Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07435259
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with medication-related osteonecrosis of the jaw (MRONJ) (AAOMS stage 0, 1, or 2) who have been treated with antiresorptive agents (e.g., bisphosphonates or denosumab) and/or selective estrogen receptor modulators (SERMs).
* Presence of an MRONJ lesion involving at least one dental implant at the affected site.
* Radiographic peri-implant bone loss between ≥20% and \<60% of the implant length at the most severe area on baseline imaging.
* No implant mobility.
* Able and willing to provide written informed consent after receiving an adequate explanation of the study purpose and procedures.
Exclusion Criteria:
* History of radiotherapy to the head and neck region.
* Presence of metastatic disease or bone diseases such as multiple myeloma or Paget's disease of the jaw.
* Current treatment with anti-angiogenic agents (e.g., bevacizumab, ranibizumab, lenalidomide, sunitinib) or immunomodulatory agents (e.g., methotrexate) for cancer therapy.
* Uncontrolled systemic disease that may contraindicate surgery or impair healing (e.g., uncontrolled diabetes, recent chemotherapy, severe immunosuppression).
* Refusal of treatment or follow-up, withdrawal of consent, or inability to comply with study procedures.
* Peri-implant bone loss outside the predefined range (\<20% or ≥60%) on preoperative imaging or intraoperative assessment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT07435259
Study Brief:
Protocol Section:
NCT07435259