CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocar… (NCT06269679) | Clinical Trial Compass
RecruitingNot Applicable
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
France170 participantsStarted 2024-12-18
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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).