Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Surgical Valve Replacement Patients
DENSVAR
Impact of Targeted Preoperative Dental Screening on Post-procedural Risk of Infective Endocarditis in Patients Undergoing Surgical Valve Replacement: a Prospective Observational Study
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 3, 2024
CompletedFirst Posted
Study publicly available on registry
May 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
August 15, 2025
August 1, 2025
7.2 years
May 3, 2024
August 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with Infectious Endocarditis
Infectious endocarditis diagnosed by healthcare professionals
Through study completion, an average of 1 year
Secondary Outcomes (6)
Number of Participants undergoing Oral surgical procedure at dental screening
Through study completion, an average of 1 year
Number of Participants undergoing Tooth extraction at dental screening
Through study completion, an average of 1 year
The different Bacteria types causing the infectious endocarditis assessed by blood culture
Through study completion, an average of 1 year
Number patients with Bacteremia assessed by positive blood culture
Through study completion, an average of 1 year
Number of Participants with IE caused by bacteria from oral foci
Through study completion, an average of 1 year
- +1 more secondary outcomes
Study Arms (2)
No preoperative dental screening
No preoperative dental screening in patients undergoing surgical valve replacement.
Mandatory preoperative dental screening
Mandatory preoperative dental screening in patients undergoing surgical valve replacement
Interventions
Discontinuance of mandatory preoperative dental screening prior surgical valve replacement which also can include oral surgery.
Eligibility Criteria
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.
You may qualify if:
- Patients undergoing surgical valve replacement
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Odense University Hospital, Cardiac Surgery Department
Odense, 5000, Denmark
Related Publications (10)
Que YA, Moreillon P. Infective endocarditis. Nat Rev Cardiol. 2011 Jun;8(6):322-36. doi: 10.1038/nrcardio.2011.43. Epub 2011 Apr 12.
PMID: 21487430BACKGROUNDPiper C, Korfer R, Horstkotte D. Prosthetic valve endocarditis. Heart. 2001 May;85(5):590-3. doi: 10.1136/heart.85.5.590. No abstract available.
PMID: 11303018BACKGROUNDOstergaard L, Valeur N, Ihlemann N, Smerup MH, Bundgaard H, Gislason G, Torp-Pedersen C, Bruun NE, Kober L, Fosbol EL. Incidence and factors associated with infective endocarditis in patients undergoing left-sided heart valve replacement. Eur Heart J. 2018 Jul 21;39(28):2668-2675. doi: 10.1093/eurheartj/ehy153.
PMID: 29584858BACKGROUNDDelgado V, Ajmone Marsan N, de Waha S, Bonaros N, Brida M, Burri H, Caselli S, Doenst T, Ederhy S, Erba PA, Foldager D, Fosbol EL, Kovac J, Mestres CA, Miller OI, Miro JM, Pazdernik M, Pizzi MN, Quintana E, Rasmussen TB, Ristic AD, Rodes-Cabau J, Sionis A, Zuhlke LJ, Borger MA; ESC Scientific Document Group. 2023 ESC Guidelines for the management of endocarditis. Eur Heart J. 2023 Oct 14;44(39):3948-4042. doi: 10.1093/eurheartj/ehad193. No abstract available.
PMID: 37622656BACKGROUNDMentias A, Girotra S, Desai MY, Horwitz PA, Rossen JD, Saad M, Panaich S, Kapadia S, Sarrazin MV. Incidence, Predictors, and Outcomes of Endocarditis After Transcatheter Aortic Valve Replacement in the United States. JACC Cardiovasc Interv. 2020 Sep 14;13(17):1973-1982. doi: 10.1016/j.jcin.2020.05.012.
PMID: 32912457BACKGROUNDButt JH, Ihlemann N, De Backer O, Sondergaard L, Havers-Borgersen E, Gislason GH, Torp-Pedersen C, Kober L, Fosbol EL. Long-Term Risk of Infective Endocarditis After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2019 Apr 9;73(13):1646-1655. doi: 10.1016/j.jacc.2018.12.078.
PMID: 30947917BACKGROUNDOtto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 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. Circulation. 2021 Feb 2;143(5):e72-e227. doi: 10.1161/CIR.0000000000000923. Epub 2020 Dec 17. No abstract available.
PMID: 33332150BACKGROUNDBuckley AJ, Hensey M, O'Connor S, Maree A. Dental screening prior to transcatheter versus surgical aortic valve replacement: International Survey of Current Practices. Catheter Cardiovasc Interv. 2023 Jul;102(1):176-177. doi: 10.1002/ccd.30675. Epub 2023 May 7. No abstract available.
PMID: 37149755BACKGROUNDVahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
PMID: 34453165BACKGROUNDKrasniqi L, Schodt Riber LP, Nissen H, Terkelsen CJ, Andersen NH, Freeman P, Povlsen JA, Gerke O, Clavel MA, Dahl JS. Impact of mandatory preoperative dental screening on post-procedural risk of infective endocarditis in patients undergoing transcatheter aortic valve implantation: a nationwide retrospective observational study. Lancet Reg Health Eur. 2023 Nov 22;36:100789. doi: 10.1016/j.lanepe.2023.100789. eCollection 2024 Jan.
PMID: 38188272BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lytfi Krasniqi, MD
Denmark Odense University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2024
First Posted
May 8, 2024
Study Start
January 1, 2020
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
August 15, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- To be announced
- Access Criteria
- A signed data access agreement, compliant with regional legislation and data authority requirements, must be obtained prior to data release.
Data from this study, encompassing both individual participant information and a comprehensive data dictionary that defines each field, will be accessible to interested parties. Specifically, the investigators will share deidentified participant data paired with the mentioned data dictionary. Study protocol and statistical analysis plan will be provided. Prospective researchers can anticipate data availability concurrent with the publication of our findings. To gain access, reach out to Lytfi.Krasniqi@rsyd.dk. Data will be shared with researchers whose proposed use has received approval. Access will be granted primarily for the replication of the results presented in our study.