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Virtual Lesion Segmentation and Mandibular Ameloblastoma Radiographic Safety Margin

A

Alexandria University

Status

Enrolling

Conditions

Ameloblastoma

Treatments

Device: Virtual lesion segmentation for mandibular ameloblastoma

Study type

Interventional

Funder types

Other

Identifiers

NCT07306962
15-12-25/SM-Amelo

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

yehia A El-Mahallawy., PhD

Data sourced from clinicaltrials.gov

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