Osteoradionecrosis

4

Review clinical trials related to Osteoradionecrosis. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Risk Factors of Jaw Osteoradionecrosis in Oral Cavity Cancer Patients Post-Radiotherapy

Osteoradionecrosis (ORN) of the jaw is a serious complication that can occur after radiation therapy for head and neck cancers, including oral cavity cancer (OCC). ORN happens when jawbone tissue dies and fails to heal, often triggered by dental issues like tooth extractions or poorly fitting dentures. Symptoms can include exposed bone, pain, difficulty opening the mouth, trouble swallowing, and even jaw fractures-leading to major physical and emotional challenges. The likelihood of ORN varies widely, from less than 1% to over 50% in head and neck cancer patients. For OCC specifically, studies report rates from 4% up to 25%. Treatment depends on how much bone is affected and can range from medication to major surgery. Risk factors include radiation dose, tumor location, oral health, dental extractions, lifestyle habits (like alcohol use), and other health conditions. Poor oral hygiene, high radiation doses, and alcohol use are among the most common risks. However, current data on OCC patients is limited and often not broadly applicable. This study will retrospectively examine what increases the risk of ORN in OCC patients who received radiation therapy before or after surgery. Using data from multiple international centers, it aims to identify patterns and provide globally relevant insights. The results will help guide prevention strategies and create evidence-based guidelines to reduce ORN and improve long-term outcomes for these patients.

Participants needed: 1,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: AO Innovation Translation CenterUpdated: Sep 23, 2026
Eligibility criteria

Adults (≥18 years) diagnosed with OCC and treated with radiotherapy with curativ... [+5]

Patients with non-oral cavity primary cancers (eg, oropharynx, larynx) [+6]

Status: Recruiting

Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors

This phase IV trial studies how well serial magnetic resonance imaging (MRI) after radiation therapy works in predicting radiation-induced changes in the normal tissue of patients with oral cavity or skull base tumors. Performing MRIs after radiation therapy for patients with oral cavity or skull base tumors may help to predict osteoradionecrosis (a change in non-cancerous tissue).

Participants needed: 425
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: M.D. Anderson Cancer CenterUpdated: May 22, 2026Locations: 1
Eligibility criteria

Patients older than 18 years of age [+6]

Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated GFR < 30ml/... [+1]

Status: Recruiting

Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible

Radiation is commonly used to treat cancer in the head and neck, however, this can lead to a serious complication called osteoradionecrosis (ORN), where there is necrotic (dead) open bone inside or outside of the mouth. This complication is difficult to treat, involves large healthcare costs, and can have devastating effects on quality of life. Two common adjuncts used in treatment of ORN are hyperbaric oxygen therapy (HBOT), which may requires up to 60 treatments at a specialized clinic where patients are treated with high concentrations of oxygen using special chambers, and a less complex option called PENTOCLO which involves treating patients with several antibiotics followed by a combination of other oral medications taken for at least 1 year. This pilot study will be guide the design of a definitive trial to examine if the combination of HBOT and a modified PENTOCLO protocol together is better than the current standard treatment of HBOT alone. Outcomes will include pain, side effects and the need for surgery in patients with ORN. Specifically, the results of this small, pilot study will help to inform the design of a future larger study.

Participants needed: 24
Trial details
Phase: Phase 3Biological sex: AllType: InterventionalSponsor: Sunnybrook Health Sciences CentreUpdated: Sep 12, 2025Locations: 1
Eligibility criteria

Diagnosis of mandibular ORN after completion of radiotherapy [+5]

Inability to give informed consent [+20]

Status: Recruiting

Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction

The investigators aim to develop a prospective database in which patient demographics, surgical, dental, prosthetic and QOL parameters collected during consecutive visits within the framework of routine practice, are being registered for each oncological patient eligible for (immediate/delayed) fixed prosthodontic rehabilitation at time of oral cavity reconstruction

Participants needed: 55
Trial details
Biological sex: AllType: ObservationalSponsor: AZ Sint-Jan AVUpdated: Feb 28, 2022Locations: 1Duration: 5 Years
Eligibility criteria

Patients of all ages [+4]

Patients with a clinically confirmed diagnosis of osteonecrosis not related to a... [+2]