Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bulevirtide, No intervention, No intervention.
- Who it may be relevant to
- Registry conditions: HEPATITIS B CHRONIC, Hepatitis D, Periodontitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Romania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Oral-Periodontal Evaluation and Assessment of Biomarkers in Oral Fluids in Patients With Hepatitis B+D Treated With Bulevirtide
Overview
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.
Detailed description
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.
Interventions
- Drug 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. - Other 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. - Other 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.
Primary outcome measures
- Salivary inflammatory biomarker levels [Time frame: Baseline and 6 months after initiation of treatment]
- Gingival crevicular fluid inflammatory biomarker levels [Time frame: Baseline and 6 months]
Secondary outcome measures (4)
- Probing Depth (PD) [Time frame: Baseline and 6 months]
- Clinical Attachment Level (CAL) [Time frame: Baseline and 6 months]
- Bleeding on Probing (BOP) [Time frame: Baseline and 6 months]
- Plaque Index (PI) [Time frame: Baseline and 6 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Romania · 2 centers
- Clinical Emergency County Hospital Craiova — Craiova
- University of Medicine and Pharmacy of Craiova — Craiova
Identifiers
NCT: NCT07491848 · UMFCV-PARO-HEPBD-2026-01