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NCT Number: NCT07511673

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.

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.

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Key information

Conditions

Infective Endocarditis (IE) Cardiovascular Diseases Endocarditis Heart Diseases Heart Valve Disease Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital, Gothenburg, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative dental screening

Other

Dental examination prior to valve intervention; treatment performed if indicated.

No preoperative dental screening

Other

No routine dental screening prior to valve intervention.

Primary outcomes

  1. 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.

Secondary outcomes

  1. All-cause mortality

    Time frame: 2 years

  2. Redo-intervention of index valve

    Time frame: 2 years

  3. Definite infective endocarditis

    Time frame: 2 years

  4. CIED extraction

    Time frame: 2 years

    Extraction of Cardiovascular Implantable Electronic Device (CIED)

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrik Gilje, MD-PhD

CONTACT

[email protected]

+46 (0)46171819

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study 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.

Acronym: SMILE

Important dates

Study start
2026
Primary completion
2030
Study completion
2036
First posted
Apr 6, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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