Immunological Parameters Between MRONJ Stages

Marmara University

Status: Enrolling

Conditions: Medication-Related Osteonecrosis of Jaw

Study type: Observational

Funder types: Other

Identifiers

NCT06420284

MU_DHF_MI_01

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

42 participants in 6 patient groups

MRONJ Stage 0

Description:

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

Description:

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

Description:

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

Description:

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

Description:

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

Description:

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.