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Trial record 77 of 1199 for:    tooth decay

Educational Intervention in Preventing Early Childhood Caries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.


Condition or disease Intervention/treatment Phase
Dental Caries Behavioral: Education Intervention Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Cluster-randomized Trial of the Effectiveness of an Educational Intervention in Preventing Early Childhood Caries
Study Start Date : June 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
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
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.

No Intervention: Control group
This group will receive no intervention



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. dental plaque index [ Time Frame: after 12 months ]
    The oral health status will be recorded by visible dental plaque index.



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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01502566


Locations
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Brazil
Federal University of Pelotas - School of Dentistry
Pelotas, RS, Brazil, 96015560
Sponsors and Collaborators
Federal University of Pelotas
Investigators
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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

Additional Information:
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Responsible Party: Maximiliano Sergio Cenci, PhD, Associate Professor, Federal University of Pelotas
ClinicalTrials.gov Identifier: NCT01502566     History of Changes
Other Study ID Numbers: UFPEL-PPGO0011
First Posted: December 30, 2011    Key Record Dates
Last Update Posted: July 22, 2013
Last Verified: July 2013

Keywords provided by Maximiliano Sergio Cenci, Federal University of Pelotas:
educational intervention
dentals caries
population
new populational caries prevention strategies.

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases