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

ConditionsOsteoradionecrosis Radiotherapy Risk Factors Oral Cancer Oral Cavity Cancer

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorAO Innovation Translation Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants

are grouped into 2 trial groups

Group A: Cases (ORN group)

Group B: Control (non-ORN group)

Trial outcomes

Primary outcomes

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.

Time frame