Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients (DENTAVI)

March 19, 2024 updated by: Jordi Dahl, Odense University Hospital

Impact of Targeted Preoperative Dental Screening on Post-procedural Risk of Infective Endocarditis in Patients Undergoing Transcatheter Aortic Valve Implantation: a Prospective Observational Study

In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with Transcatheter Aortic Valve Implantation (TAVI) was changed from mandatory to targeted PDS to between June 2023 to october 2023. The investigators will therefore compare the risk of IE before june 2023 and after october 2023.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 aortic valve replacement (SAVR) 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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Recruiting
        • Odense University Hospital, Cardiology Department
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jordi S Dahl, MD,PhD,DMSc
        • Principal Investigator:
          • Lytfi Krasniqi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

All patients undergoing TAVI from Oktober 2023 to January 2026 from Odense University Hospital and Aalborg University Hospital compared with same type of patients from the same centers from the period January 2020 to June 2023.

Description

Inclusion Criteria:

  • Patients undergoing TAVI

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No preoperative dental screening
No preoperative dental screening in patients undergoing TAVI
Procedure: No preoperative dental screening
Discontinuance of mandatory preoperative dental screening prior TAVI which also can include oral surgery.
Mandatory preoperative dental screening
Mandatory preoperative dental screening in patients undergoing TAVI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Infectious Endocarditis
Time Frame: Through study completion, an average of 1 year
Infectious endocarditis diagnosed by healthcare professionals
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1 year
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
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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
Through study completion, an average of 1 year
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
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Jordi S Dahl, MD,PhD,DMSc, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PET24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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, we'll be sharing 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.

IPD Sharing Time Frame

To be announced

IPD Sharing Access Criteria

A signed data access agreement, compliant with regional legislation and data authority requirements, must be obtained prior to data release.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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