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IRCT20220807055633N2 IRCT 2023-02-25 Esfahan University of Medical Sciences Clinical trials of 3D printing in fabrication of prosthesis for regeneration of cleft palate disorders or orbital fracture Fabrication and Clinical trial of biodegradable composite meshes manufactured through additive manufacturing for application in orbital fracture and cleft palate 2023-03-11 anticipated 7 Complete https://irct.ir/trial/68350 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Condition 1: Flexible surgical mesh for cleft palate repair. Condition 2: Flexible surgical mesh for orbital fracture repair. Intervention group: The diagnostics for this intervention include patients who suffer from cleft palate congenital disorders or patients who have suffered from a traumatic accident and are diagnosed with orbital fractures. During a cranioplasty surgery a 3D-printed mesh will be implanted on the cleft palate opening or will be used to repair the orbital floor fracture. The printed mesh will be fabricated from polycaprolactone and hydroxyapatite compounds by Adli Tissue Regeneration company.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available.
public Seyed Ali Poursamar
School of Advance Medical Technology, Esfahan University of Medical Sciences, Hezar Jerib Avenue
esfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3865 ali.poursamar@amt.mui.ac.ir Esfahan University of Medical Sciences scientific Hossein Abdali
Isfahan University of Medical Sciences, Hezar Jerib Avenue
esfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3865 abdali29223@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) People who have skull and face defects and the use of plates in surgery cannot correct the shape of the bone. no limit no limit Both Having an underlying disease, including allergies Q35.9 S02.3 Cleft palate, unspecified Fracture of orbital floor Treatment - Devices Intervention group: The diagnostics for this intervention include patients who suffer from cleft palate congenital disorders or patients who have suffered from a traumatic accident and are diagnosed with orbital fractures. During a cranioplasty surgery a 3D-printed mesh will be implanted on the cleft palate opening or will be used to repair the orbital floor fracture. The printed mesh will be fabricated from polycaprolactone and hydroxyapatite compounds by Adli Tissue Regeneration company. Close the gap in the roof of the mouth and rearrangement of the muscles and the lining of the palate. Timepoint: 2 weeks and 4 months after the surgery. Method of measurement: in person patient examination. Orbital floor fracture repair. Timepoint: 3 and 6 months after the surgery. Method of measurement: in person patient examination and CT-scan imaging. Natural patient ingrowth within the implants structure. Timepoint: 6 months after the surgery. Method of measurement: CT scan imaging and in person patient examination. Esfahan University of Medical Sciences Approved 2022-12-26 Ethics committee of Esfahan University of Medical Sciences Hezar Jerib Avenue esfahan Isfehan Iran (Islamic Republic of)