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

Nantes University Hospital170 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

170

Conditions

Infective Endocarditis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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).

Locations (10)

CHU Bordeaux - Site Pellegrin

Bordeaux, France

NOT_YET_RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, France

NOT_YET_RECRUITING

CHU Grenoble

Grenoble, France

NOT_YET_RECRUITING

HCL

Lyon, France

NOT_YET_RECRUITING

APHM

Marseille, France

NOT_YET_RECRUITING

CHRU Nancy

Nancy, France

NOT_YET_RECRUITING

CHU Nantes

Nantes, France

RECRUITING

AP-HP - Site Bretonneau

Paris, France

RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

CHRU Tours

Tours, France

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Superiority of CBCT

Number of oral infectious foci detected using orthopantomogram versus Cone Beam Computer Tomography

Time frame: Month 12

Superiority of CBCT

DFMT index comprising the number of decayed, filled and missing teeth

Time frame: Month 12

Superiority of CBCT

Number of severe periodontitis sites

Time frame: Month 12

Secondary Outcomes

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).

Time frame: Day 0

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).

Time frame: Month 12

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).

Time frame: Month 12

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).

Time frame: Day 0 and Month 12

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).

Time frame: Day 0 and Month 12

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).

Time frame: Day 0 and Month 12

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).

Time frame: Day 0 and Month 12

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).

Time frame: Month 12

Impact of dental OIF

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.

Time frame: Month 12

Impact of periodontal OIF

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.

Time frame: Month 12

Impact of mucosal OIF

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.

Time frame: Month 12