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

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.

Advances in 3D-Printed Surface-Modified Ca-Si Bioceramic Structures and Their Potential for Bone Tumor Therapy

“…Promisingly, these scaffolds performed well in animals as large as equine models, showing both biodegradability and osteogenesis [ 98 ]. Similar observations were seen in the clinics, where 3D-printed bioceramic implants were seen as a potential state-of-the-art approach for treating bone defects and bone fusions [ 99 , 100 ]. However, presently, such modified 3D-printed bioceramics have not advanced into human trials.…”

A novel classification of bone graft materials

“…Ceramic substitutes performed as promising replacements of autografts and allografts to treat orthopedic and periodontal defects. These include bioactive glass, 44,50–52,195 β‐TCP, 11 HAp obtained from natural sources like eggshells 83 and xenografts, 235 as well as synthetic HAp. The commercially available Bio‐Oss®, which is derived from bovine HAp and synthetic HAp such as OsteoGraf® 35 and CustomBone®, 85 have all produced successful clinical outcomes in human studies.…”

“…3D printed Ti cages packed with silicon substituted calcium phosphate have been used to treat spinal deformities in 93 human patients, whose fusion rates significantly improved following the surgery 194 . 3D printed customized ceramic implants have been used to treat zygomatic defects in clinical trials, showing successful aesthetic and functional outcomes 195 . A study in 2019 investigated the production of 3D printed gels using cryogenic 3D printing, where the gel is frozen, while being printed, allowing the production of gel scaffolds of complex porosity and geometry 196 …”

3D-Printing of Drug-Eluting Implants: An Overview of the Current Developments Described in the Literature

“…However, clinical trials with 3D-printed devices have been commonly performed for anatomical models for preplanning surgeries or guides to aid surgery, but only a very few for therapeutic devices [ 144 ]. Positive results regarding the acceptability, safety and effectiveness of 3D-printed products have been shown exemplarily in clinical trials testing oral printlets with customized dosages of isoleucine [ 145 ] and during the six-month follow-up of personalized drug-free glass-ceramic implants for the reconstruction of bone defects [ 146 ]. Nevertheless, the implementation of predicting in vitro models in combination with biocompatibility assays and further animal testing should be focused on in order to assure the necessary safety of the developed 3D-printed implants and to pave the road for the necessary human clinical trials in the future.…”