Aesthetic Reconstruction of Onco-surgical Maxillary Defects Using FSF With and Without CAD/CAM Customized Cutting Guide
Primary Purpose
Maxillary Tumors
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
FSF with CAD\CAM customized cutting guide
FSF without customized cutting guide
Sponsored by
About this trial
This is an interventional treatment trial for Maxillary Tumors focused on measuring maxillary tumors resection\ reconstruction, CAD\CAM, osteotomy, cutting guide, aesthetic, operation time, free scapular flap
Eligibility Criteria
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.
Sites / Locations
- Faculity of Dentistry-Cairo universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FSF with CAD\CAM customized cutting guide
FSF without customized cutting guide
Arm Description
Maxillary reconstruction using free scapular flap with CAD/CAM customized osteotomy guide.
maxillary reconstruction using free scapular flap without customized osteotomy guide. CAD/CAM 3D model for maxilla will be used.
Outcomes
Primary Outcome Measures
Aesthetic
aesthetic outcome will be measured objectively by computerized digital analysis as differential angle and differential area of reconstructed to other side of maxilla.subjectively will be evaluated using VAS.
Secondary Outcome Measures
operation time
operation time will be recorded intraoperatively in the surgery day as total operation time and ischemic time.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03757286
Brief Title
Aesthetic Reconstruction of Onco-surgical Maxillary Defects Using FSF With and Without CAD/CAM Customized Cutting Guide
Official Title
Aesthetic Reconstruction of Onco-surgical Maxillary Defects Using Free Scapular Flap With and Without CAD/CAM Customized Osteotomy Guide (A Randomized Controlled Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Tumors
Keywords
maxillary tumors resection\ reconstruction, CAD\CAM, osteotomy, cutting guide, aesthetic, operation time, free scapular flap
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FSF with CAD\CAM customized cutting guide
Arm Type
Experimental
Arm Description
Maxillary reconstruction using free scapular flap with CAD/CAM customized osteotomy guide.
Arm Title
FSF without customized cutting guide
Arm Type
Active Comparator
Arm Description
maxillary reconstruction using free scapular flap without customized osteotomy guide. CAD/CAM 3D model for maxilla will be used.
Intervention Type
Procedure
Intervention Name(s)
FSF with CAD\CAM customized cutting guide
Intervention Description
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
Intervention Name(s)
FSF without customized cutting guide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Aesthetic
Description
aesthetic outcome will be measured objectively by computerized digital analysis as differential angle and differential area of reconstructed to other side of maxilla.subjectively will be evaluated using VAS.
Time Frame
at least three months postoperative
Secondary Outcome Measure Information:
Title
operation time
Description
operation time will be recorded intraoperatively in the surgery day as total operation time and ischemic time.
Time Frame
intraoperative
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed S Al-wadeai, Phd. student
Phone
00201122538653
Email
alwadai20111@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed S Al-wadeai, Phd. student
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculity of Dentistry-Cairo university
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed S Al-wadeai, Phd. student
Phone
00201122538653
Email
alwadai20111@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36261822
Citation
Alwadeai MS, Al-Aroomy LA, Shindy MI, Amin AA, Zedan MH. Aesthetic reconstruction of onco-surgical maxillary defects using free scapular flap with and without CAD/CAM customized osteotomy guide. BMC Surg. 2022 Oct 19;22(1):362. doi: 10.1186/s12893-022-01811-9.
Results Reference
derived
Learn more about this trial
Aesthetic Reconstruction of Onco-surgical Maxillary Defects Using FSF With and Without CAD/CAM Customized Cutting Guide
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