Oral and gum health and saliva markers in people with hepatitis B and D
Oral-Periodontal Evaluation and Assessment of Biomarkers in Oral Fluids in Patients With Hepatitis B+D Treated With Bulevirtide
This project will test whether gum inflammation and specific saliva and gum-fluid markers differ in adults with hepatitis B and D—both those taking bulevirtide and those not—compared with healthy adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Research Center of Periodontal-Systemic Interactions Academic / other |
| Locations | 2 sites (Craiova and 1 other locations) |
| Trial ID | NCT07491848 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal participants are adults (age 18+) with confirmed hepatitis B and D co-infection—either receiving bulevirtide or not—or systemically healthy adults willing to undergo oral exams and saliva and gingival crevicular fluid collection.
Not a fit: People with other systemic diseases that affect periodontal health (for example uncontrolled diabetes or autoimmune conditions), recent oral or periodontal surgery within six months, pregnancy or lactation, or those unable to provide informed consent are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If successful, the work could identify oral biomarkers linked to hepatitis B+D and effects of bulevirtide, helping guide monitoring and targeted oral care for affected patients.
How similar studies have performed: Prior studies have linked oral inflammation and saliva biomarkers to systemic liver disease, but using these markers specifically in hepatitis B+D patients and in relation to bulevirtide treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Craiova and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.