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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06269679
Other study ID # RC23_0336
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date May 1, 2028

Study information

Verified date February 2024
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 170
Est. completion date May 1, 2028
Est. primary completion date May 1, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: 1. Patients hospitalized for definite IE according to the 2015 ESC classification, whatever the IE responsible microorganism; 2. 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; 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; 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 under 18 years old; 6. Patients unable to give informed consent to participate to the study (under trusteeship, guardianship and legal protection).

Study Design


Intervention

Diagnostic Test:
CBCT
Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF.

Locations

Country Name City State
France CHU Bordeaux - Site Pellegrin Bordeaux
France CHU Grenoble Grenoble
France CHRU Nancy Nancy
France CHU Nantes Nantes
France AP-HP - Site Bretonneau Paris
France CHU Toulouse Toulouse
France CHRU Tours Tours

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Superiority of CBCT Number of oral infectious foci detected using orthopantomogram versus Cone Beam Computer Tomography Month 12
Primary Superiority of CBCT DFMT index comprising the number of decayed, filled and missing teeth Month 12
Primary Superiority of CBCT Number of severe periodontitis sites Month 12
Secondary Diagnostic at inclusion 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). Day 0
Secondary Incident symptomatic OIF Monitor incident symptomatic OIF occuring during the study impacting the initial personalized OIF management (Number of incident symptomatic OIF detected during the study). Month 12
Secondary Incident asymptomatic OIF 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). Month 12
Secondary Oral hygiene 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). Day 0 and Month 12
Secondary Follow-up habits 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). Day 0 and Month 12
Secondary Follow-up habits Evaluate the follow-up habits of the IE patients included in the study by number of dental brushings per day (specific questionnaire already validated in French version) at inclusion visit and at the end-of-study visit). Day 0 and Month 12
Secondary Oral health quality of life 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). Day 0 and Month 12
Secondary Premature end of study 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). Month 12
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