Infective endocarditis.
Yok-Ai Que, Philippe Moreillon
https://pubmed.ncbi.nlm.nih.gov/21487430Actively Recruiting
Age: 18Years +
All Genders
ID06403839
Impact of Targeted Preoperative Dental Screening on Post-procedural Risk of Infective Endocarditis in Patients Undergoing Surgical Valve Replacement: a Prospective Observational Study
Led by Odense University Hospital · Updated on 2025-08-15
1000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the impact of different preoperative dental screening practices on the risk of infective endocarditis (IE) in patients undergoing surgical valve replacement. IE is a serious infection linked with high mortality and morbidity and is particularly concerning for patients with prosthetic left-sided valves, who face an estimated 1% annual risk. Guidelines recommend eliminating dental infection sources before valve implantation, but these recommendations are mainly based on registry data rather than randomized trials. The study compares two approaches: mandatory preoperative dental screening (MPDS) versus no preoperative dental screening (NPDS) before surgical valve replacement. The research is conducted as a prospective registry-based observational before-and-after study, starting from 2020 with changes in screening protocols implemented in March 2024. One group undergoes mandatory dental screening including possible oral surgery, while the other group does not have preoperative dental screening. Participants will be observed for an average of one year to assess the number of patients developing infective endocarditis. Researchers will also monitor secondary outcomes such as oral surgical procedures, tooth extractions, types of bacteria causing infections, bacteremia incidence, and infections related to cardiac devices. The study involves collecting data through routine clinical follow-up and blood cultures to better understand the relationship between dental screening practices and post-surgical infection risk.
CONDITIONS
Brief Title
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Surgical Valve Replacement Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients undergoing surgical valve replacement
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Up to hospital discharge
Participants undergo surgical valve replacement and receive immediate post-operative care.
Long-term Monitoring
Duration - Approximately 1 year
Participants are observed for up to 1 year to monitor for the development of infective endocarditis and related outcomes.
Periodic follow-up visits during the year
Trial Site Locations
Total: 1 location
1
Odense University Hospital, Cardiac Surgery Department
Odense, Denmark, 5000
Actively Recruiting
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Research Team
L
Lytfi Krasniqi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Prosthetic valve endocarditis.
C Piper, R Körfer, D Horstkotte
https://pubmed.ncbi.nlm.nih.gov/11303018Incidence and factors associated with infective endocarditis in patients undergoing left-sided heart valve replacement.
Lauge Østergaard, Nana Valeur, Nikolaj Ihlemann...
https://pubmed.ncbi.nlm.nih.gov/295848582023 ESC Guidelines for the management of endocarditis.
Victoria Delgado, Nina Ajmone Marsan, Suzanne de Waha...
https://pubmed.ncbi.nlm.nih.gov/37622656Incidence, Predictors, and Outcomes of Endocarditis After Transcatheter Aortic Valve Replacement in the United States.
Amgad Mentias, Saket Girotra, Milind Y Desai...
https://pubmed.ncbi.nlm.nih.gov/32912457Long-Term Risk of Infective Endocarditis After Transcatheter Aortic Valve Replacement.
Jawad H Butt, Nikolaj Ihlemann, Ole De Backer...
https://pubmed.ncbi.nlm.nih.gov/309479172020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.
Catherine M Otto, Rick A Nishimura, Robert O Bonow...
https://pubmed.ncbi.nlm.nih.gov/33332150Dental screening prior to transcatheter versus surgical aortic valve replacement: International Survey of Current Practices.
Anthony J Buckley, Mark Hensey, Stephen O'Connor...
https://pubmed.ncbi.nlm.nih.gov/371497552021 ESC/EACTS Guidelines for the management of valvular heart disease.
Alec Vahanian, Friedhelm Beyersdorf, Fabien Praz...
https://pubmed.ncbi.nlm.nih.gov/34453165Impact of mandatory preoperative dental screening on post-procedural risk of infective endocarditis in patients undergoing transcatheter aortic valve implantation: a nationwide retrospective observational study.
Lytfi Krasniqi, Lars Peter Schødt Riber, Henrik Nissen...
https://pubmed.ncbi.nlm.nih.gov/38188272