Clinical Trial

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.

Study acronym: SMILE
Recruiting
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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.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-05-20
notable Trial sites expanded: 1 -> 5 locations 2026-05-20
Trial Details
NCT Number NCT07511673
Lead Sponsor Region Skane
Conditions Infective Endocarditis (IE), Heart Valve Disease
Enrollment 1,300 participants
Start Date 2026-05-06
Primary Completion 2030-12-01 (estimated)
Study Completion 2036-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-19