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

NCT07836829 | Not Yet Recruiting

• 1 other identifier: ORN of the Jaw
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoradionecrosis; Radiotherapy; Risk Factors; Oral Cancer; Oral Cavity Cancer

Outcome Measures

Primary Outcomes (1)

• Development of osteoradionecrosis (ORN) of the jaw

  The primary outcome is the development occurrence (yes/no) of ORN after completion of pre- and/or postoperative RT. The objective is to identify and evaluate patient-, tumor-, treatment-, and region-related risk factors associated with the development of ORN across multiple geographic regions. Scoring Scale: The primary endpoint will be treated as a binary variable: 0 = No ORN 1 = Development of ORN Time to ORN onset (interval between completion of RT and clinical diagnosis of ORN) will also be recorded for time-to-event analyses.

  After completion of pre-and/or postoperative radiotherapy up to 24 months

Secondary Outcomes (9)

• Incidence of ORN Across Geographic Regions

  After completion of pre-and/or postoperative radiotherapy up to 24 months

• Severity of ORN by Tumor Characteristic

  After completion of pre-and/or postoperative radiotherapy up to 24 months

• Association between radiotherapy dose and ORN severity

  After completion of pre-and/or postoperative radiotherapy up to 24 months

• Incidence and severity comparison of preop vs. postop RT

  After completion of pre-and/or postoperative radiotherapy up to 24 months

• Incidence comparison across RT modalities

  After completion of pre-and/or postoperative radiotherapy up to 24 months

Study Arms (2)

Cases (ORN group)

Developed clinically and radiographically or histologically confirmed osteoradionecrosis (ORN) of the jaw following radiotherapy.

Control (non-ORN group)

No clinical, radiological, or histological diagnosis of ORN during the follow-up period.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from the primary care center where the patients received their initial treatment and followed up for at least 24months

You may qualify if:

• Adults (≥18 years) diagnosed with OCC and treated with radiotherapy with curative intent (preoperative or/and postoperative, not palliative; definitive RT)
• Patients who completed the full prescribed radiotherapy course; patients remain eligible if radiotherapy was discontinued due to suspected and subsequently confirmed ORN
• Available, complete medical records including RT details, oral status, comorbidities, dental procedure details (as applicable), and lifestyle factors (as applicable)
• Documented informed consent from the treated patient, where applicable, permitting the use of their medical records for research purposes, in accordance with the requirements of the Institutional Review Board (IRB) or Ethics Committee (EC).
• Availability of at least 24 months of follow-up data after completion of radiotherapy, or follow-up until the occurrence of ORN, death, or loss to follow-up, whichever occurs first.
• Completion of the radiotherapy course on or before 31 December 2024.

You may not qualify if:

• Patients with non-oral cavity primary cancers (eg, oropharynx, larynx)
• Patients treated only with surgery or conservatively, without any form of RT
• Incomplete or missing medical records
• Record of use of antiresorptive (eg, bisphosphonate, denosumab) and antiangiogenic drugs
• Patients with jaw necrosis attributable to non-radiation-related causes, such as medication-related osteonecrosis of the jaw (MRONJ), trauma, or odontogenic infections
• Patients with known metastatic bone disease in the jaw
• Patients who discontinued radiotherapy for reasons unrelated to ORN suspicion or confirmation (eg, death, dropout, treatment intolerance, or other non-ORN related causes)

Sponsors & Collaborators

• AO Innovation Translation Center: lead

MeSH Terms

Conditions

Osteoradionecrosis; Mouth Neoplasms

Condition Hierarchy (Ancestors)

Radiation Injuries; Wounds and Injuries; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Khalid Abdel-Galil, MD

  Hamad Medical Corporation PO Box 3050 Doha, Qatar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Bretzinger

CONTACT

+41 81 414 21 11; benjamin.bretzinger@aofoundation.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): July 15, 2029
• Last Updated: September 23, 2026

Record last verified: 2026-07