CBCT Vs OPT on the Oral Health Status At 12 Months of Patients Hospitalized for Infective Endocarditis.

Not Applicable

Recruiting

• Conditions: Infective Endocarditis
• Interventions: Diagnostic Test: CBCT

• Registration Number: NCT06269679
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-13
• Study First Posted: 2024-02-21
• Status Verified: 2024-12
• Study Start: 2024-12-18
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2028-07-18
• Study Completion: 2028-07-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBCT	CBCT	Cone Beam Computed Tomography = experimental clinical examination approach (procedure under evaluation)

Primary Outcome Measures

Name	Time	Method
Superiority of CBCT	Month 12	Number of severe periodontitis sites

Secondary Outcome Measures

Name	Time	Method
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 brushings per day (specific questionnaire already validated in French version) 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.

Trial Locations

Locations (10)

CHU Bordeaux - Site Pellegrin; 🇫🇷 Bordeaux, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU Grenoble; 🇫🇷 Grenoble, France

HCL; 🇫🇷 Lyon, France

APHM; 🇫🇷 Marseille, France

CHRU Nancy; 🇫🇷 Nancy, France

CHU Nantes; 🇫🇷 Nantes, France

AP-HP - Site Bretonneau; 🇫🇷 Paris, France

CHU Toulouse; 🇫🇷 Toulouse, France

CHRU Tours; 🇫🇷 Tours, France