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Clinical Trial NCT07491848 for HEPATITIS B CHRONIC, Hepatitis D, Periodontitis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D 25 Biomarker-Driven
Clinical Trial NCT07491848 is an observational study for HEPATITIS B CHRONIC, Hepatitis D, Periodontitis that is recruiting. It started on 15 February 2026 with plans to enroll 25 participants. Led by Research Center of Periodontal-Systemic Interactions, it is expected to complete by 15 February 2027. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
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 w...Show More
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 pr...
Show MoreOfficial Title
Oral-Periodontal Evaluation and Assessment of Biomarkers in Oral Fluids in Patients With Hepatitis B+D Treated With Bulevirtide
Conditions
HEPATITIS B CHRONICHepatitis DPeriodontitisOther Study IDs
- UMFCV-PARO-HEPBD-2026-01
NCT ID Number
Start Date (Actual)
2026-02-15
Last Update Posted
2026-03-25
Completion Date (Estimated)
2027-02-15
Enrollment (Estimated)
25
Study Type
Observational
Status
Recruiting
Arms / Interventions
| Participant Group/Arm | 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. | 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. | 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. |
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. | 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Probing Depth (PD) | 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) | Assessment of clinical attachment level (in millimeters) to evaluate periodontal tissue destruction. | Baseline and 6 months |
Bleeding on Probing (BOP) | Percentage of sites exhibiting bleeding on probing as an indicator of gingival inflammation. | Baseline and 6 months |
Plaque Index (PI) | Assessment of dental plaque accumulation using a standardized plaque index score. | Baseline and 6 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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.
- 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.
Research Center of Periodontal-Systemic Interactions- University of Medicine and Pharmacy Craiova
- Spitalul clinic judetean de urgenta Craiova
Study Central Contact
Contact: Petra Surlin, Professor, 0040745538483, [email protected]
2 Study Locations in 1 Countries
Clinical Emergency County Hospital Craiova, Craiova, Romania
Claudiu Ionele, Dr., Contact, 0040722238195, [email protected]
Recruiting
University of Medicine and Pharmacy of Craiova, Craiova, Romania
Dorin Gheorghe, PhD, Contact, 0040722238195, [email protected]
Recruiting