervention in Preventing Early Childhood Caries
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Dental Caries
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Educational 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. This intervention will be applied at the Brazilian National Vaccination Day
    Intervention: Behavioral: Education Intervention
  • No Intervention: Control group
    This group will receive no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 29, 2011)
500
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01502566
Other Study ID Numbers  ICMJE UFPEL-PPGO0011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maximiliano Sergio Cenci, Federal University of Pelotas
Study Sponsor  ICMJE Federal University of Pelotas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: 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
PRS Account Federal University of Pelotas
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP