The Study Tests if Preoperative Dental Screening is Superior to no Preoperative Dental Screening in Improving the Outcome of Patients Undergoing Surgical Cardiac Valve Replacement or Transcatheter Cardiac Valve Implantation.
SMILE: A Randomized Trial of Preoperative Dental Screening for the Prevention of Endocarditis, Reoperation or Death in Patients Undergoing Surgical or Transcatheter Cardiac Valve Intervention.
Region Skane
1,300 participants
May 6, 2026
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria3
- Age ≥18 years
- Accepted for cardiac valve intervention
- Able to provide informed consent
Exclusion Criteria6
- Previous or ongoing infective endocarditis
- Urgent surgery
- Pain from loose tooth/teeth
- Immunosuppressive therapy (excluding corticosteroids)
- Inability to provide informed consent
- Expected loss to follow-up
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Dental examination prior to valve intervention; treatment performed if indicated.
No routine dental screening prior to valve intervention.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07511673