NCT07511673

The Study is a Randomised Clinical Trial (RCT) to Test 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.

SWEDEHEART-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: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Infective endocarditis is associated with high morbidity and mortality in patients with prosthetic heart valves. Current recommendations for preoperative dental screening are based on observational data, and randomized evidence is lacking. This is a pragmatic, multicenter, randomized controlled trial conducted in Sweden. Patients accepted for surgical or transcatheter valve intervention are randomized 1:1 to: * Preoperative dental screening * No preoperative dental screening Dental treatment in the intervention group is performed according to clinical practice. No routine dental screening is performed in the control group. The primary endpoint is a composite of all-cause death, redo-intervention of the index valve, and definite infective endocarditis within 2 years. All analyses will follow the intention-to-treat principle using time-to-event methods.

Conditions

• Infective Endocarditis (IE)
• Heart Valve Disease

Interventions

Type	Name	Description
OTHER	Preoperative dental screening	Dental examination prior to valve intervention; treatment performed if indicated.
OTHER	No preoperative dental screening	No routine dental screening prior to valve intervention.

Timeline

• Start date: 2026-05-01
• Primary completion: 2030-12-01
• Completion: 2036-12-01
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: Sweden