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

Not Applicable

• Conditions: Mandibular Tumors
• Interventions: Procedure: FFF without customized cutting guide; Procedure: FFF with CAD/CAM customized cutting guide

• Registration Number: NCT03757273
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Status Verified: 2019-07
• Study Start: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-24
• Primary Completion: 2021-01
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Patients affected by tumor involving Mandibular bone.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FFF without customized cutting guide	FFF without customized cutting guide	Mandibular reconstruction using free fibular flap without customized osteotomy guide. CAD/CAM 3D model for mandible will be used.
FFF with CAD/CAM customized cutting guide	FFF with CAD/CAM customized cutting guide	Mandibular reconstruction using free fibular flap with CAD/CAM customized osteotomy guide.

Primary Outcome Measures

Name	Time	Method
Aesthetic	at least three months post operative	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

Name	Time	Method
Operation time	intraoperative	Operation time will be recorded intraoperatively in the surgery day as total operation time and ischemia time.

Trial Locations

Locations (1)

Faculty of Dentistry- Cairo University; 🇪🇬 Cairo, Egypt