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
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.
1 other identifier
interventional
1,300
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2026
CompletedFirst Posted
Study publicly available on registry
April 6, 2026
CompletedStudy Start
First participant enrolled
May 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2036
May 19, 2026
May 1, 2026
4.6 years
March 30, 2026
May 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite outcome of death, redo-intervention, or infective endocarditis
Time to first occurrence of all-cause death, redo-intervention of the index valve, or definite infective endocarditis.
2 years
Secondary Outcomes (6)
All-cause mortality
2 years
Redo-intervention of index valve
2 years
Definite infective endocarditis
2 years
CIED extraction
2 years
Oral health (GOHAI score)
3 months
- +1 more secondary outcomes
Study Arms (2)
Preoperative dental screening
EXPERIMENTALPreoperative dental examination with treatment if clinically indicated.
No preoperative dental screening
ACTIVE COMPARATORNo routine dental screening prior to valve intervention.
Interventions
Dental examination prior to valve intervention; treatment performed if indicated.
No routine dental screening prior to valve intervention.
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- Accepted for cardiac valve intervention
- Able to provide informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (5)
Sahlgrenska University Hospital
Gothenburg, Sweden
Linköping University Hospital
Linköping, Sweden
Skane University Hospital
Lund, Sweden
Örebro University Hospital
Örebro, Sweden
Karolinska University Hospital
Stockholm, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 30, 2026
First Posted
April 6, 2026
Study Start
May 6, 2026
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2036
Last Updated
May 19, 2026
Record last verified: 2026-05