Virtual Lesion Segmentation and Mandibular Ameloblastoma Radiographic Safety Margin

NCT07306962 | Recruiting

• 1 other identifier: 15-12-25/SM-Amelo
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Ameloblastoma

Keywords

segmental mandibular defect; anterior iliac crest; virtual surgical planning accuracy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative resection margin accuracy analysis

  1 week

Study Arms (1)

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.

Device: Virtual lesion segmentation for mandibular ameloblastoma

Interventions

Virtual lesion segmentation for mandibular ameloblastoma DEVICE

Patient with mandibular ameloblastoma managed with virtual surgical planning \& Virtual lesion segmentation for the determination of a radiographic 10-mm safety margin.

Virtual lesion segmentation for mandibular ameloblastoma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

RECRUITING

MeSH Terms

Conditions

Ameloblastoma

Condition Hierarchy (Ancestors)

Odontogenic Tumors; Neoplasms by Histologic Type; Neoplasms

Study Officials

• yehia A El-Mahallawy, PhD

  Faculty of Dentistry, Alexandria University, Alexandria, Alexandria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yehia A El-Mahallawy., PhD

CONTACT

+201007217014.; yehia.el-mahallawy@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)