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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-31

Study Completion Date

2021-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03757273

Mandibular Tumors

UNKNOWN NA

Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps

NCT02572869

Head and Neck Cancer

COMPLETED

Assessment of Facial Symmetry Following Fibula Free Flap Fixated in a Prosthetically Favorable Position Versus the Inferior Border Position for Mandibular Reconstruction

NCT06790628

Mandible Reconstruction

RECRUITING NA

Ascending Ramus Versus Chin Cortical Plates for Reconstruction of Atrophic Maxilla

NCT03629860

Atrophy of Edentulous Maxillary Alveolar Ridge

UNKNOWN NA

Mandibular Reconstruction Bone Plate

NCT06099431

Mandible Tumor

ENROLLING_BY_INVITATION NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Maxillofacial defects create unique challenges for the reconstructive surgeon, often involving bony and soft tissue components of the midface. Surgical reconstruction following maxillectomy is currently a topic of interest for reconstructive head and neck surgeons. maxillary defects were reconstructed with maxillofacial prosthetics including obturation. While the latter is an effective reconstruction. Over the past two decades, there has been increasing interest in the use of free tissue transfers of bone to reconstruct the maxilla.

Scapular flap It is an excellent candidate for maxillectomy defects because of its unique feature, which is characterized by additional skin paddles or muscles. and can be harvested along with a part of the scapular bone for bony reconstruction

Traditional reconstructive techniques often lead to suboptimal reconstructions due to inexact planning, poor communication between the resective and reconstructive teams or surgical difficulties in adjusting a free flap and osteosynthesis plates into a three-dimensional (3D) defect without the help of any templates or surgical guides The advent of 3D modeling in head and neck reconstruction has allowed surgeons to improve upon functional and aesthetic outcomes, which are crucial to patient satisfaction and can be difficult to achieve in maxillectomy defects The cutting guides used or not used, however debate still present for its benefits and worth for patient and surgeon. current study to evaluate how such virtual planning with using of customized cutting guide is effective and worth for patient aesthetic and operation time.

our priori-hypothesis is that utilization CAD/CAM assisted with customized osteotomy guide is not related to an altered result regarding aesthetic outcome and operation time in patient undergoing maxillary reconstruction using free scapular flap.

In order to test this hypothesis, we will compare aesthetic outcome and operation time in group of patients receive FSF by CAD/CAM-assisted with customized osteotomy guide to results of another group of patients receive FSF but without customized osteotomy guide. only model will be performed as conventional method aiding in reshaping of reconstruction plate which is another well-established concept of management of maxillary defect.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Maxillary Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Because the two interventions used in this trial are easily recognized by the participants and the investigator, neither the investigator nor the participant can be blinded. But, assessor and the statistician will be blinded.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FSF with CAD\CAM customized cutting guide

Maxillary reconstruction using free scapular flap with CAD/CAM customized osteotomy guide.

Group Type EXPERIMENTAL

FSF with CAD\CAM customized cutting guide

Intervention Type PROCEDURE

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.

FSF without customized cutting guide

maxillary reconstruction using free scapular flap without customized osteotomy guide. CAD/CAM 3D model for maxilla will be used.

Group Type ACTIVE_COMPARATOR

FSF without customized cutting guide

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients affected by tumor involving Maxillary bone.

Exclusion Criteria

* Patients having poor oncological prognosis
* Patients with poor performance status together with other relative or absolute vascular contraindication.

Eligible Sex

ALL

Accepts Healthy Volunteers

No