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

March 19, 2026 updated by: Research Center of Periodontal-Systemic Interactions

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Romania
      • Craiova, Romania
        • Recruiting
        • Clinical Emergency County Hospital Craiova
        • Contact:
      • Craiova, Romania
        • Recruiting
        • University of Medicine and Pharmacy of Craiova
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hepatitis B+D - Bulevirtide Treatment
Adult patients diagnosed with hepatitis B and D co-infection who are receiving bulevirtide therapy as part of their routine clinical management. Participants will undergo oral-periodontal clinical examination, oral cavity photography, and collection of saliva and gingival crevicular fluid for analysis of inflammatory biomarkers at baseline and after 6 months.
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.
Hepatitis B+D - No Bulevirtide Treatment
Adult patients diagnosed with hepatitis B and D co-infection who are not receiving bulevirtide therapy. Participants will undergo oral-periodontal clinical examination, oral cavity photography, and collection of saliva and gingival crevicular fluid for analysis of inflammatory biomarkers at baseline and after 6 months.
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.
Healthy Control Group
Systemically healthy adult individuals without hepatitis B or D infection, recruited from the Periodontology Clinic. Participants will undergo oral-periodontal clinical examination and collection of saliva and gingival crevicular fluid for comparison of periodontal clinical parameters and inflammatory biomarkers with the hepatitis B+D groups.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary inflammatory biomarker levels
Time Frame: 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.
Baseline and 6 months after initiation of treatment
Gingival crevicular fluid inflammatory biomarker levels
Time Frame: 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.
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing Depth (PD)
Time Frame: Baseline and 6 months
Measurement of periodontal probing depth (in millimeters) at six sites per tooth to assess periodontal status in all study groups.
Baseline and 6 months
Clinical Attachment Level (CAL)
Time Frame: Baseline and 6 months
Assessment of clinical attachment level (in millimeters) to evaluate periodontal tissue destruction.
Baseline and 6 months
Bleeding on Probing (BOP)
Time Frame: Baseline and 6 months
Percentage of sites exhibiting bleeding on probing as an indicator of gingival inflammation.
Baseline and 6 months
Plaque Index (PI)
Time Frame: Baseline and 6 months
Assessment of dental plaque accumulation using a standardized plaque index score.
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Center of Periodontal-Systemic Interactions

Collaborators

University of Medicine and Pharmacy Craiova
Spitalul clinic judetean de urgenta Craiova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2026

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

February 15, 2027

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMFCV-PARO-HEPBD-2026-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontitis

Clinical Trials on Bulevirtide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe