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.
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years
• Accepted for cardiac valve intervention
• Able to provide informed consent
Locations
Other Locations
Sweden
Sahlgrenska University Hospital
NOT_YET_RECRUITING
Gothenburg
Linköping University Hospital
NOT_YET_RECRUITING
Linköping
Skane University Hospital
RECRUITING
Lund
Örebro University Hospital
NOT_YET_RECRUITING
Örebro
Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
Contact Information
Primary
Patrik Gilje, MD-PhD
patrik.gilje@skane.se
+46 (0)46171819
Time Frame
Start Date: 2026-05-06
Estimated Completion Date: 2036-12-01
Participants
Target number of participants: 1300
Treatments
Experimental: Preoperative dental screening
Preoperative dental examination with treatment if clinically indicated.
Active_comparator: No preoperative dental screening
No routine dental screening prior to valve intervention.
Related Therapeutic Areas
Sponsors
Leads: Region Skane