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

Background: This study was aimed to compare the efficacy of customized patient-specific titanium mesh based on 3D printed model with intra-operative bending of titanium mesh for reconstructing of orbital floor fracture. Methods: This study was prospectively conducted on 10 patients with unilateral orbital floor fractures caused by accident or falls. In intervention group (n=5), the CT-scan slices were used for generating 3D reconstruction of both affected and unaffected orbits. Then, a 3D printed template of mirrored unaffected orbit was produced to mold the titanium mesh. The titanium mesh in conventional group (n=5) was bended only manually and intraoperatively by surgeon and positioned over the bony defect. All patients were followed-up within 1 week, 1 month and 4 months after surgery for assessing enophthalmos, diplopia and other complications. Results: Of 10 patients of the study only two patients in intervention group had preoperative vertical dystopia or diplopia which had been resolved after intervention. The mean enophthalmos at baseline and 1 week, 1 month and 4 months after surgery in control group were 3.8±0.7, 2.4±0.8, 2.4±0.8, and 2.4±0.8 mm, respectively, and in intervention group were 2.6±0.8, 0.35 ± 0.4, 0.35 ± 0.4 and 0.35 ± 0.4 mm, respectively. The mean enophthalmos did not differ significantly at baseline between two groups, while two groups showed significant difference after surgery. Conclusion: Finally, we concluded that the placement of patient-specific titanium implant for reconstructing of orbital bone fracture led to better outcomes when compared to manual bending in terms of enophthalmos and other complications.