Spots Global Cancer Trial Database for Application of CAD-CAM Technology in Orbital Bone Reconstruction

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Trial Identification

Brief Title: Application of CAD-CAM Technology in Orbital Bone Reconstruction

Official Title: Comparison of Two Different Modalities for Orbital Reconstruction Based on CAD-CAM Technology: A Clinical Randomized Trial

Study ID: NCT05438784

Conditions

Orbital Bone Fracture

Interventions

orbital bone reconstruction with patient specific titanium implant

orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model

Study Description

Brief Summary: Reconstruction of orbital defects resulting after trauma; tumor resection; maxillary cyst; craniofacial anomalies and sequestrated bone.... etc., has been a challenging issue over the years and this owing to the complicated anatomy of orbit. Inaccurate orbital reconstruction may lead to devastating cosmetic and functional complications. Titanium mesh for orbital reconstruction has now become "probably" the most popular material for orbital wall reconstruction worldwide. Innovation of CAD-CAM technology and its application in maxillofacial surgery will markedly improve the surgical outcome. This study will assess the accuracy of orbital reconstruction using CAD-CAM technology and to compare two different modalities for orbital reconstruction based on this technology.

Detailed Description: This study will be a prospective cohort study. It will include patients treated with the custom-made implants for orbital blow out fractures, ZMC fractures or tumors. The sample will consist of 34 patients who will need orbital reconstruction and will be operated in Maxillofacial, Head and Neck Unit, General Surgery Department, Faculty Of Medicine, Sohag University, Egypt. The patients will be randomly divided into two groups, group (A) reconstructed with patient specific implant and group (B) reconstructed with preformed plate preoperatively bended on stereolithographic model. The reconstructive outcomes are assessed by clinical and ophthalmological examinations and accuracy analysis by comparing the preoperative and postoperative multi slice computed tomography data. All patients will be assessed clinically, ophthalmologically, and radiographically using computed tomography (CT) then virtual surgical planning and custom-made patient implant will be manufactured. Post-operative clinical evaluation will be done, and radiographic evaluation of all patients will be done by CT scan within one week and 6 months after the procedure. comparing data of the two groups will be done using appropriate methods.