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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNantes University Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • CBCT

    Diagnostic test

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

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: OPTNo intervention 0 interventions
Group B: CBCTExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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