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

Infective Endocarditis Clinical Trial

— 3D STARS  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06269679
• Other study ID #: RC23_0336
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 1, 2028

Study information

• Verified date: February 2024
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Patients hospitalized for definite IE according to the 2015 ESC classification, whatever the IE responsible microorganism;

2. Patients with a stable clinical state compatible with the performance of an OPT and a CBCT during his/her initial hospitalization for acute IE management;

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;

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 under 18 years old;

6. Patients unable to give informed consent to participate to the study (under trusteeship, guardianship and legal protection).

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Intervention

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

Locations

Country	Name	City	State
France	CHU Bordeaux - Site Pellegrin	Bordeaux
France	CHU Grenoble	Grenoble
France	CHRU Nancy	Nancy
France	CHU Nantes	Nantes
France	AP-HP - Site Bretonneau	Paris
France	CHU Toulouse	Toulouse
France	CHRU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Superiority of CBCT	Number of oral infectious foci detected using orthopantomogram versus Cone Beam Computer Tomography	Month 12
Primary	Superiority of CBCT	DFMT index comprising the number of decayed, filled and missing teeth	Month 12
Primary	Superiority of CBCT	Number of severe periodontitis sites	Month 12
Secondary	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
Secondary	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).	Month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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