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Recruiting Not applicable

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

NCT06269679 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-12-18
Last updated
2026-04-06

Condition(s) studied

Infective Endocarditis

Investigational drug(s) / intervention(s)

CBCT

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

Study 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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Superiority of CBCT — Month 12
    Number of oral infectious foci detected using orthopantomogram versus Cone Beam Computer Tomography
  • Superiority of CBCT — Month 12
    DFMT index comprising the number of decayed, filled and missing teeth
  • Superiority of CBCT — Month 12
    Number of severe periodontitis sites

Trial sites (10)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06269679 on ClinicalTrials.gov ↗ ← All trials in France