CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CBCT.
- Who it may be relevant to
- Registry conditions: Infective Endocarditis. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
Interventions
- Diagnostic test CBCT
Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF.
Primary outcome measures
- Superiority of CBCT [Time frame: Month 12]
- Superiority of CBCT [Time frame: Month 12]
- Superiority of CBCT [Time frame: Month 12]
Secondary outcome measures (11)
- Diagnostic at inclusion [Time frame: Day 0]
- Incident symptomatic OIF [Time frame: Month 12]
- Incident asymptomatic OIF [Time frame: Month 12]
- Oral hygiene [Time frame: Day 0 and Month 12]
- Follow-up habits [Time frame: Day 0 and Month 12]
- Follow-up habits [Time frame: Day 0 and Month 12]
- Oral health quality of life [Time frame: Day 0 and Month 12]
- Premature end of study [Time frame: Month 12]
- Impact of dental OIF [Time frame: Month 12]
- Impact of periodontal OIF [Time frame: Month 12]
- Impact of mucosal OIF [Time frame: Month 12]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 10 centers
- CHU Bordeaux - Site Pellegrin — Bordeaux
- CHU Clermont-Ferrand — Clermont-Ferrand
- CHU Grenoble — Grenoble
- HCL — Lyon
- APHM — Marseille
- CHRU Nancy — Nancy
- CHU Nantes — Nantes
- AP-HP - Site Bretonneau — Paris
- … and 2 more centers
Publications
- Cloitre A, Duval X, Boutoille D, Pere M, Garreau A, Fouchard S, Poinas A, Lesclous P. 3D imaging cone beam computed tomography versus orthopantomogram to improve the oral health status of patients hospitalized for infective endocarditis (3D STARS): study protocol of a randomized superiority controlled trial. BMC Oral Health. 2025 Jul 2;25(1):1045. doi: 10.1186/s12903-025-06473-6. PMID 40604829
Identifiers
NCT: NCT06269679 · RC23_0336