Virtual Lesion Segmentation and Mandibular Ameloblastoma Radiographic Safety Margin

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.

Study Overview

• Status: Recruiting
• Conditions: Ameloblastoma
• Intervention / Treatment: Device: Virtual lesion segmentation for 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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yehia A El-Mahallawy., PhD; Phone Number: 002 +201007217014.; Email: yehia.el-mahallawy@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria Governorate
    • Alexandria, Alexandria Governorate, Egypt, 21523
      • Recruiting
      • Faculty of Dentistry, Alexandria University
      • Contact: Yehia A El-Mahallawy, PhD; Phone Number: +201007217014; Email: yehia.el-mahallawy@alexu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with histologically confirmed ameloblastoma using a preoperative biopsy.
2. Patients with ameloblastoma that require segmental mandibular continuity defect, not involving the condyle.

Exclusion Criteria

1. Patients with lateral segmental mandibular defect involving the condyle.
2. Patients with an active infection at the site of resection.
3. Patients with recurrent lesion after resection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual lesion segmentation for mandibular ameloblastoma; Patient 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; Patient with mandibular ameloblastoma managed with virtual surgical planning & Virtual lesion segmentation for the determination of a radiographic 10-mm safety margin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 week

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: yehia A El-Mahallawy, Phd, Faculty of Dentistry, Alexandria University, Alexandria, Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 13, 2025
• First Submitted That Met QC Criteria: December 13, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: segmental mandibular defect; anterior iliac crest; virtual surgical planning accuracy
• Additional Relevant MeSH Terms: Neoplasms; Odontogenic Tumors; Neoplasms by Histologic Type; Ameloblastoma
• Other Study ID Numbers: 15-12-25/SM-Amelo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No