CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis. (3D STARS)

N

Nantes University Hospital (NUH)

Status

Not yet enrolling

Conditions

Infective Endocarditis

Treatments

Diagnostic Test: CBCT

Study type

Interventional

Funder types

Other

Identifiers

NCT06269679
RC23_0336

Details and patient eligibility

About

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.

Enrollment

170 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients hospitalized for definite IE according to the 2015 ESC classification, whatever the IE responsible microorganism;
  • Patients with a stable clinical state compatible with the performance of an OPT and a CBCT during his/her initial hospitalization for acute IE management;
  • 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;
  • 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 under 18 years old;
  • Patients unable to give informed consent to participate to the study (under trusteeship, guardianship and legal protection).

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

170 participants in 2 patient groups

OPT
No Intervention group
Description:
Orthopantomogram = current recommended clinical examination approach (comparator procedure)
CBCT
Experimental group
Description:
Cone Beam Computed Tomography = experimental clinical examination approach (procedure under evaluation)
Treatment:
Diagnostic Test: CBCT

Trial contacts and locations

7

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems