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NCT Number: NCT07836829

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.

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Key information

Conditions

Osteoradionecrosis Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Oral Cancer Oral Cavity Cancer Radiation Injuries Radiotherapy Risk Factors Stomatognathic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. Development of osteoradionecrosis (ORN) of the jaw

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

    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.

Secondary outcomes

  1. Incidence of ORN Across Geographic Regions

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

    To compare the incidence rates across geographical regions, namely between the Eastern and Western world, and High-Income Countries versus Low and Middle-Income Countries.

  2. Severity of ORN by Tumor Characteristic

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

    To evaluate the variability in the severity of osteoradionecrosis (ORN) based on primary tumor site (eg, tongue, floor of mouth, oral tongue, buccal mucosa, gingiva), histological tumor type (eg, adenoid cystic carcinoma, squamous cell carcinoma), and tumor characteristics including size, clinical stage (T1-T4), overall stage (III-IVA), and nodal status (N0, N1-2B, N2C, N3

  3. Association between radiotherapy dose and ORN severity

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

    To investigate the association between radiotherapy dose parameters (total dose and duration) and the severity grade of ORN among patients who develop ORN. Is there a correlation between increased radiation dose and duration and the severity of the condition?

  4. Incidence and severity comparison of preop vs. postop RT

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

    To compare the incidence and severity of ORN in patients undergoing preoperative versus postoperative radiotherapy

  5. Incidence comparison across RT modalities

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

    To compare the incidence ORN across different radiation modalities, including intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT), and conventional three-dimensional conformal radiotherapy (3D-CRT)

  6. To determine whether the mandible is more susceptible to ORN than the maxilla, or vice versa.

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

    To determine whether the mandible is more susceptible to ORN than the maxilla, or vice versa.

  7. Complication evaluation with pre- or postop RT

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

    To evaluate potential complications associated with preoperative and postoperative radiotherapy

  8. To analyze the influence of pre-radiotherapy dental extractions and oral hygiene status on the risk of developing ORN

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

    To analyze the influence of pre-radiotherapy dental extractions and oral hygiene status on the risk of developing ORN

  9. To examine the variability in ORN incidence and severity between patients who undergo dental extractions before versus after the completion of RT

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

    To examine the variability in ORN incidence and severity between patients who undergo dental extractions before versus after the completion of RT

Interested in participating?

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Sponsors and collaborators

Lead sponsor

AO Innovation Translation Center

Other

Registry information

Official study title

Risk Factors of Jaw Osteoradionecrosis in Oral Cavity Cancer Patients Post-Radiotherapy: A Multi-center Retrospective Cohort Study

Acronym: AOITC

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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