OsteoradionecrosisAOITCNCT07836829
Risk Factors of Jaw Osteoradionecrosis in Oral Cavity Cancer Patients Post-Radiotherapy
An observational study of Osteoradionecrosis and Radiotherapy, run by AO Innovation Translation Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoradionecrosis, Radiotherapy, Risk Factors
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 15 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Risk Factors of Jaw Osteoradionecrosis in Oral Cavity Cancer Patients Post-Radiotherapy: A Multi-center Retrospective Cohort Study
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.
Read more
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
- Medical subject headings
- Osteoradionecrosis, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After completion of pre-and/or postoperative radiotherapy up to 24 months
Secondary outcomes (9)
Incidence of ORN Across Geographic Regions
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.
Measured: After completion of pre-and/or postoperative radiotherapy up to 24 months
Severity of ORN by Tumor Characteristic
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
Measured: After completion of pre-and/or postoperative radiotherapy up to 24 months
Association between radiotherapy dose and ORN severity
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?
Measured: After completion of pre-and/or postoperative radiotherapy up to 24 months
Incidence and severity comparison of preop vs. postop RT
To compare the incidence and severity of ORN in patients undergoing preoperative versus postoperative radiotherapy
Measured: After completion of pre-and/or postoperative radiotherapy up to 24 months
Incidence comparison across RT modalities
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)
Measured: 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.
To determine whether the mandible is more susceptible to ORN than the maxilla, or vice versa.
Measured: After completion of pre-and/or postoperative radiotherapy up to 24 months
Complication evaluation with pre- or postop RT
To evaluate potential complications associated with preoperative and postoperative radiotherapy
Measured: 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
To analyze the influence of pre-radiotherapy dental extractions and oral hygiene status on the risk of developing ORN
Measured: 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
To examine the variability in ORN incidence and severity between patients who undergo dental extractions before versus after the completion of RT
Measured: After completion of pre-and/or postoperative radiotherapy up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Mar 2027 (estimated)
- Primary completion15 Jun 2029 (estimated)
- Study completion15 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoradionecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khalid Abdel-Galil, MD, Principal investigator, Hamad Medical Corporation PO Box 3050 Doha, Qatar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836829
- Sponsor's protocol ID
- ORN of the Jaw
- Acronym
- AOITC
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Jaw Osteoradionecrosis in Oral Cavity Cancer Patients Post-Radiotherapy: A Multi-center Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07836829
- Acronym / sponsor ID
- AOITC / ORN of the Jaw
- Conditions
- Osteoradionecrosis, Radiotherapy, Risk Factors, Oral Cancer, Oral Cavity Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 15 Jul 2029 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
Incidence of ORN Across Geographic Regions
Time frame: After completion of pre-and/or postoperative radiotherapy up to 24 months
Severity of ORN by Tumor Characteristic
Time frame: After completion of pre-and/or postoperative radiotherapy up to 24 months
Association between radiotherapy dose and ORN severity
Time frame: After completion of pre-and/or postoperative radiotherapy up to 24 months
Incidence and severity comparison of preop vs. postop RT
Time frame: After completion of pre-and/or postoperative radiotherapy up to 24 months
Incidence comparison across RT modalities
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.
Time frame: After completion of pre-and/or postoperative radiotherapy up to 24 months
Complication evaluation with pre- or postop RT
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
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
Time frame: After completion of pre-and/or postoperative radiotherapy up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Platelet-Rich Fibrin for Preventing Osteoradionecrosis After Dental Extractions
Osteoradionecrosis of the Jaw
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Immunomonitoring of Circulating Immune Cells in Maxillofacial Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Khalid Abdel-Galil, MD principal investigator
Hamad Medical Corporation PO Box 3050 Doha, Qatar
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoradionecrosis and Radiotherapy, run by AO Innovation Translation Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Bretzinger (+41 81 414 21 11, benjamin.bretzinger@aofoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of osteoradionecrosis (ORN) of the jaw (time frame: After completion of pre-and/or postoperative radiotherapy up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.