Clinical trial NCT03757286: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Tumors
Keywords: maxillary tumors resection\ reconstruction
CAD\CAM
osteotomy, cutting guide
aesthetic
operation time
free scapular flap
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Aesthetic
timeFrame: at least three months postoperative
Secondary outcomes:
measure: operation time
timeFrame: intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculity of Dentistry-Cairo university
Study officials:
affiliation: Cairo University
name: Mohammed S Al-wadeai, Phd. student
role: PRINCIPAL_INVESTIGATOR
References:
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.