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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06403839
Acronym
DENSVAR
Enrollment
1000
Registered
2024-05-08
Start date
2020-01-01
Completion date
2028-03-01
Last updated
2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental, Endocarditis, Surgical Valve Replacement

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.

Interventions

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

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing surgical valve replacement

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with Infectious EndocarditisThrough study completion, an average of 1 yearInfectious endocarditis diagnosed by healthcare professionals

Secondary

MeasureTime frameDescription
Number of Participants undergoing Tooth extraction at dental screeningThrough study completion, an average of 1 yearNumber of Tooth extraction procedure performed in patients as part of the dental screening
The different Bacteria types causing the infectious endocarditis assessed by blood cultureThrough study completion, an average of 1 yearReporting all the different bacteria type causing infectious endocarditis, including the rate of each bacteria.
Number of Participants undergoing Oral surgical procedure at dental screeningThrough study completion, an average of 1 yearNumber of oral surgical procedure performed in patients as part of the dental screening
Number of Participants with IE caused by bacteria from oral fociThrough study completion, an average of 1 yearInfectious Endocarditis caused by bacteria from oral foci
Number of Participants with Cardiac implantable electronic device risk of IEThrough study completion, an average of 1 yearCardiac implantable electronic device risk of IE
Number patients with Bacteremia assessed by positive blood cultureThrough study completion, an average of 1 yearCases of bacteremia in the population

Countries

Denmark

Contacts

Primary ContactLytfi Krasniqi, MD
Lytfi.Krasniqi@rsyd.dk004524638899

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026