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Not yet recruiting Not applicable 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.

No applicable phase (e.g. observational)
Conditions: Infective Endocarditis (IE) Heart Valve Disease

Sponsor: Region Skane

trial.available_in: БГ
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.
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.
Who can participate
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
Interventions
Preoperative dental screening
OTHER
No preoperative dental screening
OTHER
Locations 1
Sweden (1)
Skane University Hospital
Lund
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
01.05.2026
Completion date
01.12.2036
Registry ID
NCT07511673
Source
clinicaltrials.gov
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