RECRUITINGOBSERVATIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Adults (≥18 years old) capable of providing willing to sign a consent form. - 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. Who Should NOT Join This Trial: - Patients with other systemic diseases that could influence periodontal health (e.g., uncontrolled diabetes, autoimmune conditions (where your immune system attacks your own body)s). - Patients currently receiving other experimental therapies that may affect oral or systemic inflammation. - Pregnancy or lactation. - Inability or unwillingness to provide willing to sign a consent form. - History of oral or periodontal surgery within the last 6 months that could affect measurements. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (2)

Clinical Emergency County Hospital Craiova

Craiova, Romania

University of Medicine and Pharmacy of Craiova

Craiova, Romania