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.
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.
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.
The study population includes adult patients diagnosed with hepatitis B and D co-infection who are treated and followed at the Gastroenterology Clinic of the Clinical Emergency County Hospital Craiova. These patients will be divided into two cohorts based on treatment status: those receiving bulevirtide therapy as part of routine clinical care and those not receiving bulevirtide treatment. A third cohort will consist of systemically healthy adult individuals without hepatitis B or D infection, recruited from the Periodontology Clinic of the University of Medicine and Pharmacy of Craiova, who will serve as a control group. All participants will undergo oral-periodontal clinical examination, oral cavity documentation, and non-invasive collection of saliva and gingival crevicular fluid for the evaluation of inflammatory biomarkers. Assessments will be performed at baseline and after 6 months.
Cohort
Prospective
Bulevirtide
DrugBulevirtide 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.
No intervention
Other interventionPatients diagnosed with hepatitis B+D who are not receiving bulevirtide therapy and are evaluated for comparison of oral-periodontal parameters and biomarkers.
No intervention
Other interventionSystemically healthy individuals without hepatitis B or D infection serving as the control group for comparison of oral-periodontal parameters and inflammatory biomarkers.
Salivary inflammatory biomarker levels
Quantitative assessment (pg/mL) of selected inflammatory biomarkers (e.g., IL-1β, IL-6, TNF-α) in saliva samples collected from participants in all study groups to evaluate the association between periodontal inflammation, hepatitis B+D infection, and bulevirtide treatment.
Gingival crevicular fluid inflammatory biomarker levels
Measurement (pg/mL) of targeted inflammatory mediators (e.g., IL-1β, IL-6, TNF-α) in gingival crevicular fluid samples to assess local periodontal inflammation and its relationship with hepatitis B+D infection and bulevirtide therapy.
Probing Depth (PD)
Measurement of periodontal probing depth (in millimeters) at six sites per tooth to assess periodontal status in all study groups.
Clinical Attachment Level (CAL)
Assessment of clinical attachment level (in millimeters) to evaluate periodontal tissue destruction.
Bleeding on Probing (BOP)
Percentage of sites exhibiting bleeding on probing as an indicator of gingival inflammation.
Plaque Index (PI)
Assessment of dental plaque accumulation using a standardized plaque index score.
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Research Center of Periodontal-Systemic Interactions
Lead sponsor
University of Medicine and Pharmacy Craiova
Collaborator
Spitalul clinic judetean de urgenta Craiova
Collaborator
