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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.

NCT07511673 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Infective Endocarditis (IE)
  • Heart Valve Disease

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.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-06
Primary Completion
2030-12-01
Completion
2036-12-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07511673 on ClinicalTrials.gov