HEPATITIS B CHRONICNCT07491848
Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D
An observational study of HEPATITIS B CHRONIC and Hepatitis D, run by Research Center of Periodontal-Systemic Interactions at 2 sites in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HEPATITIS B CHRONIC, Hepatitis D, Periodontitis
- What is being tested?
- Bulevirtide
- Type of treatment
- Pill or oral medicine
- How many people
- 25 participants
- Where
- 2 sitesRomania
- Study dates
- 15 Feb 2026to 15 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Romania2 sites, 2 recruiting
- Recruiting
Clinical Emergency County Hospital Craiova
Craiova
Claudiu Ionele, Dr., 0040722238195, claudiu.ionele@umfcv.ro
- Recruiting
University of Medicine and Pharmacy of Craiova
Craiova
Dorin Gheorghe, PhD, 0040722238195, dorin.gheorghe@umfcv.ro
About this study
Official title: 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.
Read the 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.
- Conditions
- HEPATITIS B CHRONIC, Hepatitis D, Periodontitis
- Being tested
- Bulevirtide, No intervention
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis D, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BulevirtideDrug
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.
No interventionOther
Patients diagnosed with hepatitis B+D who are not receiving bulevirtide therapy and are evaluated for comparison of oral-periodontal parameters and biomarkers.
No interventionOther
Systemically healthy individuals without hepatitis B or D infection serving as the control group for comparison of oral-periodontal parameters and inflammatory biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 6 months
Secondary outcomes (4)
Probing Depth (PD)
Measurement of periodontal probing depth (in millimeters) at six sites per tooth to assess periodontal status in all study groups.
Measured: Baseline and 6 months
Clinical Attachment Level (CAL)
Assessment of clinical attachment level (in millimeters) to evaluate periodontal tissue destruction.
Measured: Baseline and 6 months
Bleeding on Probing (BOP)
Percentage of sites exhibiting bleeding on probing as an indicator of gingival inflammation.
Measured: Baseline and 6 months
Plaque Index (PI)
Assessment of dental plaque accumulation using a standardized plaque index score.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start15 Feb 2026
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEPATITIS B CHRONICStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Center of Periodontal-Systemic Interactions
- Sponsor type
- University, hospital or other
- Collaborators
- University of Medicine and Pharmacy Craiova, Spitalul clinic judetean de urgenta Craiova
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491848
- Sponsor's protocol ID
- UMFCV-PARO-HEPBD-2026-01
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral-Periodontal Evaluation and Assessment of Biomarkers in Oral Fluids in Patients With Hepatitis B+D Treated With Bulevirtide
- ClinicalTrials.gov ID
- NCT07491848
- Acronym / sponsor ID
- UMFCV-PARO-HEPBD-2026-01
- Conditions
- HEPATITIS B CHRONIC, Hepatitis D, Periodontitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Research Center of Periodontal-Systemic InteractionsUniversity, hospital or other
- Collaborators
- University of Medicine and Pharmacy Craiova, Spitalul clinic judetean de urgenta Craiova
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hepatitis B+D - Bulevirtide Treatment | – | Drug: BulevirtideAdult 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. |
| Hepatitis B+D - No Bulevirtide Treatment | – | Other: No interventionAdult 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. |
| Healthy Control Group | – | Other: No interventionSystemically 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BulevirtideBulevirtide 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. | Drug | Hepatitis B+D - Bulevirtide Treatment |
| No interventionPatients diagnosed with hepatitis B+D who are not receiving bulevirtide therapy and are evaluated for comparison of oral-periodontal parameters and biomarkers. | Other | Hepatitis B+D - No Bulevirtide Treatment |
| No interventionSystemically healthy individuals without hepatitis B or D infection serving as the control group for comparison of oral-periodontal parameters and inflammatory biomarkers. | Other | Healthy Control Group |
Primary outcome
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.
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.
4 secondary outcomes
Probing Depth (PD)
Time frame: Baseline and 6 months
Clinical Attachment Level (CAL)
Time frame: Baseline and 6 months
Bleeding on Probing (BOP)
Time frame: Baseline and 6 months
Plaque Index (PI)
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HEPATITIS B CHRONIC and Hepatitis D, run by Research Center of Periodontal-Systemic Interactions at 2 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Surlin, Professor (0040745538483, petra.surlin@umfcv.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary inflammatory biomarker levels (time frame: Baseline and 6 months after initiation of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.