Oral and gum health and saliva markers in people with hepatitis B and D

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective case-control study will compare oral-periodontal clinical measures and targeted inflammatory biomarkers in saliva and gingival crevicular fluid across three groups: adults with hepatitis B+D on bulevirtide, adults with hepatitis B+D not on bulevirtide, and healthy controls. A specialist periodontist will perform standardized oral exams with photographs, and non-invasive saliva and crevicular fluid samples will be collected at baseline and at six months. Samples will be analyzed at the Immunology Laboratory of the University of Medicine and Pharmacy of Craiova and at the University of Amsterdam to quantify inflammatory mediators. Statistical analysis will examine associations between periodontal inflammation, oral biomarkers, and hepatitis B+D status and treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Petra Surlin, Professor
• Email: petra.surlin@umfcv.ro
• Phone: 0040745538483

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.