Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D

Официальное название

Oral-Periodontal Evaluation and Assessment of Biomarkers in Oral Fluids in Patients With Hepatitis B+D Treated With Bulevirtide

Обзор

Periodontal disease is a chronic inflammatory condition associated with systemic diseases, highlighting the concept of periodontal medicine. This study aims to investigate the relationship between periodontal inflammation, oral lesions, and hepatitis B+D infection, with or without bulevirtide treatment. Oral-periodontal clinical parameters and targeted inflammatory biomarkers in saliva and gingival crevicular fluid will be evaluated in three groups: patients with hepatitis B+D receiving bulevirtide, patients with hepatitis B+D not receiving bulevirtide, and healthy controls.

Подробное описание

Periodontal disease is characterized by chronic inflammation and destruction of tooth-supporting tissues. Emerging evidence links oral inflammatory conditions with systemic diseases, forming the basis of periodontal medicine. Hepatitis B+D infection is associated with systemic inflammation and immune dysregulation, yet little is known about its impact on oral health and inflammatory mediators in oral fluids.

This prospective, observational case-control study will recruit adult participants from the University of Medicine and Pharmacy of Craiova. Participants will be divided into three groups:

Hepatitis B+D - Bulevirtide: Patients receiving bulevirtide therapy.

Hepatitis B+D - No Bulevirtide: Patients not receiving bulevirtide.

Healthy Controls: Systemically healthy adults.

Clinical oral-periodontal examinations will be performed by a specialist periodontist, with photographs documenting oral findings. Saliva and gingival crevicular fluid will be collected using non-invasive methods to measure targeted inflammatory biomarkers. Biological samples will be analyzed at the Immunology Laboratory of the University of Medicine and Pharmacy of Craiova and at the University of Amsterdam.

Assessments will be performed at baseline and 6 months. Relevant clinical data will be extracted from medical records following data protection regulations. Statistical analysis will evaluate associations between periodontal inflammation, oral biomarkers, and hepatitis B+D status, as well as the potential impact of bulevirtide therapy.

Вмешательства

• Препарат Bulevirtide
  Bulevirtide is an entry inhibitor used for the treatment of hepatitis B and D virus co-infection. In this observational study, patients receiving bulevirtide therapy as part of their routine clinical care will be evaluated for oral-periodontal clinical parameters and inflammatory biomarkers in saliva and gingival crevicular fluid.
• Другое No intervention
  Patients diagnosed with hepatitis B+D who are not receiving bulevirtide therapy and are evaluated for comparison of oral-periodontal parameters and biomarkers.
• Другое No intervention
  Systemically healthy individuals without hepatitis B or D infection serving as the control group for comparison of oral-periodontal parameters and inflammatory biomarkers.

Первичные конечные точки

• Salivary inflammatory biomarker levels [Срок оценки: Baseline and 6 months after initiation of treatment]
• Gingival crevicular fluid inflammatory biomarker levels [Срок оценки: Baseline and 6 months]

Вторичные конечные точки (4)

• Probing Depth (PD) [Срок оценки: Baseline and 6 months]
• Clinical Attachment Level (CAL) [Срок оценки: Baseline and 6 months]
• Bleeding on Probing (BOP) [Срок оценки: Baseline and 6 months]
• Plaque Index (PI) [Срок оценки: Baseline and 6 months]

Критерии участия

Критерии включения

• Adults (≥18 years old) capable of providing informed consent.
• For Hepatitis B+D groups: confirmed hepatitis B and D co-infection.
• Bulevirtide group: receiving bulevirtide therapy as prescribed.
• No Bulevirtide group: not receiving bulevirtide.
• For Healthy Control group: systemically healthy adults without hepatitis B or D infection.
• Willingness to undergo oral-periodontal examination, saliva and gingival crevicular fluid collection, and oral cavity photography.

Критерии исключения

• Patients with other systemic diseases that could influence periodontal health (e.g., uncontrolled diabetes, autoimmune diseases).
• Patients currently receiving other experimental therapies that may affect oral or systemic inflammation.
• Pregnancy or lactation.
• Inability or unwillingness to provide informed consent.
• History of oral or periodontal surgery within the last 6 months that could affect measurements.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Румыния · 2 центра

• Clinical Emergency County Hospital Craiova — Craiova
• University of Medicine and Pharmacy of Craiova — Craiova

Идентификаторы

NCT: NCT07491848 · UMFCV-PARO-HEPBD-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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