CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.

NCT ID: NCT06269679

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-18

Study Completion Date

2028-07-18

Brief Summary

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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.

Detailed Description

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Conditions

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Infective Endocarditis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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OPT

Orthopantomogram = current recommended clinical examination approach (comparator procedure)

Group Type NO_INTERVENTION

No interventions assigned to this group

CBCT

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

Group Type EXPERIMENTAL

CBCT

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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CBCT

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. 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;
2. 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;
3. Patients whose life expectancy is expected to be longer than 6 months;
4. Patients who agree to visit the dental department of the hospital to carry out OIF eradication or at his/her personal dentist;
5. Patients over 18 years old;
6. Patients affiliated to a Social Security or a health insurance scheme;
7. Patients who have given informed consent to participate to the study.

Exclusion Criteria

1. OPT or CBCT already performed before the inclusion of the patients in the study and available for the investigator during the patient's hospitalization.
2. Medical contraindications to perform OPT or CBCT imaging;
3. Absence of microbiologic identification of the IE responsible microorganism;
4. Pregnant or breastfeeding women;
5. Patients unable to give informed consent to participate to the study (under trusteeship, guardianship and legal protection).
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Bordeaux - Site Pellegrin

Bordeaux, , France

Site Status NOT_YET_RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

CHU Grenoble

Grenoble, , France

Site Status NOT_YET_RECRUITING

HCL

Lyon, , France

Site Status NOT_YET_RECRUITING

APHM

Marseille, , France

Site Status NOT_YET_RECRUITING

CHRU Nancy

Nancy, , France

Site Status NOT_YET_RECRUITING

CHU Nantes

Nantes, , France

Site Status RECRUITING

AP-HP - Site Bretonneau

Paris, , France

Site Status RECRUITING

CHU Toulouse

Toulouse, , France

Site Status RECRUITING

CHRU Tours

Tours, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Facility Contacts

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Elise ARRIVE

Role: primary

+33/5 56 79 56 79

Magali VIDAL

Role: primary

+33473754405

Cécile CHATEL

Role: primary

+33/4 76 76 50 26

Sarah MILLOT GUARD

Role: primary

+33426680250

Jean-Hugues CATHERINE

Role: primary

+33676320760

Vanessa MOBY

Role: primary

+33/3 83 39 18 00

Philippe LESCLOUS

Role: primary

+33/2.40.41.29.40

Astrid GARREAU

Role: backup

MESSECA Clément

Role: primary

+33/1 53 11 18 00

Sarah COUSTY

Role: primary

+33/5.61.32.20.30

Frédéric DENIS

Role: primary

+33/2 47 47 47 47

Other Identifiers

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RC23_0336

Identifier Type: -

Identifier Source: org_study_id

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