Infective Endocarditis
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTCBCT
Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF.
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Superiority of CBCT | Month 12 | Number of oral infectious foci detected using orthopantomogram versus Cone Beam Computer Tomography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic at inclusion | Day 0 | Determine the diagnostic impact of clinical examination combined with CBCT at inclusion visit (Number of OIF detected at inclusion visit through clinical examination and CBCT versus clinical examination and OPT). |
| Incident symptomatic OIF | Month 12 | Monitor incident symptomatic OIF occuring during the study impacting the initial personalized OIF management (Number of incident symptomatic OIF detected during the study). |
| Incident asymptomatic OIF | Month 12 | Monitor incident asymptomatic OIF occuring during the study i.e. OIF absent at the initial examination but identified at the ultimate visit without symptomatic episode, in patients subjected to a clinical oral examination coupled with a CBCT (Number of incident asymptomatic OIF occuring during the study i.e. OIF absent at the initial examination but detected at the ultimate visit without symptomatic episode, in patients subjected to a clinical oral examination coupled with a CBCT). |
| Oral hygiene | Day 0 and Month 12 | Evaluate the oral hygiene of the IE patients included in the study (Oral hygiene using the Oral Hygiene Index- Simplified score (OHI-S) at inclusion visit and at the end-of-study visit). |
| Follow-up habits | Day 0 and Month 12 | Evaluate the follow-up habits of the IE patients included in the study by number of dental visits per year at inclusion visit and at the end-of-study visit). |
| Oral health quality of life | Day 0 and Month 12 | Assess the oral health quality of life of the IE patients included in this study (Oral health quality of life using by the short version of the self-administrated Oral Health impact profile-14 questionnaire (OHIP-14), at inclusion visit and at the end-of-study visit). |
| Premature end of study | Month 12 | Analyse the patient's premature end of study (Causes of the patient's premature end of study: loss to follow-up, death, patient withdrawing consent). |
| Impact of dental OIF | Month 12 | Number of dental OIF detected at the end-of-study visit through clinical examination versus number of periodontal OIF detected at the inclusion visit through clinical examination. |
| Impact of periodontal OIF | Month 12 | Number of periodontal OIF detected at the end-of-study visit through clinical examination versus number of periodontal OIF detected at the inclusion visit through clinical examination. |
| Impact of mucosal OIF | Month 12 | Number of mucosal OIF detected at the end-of-study visit through clinical examination versus number of periodontal OIF detected at the inclusion visit through clinical examination. |
Countries
France
Outcome results
None listed