NCT06269679

Brief Summary

1\. Infective Endocarditis (IE) is a rare and serious disease with high morbidity and mortality; 2. Streptoccoci of oral origin are the second more frequent microorganisms responsible for IE; 3. Oral Infectious Foci (OIF) are underdetected using the current recommended clinical examination/Orthopantomogram (OPT) approach; 4. Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF than OPT; 5. To date, no study has been performed to assess the potential benefit of a clinical examination/CBCT approach on the oral health status in IE patients. Thus, conducting a randomized controlled trial is highly desirable to assess the potential impact of a clinical examination/CBCT approach on the oral health status of patients hospitalized for IE and potentially to reduce IE new episodes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Dec 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
recruiting

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 Progress39%
Dec 2024Jul 2028

First Submitted

Initial submission to the registry

February 5, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

December 18, 2024

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2028

Last Updated

September 17, 2025

Status Verified

December 1, 2024

Enrollment Period

3.6 years

First QC Date

February 5, 2024

Last Update Submit

September 11, 2025

Conditions

Infective Endocarditis

Outcome Measures

Primary Outcomes (3)

  • Superiority of CBCT

    Number of oral infectious foci detected using orthopantomogram versus Cone Beam Computer Tomography

    Month 12

  • Superiority of CBCT

    DFMT index comprising the number of decayed, filled and missing teeth

    Month 12

  • Superiority of CBCT

    Number of severe periodontitis sites

    Month 12

Secondary Outcomes (11)

  • Diagnostic at inclusion

    Day 0

  • Incident symptomatic OIF

    Month 12

  • Incident asymptomatic OIF

    Month 12

  • Oral hygiene

    Day 0 and Month 12

  • Follow-up habits

    Day 0 and Month 12

  • +6 more secondary outcomes

Study Arms (2)

OPT

NO INTERVENTION

Orthopantomogram = current recommended clinical examination approach (comparator procedure)

CBCT

EXPERIMENTAL

Cone Beam Computed Tomography = experimental clinical examination approach (procedure under evaluation)

Diagnostic Test: CBCT

Interventions

CBCTDIAGNOSTIC_TEST

Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF.

CBCT

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients hospitalized or recently hospitalized for definite IE according to the 2015 ESC classification, naive patients for dental examination and imaging, whatever the IE responsible microorganism;
  • Patients with a stable clinical state, meaning stabilized IE patients out of the critical phase, compatible with the performance of an OPT and a CBCT;
  • Patients whose life expectancy is expected to be longer than 6 months;
  • Patients who agree to visit the dental department of the hospital to carry out OIF eradication or at his/her personal dentist;
  • Patients over 18 years old;
  • Patients affiliated to a Social Security or a health insurance scheme;
  • Patients who have given informed consent to participate to the study.

You may not qualify if:

  • Medical contraindications to perform OPT or CBCT imaging;
  • Absence of microbiologic identification of the IE responsible microorganism;
  • Pregnant or breastfeeding women;
  • Patients unable to give informed consent to participate to the study (under trusteeship, guardianship and legal protection).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU Bordeaux - Site Pellegrin

Bordeaux, France

NOT YET RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, France

NOT YET RECRUITING

CHU Grenoble

Grenoble, France

NOT YET RECRUITING

HCL

Lyon, France

NOT YET RECRUITING

APHM

Marseille, France

NOT YET RECRUITING

CHRU Nancy

Nancy, France

NOT YET RECRUITING

CHU Nantes

Nantes, France

RECRUITING

AP-HP - Site Bretonneau

Paris, France

RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

CHRU Tours

Tours, France

NOT YET RECRUITING

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 21, 2024

Study Start

December 18, 2024

Primary Completion (Estimated)

July 18, 2028

Study Completion (Estimated)

July 18, 2028

Last Updated

September 17, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(10)