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RecruitingNCT062696793D STARSUpdated Nov 3, 2026

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

An interventional study of CBCT in Infective Endocarditis, sponsored by Nantes University Hospital. Recruiting at 10 sites in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Nantes University Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Infective Endocarditis

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03

In context

Endocarditis

173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.

This study's planned enrollment of 170 is above the median of 92 across 86 interventional studies indexed under Endocarditis.

Browse Endocarditis studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 to participate to the study.

Exclusion criteria

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 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 to participate to the study (under trusteeship, guardianship and legal protection).
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants (estimated)

Study arms

  • 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

Interventions

  • Diagnostic testCBCT

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

06

What researchers measure

Primary outcomes

  1. Superiority of CBCT

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

    Time frame: Month 12

  2. Superiority of CBCT

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

    Time frame: Month 12

  3. Superiority of CBCT

    Number of severe periodontitis sites

    Time frame: Month 12

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

07

Study locations

10 of 10 sites recruiting
08

References and documents

Publications

  • Cloitre A, Duval X, Boutoille D, Pere M, Garreau A, Fouchard S, Poinas A, Lesclous P. 3D imaging cone beam computed tomography versus orthopantomogram to improve the oral health status of patients hospitalized for infective endocarditis (3D STARS): study protocol of a randomized superiority controlled trial. BMC Oral Health. 2025 Jul 2;25(1):1045. doi: 10.1186/s12903-025-06473-6. PubMed 40604829 ↗
09

Updates

1 registry update since Sep 25, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • CHU Nantes · Nantes, FranceContact p•••@chu-nantes.fr · •••2940→a•••@univ-nantes.fr · •••2985
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Site contacts Changed at 1 site. See the sites
    Show the site
    • CHU Nantes · Nantes, FranceContact p•••@chu-nantes.fr · •••2940→a•••@univ-nantes.fr · •••2985
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06269679
Responsible party
Sponsor
First posted
Feb 21, 2024
Start date
Dec 18, 2024
Primary completion
Jul 18, 2028 (estimated)
Completion
Jul 18, 2028 (estimated)
Last update
Nov 3, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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