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
The aim of this study is to assess the effectiveness of an oral health educative intervention in preventing early childhood caries (ECC).
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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
- 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.
- dental plaque index [ Time Frame: after 12 months ]The oral health status will be recorded by visible dental plaque index.
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
|Federal University of Pelotas - School of Dentistry|
|Pelotas, RS, Brazil, 96015560|
|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|