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

Primary Purpose

Mandibular Tumors

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
FFF with CAD/CAM customized cutting guide
FFF without customized cutting guide
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandibular Tumors focused on measuring Mandibular tumors resection/reconstruction, CAD/CAM, Osteotomy, Cutting guide, Aesthetic, Operation time, Free fibular flap

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients affected by tumor involving Mandibular bone.

Exclusion Criteria:

  • Patients having poor oncological prognosis
  • Patients with poor performance status together with other relative or absolute vascular contraindication.
  • Patients require marginal resection or with bilateral fibular fracture

Sites / Locations

  • Faculty of Dentistry- Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FFF with CAD/CAM customized cutting guide

FFF without customized cutting guide

Arm Description

Mandibular reconstruction using free fibular flap with CAD/CAM customized osteotomy guide.

Mandibular reconstruction using free fibular flap without customized osteotomy guide. CAD/CAM 3D model for mandible 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 the other side of the mandible. 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 ischemia time.

Full Information

First Posted
November 27, 2018
Last Updated
July 22, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03757273
Brief Title
Aesthetic Reconstruction of Onco-surgical Mandibular Defects Using FFF With and Without CAD/CAM Customized Cutting Guide
Official Title
Aesthetic Reconstruction of Onco-surgical Mandibular Defects Using Free Fibular 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 purpose of this study is to compare Aesthetic results and operation time of free fibular flap with and without CAD/CAM customized osteotomy guide for reconstruction of mandibular defects.
Detailed Description
Oral and maxillofacial tumors posing an important fact as a demanding challenge for surgeons causing face disfigurement which require post-ablation reconstruction. One of the most challenging procedure facing reconstructive surgeons lies in mandibular defects after tumor resection causing facial disharmony affecting aesthetics and function. Free flaps are considered the gold standard for the reconstruction during oncologic surgery combining a high success rate with low donor site morbidity. Various techniques have been practiced and performed in mandibular defect reconstruction. Hidalgo introduced the fibular graft as an option, offering many Assorted advantages: as it provides a sufficient source for bone and soft tissue harvesting; long reliable vascular pedicle; moreover, only minor donor site morbidity may be involved and flap harvesting require no patient reposition. Mandibular reconstruction using FFF has become the gold standard. However, flap contouring remain an issue and imprecise with inconvenient or suboptimal final results regrading aesthetic and even more consuming time and efforts owing to poor planning when performed traditionally. Recently, with newly introduced technology and virtual planning, the process has become more uniform and reproducible thus enhancing final outcome improving patient life. Prefabricated cutting guides may be used may be not, however it still in debate regarding its benefits and worth for patient and surgeon. believing that ability of CAD/CAM technology to achieve Aesthetic and operation time improvement with more detailed evaluation in patients undergoing mandibular reconstruction using free fibular flap with CAD/CAM customized cutting guide. Our priori-hypothesis is that utilization of CAD/CAM-assisted with customized osteotomy guide is not related to an altered result regarding aesthetic outcome and operation time in patient undergoing mandibular reconstruction using free fibular flap. In order to test this hypothesis, we will compare aesthetic outcome and operation time in group of patients receive FFF by CAD/CAM-assisted with customized osteotomy guide to the results of another group of patients receive FFF but without customized osteotomy guide. only model will be performed as conventional method helping in pre-shaping of reconstruction plate which is another well-established concept of management of mandibular defect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandibular Tumors
Keywords
Mandibular tumors resection/reconstruction, CAD/CAM, Osteotomy, Cutting guide, Aesthetic, Operation time, Free fibular 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 participant and the investigators, neither the investigator nor the participant can be blinded. But, the assessor and the statistician will be blinded.
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FFF with CAD/CAM customized cutting guide
Arm Type
Experimental
Arm Description
Mandibular reconstruction using free fibular flap with CAD/CAM customized osteotomy guide.
Arm Title
FFF without customized cutting guide
Arm Type
Active Comparator
Arm Description
Mandibular reconstruction using free fibular flap without customized osteotomy guide. CAD/CAM 3D model for mandible will be used.
Intervention Type
Procedure
Intervention Name(s)
FFF with CAD/CAM customized cutting guide
Intervention Description
This began with the acquisition of a high-resolution CT scan of the craniofacial skeleton and lower legs. the CT scan will be sent to the modeling company for producing autoclavable 3D models and cutting guides of the mandible and fibula to be used during the workflow as well as a model of the final reconstructed mandible. Surgery will be performed by two surgical teams, one for cervicofacial resection and the other harvesting the flap. access to the mandible is obtained, osteotomy guides secured; cuts then accomplished as planned virtually. fibular flap is harvested and cutting guides secured to replicate osteotomies and reshaping as planned to conform with remaining mandible. fixation and pedicle anastomosis is performed. Finally, the operation completed with soft tissue reconstruction.
Intervention Type
Procedure
Intervention Name(s)
FFF without customized cutting guide
Intervention Description
This began with the acquisition of a high-resolution CT scan of the craniofacial skeleton. the C.T scan will be sent to the modeling company for planning three-dimensional model of the mandible. autoclavable model will be prepared for mandible to be used during the workflow for plate reshaping and positioning to conform with the remaining mandible. Surgery will be performed by two surgical teams, one in charge of cervicofacial resection and the other harvesting the flap. access to the mandible is obtained, and resection/ reconstruction then performed in conventional surgical manner with microvascular anastomosis. Finally, the operation will be completed with soft tissue reconstruction.
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 the other side of the mandible. subjectively will be evaluated using VAS.
Time Frame
at least three months post operative
Secondary Outcome Measure Information:
Title
Operation time
Description
Operation time will be recorded intraoperatively in the surgery day as total operation time and ischemia time.
Time Frame
intraoperative

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients affected by tumor involving Mandibular bone. Exclusion Criteria: Patients having poor oncological prognosis Patients with poor performance status together with other relative or absolute vascular contraindication. Patients require marginal resection or with bilateral fibular fracture
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed E Al-Sabahi, Phd. student
Phone
00201111960834
Email
mea.sabahi2014@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed E Al-Sabahi, Phd. student
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry- Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed E Al-Sabahi, Phd. student
Phone
00201111960834
Email
mea.sabahi2014@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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