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

Sponsors

Lead Sponsor: Hatem Adel Aboelhassan

Source Sohag University
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.

Overall Status Recruiting
Start Date 2022-06-01
Completion Date 2024-06-01
Primary Completion Date 2023-12-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
measurement of Changes in orbital bony volume preoperative and one week and 6 months post-operative
Secondary Outcome
Measure Time Frame
measurement of Changes in globe position in the bony orbit preoperative and one week and 6 months post operative
measurement of Changes in zygomaticomaxillary complex symmetry preoperative and one week and 6 months post operative
Enrollment 34
Condition
Intervention

Intervention Type: Procedure

Intervention Name: orbital bone reconstruction with patient specific titanium implant

Description: 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

Arm Group Label: Group A (patient specific titanium implant)

Intervention Type: Procedure

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

Description: 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.

Arm Group Label: Group B (preformed plate bended on stereolithographic model)

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

16 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Hatem A Abo El Hassan El Shazly, MMed

Phone: +201002760859

Phone Ext.: +201114455343

Email: [email protected]

Location
Facility: Status: Contact: Sohag faculty of medicine Sohag F Medicine +2093602963 [email protected]
Location Countries

Egypt

Verification Date

2022-06-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Sohag University

Investigator Full Name: Hatem Adel Aboelhassan

Investigator Title: specialist of maxillofacial, head and neck surgery

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Group A (patient specific titanium implant)

Type: Active Comparator

Description: (reconstruction with patient specific titanium implant)

Label: Group B (preformed plate bended on stereolithographic model)

Type: Active Comparator

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

Acronym CAD-CAM
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: 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

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

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