Aesthetic Reconstruction of Onco-surgical Maxillary Defects Using FSF With and Without CAD/CAM Customized Cutting Guide

NCT03757286 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-07-24

No results posted yet for this study

Summary

The aim of the study is to compare aesthetic results and operation time of Free Scapular flap with and without CAD/CAM customized osteotomy guide for reconstruction of maxillary Defects.

Conditions

  • Maxillary Tumors

Interventions

PROCEDURE

FSF with CAD\CAM customized cutting guide

This began with the acquisition of a high-resolution CT scan of the patient's maxilla and scapula. The CT scan will be sent to the modeling company that produce 3D autoclavable models and cutting guides to be used during resection and scapular harvesting as well as a model of the final reconstructed maxilla. surgery will performed by two surgical teams one for tumor resection and the other harvesting the flap. access to the maxilla was obtained and the cutting guides were secured in the planned position; the cuts were completed. The scapular guides were secured to the harvested scapula to replicate the cuts that were planned previously. The scapula and plate will be fixed and pedicle anastomosis is performed. the operation then completed with soft tissue reconstruction.

PROCEDURE

FSF without customized cutting guide

This began with the acquisition of a high-resolution CT scan of the patient's maxilla . The C.T scan will be sent to the modeling company for planning three-dimensional model of the maxilla. autoclavable model will be prepared to be used during the workflow for plate reshaping to conforme the prices position of the maxilla. surgery will performed in a single step by two surgical teams, one for cervicofacial resection and the other for harvesting the flap. Resection-reconstruction then performed in aconventional surgical manner with microvascular anastomosis. finally the operation will be completed with soft tissue reconstruction as needed.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Mohammed S Al-wadeai, Phd. student · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2021-01-31
Completion
2021-02-28

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03757286 on ClinicalTrials.gov