Craniofacial Implants Research Articles

Integrating Clay Modeling in Implant Fabrication for Craniofacial Defect.

Manufacturing craniofacial implants using 3-dimensional (3D) methods and computed tomography data has become popular. The image object for the defect is produced as the first step, followed by several methods to create the implant. The authors have used a novel method that combines clay modeling with 3D scanning to create implants for craniofacial contour reconstruction. This approach does not require complicated resources. The method allows for high customization and immediate modifications, resulting in implants that achieve an accurate fit and high patient satisfaction. It is particularly beneficial for addressing complex defects and achieving aesthetic improvements. In addition, it reduces the need for cumbersome digital processing and expensive materials, making it a practical and feasible solution for a wide range of craniofacial deformities.

Translational Aspects of 3D and 4D Printing and Bioprinting.

Three-dimensional (3D) printed medical devices include orthopedic and craniofacial implants, surgical tools, and external prosthetics that have been directly used in patients. While the advances of additive manufacturing techniques in the production of medical devices have been on the rise, clinical translation of living cellular constructs face significant limitations in terms of regulatory affairs, process technology, and materials development. In this perspective, the current status-quo of 3D and four-dimensional (4D) (bio)printing is summarized, current advancements are discussed and the challenges that need to be addressed for improved industrial translation and clinical applications of bioprinting are highlighted. It is focused on a multidisciplinary approach in discussing the key translational considerations, from the perspective of industry, regulatory bodies, funding strategies, and future directions.

Active osseointegration in an ex vivo porcine bone model.

Achieving osseointegration is a fundamental requirement for many orthopaedic, oral, and craniofacial implants. Osseointegration typically takes three to 6months, during which time implants are at risk of loosening. The aim of this study was to investigate whether osseointegration could be actively enhanced by delivering controllable electromechanical stimuli to the periprosthetic bone. First, the osteoconductivity of the implant surface was confirmed using an in vitro culture with murine preosteoblasts. The effects of active treatment on osseointegration were then investigated in a 21-day ex vivo model with freshly harvested cancellous bone cylinders (n = 24; Ø10 mm × 5mm) from distal porcine femora, with comparisons to specimens treated by a distant ultrasound source and static controls. Cell viability, proliferation and distribution was evident throughout culture. Superior ongrowth of tissue onto the titanium discs during culture was observed in the actively stimulated specimens, with evidence of ten-times increased mineralisation after 7 and 14days of culture (p < 0.05) and 2.5 times increased expression of osteopontin (p < 0.005), an adhesive protein, at 21days. Moreover, histological analyses revealed increased bone remodelling at the implant-bone interface in the actively stimulated specimens compared to the passive controls. Active osseointegration is an exciting new approach for accelerating bone growth into and around implants.

Development of a Critical Edge-Based Adaptive Toolpath Strategy to Improve Geometrical Accuracy of Incrementally Formed Titanium Implants

Incremental sheet forming has become increasingly popular due to its advantages over traditional metal forming processes, including flexibility, low setup cost, and enhanced formability. It holds great potential for manufacturing asymmetrical components, particularly biomedical implants like cranio-facial implants. However, a significant drawback of this technique is a lack of geometrical accuracy in the produced parts. This research aims to enhance the geometric accuracy of a patient-specific frontal cranial implant by introducing a novel tool path strategy called the adaptive tool path strategy (ATP). The ATP dynamically adjusts step sizes by selectively removing slices based on local curvature requirements. The proposed strategy begins with slicing a CAD model at an extremely fine step depth (0.01 mm) to generate the initial dataset. Subsequently, slices are strategically eliminated to conform to desired curvature specifications. The manufacturing process utilizes commercially pure titanium grade 2 alloy, which is incrementally formed into the desired implant shape using both the traditional constant step depth method and the new adaptive tool path strategy. The produced parts are then scanned using high resolution 3D scanners and a detailed comparison is made between the final geometries and the design geometry. The assessment includes evaluating the forming depth, analysing bending due to spring back, and measuring geometric deviations. Furthermore, numerical simulations are conducted to assess the estimation capabilities of finite element analysis in predicting the forming process. The results demonstrate that the ATP tool path strategy significantly reduces spring back, indicated by a nearly 30 % decrease in the angle of bend along the critical edge. Moreover, the root mean square deviation is reduced by 11 %. Importantly, the experimental results aligned with the patterns observed in the numerical simulations, validating the findings obtained through the study.

Manufacturing Process of Low‐Contamination Titanium Foam as Implant Material for Cranioplasty Based on Replica Technique

The article investigates the development of a manufacturing route for highly porous titanium foams suitable for craniofacial surgery applications, particularly in cranioplasties. The study focuses on the polyurethane replication method for foam production and emphasizes reducing residual gas content, as it significantly affects the mechanical properties and suitability for approval of the foams. Various factors such as starting materials, solvent debinding, heating schedules, and hydrogen atmosphere are analyzed for their impact on residual gas content. It is shown that significant reductions in residual gas content can only be achieved by reworking each step of the process. A combination of initial solvent debinding of the PU template with dimethyl sulphoxide, reduction of suspension additives, use of coarser Gd. 1 powders, and an integrated debinding and sintering process under partial hydrogen atmosphere achieves a significant reduction in residual gas content. This way, the potential for producing titanium foams that comply with relevant standards for craniofacial implants is demonstrated.

Polyether Ether Ketone (PEEK) Implants and the Manufacturer and User Facility Device Experience (MAUDE) Database: An Updated Review of Adverse Events and Complications.

Polyether ether ketone (PEEK) custom implants have been fundamental in addressing bone malformations and restoring traumatic defects within the field of craniofacial surgery. Although such implants are generally considered safe and appropriate alternatives to autologous bone grafts, there has been a lack of standardized reporting of adverse events associated with PEEK implants. The purpose of this study is multi-fold: (1) to explore the current landscape of autologous and allogeneic materials utilized for bone grafting; (2) to analyze and characterize adverse events associated within PEEK implants from the widely accredited, FDA-run database, Manufacturer and User Facility Device Experience (MAUDE); and using the data, (3) to provide guidance to craniofacial surgeons using PEEK implants in their surgical practice. A retrospective review of the adverse events associated with PEEK implants were performed through the FDA-run database, Manufacturer and User Facility Device Experience (MAUDE). The database was surveyed from July 2013 to January 2023. Event types were categorized by injury or malfunction, and device-reported adverse events were recorded, respectively. Database search initially yielded 77 adverse event reports, but after duplicates were removed, 69 event reports were included in the analysis. These events were sorted into the following categories: device-related and patient-related. Event types were categorized by injury (48.3%) or malfunction (53.6%). The most common reported device-related adverse events were "Poor Fit" (53.6%) and "Adverse Event without Identified Use or Problem " (26.1%). The most common reported patient-related event was "Infection" (32.8%). Of these adverse event reports, 14 (20.2%) patients required a second surgery; 21(30.4%) required implant modification whereas in the operating room; 17 (24.6%) underwent implant removal. Nine (13%) patients experienced operative case delays due to implant modifications. Infection and poor fit were among the most commonly reported adverse events associated with PEEK customizable implants. Although PEEK implants have been widely implemented in addressing craniofacial bony defects, our database analysis does call for further investigation in studying the long-term outcomes associated with PEEK craniofacial implants. With such analyses and collaboration among plastic surgeons and device engineers, there is great opportunity for innovation of these devices.

Applications of CAD/CAM Technology for Craniofacial Implants Placement and Manufacturing of Auricular Prostheses-Systematic Review.

This systematic review was aimed at gathering the clinical and technical applications of CAD/CAM technology for craniofacial implant placement and processing of auricular prostheses based on clinical cases. According to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, an electronic data search was performed. Human clinical studies utilizing digital planning, designing, and printing systems for craniofacial implant placement and processing of auricular prostheses for prosthetic rehabilitation of auricular defects were included. Following a data search, a total of 36 clinical human studies were included, which were digitally planned and executed through various virtual software to rehabilitate auricular defects. Preoperative data were collected mainly through computed tomography scans (CT scans) (55 cases); meanwhile, the most common laser scanners were the 3dMDface System (3dMD LLC, Atlanta, Georgia, USA) (6 cases) and the 3 Shape scanner (3 Shape, Copenhagen, Denmark) (6 cases). The most common digital design software are Mimics Software (Mimics Innovation Suite, Materialize, Leuven, Belgium) (18 cases), Freeform software (Freeform, NC, USA) (13 cases), and 3 Shape software (3 Shape, Copenhagen, Denmark) (12 cases). Surgical templates were designed and utilized in 35 cases to place 88 craniofacial implants in auricular defect areas. The most common craniofacial implants were Vistafix craniofacial implants (Entific Medical Systems, Goteborg, Sweden) in 22 cases. A surgical navigation system was used to place 20 craniofacial implants in the mastoid bone. Digital applications of CAD/CAM technology include, but are not limited to, study models, mirrored replicas of intact ears, molds, retentive attachments, customized implants, substructures, and silicone prostheses. The included studies demonstrated a predictable clinical outcome, reduced the patient's visits, and completed the prosthetic rehabilitation in reasonable time and at reasonable cost. However, equipment costs and trained technical staff were highlighted as possible limitations to the use of CAD/CAM systems.

Effect of the Advanced Cranial and Craniofacial Implant Fabrication on Their Degradation Affinity.

Biodegradable craniofacial and cranial implants are a new aspect in terms of reducing potential complications, especially in the long term after surgery. They are also an important contribution in the field of surgical reconstructions for children, for whom it is important to restore natural bone in a relatively short time, due to the continuous growth of bones. The aim of this study was to verify the impact of the technology on biodegradability and to estimate the risk of inappropriate implant resorption time, which is an important aspect necessary to select prototypes of implants for in vivo testing. Prototypes of implants were made using two technologies: 3D printing using a PLDLA: poly(L-co-D,L lactide) (PLDLA) filament containing hydroxyapatite nanoparticles, and injection using PLDLA. After the radiation sterilization process, they were subjected to in vitro degradation under accelerated conditions. As part of this study, the in vitro degradation of newly developed biodegradable implant technologies was assessed in accordance with the guidelines of European standards. It was found that the implant manufacturing process had a significant impact on the degradation time under simulated conditions in various media. Implants made using the injection technique were characterized by lower susceptibility to degradation media compared to the 3D-printed implant under accelerated conditions.

Maxillofacial prosthetics and digital technologies: Cross-sectional study of healthcare service provision, patient attitudes, and opinions.

Digital technologies are continuously improving the accuracy and quality of maxillofacial prosthetics, but their impact on patients remains unclear. This cross-sectional study aimed to analyze the impact of facial prosthetics service provision, patients' perception, and digital technology on prostheses construction. All patients who presented for evaluation and management of facial defects between January 2021 and December 2021 at the ENT clinic were eligible for study enrollment. Patients requiring prosthetic reconstruction of their missing facial parts were included in the study. Forty-five questionnaires were delivered, inquiring about the patients' prosthetic demographics, prosthesis manufacture using 3D technologies, and their perceptions and attitudes. A total of 37 patients responded (29 males, eight females; mean age 20.50 years). The congenital cause was the highest among other causes (p = 0.001) with auricular defects being the highest (p = 0.001). A total of 38 prostheses were constructed and 17 prostheses were retained by 36 craniofacial implants (p = 0.014). The auricular and orbital implants success rates were 97% and 25%, respectively. The implant locations were digitally planned pre-operatively. Digital 3D technologies of defect capture, data designing, and 3D modeling were used and perceived as helpful and comfortable (p = 0.001). Patients perceived their prosthesis as easy to handle, suited them, and they felt confident with it (p = 0.001). They wore it for more than 12 h daily (p = 0.001). They were not worried that it would be noticed, and found it comfortable and stable during various activities (p = 0.001). Implant-retained prosthesis patients were more satisfied with it, and found it easy to handle and stable (p = 0.001). Congenital defects are the main cause of facial defects in the study country. The overall acceptance of maxillofacial prostheses was good, showing high patient perception and satisfaction. Ocular and implant-retained silicone prostheses are better handled, more stable, and the latter is more satisfying than traditional adhesive prostheses. Digital technologies save time and effort invested in manufacturing facial prostheses.

The simplified tailor-made workflows for a 3D slicer-based craniofacial implant design

A specific design of craniofacial implant model is vital and urgent for patients with traumatic head injury. The mirror technique is commonly used for modeling these implants, but it requires the presence of a healthy skull region opposite to the defect. To address this limitation, we propose three processing workflows for modeling craniofacial implants: the mirror method, the baffle planner, and the baffle-based mirror guideline. These workflows are based on extension modules on the 3D Slicer platform and were developed to simplify the modeling process for a variety of craniofacial scenarios. To evaluate the effectiveness of these proposed workflows, we investigated craniofacial CT datasets collected from four accidental cases. The designed implant models were created using the three proposed workflows and compared to reference models created by an experienced neurosurgeon. The spatial properties of the models were evaluated using performance metrics. Our results show that the mirror method is suitable for cases where a healthy skull region can be completely reflected to the defect region. The baffle planner module offers a flexible prototype model that can be fit independently to any defect location, but it requires customized refinement of contour and thickness to fill the missing region seamlessly and relies on the user's experience and expertise. The proposed baffle-based mirror guideline method strengthens the baffle planner method by tracing the mirrored surface. Overall, our study suggests that the three proposed workflows for craniofacial implant modeling simplify the process and can be practically applied to a variety of craniofacial scenarios. These findings have the potential to improve the care of patients with traumatic head injuries and could be used by neurosurgeons and other medical professionals.

Biomimetic Strategy to Enhance Epithelial Cell Viability and Spreading on PEEK Implants.

Polyetheretherketone (PEEK) is a biocompatible material widely used in spinal and craniofacial implants, with potential use in percutaneous implants. However, its inertness prevents it from forming a tight seal with the surrounding soft tissue, which can lead to infections and implant failure. Conversely, the surface chemistry of percutaneous organs (i.e., teeth) helps establish a strong interaction with the epithelial cells of the contacting soft tissues, and hence a tight seal, preventing infection. The seal is created by adsorption of basement membrane (BM) proteins, secreted by epithelial cells, onto the percutaneous organ surfaces. Here, we aim to create a tight seal between PEEK and epithelial tissues by mimicking the surface chemistry of teeth. Our hypothesis is that collagen I, the most abundant tooth protein, enables integration between the epithelial tissue and teeth by promoting adsorption of BM proteins. To test this, we immobilized collagen I via EDC/NHS coupling on a carboxylated PEEK surface modified using diazonium chemistry. We used titanium alloy (Ti-6Al-4V) for comparison, as titanium is the most widely used percutaneous biomaterial. Both collagen-modified PEEK and titanium showed a larger adsorption of key BM proteins (laminin, nidogen, and fibronectin) compared to controls. Keratinocyte epithelial cell viability on collagen-modified PEEK was twice that of control PEEK and ∼1.5 times that of control titanium after 3 days of cell seeding. Both keratinocytes and fibroblasts spread more on collagen-modified PEEK and titanium compared to controls. This work introduces a versatile and biomimetic surface modification technique that may enhance PEEK-epithelial tissue sealing with the potential of extending PEEK applications to percutaneous implants, making it competitive with titanium.

SURG-40. SINGLE-STAGE RECONSTRUCTION FOLLOWING ONCOLOGIC RESECTION OF BRAIN TUMORS WITH SKULL INVASION

Abstract BACKGROUND: Craniectomies requiring skull reconstruction are indicated following oncological resection of masses involving the underlying brain and/or skull. Immediate cranioplasties have previously been performed using suboptimal hand-bending or molding techniques using ‘‘off – the – shelf’’ products. Today with computer – aided design, customized craniofacial implants have become widely available for personalized reconstruction of resected bone and soft tissue. We present the largest series to date of single stage reconstruction using alloplastic biomaterials in consecutive patient series with oversized customized implants.In total, 56 patients underwent resection of skull neoplasms and subsequent cranioplasty reconstruction using customized implants. The most common neoplasms were meningiomas (39%). The most common complications seen among patients were dehiscence – (7%), and extrusion of implant – (3.5%). There was no significant difference in the incidence of postoperative complications between patients who had postoperative chemotherapy/radiotherapy versus those that did not (22.2% versus 13.1%, P 0.39). One-year follow-up revealed acceptable cranial contour and symmetry in all 56 cases.

Effect of Zn-nanoHA concentration on the mechanical performance and bioactivity of 3D printed PEEK composites for craniofacial implants

ABSTRACT This study aims to investigate the mechanical performance and bioactive potential of polyetheretherketone (PEEK)-based composites. PEEK powder is mixed with up to 20 wt-% zinc doped nano-hydroxyapatite (ZnHA) powder to extrude filaments. Subsequently, 3D-printed samples are prepared via fused deposition modelling (FDM). Micro-Computed Tomography (µ-CT) analysis shows the distribution of ZnHA particles in extruded filaments. Fourier transform infrared spectroscopy (FTIR) confirms the functional groups in 3D-printed samples. The tensile testing results showed that at higher concentration of ZnHA, the strength and strain at failure decrease, while the elastic modulus increases within the acceptable range of human cortical bone. Bioactivity tests in simulated body fluid (SBF) for up to 14 days illustrate the formation of apatite precipitates on the composite samples’ surface compared to pure PEEK. Based on the results, it can be concluded that FDM 3D-printing of PEEK/ZnHA composites can be used effectively in manufacturing customised craniofacial/orthopedic implants.

Auricular prosthesis positioning using virtual planning in combination with additive manufacturing

IntroductionThis study focused on deformed or missing auricles and their replacement with silicone prostheses which are retained by craniofacial implants. Surgeons find it difficult to accurately place the implants in relation to the missing auricle in theatre. The aim of this study was to develop patient-specific devices using additive manufacturing technologies and associated software to indicate the positions of implants and to correctly orientate the prostheses relative to the positions of the implants. Material and methodsThe morphology of the patient was determined using Computed-Tomography (CT) scanning and the opposite auricle was mirrored in the virtual environment through specialized software from Materialise. A positioning guide for placing the implants was developed, together with an orientation guide that orientates the prosthesis accurately in relation to the implants. The orientation guide is a new development in the field of maxillofacial prosthetics and has not been attempted before. The guides are produced in nylon through laser sintering additive manufacturing. ResultsThe accuracy of implant placements was determined and the results showed relatively accurate positioning using the guides. DiscussionImplant placement showed some deviation which can largely be attributed to improper use of the guide by the surgeon during the marking of implant positions. The orientation guide can however somewhat compensate for this to still achieve aesthetically pleasing results. Using the guides significantly reduces risk, time and cost in placing the implants and producing auricular silicone prostheses.

Hybrid metal-ceramic biomaterials fabricated through powder bed fusion and powder metallurgy for improved impact resistance of craniofacial implants

The mechanical compliance of craniofacial implants is of paramount importance in the medical field, as the primary concern is to protect the cerebrum after trauma or neurosurgical operation. To develop novel cranial implants, three types of bioactive ceramic powders were embedded in the metallic scaffolds. The scaffolds were fabricated by combining powder bed fusion technology and powder metallurgy. Ti6Al4V lattice structures fabricated by selective laser melting were filled with three different wollastonite-based bioceramics applied for critical-sized craniofacial defects: 1. CaSiO3 (wollastonite, W), 2. Si-CaSiO3 (50 wt.% silicon-wollastonite, W-Si) and 3. CaSiO3Ca3(PO4)2−MgCa(SiO3)2 (62 wt.% wollastonite ceramic glass, W62) by spark plasma sintering. The mechanical behavior of the Ti6Al4V-CaSiO3 hybrid metal-ceramic biomaterial composite was evaluated by the dynamic impact test designed by the authors. Furthermore, the proposed fabrication process implies that the metallic scaffolds can bear the mechanical loads, hold the composite structure together, and deliberately induced cracks/pores in the ceramic region can be exploited for drug delivery. Except Ti6Al4V which is known for implants, the potential of using TiNi and Ti22Al25Nb is investigated here for dynamic impact-resistance applications. Due to ductility of TiNi and rigidity of Ti22Al25Nb, an average stress distributed in structures under loading is approximately 600, 550 and 400 MPa for Ti6Al4V, TiNi, and Ti22Al25Nb, respectively. Results show declination in the level of porosity from ceramic (W) to metalloid-ceramic (W-Si) and ceramic-glass (W62) in the composite, respectively, and limited cracking in the impact region of the ceramic and the metallic struts interface when subjected to multiple dynamic impacts.

Retention in maxillofacial prostheses

Facial disfigurement affects the functional, social and psychological well-being of an individual.&#x0D; It reduces an individual’s self esteem and acceptance in the society. It can be congenital or acquired. Prosthetic rehabilitation and surgical reconstruction techniques are the ways to lessen or diminish the problems associated with facial disfigurement. Prosthetic rehabilitation is favored as it is less invasive and affordable. The success of a prosthetic rehabilitation of any part relies on the availability of a method of attaching the artificial substitute securely to its place. Various means of retention have been developed over the years from metal bands to implants. With the advancing technology, in cases where anatomic undercuts are futile, craniofacial implants prove to be a boon for rehabilitation. In this literature review, the various modes of retention available for maxillofacial prostheses were assessed and appraised.

Craniofacial Reconstruction with Personalized Lightweight Scaffold Fabricated Using Electron-Beam Additive Manufacturing

Implants are the most popular option for restoring the facial anatomy in the event of a mishap. The commercially available craniofacial implants are of standard shapes, which need to be tailored and shaped to accurately fit the patient’s anatomy. The manual shaping of the implant to match the bone contours is conducted during surgical operation, and is a cumbersome and inaccurate process. Recent breakthroughs in computer-aided design, analysis, and additive manufacturing (AM) have allowed the precise and rapid manufacture of bespoke scaffolds for difficult anatomical restoration. The goal of this research is to investigate the use of scaffolds for craniofacial reconstruction and their fabrication using electron-beam additive manufacturing (EBAM). Personalized cheekbone scaffolds are additively fabricated using Ti6Al4V and subjected to compression testing. Finally, the scaffold design with the highest compressive strength is subjected to biomechanical analysis. The biomechanical analysis results indicate that the maximum Von Mises stress (40 MPa) and equivalent strain (0.4 µm) are significantly low in magnitude, thus providing a desirable implant that is both flexible and stable. The custom-designed cheekbone scaffold manufactured with AM technology not only aids in bone-implant ingrowth but also helps in reducing implant weight and ensuring implant stability and long-term effectiveness.

Cranioplasty With Customized Craniofacial Implants and Intraoperative Resizing for Single-Stage Reconstruction Following Oncologic Resection of Skull Neoplasms.

Craniectomies requiring skull reconstruction are indicated following oncological resection of masses involving the underlying brain and/or skull. Immediate cranioplasties have previously been performed using suboptimal hand-bending or molding techniques using "off - the - shelf" products. Today with computer - aided design, customized craniofacial implants have become widely available for personalized reconstruction of resected bone and soft tissue. We present here the largest series to date of single stage reconstruction using alloplastic biomaterials in consecutive patient series with oversized customized implants. A single-surgeon, retrospective, 8-year study was conducted on all consecutive patients undergoing single stage cranioplasty with prefabricated implants using a myriad of biomaterials. All outcomes were analyzed in detail and compared with previous studies utilizing similar alloplastic implants. In total, 56 patients underwent resection of skull neoplasms and subsequent cranioplasty reconstruction using customized implants. The most common neoplasms were meningiomas (39%). The most common complications seen among patients were dehiscence - (7%), and extrusion of implant - (3.5%). There was no significant difference in the incidence of postoperative complications between patients who had postoperative chemotherapy/radiotherapy versus those that did not (22.2% versus 13.1%, P = 0.39). One-year follow-up revealed acceptable cranial contour and symmetry in all 56 cases. This is a consecutive case series of prefabricated single-stage cranioplasty, following resection of brain tumors with bone extension or skull bone neoplasm, demonstrating excellent results with regards to safety and patient satisfaction. There are several advantages such as comprehensive resection and reconstruction plan using 3D models, shorter operative time, and better restoration of complex anatomy.

Obstacles for accessing customised craniofacial implants in low- and middle-income countries

IntroductionMany low resourced low- and middle-income countries (LMICs) do not have access to (high tech) developments in the medical field. The aim of this study is to research how a contemporary high-tech solution, such as customized medical implants, can be transferred to low resource LMICs. Materials and methodsWe explored the internet to retrieve data regarding internet coverage, services providing free email accounts, and the availability of connecting devices. Additionally, a computerized search was performed for currently available PSI concepts and other important emerging technologies with potential value in craniomaxillofacial surgery. Lastly, we searched the internet for the availability of CT scan devices and smartphones in the LMICs. ResultsInternet penetration and access to computers/smartphones is low in the LMICs. Moreover, availability of radiology departments and radiologists is very limited (60 radiologists per 190 million Nigerian inhabitants) and a lack of knowledge concerning import regulations and customs clearance, limits the accessibility/availability for patient-specific implants, since this is crucial in developing and delivering these devices. Lastly, appropriate training and instrumentation are vital (yet, currently difficult) to acquire and foresee, in order to achieve the best post-operative results. ConclusionThis research confirms great difficulties achieving our aims but with persistence and adoption of well-constructed programs it should be possible.

Systematic Review of Clinical Applications of CAD/CAM Technology for Craniofacial Implants Placement and Manufacturing of Orbital Prostheses.

This systematic review was aimed at gathering technical and clinical applications of CAD/CAM technology for the preoperative planning of craniofacial implants placement, designing of molds and substructures and fabrication of orbital prostheses. Following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines, an electronic search was executed. Human studies that utilized digital planning systems for the prosthetic rehabilitation of orbital defects were included. A total of 16 studies of 30 clinical cases, which were virtually planned through various digital planning and designing software, were included. The most common preoperative data required for digital planning were CT scans in 15 cases, the 3DSS-STD-II scanning system in 5 cases, an Artec Color 3D scanner in 3 cases and a NextEngine Desktop 3D laser scanner in 2 cases. Meanwhile, the digital designing software were Ease Orbital Implant Planning EOIPlan software in eight cases, Geomagic software in eight cases, Simplant software in four cases and Artec Studio 12 Professional in three cases. Surgical templates were fabricated for 12 cases to place 41 craniofacial implants in the orbital defect area. An image-guided surgical navigation system was utilized for the placement of five orbital implants in two cases. Digital designing and printing systems were reported for the preoperative planning of craniofacial implants placement, designing of molds and substructures and fabrication of orbital prostheses. The studies concluded that the digital planning, designing and fabrication of orbital prostheses reduce the clinical and laboratory times, reduces patient visits and provide a satisfactory outcome; however, technical skills and equipment costs are posing limitations on the use of these digital systems.