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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPT | No Intervention | Orthopantomogram = current recommended clinical examination approach (comparator procedure) | |
| CBCT | Experimental | Cone Beam Computed Tomography = experimental clinical examination approach (procedure under evaluation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBCT | Diagnostic Test | Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Superiority of CBCT | Number of oral infectious foci detected using orthopantomogram versus Cone Beam Computer Tomography | Month 12 |
| Superiority of CBCT | DFMT index comprising the number of decayed, filled and missing teeth | Month 12 |
| Superiority of CBCT | Number of severe periodontitis sites | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 0 |
| Incident symptomatic OIF |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux - Site Pellegrin | Recruiting | Bordeaux | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40604829 | Derived | 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. |
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| ID | Term |
|---|---|
| D004696 | Endocarditis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | France |
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| CHU Grenoble | Recruiting | Grenoble | France |
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| HCL | Recruiting | Lyon | France |
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| APHM | Recruiting | Marseille | France |
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| CHRU Nancy | Recruiting | Nancy | France |
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| CHU Nantes | Recruiting | Nantes | France |
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| AP-HP - Site Bretonneau | Recruiting | Paris | France |
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| CHU Toulouse | Recruiting | Toulouse | France |
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| CHRU Tours | Recruiting | Tours | France |
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