Diseases and Abnormalities at or Before Birth

All Conditions

Wounds and Injuries

Symptoms and General Pathology

Neoplasms

Nervous System Diseases

Musculoskeletal Diseases

Eye Diseases

Mouth and Tooth Diseases

Congenital Abnormalities

Fractures, Bone

Facies

Cysts

Orbital Fractures

Orbital Neoplasms

Zygomatic Fractures

Maxillary Neoplasms

Maxillofacial Injuries

Facial Injuries

Craniocerebral Trauma

Trauma, Nervous System

Skull Fractures

Jaw Neoplasms

Skull Neoplasms

Bone Neoplasms

Bone Diseases

Jaw Diseases

Maxillary Diseases

Stomatognathic Diseases

Eye Neoplasms

Orbital Diseases

(reconstruction with patient specific titanium implant)

(reconstruction with preformed titanium plate preoperatively bended on stereolithographic model)

orbital defects reconstruction will be virtually planned by software and a patient specific titanium implant will be manufactured using milling technique depending on CAD-CAM technology

orbital bone reconstruction with patient specific titanium implant

orbital defects reconstruction will be virtually planned by software and a reconstructed stereolithographic model will be 3D printed and used for preoperatively bending of preformed titanium implant.

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

Hatem A Abo El Hassan El Shazly, MMed

Sohag F Medicine

Kamal A Hassanein, Professor

Tarek A Ftohy, Ass. prof

Islam AA Amer, Ass. prof

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.

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.

the participants are assigned to two groups randomly A and B and receive two different intervention modality throughout the study and the results will be compared between the two groups

Application of CAD-CAM Technology in Orbital Bone Reconstruction

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

assessment of motility of eye globe using extraocular muscle function test

cost of the patient specific implant and the cost of the stereolithographic model and preformed titanium implant

implant displacement, bleeding, infection, pain

assessment of the patients satisfaction to the results post operative using scoring system from 1 to 5 in which :

* 1 = Excellent
* 2 = good
* 3 = Fair
* 4 = not bad
* 5 = poor

testing of visual acuity of the affected eye pre and post operative

assessment of changes in cosmetic results following surgery by one of the supervisors using a scoring system from 1 to 4 in which:

* 1 = Excellent
* 2 = good
* 3 = Fair
* 4 = poor

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Application of CAD-CAM Technology in Orbital Bone Reconstruction	NCT05438784	Orbital Bone Fr... Maxillary Cyst Maxillary Neopl... Zygomatic Fract... Orbital Neoplas... Facial Deformit...	orbital bone re... orbital bone re...	16 Years -	Sohag University
Application of CAD-CAM Technology in Orbital Bone Reconstruction	NCT05438784	Orbital Bone Fr... Maxillary Cyst Maxillary Neopl... Zygomatic Fract... Orbital Neoplas... Facial Deformit...	orbital bone re... orbital bone re...	16 Years -	Sohag University

Spots Global Cancer Trial Database for orbital bone reconstruction with preformed titanium plate preoperatively bended on stereolithographic model