Mandibular Tumors Clinical Trial
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)
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.
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.
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