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

NCT07491848 | Recruiting

• 1 other identifier: UMFCV-PARO-HEPBD-2026-01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

HEPATITIS B CHRONIC; Hepatitis D; Periodontitis

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 6 months after initiation of 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.

  Baseline and 6 months

Secondary Outcomes (4)

• Probing Depth (PD)

  Baseline and 6 months

• Clinical Attachment Level (CAL)

  Baseline and 6 months

• Bleeding on Probing (BOP)

  Baseline and 6 months

• Plaque Index (PI)

  Baseline and 6 months

Study Arms (3)

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

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

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

Interventions

Bulevirtide DRUG

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 - Bulevirtide Treatment

No intervention OTHER

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

Hepatitis B+D - No Bulevirtide Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Center of Periodontal-Systemic Interactions: lead
• University of Medicine and Pharmacy Craiova: collaborator
• Spitalul clinic judetean de urgenta Craiova: collaborator

Study Sites (2)

Clinical Emergency County Hospital Craiova

Craiova, Romania

RECRUITING

University of Medicine and Pharmacy of Craiova

Craiova, Romania

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis D; Periodontitis

Interventions

bulevirtide

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; RNA Virus Infections; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Petra Surlin, Professor

CONTACT

0040745538483; petra.surlin@umfcv.ro

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 25, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

RO (2)