Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
This randomized, multicenter, open-label trial evaluates whether preoperative dental screening improves outcomes in patients undergoing surgical or transcatheter cardiac valve intervention. Participants are randomized 1:1 to preoperative dental screening or no screening. The primary outcome is time to first occurrence of all-cause death, redo-intervention of the index valve, or definite infective endocarditis within 2 years. The study uses registry-based follow-up to ensure complete outcome ascertainment.
Eligibility criteria
Qualifiers
Age ≥18 years
Accepted for cardiac valve intervention
Able to provide informed consent
Disqualifiers
Previous or ongoing infective endocarditis
Urgent surgery
Pain from loose tooth/teeth
Immunosuppressive therapy (excluding corticosteroids)
Trial design
Treatments tested in this trial
- Preoperative dental screening
- No preoperative dental screening
Treatment groups
1,300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov