Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403839
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-05-03
Brief Title:
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Surgical Valve Replacement Patients
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DENSVAR
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None