Application of CAD-CAM Technology in Orbital Bone Reconstruction

Not Applicable

• Conditions: Maxillary Cyst; Orbital Bone Fracture; Facial Deformity; Maxillary Neoplasms; Zygomatic Fractures; Orbital Neoplasms

• Registration Number: NCT05438784
• Lead Sponsor: Hatem Adel Aboelhassan

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.

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06-01
• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-25
• Last Update Submitted: 2022-06-25
• Study First Posted: 2022-06-30
• Last Update Posted: 2022-06-30
• Primary Completion: 2023-12-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• fracture of the orbital floor and/or medial wall and/or lateral wall.
• complex fracture of the zygomatic bone (those affecting orbital volume).
• Old orbital fractures on either side causing enophthalmos, diplopia, cosmetic asymmetry.
• Periorbital neoplasm affecting orbital volume and need surgical resection

Exclusion Criteria

• injury to the globe that restricts surgical reconstruction.
• neurological diseases with influence on eye motility or sight.
• Patients with special needs.
• Medically compromised patients who are not fit for surgery.
• Patients refused participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
measurement of Changes in orbital bony volume	preoperative and one week and 6 months post-operative	pre and post operative reconstructed orbit volume will be measured using multi slice computed tomography (MSCT) image loaded on software and compared with preoperative and with healthy non affected orbit

Secondary Outcome Measures

Name	Time	Method
measurement of Changes in globe position in the bony orbit	preoperative and one week and 6 months post operative	pre and post operative measurement of globe position within the bony orbit using MSCT image loaded on software and comparing measures with preoperative and with healthy non affected orbit
measurement of Changes in zygomaticomaxillary complex symmetry	preoperative and one week and 6 months post operative	in patients with associated ZMC affection, symmetry with the healthy side and prominence of the zygomatic eminence will be measured using MSCT image loaded on software and compared with preoperative and with healthy non affected ZMC

Trial Locations

Locations (1)

Sohag faculty of medicine; 🇪🇬 Sohag, Egypt