Status:
ACTIVE_NOT_RECRUITING
Improved Oral Health and Dental Care in Children with Congenital Heart Disease
Lead Sponsor:
My Blomqvist
Conditions:
Oral Health
Dental Caries
Eligibility:
All Genders
Up to 12 years
Phase:
NA
Brief Summary
Background: Congenital heart disease (CHD) is one of the most common congenital anomalies in children. As the risk for endocarditis following bacteraemia is more common during daily oral hygiene routi...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age \< 12 months and prostethic cardiac valve or patient likely to undergo valve surgery using foreign material including homograft (potentially included in the criteria of endocarditis prophylaxis)
- Age \< 12 months and unrepaired cyanotic CHD including palliative shunts and conduits
- Age \< 12 months and repaired CHD with residual defects at the site or adjacent to the site of the prosthetic patch or device which inhibits endothelialization
- Age \< 12 months and cardiac transplantation recipient or listed for transplantation (potentially included in the criteria of endocarditis prophylaxis)
- Age \< 12 months and cardiomyopathy (potential cardiac transplantation recipient)
- Age \< 12 months and chromosomal abnormality or syndrome and any invasive intevention (surgery or cath) for CHD or likely to require invasive intervention for CHD
- Exclusion criteria:
- Neither parent amenable to comprehend intervention instructions provided in Finnish
- Child in out-of-home care (eg foster care)
Exclusion
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2030
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03329170
Start Date
July 1 2017
End Date
December 31 2030
Last Update
October 2 2024
Active Locations (1)
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1
Department of Pediatrics, Children´s Hospital, Helsinki University Central Hospital.
Helsinki, Finland