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. 2020 Oct 12;13(20):4515.
doi: 10.3390/ma13204515.

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

Ui-Lyong Lee  1   2 , Jun-Young Lim  3 , Sung-Nam Park  3 , Byoung-Hun Choi  3 , Hyun Kang  4 , Won-Cheul Choi  2   5
Affiliations

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

Ui-Lyong Lee et al. Materials (Basel). .

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.

Keywords: 3D printing; additive manufacturing; bioceramic; clinical trial; patient-specific.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
(A) The malar complex is dislocated inferiorly and rotated externally, which leads to facial asymmetry, bony gap, and facial drooping. (B) The implant for reconstructing the defected part is basically designed to be smoothly connected based on the normal bone. (C) After removing all the intervening soft tissue and exposing the bony margin of both sides, a 3D printed implant was applied and fixed with a mini-plate. (D) CT taken at 6 months after surgery shows that the bony defect is well reconstructed.
Figure 2
Figure 2
(A) A cross-section is created based on the newly reorientated plane. (B–D) The multi-planar plane is re-oriented so that the longest axis of the implant is perpendicular to the reference plane and the minor axis is horizontal to the reference plane.
Figure 3
Figure 3
(A) CT data were converted into stereolithography (STL) files and imported into Geomagic Control X, and superimposition of CT data taken immediate post surgery (reference data) and CT data taken at 6 months after surgery (measured data) was performed using the Geomagic Control X software. The images were positioned using both the Initial Alignment and Best-Fit Alignment tools. The colors show overlays of 2 CT scan data. (B) Deviations between reference data and measured data were measured at ten evenly spaced points on the implants. The specific values of deviation on the implants are demonstrated. The value of deviation across the entire scan is color-graded from 1 mm (blue) to +1 mm (red).
Figure 4
Figure 4
Linear mixed-effects model (LMEM) showed no evidence of significant difference between each cases (F(9, 9) = 0.900, p = 0.561), but significant differences for fusion status (F(1, 9) = 40.438, p < 0.001).
Figure 5
Figure 5
Linear mixed-effects model (LMEM) also showed significant differences between cases (F(9, 16.76) = 6.095, p = 0.001).
Figure 6
Figure 6
3D comparison between immediately after surgery and after 6 months. This figure shows that the implant was attached closer to the surrounding bone. The specific values of deviation on the implants are demonstrated. The value of deviation across the entire scan is color-graded from 1 mm (blue) to +1 mm (red).
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