Infective Endocarditis3D STARSNCT06269679
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
A study testing CBCT in people with Infective Endocarditis, run by Nantes University Hospital at 10 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Infective Endocarditis
- What is being tested?
- CBCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 10 sitesFrance
- Study dates
- 18 Dec 2024to 18 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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;
- Patients whose life expectancy is expected to be longer than 6 months;
- Patients who agree to visit the dental department of the hospital to carry out OIF eradication or at his/her personal dentist;
- Patients over 18 years old;
- Patients affiliated to a Social Security or a health insurance scheme;
- Patients who have given informed consent to participate to the study.
Who cannot join
- OPT or CBCT already performed before the inclusion of the patients in the study and available for the investigator during the patient's hospitalization.
- Medical contraindications to perform OPT or CBCT imaging;
- Absence of microbiologic identification of the IE responsible microorganism;
- Pregnant or breastfeeding women;
- Patients unable to give informed consent to participate to the study (under trusteeship, guardianship and legal protection).
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
CHU Bordeaux - Site Pellegrin
Bordeaux
Elise ARRIVE, +33/5 56 79 56 79, elise.arrive@u-bordeaux.fr
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Magali VIDAL, +33473754405, mvidal@chu-clermontferrand.fr
- Recruiting
CHU Grenoble
Grenoble
Cécile CHATEL, +33/4 76 76 50 26, cchatel1@chu-grenoble.fr
- Recruiting
HCL
Lyon
Sarah MILLOT GUARD, +33426680250, sarah.millot-guard@chu-lyon.fr
- Recruiting
APHM
Marseille
Jean-Hugues CATHERINE, +33676320760, jean-hugues.catherine@ap-hm.fr
- Recruiting
CHRU Nancy
Nancy
Vanessa MOBY, +33/3 83 39 18 00, vanessa.moby@univ-lorraine.fr
- Recruiting
CHU Nantes
Nantes
Alexandra CLOITRE, +33/2.40.41.29.85, alexandra.cloitre@univ-nantes.fr
Astrid GARREAU, astrid.garreau@chu-nantes.fr
- Recruiting
AP-HP - Site Bretonneau
Paris
MESSECA Clément, +33/1 53 11 18 00, clement.messeca@aphp.fr
- Recruiting
CHU Toulouse
Toulouse
Sarah COUSTY, +33/5.61.32.20.30, cousty.s@chu-toulouse.fr
- Recruiting
CHRU Tours
Tours
Frédéric DENIS, +33/2 47 47 47 47, frederic.denis@univ-tours.fr
About this study
Official title: 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.
- 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.
- Conditions
- Infective Endocarditis
- Being tested
- CBCT
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCTDiagnostic test
Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF.
| Study group | Role | What they receive |
|---|---|---|
| OPT | No intervention | Orthopantomogram = current recommended clinical examination approach (comparator procedure) |
| CBCT | Experimental | Cone Beam Computed Tomography = experimental clinical examination approach (procedure under evaluation) Receives: Diagnostic Test: CBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority of CBCT
Number of oral infectious foci detected using orthopantomogram versus Cone Beam Computer Tomography
Measured: Month 12
Superiority of CBCT
DFMT index comprising the number of decayed, filled and missing teeth
Measured: Month 12
Superiority of CBCT
Number of severe periodontitis sites
Measured: Month 12
Secondary outcomes (11)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start18 Dec 2024
- Primary completion18 Jul 2028 (estimated)
- Study completion18 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269679
- Sponsor's protocol ID
- RC23_0336
- Acronym
- 3D STARS
- Status last verified
- Oct 2026
- First submitted
- 5 Feb 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06269679
- Acronym / sponsor ID
- 3D STARS / RC23_0336
- Conditions
- Infective Endocarditis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 18 Jul 2028 (estimated)
- Study completion
- 18 Jul 2028 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPT | No intervention | –Orthopantomogram = current recommended clinical examination approach (comparator procedure) |
| CBCT | Experimental | Diagnostic Test: CBCTCone Beam Computed Tomography = experimental clinical examination approach (procedure under evaluation) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
- 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;
- Patients whose life expectancy is expected to be longer than 6 months;
- Patients who agree to visit the dental department of the hospital to carry out OIF eradication or at his/her personal dentist;
- Patients over 18 years old;
Key exclusion criteria (5 listed)
- OPT or CBCT already performed before the inclusion of the patients in the study and available for the investigator during the patient's hospitalization.
- Medical contraindications to perform OPT or CBCT imaging;
- Absence of microbiologic identification of the IE responsible microorganism;
- Pregnant or breastfeeding women;
- Patients unable to give informed consent to participate to the study (under trusteeship, guardianship and legal protection).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBCTCone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF. | Diagnostic test | CBCT |
Primary outcome
Superiority of CBCT
Time frame: Month 12
Number of oral infectious foci detected using orthopantomogram versus Cone Beam Computer Tomography
Superiority of CBCT
Time frame: Month 12
DFMT index comprising the number of decayed, filled and missing teeth
Superiority of CBCT
Time frame: Month 12
Number of severe periodontitis sites
11 secondary outcomes
Diagnostic at inclusion
Time frame: Day 0
Incident symptomatic OIF
Time frame: Month 12
Incident asymptomatic OIF
Time frame: Month 12
Oral hygiene
Time frame: Day 0 and Month 12
Follow-up habits
Time frame: Day 0 and Month 12
Follow-up habits
Time frame: Day 0 and Month 12
Oral health quality of life
Time frame: Day 0 and Month 12
Premature end of study
Time frame: Month 12
Impact of dental OIF
Time frame: Month 12
Impact of periodontal OIF
Time frame: Month 12
Impact of mucosal OIF
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Derived from this study: PubMed 40604829Cloitre 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBCT in people with Infective Endocarditis, run by Nantes University Hospital at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superiority of CBCT (time frame: Month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06269679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.