CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
Recruiting now · Not applicable
Conditions studied: Infective Endocarditis
In brief
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.
Key facts
- Study ID
- NCT06269679
- Run by
- Nantes University Hospital
- People needed
- 170
- Starts
- 2024-12-18
- Expected to finish
- 2028-07-18
- Last updated by the study team
- 2026-04-06
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
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…
- OPT or CBCT already performed before the inclusion of the patients in the study and available for the investigator during the patient's hospitalization.
- 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).
Where it is running
- CHU Bordeaux - Site Pellegrin — Bordeaux, France (enrolling)
- CHU Clermont-Ferrand — Clermont-Ferrand, France (enrolling)
- CHU Grenoble — Grenoble, France (enrolling)
- HCL — Lyon, France (enrolling)
- APHM — Marseille, France (enrolling)
- CHRU Nancy — Nancy, France (enrolling)
- CHU Nantes — Nantes, France (enrolling)
- AP-HP - Site Bretonneau — Paris, France (enrolling)
- CHU Toulouse — Toulouse, France (enrolling)
- CHRU Tours — Tours, France (enrolling)
Full record on ClinicalTrials.gov
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