CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis. (3D STARS)

Nantes University Hospital (NUH)

Status: Enrolling

Conditions: Infective Endocarditis

Treatments: Diagnostic Test: CBCT

Study type: Interventional

Funder types: Other

Identifiers

NCT06269679

RC23_0336

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

OPT

No Intervention group

Description:

Orthopantomogram = current recommended clinical examination approach (comparator procedure)

CBCT

Experimental group

Description:

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

Treatment:

Diagnostic Test: CBCT