Actively Recruiting
Does Computer-assist Virtual Lesion Segmentation Change the Literature Consensus on Mandibular Ameloblastoma Radiographic Safety Margin? A Clinical Case Series
Led by Alexandria University · Updated on 2025-12-29
10
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of computer-assisted virtual lesion segmentation guided by CT scans to plan surgery and determine safety margins for mandibular ameloblastoma, a type of tumor affecting the jawbone. The study aims to evaluate how virtual surgical planning (VSP) combined with histopathological analysis can help achieve negative surgical margins and prevent tumor recurrence. This clinical case series involves patients with segmental defects in the mandible requiring reconstruction. The study involves 10 patients who will undergo mandibular reconstruction using bone harvested from the anterior iliac crest, known for its favorable bone quality. Each surgery will be planned preoperatively using virtual surgical planning and intraoperative guides to assist with precise resection and reconstruction. The approach includes a radiographic 10-mm safety margin for tumor removal determined by virtual lesion segmentation. Participants will have their resected mandibles evaluated by three-dimensional radiographic imaging to assess the accuracy of the virtual surgical planning. Histological analysis will be performed one month after surgery to determine the degree of lesion invasion. A postoperative analysis of the resection margin accuracy will be completed within one week. The total study period includes these evaluation steps to monitor safety and surgical precision.
CONDITIONS
Brief Title
Virtual Lesion Segmentation and Mandibular Ameloblastoma Radiographic Safety Margin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed ameloblastoma using a preoperative biopsy.
- Patients with ameloblastoma requiring segmental mandibular continuity defect not involving the condyle.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to surgery day
Participants undergo virtual surgical planning and virtual lesion segmentation for the determination of a radiographic 10-mm safety margin, followed by surgical resection and reconstruction using anterior iliac crest grafts.
1 surgical visit (in-person)
Duration - 1 month
Participants are monitored for resection margin accuracy and histological analysis of the lesion invasion.
Approximately 2 visits within 1 month post-surgery
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate, Egypt, 21523
Actively Recruiting
Research Team
Y
yehia A El-Mahallawy., PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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