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RecruitingNCT06403839

Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Surgical Valve Replacement Patients

Impact of Targeted Preoperative Dental Screening on Post-procedural Risk of Infective Endocarditis in Patients Undergoing Surgical Valve Replacement: a Prospective Observational Study

Status
Recruiting
Phase
Study type
Observational
Enrollment
1,000 (estimated)
Sponsor
Odense University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with surgical valve replacement was changed from mandatory to targeted PDS to from march 2024. The investigators will therefore compare the risk of IE before vs after march 2024.

Detailed description

Infective endocarditis (IE), a condition linked with significant mortality and morbidity rates, is particularly concerning for patients with prosthetic left-sided valves. These patients face an elevated IE risk, estimated at about 1% annually in tertiary care settings, cumulatively impacting around one in every 20 patients over a decade. In line with this, both the American Heart Association (AHA) and the European Society of Cardiology (ESC) strongly advocate for the elimination of potential dental sepsis sources at least two weeks before prosthetic valve implantation, except in urgent cases. These guidelines, while not grounded in randomized trials, largely draw upon registry data detailing IE incidence among surgical valve replacement patients. In a recent study the investigators found no difference in risk of IE when comparing mandatory preoperative dental screening (MPDS) with no preoperative dental screening (NPDS). Thus, this prospective registry-based observational before-and-after study aims to investigate the impact of different preoperative dental screening practices on the risk of IE in patients undergoing.

Conditions

Interventions

TypeNameDescription
PROCEDURENo preoperative dental screeningDiscontinuance of mandatory preoperative dental screening prior surgical valve replacement which also can include oral surgery.

Timeline

Start date
2020-01-01
Primary completion
2027-03-01
Completion
2028-03-01
First posted
2024-05-08
Last updated
2025-08-15

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT06403839. Inclusion in this directory is not an endorsement.