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Virtual Lesion Segmentation and Mandibular Ameloblastoma Radiographic Safety Margin

NCT ID: NCT07306962

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-01-01

Brief Summary

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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

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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.

Conditions

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Ameloblastoma

Keywords

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segmental mandibular defect anterior iliac crest virtual surgical planning accuracy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual lesion segmentation for mandibular ameloblastoma

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yehia A El-Mahallawy, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Alexandria University, Alexandria, Alexandria

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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yehia A El-Mahallawy., PhD

Role: CONTACT

Phone: +201007217014.

Email: [email protected]

Facility Contacts

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Yehia A El-Mahallawy, PhD

Role: primary

Other Identifiers

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15-12-25/SM-Amelo

Identifier Type: -

Identifier Source: org_study_id