Odense University Hospital, Cardiac Surgery Department
Odense, 5000, Denmark
Location status: Recruiting
Recruiting
NCT Number: NCT06403839
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Surgical Valve Replacement Patients
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients undergoing surgical valve replacement
Exclusion criteria
- None
Treatment and study plan
No preoperative dental screening
ProcedureDiscontinuance of mandatory preoperative dental screening prior surgical valve replacement which also can include oral surgery.
Primary outcomes
-
Number of Participants with Infectious Endocarditis
Time frame: Through study completion, an average of 1 year
Infectious endocarditis diagnosed by healthcare professionals
Secondary outcomes
-
Number of Participants undergoing Oral surgical procedure at dental screening
Time frame: Through study completion, an average of 1 year
Number of oral surgical procedure performed in patients as part of the dental screening
-
Number of Participants undergoing Tooth extraction at dental screening
Time frame: Through study completion, an average of 1 year
Number of Tooth extraction procedure performed in patients as part of the dental screening
-
The different Bacteria types causing the infectious endocarditis assessed by blood culture
Time frame: Through study completion, an average of 1 year
Reporting all the different bacteria type causing infectious endocarditis, including the rate of each bacteria.
-
Number patients with Bacteremia assessed by positive blood culture
Time frame: Through study completion, an average of 1 year
Cases of bacteremia in the population
-
Number of Participants with IE caused by bacteria from oral foci
Time frame: Through study completion, an average of 1 year
Infectious Endocarditis caused by bacteria from oral foci
-
Number of Participants with Cardiac implantable electronic device risk of IE
Time frame: Through study completion, an average of 1 year
Cardiac implantable electronic device risk of IE
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Odense University Hospital
Other
Registry information
Official study title
Impact of Targeted Preoperative Dental Screening on Post-procedural Risk of Infective Endocarditis in Patients Undergoing Surgical Valve Replacement: a Prospective Observational Study
Acronym: DENSVAR
Important dates
- Study start
- 2020
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- May 8, 2024
- Registry last updated
- Aug 15, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Not Yet Recruiting
Self-Expanding Hydra Transcatheter Heart Valve (THV) Series Versus Balloon-Expandable Devices for Valve-In-Valve Transcatheter Aortic Valve Implantation (TAVI) for Patients With Failed Surgical Aortic Bioprosthesis.
NCT07524595
AORTIC VALVE DISEASES, Aortic Valve Disease
Galway, Ireland
View Trial Details
Completed
Evaluating the Risk of Cognitive Impairment After Surgical and Transcatheter Aortic Valve Replacement
NCT02971020
Aortic Valve Disease, Aortic Valve Stenosis
Minneapolis, Minnesota, United States
View Trial Details
Recruiting
Barts Endocarditis Research Registry
NCT06434012
Bacterial Infections, Bacterial Infections and Mycoses
London, United Kingdom
View Trial Details
Recruiting
Clinical and Diagnostic Features of Endocarditis
NCT05547607
Cardiovascular Diseases, Endocarditis
Cona, Ferrara, Italy
View Trial Details