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3D Imaging (Cone Beam Computed Tomography) Versus Orthopantomogram on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis: a Multicenter Randomized Superiority Controlled Trial.
Led by Nantes University Hospital · Updated on 2026-04-06
170
Participants Needed
10
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Infective Endocarditis (IE) is a serious and rare disease with high rates of complications and death. Streptococci from the mouth are the second most common cause of IE. The usual clinical exam combined with Orthopantomogram (OPT) imaging often misses oral infectious foci (OIF), which may contribute to IE. Cone Beam Computed Tomography (CBCT) is thought to detect these oral infections more accurately, but its impact on oral health in IE patients has not been studied before. This trial compares two approaches to oral examination in patients hospitalized for IE: the standard clinical exam with OPT and the newer clinical exam with CBCT. Participants will be randomly assigned to either the OPT group or the CBCT group. The study aims to see if CBCT improves oral health status over 12 months and if it can better detect oral infectious foci. Participants will be monitored over 12 months with evaluations at the start and after one year. These include assessments of oral hygiene, detection of symptomatic and asymptomatic oral infections, and oral health quality of life. Researchers will also track patients' dental follow-up habits and any premature study discontinuation. The main measure is whether CBCT offers superiority in oral health outcomes at 12 months compared to OPT. The study is sponsored by Nantes University Hospital and runs until mid-2028.
CONDITIONS
Brief Title
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients hospitalized or recently hospitalized for definite Infective Endocarditis according to the 2015 ESC classification
- Patients naive to dental examination and imaging regardless of the infecting microorganism
- Stable clinical condition compatible with undergoing OPT and CBCT imaging
- Life expectancy expected to be longer than 6 months
- Agree to visit the hospital dental department or personal dentist for oral infectious focus eradication
- Age over 18 years
- Affiliated with Social Security or a health insurance scheme
- Provided informed consent to participate in the study
You will not qualify if you...
- OPT or CBCT imaging already performed before inclusion and available during hospitalization
- Medical contraindications to perform OPT or CBCT imaging
- No microbiologic identification of the infective endocarditis microorganism
- Pregnant or breastfeeding women
- Unable to give informed consent due to trusteeship, guardianship, or legal protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day 0
Participants undergo either Cone Beam Computed Tomography (CBCT) or Orthopantomogram (OPT) imaging to assess oral infectious focus.
1 visit (in-person)
Duration - 12 months
Participants are observed for oral health status changes and outcomes over a 12-month period after imaging.
1 follow-up visit at Month 12
Trial Site Locations
Total: 10 locations
1
CHU Bordeaux - Site Pellegrin
Bordeaux, France
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2
CHU Clermont-Ferrand
Clermont-Ferrand, France
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3
CHU Grenoble
Grenoble, France
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4
HCL
Lyon, France
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5
APHM
Marseille, France
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6
CHRU Nancy
Nancy, France
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7
CHU Nantes
Nantes, France
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8
AP-HP - Site Bretonneau
Paris, France
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9
CHU Toulouse
Toulouse, France
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10
CHRU Tours
Tours, France
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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