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Application of CAD-CAM Technology in Orbital Bone Reconstruction

NCT ID: NCT05438784

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-06-01

Brief Summary

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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

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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.

Conditions

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Orbital Bone Fracture Maxillary Cyst Maxillary Neoplasms Zygomatic Fractures Orbital Neoplasms Facial Deformity

Keywords

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Orbital bone reconstruction zygomaticomaxillary complex fracture (ZMC) patient specific implant preformed plates CAD-CAM

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A (patient specific titanium implant)

(reconstruction with patient specific titanium implant)

Group Type ACTIVE_COMPARATOR

orbital bone reconstruction with patient specific titanium implant

Intervention Type PROCEDURE

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

Group B (preformed plate bended on stereolithographic model)

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

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.

Interventions

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orbital bone reconstruction with patient specific titanium implant

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

Intervention Type PROCEDURE

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

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hatem Adel Aboelhassan

OTHER

Sponsor Role lead

Responsible Party

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Hatem Adel Aboelhassan

specialist of maxillofacial, head and neck surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kamal A Hassanein, Professor

Role: STUDY_CHAIR

Sohag University

Tarek A Ftohy, Ass. prof

Role: STUDY_DIRECTOR

Sohag University

Islam AA Amer, Ass. prof

Role: STUDY_DIRECTOR

Sohag University

Locations

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Sohag faculty of medicine

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hatem A Abo El Hassan El Shazly, MMed

Role: CONTACT

Phone: +201002760859

Email: [email protected]

Facility Contacts

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Sohag F Medicine

Role: primary

References

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Abbate V, Iaconetta G, Califano L, Pansini A, Bonavolonta P, Romano A, Salzano G, Somma T, D'Andrea L, Dell'Aversana Orabona G. Self-Made Rapid Prototyping Technique for Orbital Floor Reconstruction: Showcases for Technical Description. J Craniofac Surg. 2019 Oct;30(7):2106-2110. doi: 10.1097/SCS.0000000000006004.

Reference Type BACKGROUND
PMID: 31513039 (View on PubMed)

Zimmerer RM, Ellis E 3rd, Aniceto GS, Schramm A, Wagner ME, Grant MP, Cornelius CP, Strong EB, Rana M, Chye LT, Calle AR, Wilde F, Perez D, Tavassol F, Bittermann G, Mahoney NR, Alamillos MR, Basic J, Dittmann J, Rasse M, Gellrich NC. A prospective multicenter study to compare the precision of posttraumatic internal orbital reconstruction with standard preformed and individualized orbital implants. J Craniomaxillofac Surg. 2016 Sep;44(9):1485-97. doi: 10.1016/j.jcms.2016.07.014. Epub 2016 Jul 21.

Reference Type BACKGROUND
PMID: 27519662 (View on PubMed)

Felding UNA. Blowout fractures - clinic, imaging and applied anatomy of the orbit. Dan Med J. 2018 Mar;65(3):B5459.

Reference Type BACKGROUND
PMID: 29510812 (View on PubMed)

Mustafa SF, Evans PL, Bocca A, Patton DW, Sugar AW, Baxter PW. Customized titanium reconstruction of post-traumatic orbital wall defects: a review of 22 cases. Int J Oral Maxillofac Surg. 2011 Dec;40(12):1357-62. doi: 10.1016/j.ijom.2011.04.020. Epub 2011 Aug 31.

Reference Type BACKGROUND
PMID: 21885249 (View on PubMed)

Raisian S, Fallahi HR, Khiabani KS, Heidarizadeh M, Azdoo S. Customized Titanium Mesh Based on the 3D Printed Model vs. Manual Intraoperative Bending of Titanium Mesh for Reconstructing of Orbital Bone Fracture: A Randomized Clinical Trial. Rev Recent Clin Trials. 2017;12(3):154-158. doi: 10.2174/1574887112666170821165206.

Reference Type BACKGROUND
PMID: 28828975 (View on PubMed)

Sugar AW, Kuriakose M, Walshaw ND. Titanium mesh in orbital wall reconstruction. Int J Oral Maxillofac Surg. 1992 Jun;21(3):140-4. doi: 10.1016/s0901-5027(05)80780-5.

Reference Type BACKGROUND
PMID: 1640125 (View on PubMed)

Bly RA, Chang SH, Cudejkova M, Liu JJ, Moe KS. Computer-guided orbital reconstruction to improve outcomes. JAMA Facial Plast Surg. 2013 Mar 1;15(2):113-20. doi: 10.1001/jamafacial.2013.316.

Reference Type BACKGROUND
PMID: 23306963 (View on PubMed)

Longeac M, Depeyre A, Pereira B, Barthelemy I, Pham Dang N. Virtual surgical planning and three-dimensional printing for the treatment of comminuted zygomaticomaxillary complex fracture. J Stomatol Oral Maxillofac Surg. 2021 Sep;122(4):386-390. doi: 10.1016/j.jormas.2020.05.009. Epub 2020 May 18.

Reference Type BACKGROUND
PMID: 32439600 (View on PubMed)

Scolozzi P. Applications of 3D orbital computer-assisted surgery (CAS). J Stomatol Oral Maxillofac Surg. 2017 Sep;118(4):217-223. doi: 10.1016/j.jormas.2017.05.007. Epub 2017 Jun 19.

Reference Type BACKGROUND
PMID: 28642192 (View on PubMed)

Other Identifiers

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Soh-Med-22-06-18

Identifier Type: -

Identifier Source: org_study_id