Aesthetic Reconstruction of Onco-surgical Mandibular Defects Using FFF With and Without CAD/CAM Customized Cutting Guide
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About
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.
Full 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.
Enrollment
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
22 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Mohammed E Al-Sabahi, Phd. student
Data sourced from clinicaltrials.gov
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