Comparing imaging techniques for oral health in patients with infective endocarditis

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.

This study is testing if a special type of dental scan called Cone Beam Computed Tomography can find oral infections better than a regular dental X-ray in patients with infective endocarditis to help improve their oral health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Nantes University Hospital (other)
• Locations: 10 sites (Bordeaux and 9 other locations)
• Trial ID: NCT06269679 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of Cone Beam Computed Tomography (CBCT) compared to traditional Orthopantomogram (OPT) in detecting Oral Infectious Foci (OIF) in patients hospitalized for infective endocarditis (IE). Given that streptococci of oral origin are a common cause of IE, the study will assess whether the enhanced sensitivity of CBCT can lead to better oral health outcomes and potentially reduce new episodes of IE. Patients will be randomly assigned to receive either imaging technique during their hospitalization, and their oral health status will be monitored over a 12-month period.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who are hospitalized for definite infective endocarditis and have a stable clinical state.

Not a fit: Patients who have already undergone OPT or CBCT imaging prior to the study or have medical contraindications for these imaging techniques may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved detection and management of oral infections in patients with infective endocarditis, potentially reducing morbidity and mortality associated with the condition.

How similar studies have performed: While this approach is novel in the context of infective endocarditis, similar imaging techniques have shown promise in other dental and medical studies for detecting oral infections.

Eligibility criteria

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).

Where this trial is running

Bordeaux and 9 other locations

• CHU Bordeaux - Site Pellegrin — Bordeaux, France (RECRUITING)
• CHU Clermont-Ferrand — Clermont-Ferrand, France (RECRUITING)
• CHU Grenoble — Grenoble, France (RECRUITING)
• HCL — Lyon, France (RECRUITING)
• APHM — Marseille, France (RECRUITING)
• CHRU Nancy — Nancy, France (RECRUITING)
• CHU Nantes — Nantes, France (RECRUITING)
• AP-HP - Site Bretonneau — Paris, France (RECRUITING)
• CHU Toulouse — Toulouse, France (RECRUITING)
• CHRU Tours — Tours, France (RECRUITING)

Conditions: Infective Endocarditis