Best Treatment Choice for Osteonecrosis of the Jaw

Launched by TIM VAN DEN WYNGAERT · Aug 11, 2020

Keywords

ClinConnect Summary

This clinical trial, titled "Best Treatment Choice for Osteonecrosis of the Jaw," is looking to find out which treatment works best for patients with a condition called Medication-Related Osteonecrosis of the Jaw (MRONJ). Specifically, the study is comparing two different methods: a less invasive option using special membranes (called LPRF) and a more direct surgical approach, against the usual treatment which involves conservative care without surgery. The main goal is to see how long it takes for the mouth to heal after treatment, along with other factors such as how patients feel, their quality of life, and overall well-being.

To be eligible for this trial, participants should be at least 18 years old and have received treatment with a bone-modifying drug for conditions like bone cancer. They should have been diagnosed with early-stage MRONJ within the last two months. However, those who have already received certain treatments for MRONJ, had radiation therapy to the head and neck, or have advanced cases of MRONJ are not eligible. Participants can expect to receive care at multiple centers and will be part of a study that aims to improve treatment options for this condition.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • \>18 years of age
• • Provision of signed informed consent
• • A history of at least one administration of, or an ongoing treatment with, a bone modifying agent in dose registered for the prevention of skeletal related events in bone metastatic disease or multiple myeloma
• • Diagnosis of stage I-II MRONJ according to AAOMS 2014 criteria not more than 8 weeks prior to the date of screening
• Exclusion criteria:
• • Any prior treatment for MRONJ other than local antiseptic rinses, systemic antibiotics, or analgesics
• • Prior radiotherapy to the head and neck region
• • Medical contraindication to receive any of the possible study treatments
• • Stage III MRONJ characterized by very extensive bone necrosis, pathological fracture, or fistulas to the skin or sinuses
• • Multiple MRONJ lesions that cannot be closed in a single surgical procedure