Clinical trial NCT06269679: CBCT Vs OPT on the Oral Health Status At 12 Months of Patients Hospitalized for Infective Endocarditis.
Official title: 3D Imaging (Cone Beam Computed Tomography) Versus Orthopantomogram on the Oral Health Status At 12 Months of Patients Hospitalized for Infective Endocarditis: a Multicenter Randomized Superiority Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infective Endocarditis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

1. Patients hospitalized for definite IE according to the 2015 ESC classification, whatever the IE responsible microorganism;
2. Patients with a stable clinical state compatible with the performance of an OPT and a CBCT during his/her initial hospitalization for acute IE management;
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).

Primary outcomes:
measure: Superiority of CBCT
timeFrame: Month 12
measure: Superiority of CBCT
timeFrame: Month 12
measure: Superiority of CBCT
timeFrame: Month 12
Secondary outcomes:
measure: Diagnostic at inclusion
timeFrame: Day 0
measure: Incident symptomatic OIF
timeFrame: Month 12
measure: Incident asymptomatic OIF
timeFrame: Month 12
measure: Oral hygiene
timeFrame: Day 0 and Month 12
measure: Follow-up habits
timeFrame: Day 0 and Month 12
measure: Follow-up habits
timeFrame: Day 0 and Month 12
measure: Oral health quality of life
timeFrame: Day 0 and Month 12
measure: Premature end of study
timeFrame: Month 12
measure: Impact of dental OIF
timeFrame: Month 12
measure: Impact of periodontal OIF
timeFrame: Month 12
measure: Impact of mucosal OIF
timeFrame: Month 12
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux - Site Pellegrin
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Grenoble
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: HCL
city: Marseille
country: France
facility: APHM
city: Nancy
country: France
facility: CHRU Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: AP-HP - Site Bretonneau
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHRU Tours
Study officials:
References: