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

Официальное название

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.

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Superiority of CBCT [Срок оценки: Month 12]
• Superiority of CBCT [Срок оценки: Month 12]
• Superiority of CBCT [Срок оценки: Month 12]

Вторичные конечные точки (11)

• Diagnostic at inclusion [Срок оценки: Day 0]
• Incident symptomatic OIF [Срок оценки: Month 12]
• Incident asymptomatic OIF [Срок оценки: Month 12]
• Oral hygiene [Срок оценки: Day 0 and Month 12]
• Follow-up habits [Срок оценки: Day 0 and Month 12]
• Follow-up habits [Срок оценки: Day 0 and Month 12]
• Oral health quality of life [Срок оценки: Day 0 and Month 12]
• Premature end of study [Срок оценки: Month 12]
• Impact of dental OIF [Срок оценки: Month 12]
• Impact of periodontal OIF [Срок оценки: Month 12]
• Impact of mucosal OIF [Срок оценки: Month 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 10 центров

• CHU Bordeaux - Site Pellegrin — Bordeaux
• CHU Clermont-Ferrand — Clermont-Ferrand
• CHU Grenoble — Grenoble
• HCL — Lyon
• APHM — Marseille
• CHRU Nancy — Nancy
• CHU Nantes — Nantes
• AP-HP - Site Bretonneau — Paris
• … и ещё 2 центра

Публикации

• 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. PMID 40604829

Идентификаторы

NCT: NCT06269679 · RC23_0336

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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