CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis. (3D STARS)

March 31, 2026 updated by: Nantes University Hospital

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: OPT
Orthopantomogram = current recommended clinical examination approach (comparator procedure)
Experimental: CBCT
Cone Beam Computed Tomography = experimental clinical examination approach (procedure under evaluation)
Diagnostic test: CBCT
Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superiority of CBCT
Time Frame: Month 12
Number of oral infectious foci detected using orthopantomogram versus Cone Beam Computer Tomography
Month 12
Superiority of CBCT
Time Frame: Month 12
DFMT index comprising the number of decayed, filled and missing teeth
Month 12
Superiority of CBCT
Time Frame: Month 12
Number of severe periodontitis sites
Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic at inclusion
Time Frame: 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).
Day 0
Incident symptomatic OIF
Time Frame: 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).
Month 12
Incident asymptomatic OIF
Time Frame: 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).
Month 12
Oral hygiene
Time Frame: 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).
Day 0 and Month 12
Follow-up habits
Time Frame: 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).
Day 0 and Month 12
Follow-up habits
Time Frame: 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).
Day 0 and Month 12
Oral health quality of life
Time Frame: 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).
Day 0 and Month 12
Premature end of study
Time Frame: 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).
Month 12
Impact of dental OIF
Time Frame: 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.
Month 12
Impact of periodontal OIF
Time Frame: 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.
Month 12
Impact of mucosal OIF
Time Frame: 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.
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2024

Primary Completion (Estimated)

July 18, 2028

Study Completion (Estimated)

July 18, 2028

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC23_0336

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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