Clinical trial NCT06403839: Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Surgical Valve Replacement Patients
Official title: Impact of Targeted Preoperative Dental Screening on Post-procedural Risk of Infective Endocarditis in Patients Undergoing Surgical Valve Replacement: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgical Valve Replacement
Dental
Endocarditis
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing surgical valve replacement from March 2024 to March 2027 from Odense University Hospital compared with same type of patients from the same center from the period January 2020 to March 2024.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgical valve replacement

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants with Infectious Endocarditis
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Number of Participants undergoing Oral surgical procedure at dental screening
timeFrame: Through study completion, an average of 1 year
measure: Number of Participants undergoing Tooth extraction at dental screening
timeFrame: Through study completion, an average of 1 year
measure: The different Bacteria types causing the infectious endocarditis assessed by blood culture
timeFrame: Through study completion, an average of 1 year
measure: Number patients with Bacteremia assessed by positive blood culture
timeFrame: Through study completion, an average of 1 year
measure: Number of Participants with IE caused by bacteria from oral foci
timeFrame: Through study completion, an average of 1 year
measure: Number of Participants with Cardiac implantable electronic device risk of IE
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital, Cardiac Surgery Department
Study officials:
affiliation: Denmark Odense University Hospital
name: Lytfi Krasniqi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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