HEPATITIS B CHRONIC, Hepatitis D, Periodontitis
Conditions
Brief 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.
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
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.
Sponsors
Research Center of Periodontal-Systemic Interactions
University of Medicine and Pharmacy Craiova
Spitalul clinic judetean de urgenta Craiova
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary inflammatory biomarker levels | Baseline and 6 months after initiation of treatment | 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 | Baseline and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Probing Depth (PD) | Baseline and 6 months | Measurement of periodontal probing depth (in millimeters) at six sites per tooth to assess periodontal status in all study groups. |
| Clinical Attachment Level (CAL) | Baseline and 6 months | Assessment of clinical attachment level (in millimeters) to evaluate periodontal tissue destruction. |
| Bleeding on Probing (BOP) | Baseline and 6 months | Percentage of sites exhibiting bleeding on probing as an indicator of gingival inflammation. |
| Plaque Index (PI) | Baseline and 6 months | Assessment of dental plaque accumulation using a standardized plaque index score. |
Countries
Romania
Contacts
CONTACTPetra Surlin, Professor
Outcome results
None listed