Does preoperative dental screening improve outcomes for people having heart valve surgery or TAVR?
Official title: 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.
Run by Region Skane · NCT07511673 · Data updated 2026-11-12
This trial tests whether doing a dental check before valve surgery or transcatheter valve implantation helps patients by reducing death, need for another valve procedure, or endocarditis within two years.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1300 (estimated) |
| Sponsor | Region Skane Academic / other |
| Locations | 5 sites (Gothenburg and 4 other locations) |
| Status | Recruiting |
| Started | May 6, 2026 |
| Main results expected | December 1, 2030 |
| Study ends | December 1, 2036 |
| Registry record updated | May 19, 2026 |
| Trial ID | NCT07511673 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older accepted for surgical or transcatheter cardiac valve intervention who can provide informed consent.
✕Probably not a fit
Patients lacking an established link between dental health and valve infection, or those undergoing urgent surgery, may not benefit from screening according to this trial design.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized trial in Sweden that assigns adults undergoing surgical or transcatheter valve procedures to either preoperative dental screening or no screening. The primary outcome is a composite of all-cause death, redo-valve intervention, or definite infective endocarditis within 2 years, analyzed by time-to-event methods. The study uses registry-based follow-up to ensure complete outcome data and follows intention-to-treat principles. Dental care in the intervention arm is given per clinical practice, while the control arm receives no routine preoperative dental screening.
Why it matters
Potential benefit: If successful, preoperative dental screening could become a standard step to lower serious cardiac infection and related complications after valve procedures.
How similar studies have gone: Previous observational data suggested a potential benefit of dental screening, but randomized evidence is currently lacking; this trial addresses that gap.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Accepted for cardiac valve intervention * Able to provide informed consent Exclusion Criteria: * 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
Where it's running
-
Skane University Hospital
Lund, Sweden Recruiting -
Sahlgrenska University Hospital
Gothenburg, Sweden Not yet recruiting -
Linköping University Hospital
Linköping, Sweden Not yet recruiting -
Örebro University Hospital
Örebro, Sweden Not yet recruiting -
Karolinska University Hospital
Stockholm, Sweden Not yet recruiting
Study contacts
- Study coordinator: Patrik Gilje, MD-PhD
- Email: patrik.gilje@skane.se
- Phone: +46 (0)46171819
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.