Improved Oral Health and Dental Care in Children With Congenital Heart Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dental Caries
- Oral Health
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 12 years
- Gender
- Both males and females
Description
Power analysis: Children with CHD are at high risk of developing caries (Stecksén-Blicks C et al 2004). In Swedish high-risk areas for developing caries, 12 % of three-year-old children had moderate and severe carious lesions (ICDAS II 3-6) and 11% initial carious lesions (ICDAS II 1-2) (Anderson et...
Power analysis: Children with CHD are at high risk of developing caries (Stecksén-Blicks C et al 2004). In Swedish high-risk areas for developing caries, 12 % of three-year-old children had moderate and severe carious lesions (ICDAS II 3-6) and 11% initial carious lesions (ICDAS II 1-2) (Anderson et al 2016). Based on the assumption that 10% in the intervention group and 30% in the control group will develop caries (ICDAS II 1-6), p<0.05 and power 0.80, a sample size of at least 65 individuals in each age group is required. 1.7.2017-31.12.2021 198 Finnish speaking families will be offered to participate in the study. To secure an even distribution block randomization will be used. The patients will be randomized into blocks of 4 and 8, with the help of www.randomization.com (Pandis et al 2011).
Tracking Information
- NCT #
- NCT03329170
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: My Blomqvist, PhD Department of Oral and Maxillofacial Diseases, Helsinki University Central Hospital.
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