Patient With a History of Previous RadiotherapyDeep LearningNCT07809048
Deep Learning for Automatic Segmentation of Bone Sequestra on Orthopantomographs: A UNet-Based Approach
An observational study of Patient With a History of Previous Radiotherapy, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
This study developed and evaluated a UNet-based deep learning model for automatic segmentation of bone sequestra on orthopantomographs (OPGs), with the goal of improving diagnostic efficiency and reducing inter-observer variability in osteomyelitis, osteoradionecrosis, and medication-related osteonecrosis of the jaw. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Patient With a History of Previous Radiotherapy
- What is being tested?
- Radiographic Evaluation
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected among the patients with osteomyelitis with sequestrum
Who may be able to join
- Patient with exposed bone over 8 weeks with a history of bisphosphonates or antiangiogenic drugs,
- Patient with a history of previous radiotherapy,
- Patients with necrotic exposed bone with or without a history of trauma
- Patients with osteomyelitis.
Who cannot join
- Patients with no clear vision of the borders of the sequestra,
- Panoramic images with artifacts in and around the lesion.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Katip Celebi University
Izmir, Çiğli, 35640
About this study
This study developed and evaluated a UNet-based deep learning model for automatic segmentation of bone sequestra on orthopantomographs (OPGs), with the goal of improving diagnostic efficiency and reducing inter-observer variability in osteomyelitis, osteoradionecrosis, and medication-related osteonecrosis of the jaw. A total of 120 anonymized OPGs with 134 annotated sequestra were used for training. Images were preprocessed with min-max normalization and augmented to enhance robustness. Manual expert annotations served as ground truth. A UNet architecture, optimized with Dice loss and the AdamW optimizer, was trained for 300 epochs. Performance was assessed using Dice coefficient, Intersection over Union (IoU), precision, recall, F1-score, and accuracy. ROC analysis and confusion matrix evaluations were performed. Agreement with clinicians was quantified using the Intraclass Correlation Coefficient (ICC). The model achieved a best-checkpoint validation Dice of 0.79 and IoU of 0.93. On the test set, performance included a Dice of 0.79, IoU of 0.74, recall of 0.81, precision of 0.81, and F1-score of 0.81. ROC analysis showed balanced discriminative performance with an AUC of 0.76. The confusion matrix indicated strong lesion/background classification, with minor under-segmentation. ICC analysis showed excellent agreement with an experienced surgeon (ICC = 0.85), though lower with a less experienced dentist (ICC = 0.57). The proposed UNet-based model enables efficient segmentation of sequestra, reducing annotation time by >90% while maintaining diagnostic accuracy. The model highlights the clinical utility of AI-assisted decision support in maxillofacial radiology.
Read the detailed description
Bone sequestration is the formation of a dead bone fragment demarcated from normal bone tissue, usually following dental extractions, delayed healing, chronic infection, or compromised blood supply. It is most frequently associated with osteomyelitis, an infectious process leading to bone inflammation. Osteomyelitis is mostly diagnosed based on clinical presentation with imaging and laboratory evidence but is established through bone biopsy and microbial culture.
Infection of the alveolar bone may be due to various reasons like dental caries, trauma, surgery, and local infection. The dental infections in the majority of instances have localized abscesses, but occasionally, the infection is disseminated, and osteomyelitis follows. Radiation therapy (RT), a standard head and neck cancer therapy, also can lead to osteoradionecrosis (ORN), a disease process in which irradiated bone becomes devitalized, open, and nonhealing. Another mechanism of bone sequestration is medication-related osteonecrosis of the jaw (MRONJ), a complication of antiresorptive and antiangiogenic therapy. First described in 2003 as bisphosphonate-related osteonecrosis of the jaw (BRONJ), the disease was later reclassified by the American Association of Oral and Maxillofacial Surgeons (AAOMS) in 2014 to include cases with non-bisphosphonate therapy, denosumab, and antiangiogenic agents. The medications, given chronically to treat osteoporosis and cancer-related bone disease, lead to interference of vascular supply and thus result in ischemia, hypoperfusion, and eventually bone death.
Although MRONJ is a rare complication, it significantly affects the quality of life of the patient by causing chronic bone exposure, pain, and functional disability. Bone sequestration is a significant problem in the context of all categories of bone disease, including osteomyelitis, ORN, and MRONJ. Pathogenesis, risk factors, and diagnostic criteria should be familiarized with to improve patient outcomes and minimize complications of bone necrosis.
Precise definition of bone sequestrum is essential for diagnosis, treatment planning, and surgical decision-making. Orthopantomography (OPG) or panoramic radiography is widely used in oral and maxillofacial radiology to assess bone disease, such as sequestrum formation. Manual segmentation of sequestrum in OPG is challenging because of anatomical structure superimposition, varying radiopacity, and subjective.
Artificial intelligence (AI) has rapidly expanded in the medical imaging field by providing automated and objective solutions to segmentation challenges. Solutions based on deep learning in the form of CNNs and U-Net-type architectures have been found to be high in accuracy to segment pathological structures from radiographic images. The techniques utilize large data sets to train to identify complex patterns and to differentiate between pathologic areas of bone and normal tissue, potentially improving the capacity to identify sequestrum on OPGs.
Although AI-based segmentation has been comprehensively explored in CT and MRI in most medical centers, it is comparatively less developed in the context of OPG imaging. Since OPG is more accessible and cheaper than cross-sectional imaging modalities, AI-based segmentation of OPGs has the potential to make diagnostic procedures and decision-making in dental and maxillofacial practice more efficient.Variable image quality, annotation challenges, and model generalizability across populations remain barriers that must be addressed before clinical deployment. This study presents an AI-based approach for automated sequestrum segmentation from OPG radiographs, describes the deep learning methodology employed, evaluates model performance, and discusses future clinical applications in dental radiology.
- Being tested
- Radiographic Evaluation
- Keywords
- deep learning, bone sequestrum, osteonecrosis
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiographic EvaluationOther
panoramic images evaluated for deep learning segmentation
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep Learning Segmentation
evaluated how artificial intelligence can identify the lesions on panoramic images
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Mar 2024
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient With a History of Previous RadiotherapyStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur ŞAHİN, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809048
- Sponsor's protocol ID
- IRB No: 0206
- Acronym
- Deep Learning
- Status last verified
- May 2025
- First submitted
- 4 May 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data is limited for this project
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Learning for Automatic Segmentation of Bone Sequestra on Orthopantomographs: A UNet-Based Approach
- ClinicalTrials.gov ID
- NCT07809048
- Acronym / sponsor ID
- Deep Learning / IRB No: 0206
- Keywords
- deep learning, bone sequestrum, osteonecrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 9 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.
This study developed and evaluated a UNet-based deep learning model for automatic segmentation of bone sequestra on orthopantomographs (OPGs), with the goal of improving diagnostic efficiency and reducing inter-observer variability in osteomyelitis, osteoradionecrosis, and medication-related osteonecrosis of the jaw. A total of 120 anonymized OPGs with 134 annotated sequestra were used for training. Images were preprocessed with min-max normalization and augmented to enhance robustness. Manual expert annotations served as ground truth. A UNet architecture, optimized with Dice loss and the AdamW optimizer, was trained for 300 epochs. Performance was assessed using Dice coefficient, Intersection over Union (IoU), precision, recall, F1-score, and accuracy. ROC analysis and confusion matrix evaluations were performed. Agreement with clinicians was quantified using the Intraclass Correlation Coefficient (ICC). The model achieved a best-checkpoint validation Dice of 0.79 and IoU of 0.93. On the test set, performance included a Dice of 0.79, IoU of 0.74, recall of 0.81, precision of 0.81, and F1-score of 0.81. ROC analysis showed balanced discriminative performance with an AUC of 0.76. The confusion matrix indicated strong lesion/background classification, with minor under-segmentation. ICC analysis showed excellent agreement with an experienced surgeon (ICC = 0.85), though lower with a less experienced dentist (ICC = 0.57). The proposed UNet-based model enables efficient segmentation of sequestra, reducing annotation time by >90% while maintaining diagnostic accuracy. The model highlights the clinical utility of AI-assisted decision support in maxillofacial radiology.
Detailed description
Bone sequestration is the formation of a dead bone fragment demarcated from normal bone tissue, usually following dental extractions, delayed healing, chronic infection, or compromised blood supply. It is most frequently associated with osteomyelitis, an infectious process leading to bone inflammation. Osteomyelitis is mostly diagnosed based on clinical presentation with imaging and laboratory evidence but is established through bone biopsy and microbial culture.
Infection of the alveolar bone may be due to various reasons like dental caries, trauma, surgery, and local infection. The dental infections in the majority of instances have localized abscesses, but occasionally, the infection is disseminated, and osteomyelitis follows. Radiation therapy (RT), a standard head and neck cancer therapy, also can lead to osteoradionecrosis (ORN), a disease process in which irradiated bone becomes devitalized, open, and nonhealing. Another mechanism of bone sequestration is medication-related osteonecrosis of the jaw (MRONJ), a complication of antiresorptive and antiangiogenic therapy. First described in 2003 as bisphosphonate-related osteonecrosis of the jaw (BRONJ), the disease was later reclassified by the American Association of Oral and Maxillofacial Surgeons (AAOMS) in 2014 to include cases with non-bisphosphonate therapy, denosumab, and antiangiogenic agents. The medications, given chronically to treat osteoporosis and cancer-related bone disease, lead to interference of vascular supply and thus result in ischemia, hypoperfusion, and eventually bone death.
Although MRONJ is a rare complication, it significantly affects the quality of life of the patient by causing chronic bone exposure, pain, and functional disability. Bone sequestration is a significant problem in the context of all categories of bone disease, including osteomyelitis, ORN, and MRONJ. Pathogenesis, risk factors, and diagnostic criteria should be familiarized with to improve patient outcomes and minimize complications of bone necrosis.
Precise definition of bone sequestrum is essential for diagnosis, treatment planning, and surgical decision-making. Orthopantomography (OPG) or panoramic radiography is widely used in oral and maxillofacial radiology to assess bone disease, such as sequestrum formation. Manual segmentation of sequestrum in OPG is challenging because of anatomical structure superimposition, varying radiopacity, and subjective.
Artificial intelligence (AI) has rapidly expanded in the medical imaging field by providing automated and objective solutions to segmentation challenges. Solutions based on deep learning in the form of CNNs and U-Net-type architectures have been found to be high in accuracy to segment pathological structures from radiographic images. The techniques utilize large data sets to train to identify complex patterns and to differentiate between pathologic areas of bone and normal tissue, potentially improving the capacity to identify sequestrum on OPGs.
Although AI-based segmentation has been comprehensively explored in CT and MRI in most medical centers, it is comparatively less developed in the context of OPG imaging. Since OPG is more accessible and cheaper than cross-sectional imaging modalities, AI-based segmentation of OPGs has the potential to make diagnostic procedures and decision-making in dental and maxillofacial practice more efficient.Variable image quality, annotation challenges, and model generalizability across populations remain barriers that must be addressed before clinical deployment. This study presents an AI-based approach for automated sequestrum segmentation from OPG radiographs, describes the deep learning methodology employed, evaluates model performance, and discusses future clinical applications in dental radiology.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected among the patients with osteomyelitis with sequestrum
Key inclusion criteria (4 listed)
- Patient with exposed bone over 8 weeks with a history of bisphosphonates or antiangiogenic drugs,
- Patient with a history of previous radiotherapy,
- Patients with necrotic exposed bone with or without a history of trauma
- Patients with osteomyelitis.
Key exclusion criteria (2 listed)
- Patients with no clear vision of the borders of the sequestra,
- Panoramic images with artifacts in and around the lesion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiographic Evaluationpanoramic images evaluated for deep learning segmentation | Other | – |
Primary outcome
Deep Learning Segmentation
Time frame: Up to 10 weeks
evaluated how artificial intelligence can identify the lesions on panoramic images
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. Study data is limited for this project
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient With a History of Previous Radiotherapy, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep Learning Segmentation (time frame: Up to 10 weeks). 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 9 Sep 2026.