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Recruiting NCT07306962

Virtual Lesion Segmentation and Mandibular Ameloblastoma Radiographic Safety Margin

No phase Interventional Ameloblastoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual lesion segmentation for mandibular ameloblastoma.
Who it may be relevant to
Registry conditions: Ameloblastoma. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Histological analysis and degree of lesion invasion determination [Time frame: 1 month]
Secondary outcome measures (1)
  • Postoperative resection margin accuracy analysis [Time frame: 1 week]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry, Alexandria University — Alexandria

Identifiers

NCT: NCT07306962 · 15-12-25/SM-Amelo

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗