Medication-Related Osteonecrosis of JawNCT06420284
Immunological Parameters Between MRONJ Stages
An observational study of Medication-Related Osteonecrosis of Jaw, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to conduct a detailed analysis of the immunological response profiles that emerge at different clinical stages of medication-related osteonecrosis of the jaw (MRONJ). The research seeks to understand how these responses influence the pathogenesis, staging, and treatment of MRONJ. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication-Related Osteonecrosis of Jaw
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population for this research comprises adults aged 18 and older, both male and female, who present with medication-related osteonecrosis of the jaw (MRONJ) at the Oral and Maxillofacial Surgery Clinic of Marmara University Faculty of Dentistry. All participants must have provided written informed consent either personally or through a legal representative to be included in the study.
Who may be able to join
- Individuals aged 18 and over
- Both male and female participants
- Individuals who apply to the Oral and Maxillofacial Surgery Clinic at Marmara University Faculty of Dentistry due to medication-related osteonecrosis of the jaw during the study period
- Individuals or their legal representatives who have provided written consent to participate in the study
Who cannot join
- Non-drug-related osteonecrosis/osteomyelitis
- Osteoradionecrosis
- Metastasis to the oral region
- Individuals who have not given written consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University School of Dentistry
Istanbul, 34854
Ferit Bayram, Ph. D., 2167775074, ferit.bayram@marmara.edu.tr
Tunç Akkoç, Prof. Dr.
About this study
Official title: Characterization of Immunological Parameters in Different Clinical Stages of Medication-Related Osteonecrosis of the Jaw
This study aims to conduct a detailed analysis of the immunological response profiles that emerge at different clinical stages of medication-related osteonecrosis of the jaw (MRONJ). The research seeks to understand how these responses influence the pathogenesis, staging, and treatment of MRONJ. Throughout the study, cytokine levels, inflammation markers, and other immunological parameters observed at various stages will be comprehensively assessed. The results of these analyses are expected to provide insights into how stage-specific immunological variables could play a role in the diagnosis and treatment of MRONJ.
- Conditions
- Medication-Related Osteonecrosis of Jaw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MRONJ Stage 0 | Participants in this group are receiving antiresorptive/antiangiogenic therapy and exhibit nonspecific symptoms but no exposed bone. This stage is considered a precursor stage, where the risk of developing MRONJ is present but not yet visible through exposed bone. | |
| MRONJ Stage I | Individuals in this group are on antiresorptive/antiangiogenic therapy and show exposed bone without any symptoms. This stage represents the early manifestation of MRONJ, characterized by visible bone changes without associated pain or infection. | |
| MRONJ Stage II | This group includes patients treated with antiresorptive/antiangiogenic agents, who have exposed bone accompanied by symptoms such as pain or infection but without extensive bone involvement. This stage indicates a progression in the severity of MRONJ. | |
| MRONJ Stage III | Participants are undergoing antiresorptive/antiangiogenic treatment and exhibit exposed bone with symptoms, where the exposed bone extends beyond the alveolar bone, indicating advanced disease with significant bone and surrounding tissue involvement. | |
| At-Risk Group | This group consists of individuals receiving antiresorptive/antiangiogenic therapy who do not yet show any exposed bone or symptoms. They are considered at risk for developing MRONJ and are monitored for any potential progression. | |
| Healthy Control Group | This control group comprises individuals who have not received antiresorptive/antiangiogenic therapy and show no signs of exposed bone or symptoms. This group serves to provide baseline data for comparing immunological parameters against those receiving treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphocyte Proliferation Analysis
This outcome evaluates the proliferation capacity of peripheral blood mononuclear cells (PBMCs) isolated from the study participants. This analysis will help quantify and understand the dynamics of lymphocyte activation and proliferation in response to different clinical stages of MRONJ and potentially identify immunological differences that could inform therapeutic strategies.
Measured: Baseline
Apoptosis Analysis in Lymphocytes
This outcome assesses apoptosis in lymphocytes isolated from the peripheral blood of participants included in the study. This analysis aims to quantify apoptotic processes in lymphocytes, offering insights into cell death mechanisms under varying conditions of culture and potentially relating these mechanisms to the immunopathology of MRONJ.
Measured: Baseline
Cytokine Profile Analysis
This outcome measures the levels of specific cytokines as indicators of immunological response in MRONJ at different disease stages. The cytokines to be analyzed include IL-17, IL-2, IL-4, IL-6, IL-10, TNF-α, and IFN-γ.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 May 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication-Related Osteonecrosis of JawStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferit Bayram, Marmara University
- Investigators
- Ferit Bayram, PhD, Study chair, Marmara University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420284
- Sponsor's protocol ID
- MU_DHF_MI_01
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ruggiero SL, Dodson TB, Aghaloo T, Carlson ER, Ward BB, Kademani D. American Association of Oral and Maxillofacial Surgeons' Position Paper on Medication-Related Osteonecrosis of the Jaws-2022 Update. J Oral Maxillofac Surg. 2022 May;80(5):920-943. doi: 10.1016/j.joms.2022.02.008. Epub 2022 Feb 21.
PubMed 35300956
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Immunological Parameters in Different Clinical Stages of Medication-Related Osteonecrosis of the Jaw
- ClinicalTrials.gov ID
- NCT06420284
- Acronym / sponsor ID
- MU_DHF_MI_01
- Conditions
- Medication-Related Osteonecrosis of Jaw
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 20 May 2024 (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.
This study aims to conduct a detailed analysis of the immunological response profiles that emerge at different clinical stages of medication-related osteonecrosis of the jaw (MRONJ). The research seeks to understand how these responses influence the pathogenesis, staging, and treatment of MRONJ. Throughout the study, cytokine levels, inflammation markers, and other immunological parameters observed at various stages will be comprehensively assessed. The results of these analyses are expected to provide insights into how stage-specific immunological variables could play a role in the diagnosis and treatment of MRONJ.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MRONJ Stage 0 | – | –Participants in this group are receiving antiresorptive/antiangiogenic therapy and exhibit nonspecific symptoms but no exposed bone. This stage is considered a precursor stage, where the risk of developing MRONJ is present but not yet visible through exposed bone. |
| MRONJ Stage I | – | –Individuals in this group are on antiresorptive/antiangiogenic therapy and show exposed bone without any symptoms. This stage represents the early manifestation of MRONJ, characterized by visible bone changes without associated pain or infection. |
| MRONJ Stage II | – | –This group includes patients treated with antiresorptive/antiangiogenic agents, who have exposed bone accompanied by symptoms such as pain or infection but without extensive bone involvement. This stage indicates a progression in the severity of MRONJ. |
| MRONJ Stage III | – | –Participants are undergoing antiresorptive/antiangiogenic treatment and exhibit exposed bone with symptoms, where the exposed bone extends beyond the alveolar bone, indicating advanced disease with significant bone and surrounding tissue involvement. |
| At-Risk Group | – | –This group consists of individuals receiving antiresorptive/antiangiogenic therapy who do not yet show any exposed bone or symptoms. They are considered at risk for developing MRONJ and are monitored for any potential progression. |
| Healthy Control Group | – | –This control group comprises individuals who have not received antiresorptive/antiangiogenic therapy and show no signs of exposed bone or symptoms. This group serves to provide baseline data for comparing immunological parameters against those receiving treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population for this research comprises adults aged 18 and older, both male and female, who present with medication-related osteonecrosis of the jaw (MRONJ) at the Oral and Maxillofacial Surgery Clinic of Marmara University Faculty of Dentistry. All participants must have provided written informed consent either personally or through a legal representative to be included in the study.
Key inclusion criteria (4 listed)
- Individuals aged 18 and over
- Both male and female participants
- Individuals who apply to the Oral and Maxillofacial Surgery Clinic at Marmara University Faculty of Dentistry due to medication-related osteonecrosis of the jaw during the study period
- Individuals or their legal representatives who have provided written consent to participate in the study
Key exclusion criteria (4 listed)
- Non-drug-related osteonecrosis/osteomyelitis
- Osteoradionecrosis
- Metastasis to the oral region
- Individuals who have not given written consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lymphocyte Proliferation Analysis
Time frame: Baseline
This outcome evaluates the proliferation capacity of peripheral blood mononuclear cells (PBMCs) isolated from the study participants. This analysis will help quantify and understand the dynamics of lymphocyte activation and proliferation in response to different clinical stages of MRONJ and potentially identify immunological differences that could inform therapeutic strategies.
Apoptosis Analysis in Lymphocytes
Time frame: Baseline
This outcome assesses apoptosis in lymphocytes isolated from the peripheral blood of participants included in the study. This analysis aims to quantify apoptotic processes in lymphocytes, offering insights into cell death mechanisms under varying conditions of culture and potentially relating these mechanisms to the immunopathology of MRONJ.
Cytokine Profile Analysis
Time frame: Baseline
This outcome measures the levels of specific cytokines as indicators of immunological response in MRONJ at different disease stages. The cytokines to be analyzed include IL-17, IL-2, IL-4, IL-6, IL-10, TNF-α, and IFN-γ.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Background: PubMed 35300956Ruggiero SL, Dodson TB, Aghaloo T, Carlson ER, Ward BB, Kademani D. American Association of Oral and Maxillofacial Surgeons' Position Paper on Medication-Related Osteonecrosis of the Jaws-2022 Update. J Oral Maxillofac Surg. 2022 May;80(5):920-943. doi: 10.1016/j.joms.2022.02.008. Epub 2022 Feb 21.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ferit Bayram, PhD study chair
Marmara University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication-Related Osteonecrosis of Jaw, run by Marmara University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ferit Bayram, PhD (00902167775000, ferit.bayram@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphocyte Proliferation Analysis (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06420284, which also lists 1 linked publication.
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 20 May 2024.