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NCT Number: NCT07306962

Virtual Lesion Segmentation and Mandibular Ameloblastoma Radiographic Safety Margin

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

Location status: Recruiting

Location contact

Yehia A El-Mahallawy, PhD

CONTACT

[email protected]

+201007217014

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Postoperative resection margin accuracy analysis

    Time frame: 1 week

    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

Study contacts

Contact information is provided by the study sponsor or research team.

yehia A El-Mahallawy., PhD

CONTACT

[email protected]

+201007217014. ext. 002

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 29, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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