Immunological Parameters Between MRONJ Stages

May 14, 2024 updated by: Ferit Bayram, Marmara University

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey, 34854
        • Recruiting
        • Marmara University School of Dentistry
        • Contact:
        • Principal Investigator:
          • Tunç Akkoç, Prof. Dr.
        • Principal Investigator:
          • Gül Emren, DDS
        • Principal Investigator:
          • Zeynep Tunca
        • Principal Investigator:
          • Sabriye Senem Kılıç

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Non-drug-related osteonecrosis/osteomyelitis
  • Osteoradionecrosis
  • Metastasis to the oral region
  • Individuals who have not given written consent to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Study Chair: Ferit Bayram, PhD, Marmara University Faculty of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU_DHF_MI_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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