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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Preoperative dental screening, No preoperative dental screening.
- Who it may be relevant to
- Registry conditions: Infective Endocarditis (IE), Heart Valve Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- 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.
Primary outcome measures
- Composite outcome of death, redo-intervention, or infective endocarditis [Time frame: 2 years]
Secondary outcome measures (6)
- All-cause mortality [Time frame: 2 years]
- Redo-intervention of index valve [Time frame: 2 years]
- Definite infective endocarditis [Time frame: 2 years]
- CIED extraction [Time frame: 2 years]
- Oral health (GOHAI score) [Time frame: 3 months]
- Quality of life (EQ-5D-5L index and VAS score) [Time frame: 3 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 5 centers
- Sahlgrenska University Hospital — Gothenburg
- Linköping University Hospital — Linköping
- Skane University Hospital — Lund
- Örebro University Hospital — Örebro
- Karolinska University Hospital — Stockholm
Identifiers
NCT: NCT07511673 · 2025-08978-01