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)

May 15, 2026 updated by: Patrik Gilje, Region Skane

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Not yet recruiting
        • Sahlgrenska University Hospital
        • Contact:
      • Linköping, Sweden
      • Lund, Sweden
        • Recruiting
        • Skåne University Hospital
        • Contact:
      • Stockholm, Sweden
        • Not yet recruiting
        • Karolinska University Hospital
        • Contact:
          • Ulrik Sartipy, Professor
          • Phone Number: +46812370000
      • Örebro, Sweden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperative dental screening
Preoperative dental examination with treatment if clinically indicated.
Other: Preoperative dental screening
Dental examination prior to valve intervention; treatment performed if indicated.
Active Comparator: No preoperative dental screening
No routine dental screening prior to valve intervention.
Other: No preoperative dental screening
No routine dental screening prior to valve intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite outcome of death, redo-intervention, or infective endocarditis
Time Frame: 2 years
Time to first occurrence of all-cause death, redo-intervention of the index valve, or definite infective endocarditis.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 2 years
2 years
Redo-intervention of index valve
Time Frame: 2 years
2 years
Definite infective endocarditis
Time Frame: 2 years
2 years
CIED extraction
Time Frame: 2 years
Extraction of Cardiovascular Implantable Electronic Device (CIED)
2 years
Oral health (GOHAI score)
Time Frame: 3 months
The GOHAI consists of 12 items with a total score ranging from 12 to 60, where higher scores indicate better oral health-related quality of life.
3 months
Quality of life (EQ-5D-5L index and VAS score)
Time Frame: 3 months
The EQ-5D-5L descriptive system generates an index value typically ranging from less than 0 (worse than death) to 1 (full health), where higher values indicate better health-related quality of life. The EQ Visual Analogue Scale (EQ VAS) ranges from 0 to 100, where higher scores indicate better perceived health.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2036

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-08978-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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