RecruitingNCT07491848

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


Sponsor

Research Center of Periodontal-Systemic Interactions

Enrollment

25 participants

Start Date

Feb 15, 2026

Study Type

OBSERVATIONAL

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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.

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Interventions

DRUGBulevirtide

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.

OTHERNo intervention

Patients diagnosed with hepatitis B+D who are not receiving bulevirtide therapy and are evaluated for comparison of oral-periodontal parameters and biomarkers.

OTHERNo 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

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NCT07491848