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.

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Bordeaux - Site Pellegrin
NOT_YET_RECRUITING
Bordeaux
CHU Clermont-Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
CHU Grenoble
NOT_YET_RECRUITING
Grenoble
HCL
NOT_YET_RECRUITING
Lyon
APHM
NOT_YET_RECRUITING
Marseille
CHRU Nancy
NOT_YET_RECRUITING
Nancy
CHU Nantes
RECRUITING
Nantes
AP-HP - Site Bretonneau
RECRUITING
Paris
CHU Toulouse
RECRUITING
Toulouse
CHRU Tours
NOT_YET_RECRUITING
Tours
Time Frame
Start Date: 2024-12-18
Estimated Completion Date: 2028-07-18
Participants
Target number of participants: 170
Treatments
No_intervention: OPT
Orthopantomogram = current recommended clinical examination approach (comparator procedure)
Experimental: CBCT
Cone Beam Computed Tomography = experimental clinical examination approach (procedure under evaluation)
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov