A Clinical Trial to Evaluate the Efficacy and Safety of 3D Printed Bioceramic Implants for the Reconstruction of Zygomatic Bone Defects.

Jun-Young Lim,Hyun Kang,Ui-Lyong Lee,Sung-Nam Park,Won-Cheul Choi,Byoung-Hun Choi

doi:10.3390/ma13204515

Jun-Young Lim, Hyun Kang + Show 4 more

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https://doi.org/10.3390/ma13204515

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Abstract

The purpose of this study was to evaluate the clinical efficacy and safety of patient-specific additive-manufactured CaOSiO2-P2O5-B2O3 glass-ceramic (BGS-7) implants for reconstructing zygomatic bone defects at a 6-month follow-up. A prospective, single-arm, single-center, clinical trial was performed on patients with obvious zygoma defects who needed and wanted reconstruction. The primary outcome variable was a bone fusion between the implant and the bone evaluated by computed tomography (CT) at 6 months post surgery. Secondary outcomes, including implant immobilization, satisfaction assessment, osteolysis, subsidence of the BGS-7 implant, and safety, were assessed. A total of eight patients were enrolled in the study. Two patients underwent simultaneous reconstruction of the left and right malar defects using a BGS-7 3D printed implant. Cone beam CT analysis showed that bone fusion at 6 months after surgery was 100%. We observed that the average fusion rate was 76.97%. Osteolysis around 3D printed BGS-7 implants was not observed. The mean distance displacement of all 10 implants was 0.4149 mm. Our study showed no adverse event in any of the cases. The visual analog scale score for satisfaction was 9. All patients who enrolled in this trial were aesthetically and functionally satisfied with the surgical results. In conclusion, this study demonstrates the safety and promising value of patient-specific 3D printed BGS-7 implants as a novel facial bone reconstruction method.

Highlights

Trauma, osteoradionecrosis, and various other causes may result in maxillofacial bone defects
Investigational New Drug application (IND) means that the clinician who intends to conduct clinical trials using the drug or medical device to collect safety efficacy data for the human body applies for approval from the Korean Ministry of Food and Drug Safety
The primary outcome variable was the fusion between the implant and the bone evaluated by computed tomography (CT)

Summary

Introduction

Trauma, osteoradionecrosis, and various other causes may result in maxillofacial bone defects. The ultimate goal of reconstruction of maxillofacial bone defects is to restore bone defects and facial shape to their original form, minimize malocclusion, and restore masticatory function. The morbidity of the donor and recipient should be minimized and reconstruction should be done with a minimum number of operations [1]. There are many options for the reconstruction of maxillofacial bone defects. Grafting with allograft bone has been documented to be a useful tool in reconstructing jawbone defects [2,3]. Microvascular bone transfer has become the gold standard for reconstruction. Donor site morbidity, prolonged hospitalization time, and a lengthy recovery period with delayed functional rehabilitation are frequently noted [4].

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