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NCT Number: NCT06269679

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

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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Key information

Conditions

Infective Endocarditis Cardiovascular Diseases Endocarditis Heart Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux - Site Pellegrin, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

CBCT

Diagnostic Test

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

Primary outcomes

  1. Superiority of CBCT

    Time frame: Month 12

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

  2. Superiority of CBCT

    Time frame: Month 12

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

  3. Superiority of CBCT

    Time frame: Month 12

    Number of severe periodontitis sites

Secondary outcomes

  1. Diagnostic at inclusion

    Time frame: Day 0

    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).

  2. Incident symptomatic OIF

    Time frame: Month 12

    Monitor incident symptomatic OIF occuring during the study impacting the initial personalized OIF management (Number of incident symptomatic OIF detected during the study).

  3. Incident asymptomatic OIF

    Time frame: Month 12

    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).

  4. Oral hygiene

    Time frame: Day 0 and Month 12

    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).

  5. Follow-up habits

    Time frame: Day 0 and Month 12

    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).

  6. Follow-up habits

    Time frame: Day 0 and Month 12

    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).

  7. Oral health quality of life

    Time frame: Day 0 and Month 12

    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).

  8. Premature end of study

    Time frame: Month 12

    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).

  9. Impact of dental OIF

    Time frame: Month 12

    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.

  10. Impact of periodontal OIF

    Time frame: Month 12

    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.

  11. Impact of mucosal OIF

    Time frame: Month 12

    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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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.

Acronym: 3D STARS

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Feb 21, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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