A Phase 3 interventional study of Education Intervention in Dental Caries, sponsored by Federal University of Pelotas. Completed at 1 site in Brazil. Open to participants aged Up to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-22.
Sponsored by Federal University of Pelotas · Phase 3, Interventional, and Prevention
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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 500 is above the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →Federal University of Pelotas is the lead sponsor of 52 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
This group will receive no 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.
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.
Time frame: after 12 months
dental plaque index
The oral health status will be recorded by visible dental plaque index.
Time frame: after 12 months
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Federal University of Pelotas