AmeloblastomaNCT07306962
Virtual Lesion Segmentation and Mandibular Ameloblastoma Radiographic Safety Margin
A study testing Virtual lesion segmentation for mandibular ameloblastoma in people with Ameloblastoma, run by Alexandria University at 1 site in Egypt.
Trial summary
Reconstruction of segmental mandibular defects is in a continuous state of evolution utilizing the recent advances in Computer-Aided Designing (CAD) and preoperative Virtual Surgical Planning (VSP). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ameloblastoma
- What is being tested?
- Virtual lesion segmentation for mandibular ameloblastoma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Jan 2027
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with histologically confirmed ameloblastoma using a preoperative biopsy.
- Patients with ameloblastoma that require segmental mandibular continuity defect, not involving the condyle.
Who cannot join
- Patients with lateral segmental mandibular defect involving the condyle.
- Patients with an active infection at the site of resection.
- Patients with recurrent lesion after resection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate, 21523
Yehia A El-Mahallawy, PhD, +201007217014, yehia.el-mahallawy@alexu.edu.eg
About this study
Official title: Does Computer-assist Virtual Lesion Segmentation Ushers to a Change in the Literature Consensus Regarding Mandibular Ameloblastoma Radiographic Safety Margin?. A Clinical Case Series
Reconstruction of segmental mandibular defects is in a continuous state of evolution utilizing the recent advances in Computer-Aided Designing (CAD) and preoperative Virtual Surgical Planning (VSP). The anterior iliac crest is one of the ideal reservoirs for autogenous harvesting of a bi-cortical bone block with 1:1 cortical to cancellous bone ratio which is optimal for rapid and predictable consolidation. The aim of this study is the utility of VSP guided by CT and confirmation by histopathological analysis in achieving negative margins and preventing recurrence of mandibular ameloblastoma.
Read the detailed description
A total of 10 patients having segmental mandibular defects will be selected. All defects will be reconstructed using anterior iliac crest in utilizing preoperative virtual surgical planning and intraoperative resection and reconstruction guides. The resected mandible will be evaluated by radiographic three-dimensional that will be performed to determine the accuracy of the VSP guided by CT, along with histopathological analysis.
- Conditions
- Ameloblastoma
- Being tested
- Virtual lesion segmentation for mandibular ameloblastoma
- Keywords
- segmental mandibular defect, anterior iliac crest, virtual surgical planning accuracy
- Medical subject headings
- Ameloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual lesion segmentation for mandibular ameloblastomaDevice
Patient with mandibular ameloblastoma managed with virtual surgical planning \& Virtual lesion segmentation for the determination of a radiographic 10-mm safety margin.
| Study group | Role | What they receive |
|---|---|---|
| Virtual lesion segmentation for mandibular ameloblastoma | Experimental | Patient with mandibular ameloblastoma managed with virtual surgical planning \& Virtual lesion segmentation for the determination of a radiographic 10-mm safety margin. Receives: Device: Virtual lesion segmentation for mandibular ameloblastoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological analysis and degree of lesion invasion determination
The specimen with the the mounted Safety Margin Calibration Guide will be sent for histological evaluation. For light microscopic examination, the specimens will be embedded in paraffin wax blocks after being fixed in 10% formalin, neutrally buffered, cleaned, and dehydrated using increasing ethanol concentrations. Tissue sections will be cut to a thickness of 4 μm, and stained with hematoxylin and eosin to be examined under a light microscope.
The specimen will be cut, using the S35 (0.254-mm thickness) microtome blade, at the preoperatively determined margins according to the virtual lesion segmentation from the proximal and distal sides of the lesion. Since the study is limited to segmental mandibular resection, the full lower border of the mandible was resected and their will be no need for assessment of either coronal or apical margins
Measured: 1 month
Secondary outcomes (1)
Postoperative resection margin accuracy analysis
At the end of the surgical procedure, the Safety margin caliberation guide was mounted on the specimen and fixed using 2 2.0-mm miniscrews. A radiographic MSCT scan for the resected mandible with the Safety margin caliberation guide will be obtained using same preoperative scanning parameters. The DICOM data of the scanned Specimen will be segemented to create an Actual Resected Specimen Model (ARSM). The RSM will be superimposed with the preoperative Virtual Resected Specimen Model (VRSM) using the miniscrews as radiographic markers for superimposition. The postoperative accuracy of the virtually assisted surgery will be conducted using the 3D-analysis software (GOM-Inspect software*) For each of the selected 2D and 3D parameters, the Deviation will be calculated by subtracting the ARSM values from the VRSM. The absolute mean (Δ) for all of the operated patients will be calculated
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Jan 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmeloblastomaStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yehia A El-Mahallawy, PhD, Principal investigator, Faculty of Dentistry, Alexandria University, Alexandria, Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306962
- Sponsor's protocol ID
- 15-12-25/SM-Amelo
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Computer-assist Virtual Lesion Segmentation Ushers to a Change in the Literature Consensus Regarding Mandibular Ameloblastoma Radiographic Safety Margin?. A Clinical Case Series
- ClinicalTrials.gov ID
- NCT07306962
- Acronym / sponsor ID
- 15-12-25/SM-Amelo
- Conditions
- Ameloblastoma
- Keywords
- segmental mandibular defect, anterior iliac crest, virtual surgical planning accuracy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 29 Dec 2025 (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.
Reconstruction of segmental mandibular defects is in a continuous state of evolution utilizing the recent advances in Computer-Aided Designing (CAD) and preoperative Virtual Surgical Planning (VSP). The anterior iliac crest is one of the ideal reservoirs for autogenous harvesting of a bi-cortical bone block with 1:1 cortical to cancellous bone ratio which is optimal for rapid and predictable consolidation. The aim of this study is the utility of VSP guided by CT and confirmation by histopathological analysis in achieving negative margins and preventing recurrence of mandibular ameloblastoma.
Detailed description
A total of 10 patients having segmental mandibular defects will be selected. All defects will be reconstructed using anterior iliac crest in utilizing preoperative virtual surgical planning and intraoperative resection and reconstruction guides. The resected mandible will be evaluated by radiographic three-dimensional that will be performed to determine the accuracy of the VSP guided by CT, along with histopathological analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual lesion segmentation for mandibular ameloblastoma | Experimental | Device: Virtual lesion segmentation for mandibular ameloblastomaPatient with mandibular ameloblastoma managed with virtual surgical planning \& Virtual lesion segmentation for the determination of a radiographic 10-mm safety margin. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with histologically confirmed ameloblastoma using a preoperative biopsy.
- Patients with ameloblastoma that require segmental mandibular continuity defect, not involving the condyle.
Key exclusion criteria (3 listed)
- Patients with lateral segmental mandibular defect involving the condyle.
- Patients with an active infection at the site of resection.
- Patients with recurrent lesion after resection.
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 |
|---|---|---|
| Virtual lesion segmentation for mandibular ameloblastomaPatient with mandibular ameloblastoma managed with virtual surgical planning \& Virtual lesion segmentation for the determination of a radiographic 10-mm safety margin. | Device | Virtual lesion segmentation for mandibular ameloblastoma |
Primary outcome
Histological analysis and degree of lesion invasion determination
Time frame: 1 month
The specimen with the the mounted Safety Margin Calibration Guide will be sent for histological evaluation. For light microscopic examination, the specimens will be embedded in paraffin wax blocks after being fixed in 10% formalin, neutrally buffered, cleaned, and dehydrated using increasing ethanol concentrations. Tissue sections will be cut to a thickness of 4 μm, and stained with hematoxylin and eosin to be examined under a light microscope. The specimen will be cut, using the S35 (0.254-mm thickness) microtome blade, at the preoperatively determined margins according to the virtual lesion segmentation from the proximal and distal sides of the lesion. Since the study is limited to segmental mandibular resection, the full lower border of the mandible was resected and their will be no need for assessment of either coronal or apical margins
1 secondary outcome
Postoperative resection margin accuracy analysis
Time frame: 1 week
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 29 Dec 2025.
- Individual participant dataSharing planned: No. All data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study.
Related trials for Ameloblastoma
Not yet recruitingPhase 2/3
Neoadjuvant Therapy With Conservative Surgery vs. Up-front Conservative Surgery for BRAF V600E-Mutated Ameloblastoma
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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.
yehia A El-Mahallawy, PhD principal investigator
Faculty of Dentistry, Alexandria University, Alexandria, Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual lesion segmentation for mandibular ameloblastoma in people with Ameloblastoma, run by Alexandria University at 1 site in Egypt.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 Dec 2025. 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 Egypt. 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?
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 yehia A El-Mahallawy., PhD (+201007217014. ext. 002, yehia.el-mahallawy@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological analysis and degree of lesion invasion determination (time frame: 1 month). 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 29 Dec 2025.