Temporomandibular Joint Implants Research Articles

Multi-material 3D printing of functionally graded soft-hard interfaces for enhancing mandibular kinematics of temporomandibular joint replacement prostheses

Temporomandibular joint (TMJ) replacement prostheses often face limitations in accommodating translational movements, leading to unnatural kinematics and loading conditions, which affect functionality and longevity. Here, we investigate the potential of functionally graded materials (FGMs) in TMJ prostheses to enhance mandibular kinematics and reduce joint reaction forces. We develop a functionally graded artificial cartilage for the TMJ implant and evaluate five FGM designs: hard, hard-soft, and three FGM gradients with gradual transitions from 90% hard material to 0%, 10%, and 20%. These designs are 3D printed, mechanically tested under quasi-static compression, and simulated under physiological conditions. Results from computational modeling and experiments are compared to an intact mandible during incisal clenching and left group biting. The FGM design with a transition from 90% to 0% hard material improves kinematics by 19% and decreases perfomance by 3%, reduces joint reaction forces by 8% and 10%, and increases mandibular movement by 20% and 88% during incisal clenching and left group biting, respectively. These findings provide valuable insights for next-generation TMJ implants.

Customised Implant for Temporomandibular Joint: New Technique to Design and Stress Analysis to Balance the Loading at Both Ends.

The temporomandibular joint (TMJ) is a critical joint for the opening and closing of the mouth. The generation of customised TMJs according to individuals' dental anatomy is needed. Currently, the implants available on the market lack consideration of the patient's dental anatomy. This leads to the creation of an imbalance in the reaction forces on both ends of the TMJ. This requires a slight structural change in the design parameters to give a solution. The purpose of this study is to propose a new design that includes the geometry and materials for a TMJ implant. Stress analysis was carried out on the TMJ to balance the reaction forces at both TMJ ends. A static analysis was performed using ANSYS Workbench, to compare the results of two customised designs of TMJ implants, in order to better balance the reaction forces at both ends. The model in the study showed that the reaction forces for both the patient-specific TMJ implants were nearly balanced. The reaction forces were better balanced, and almost equivalent to the intact conditions. The stresses in the mandible were more uniformly distributed in the customised design of the TMJ implant. The two types of design showed that the custom design took up less space in the patient's region of surgery, making it a better option compared to a stock TMJ implant. The custom implant would allow faster patient rehabilitation, as the reaction forces would be close to those in intact conditions.

Building the foundation for a modern patient-partnered infrastructure to study temporomandibular disorders.

Conflicting reports from varying stakeholders related to prognosis and outcomes following placement of temporomandibular joint (TMJ) implants gave rise to the development of the TMJ Patient-Led RoundTable initiative. Following an assessment of the current availability of data, the RoundTable concluded that a strategically Coordinated Registry Network (CRN) is needed to collect and generate accessible data on temporomandibular disorder (TMD) and its care. The aim of this study was therefore to advance the clinical understanding, usage, and adoption of a core minimum dataset for TMD patients as the first foundational step toward building the CRN. Candidate data elements were extracted from existing data sources and included in a Delphi survey administered to 92 participants. Data elements receiving less than 75% consensus were dropped. A purposive multi-stakeholder sub-group triangulated the items across patient and clinician-based experience to remove redundancies or duplicate items and reduce the response burden for both patients and clinicians. To reliably collect the identified data elements, the identified core minimum data elements were defined in the context of technical implementation within High-performance Integrated Virtual Environment (HIVE) web-application framework. HIVE was integrated with CHIOS™, an innovative permissioned blockchain platform, to strengthen the provenance of data captured in the registry and drive metadata to record all registry transaction and create a robust consent network. A total of 59 multi-stakeholder participants responded to the Delphi survey. The completion of the Delphi surveys followed by the application of the required group consensus threshold resulted in the selection of 397 data elements (254 for patient-generated data elements and 143 for clinician generated data elements). The infrastructure development and integration of HIVE and CHIOS™ was completed showing the maintenance of all data transaction information in blockchain, flexible recording of patient consent, data cataloging, and consent validation through smart contracts. The identified data elements and development of the technological platform establishes a data infrastructure that facilitates the standardization and harmonization of data as well as perform high performance analytics needed to fully leverage the captured patient-generated data, clinical evidence, and other healthcare ecosystem data within the TMJ/TMD-CRN.

A randomized controlled preclinical trial on 3 interposal temporomandibular joint disc implants: TEMPOJIMS—Phase 2

The effort to develop an effective and safe temporomandibular joint (TMJ) disc substitute has been one of the mainstreams of tissue engineering. Biodegradable customized scaffolds could approach safety and effectiveness to regenerate a new autologous disc, rather than using non-biodegradable materials. However, it is still technically challenging to mimic the biomechanical properties of the native disc with biodegradable polymers. In this study, new 3D tailored TMJ disc implants were developed: (1) Poly(glycerol sebacate) (PGS) scaffold reinforced with electrospun Poly(εcaprolactone) (PCL) fibers on the outer surface (PGS+PCL); (2) PCL and polyethylene glycol diacrylate (PEGDA) (PCL+PEGDA); and (3) PCL. The TMJ implants were tested in a randomized preclinical trial, conducted in 24 black Merino sheep TMJ, perfoming bilateral interventions. Histologic, imaging, and kinematics analysis was performed. No statistical changes were observed between the PGS+PCL disc and the control group. The PCL+PEGDA and PCL groups were associated with statistical changes in histology (p=0.004 for articular cartilage mid-layer; p=0.019 for structure changes and p=0.017 for cell shape changes), imaging (p=0.027 for global appreciation) and dangerous material fragmentation was observed. No biomaterial particles were observed in the multi-organ analysis in the different groups. The sheep confirmed to be a relevant animal model for TMJ disc surgery and regenerative approaches. The PCL and PCL+PEGDA discs presented a higher risk to increase degenerative changes, due to material fragmentation. None of the tested discs regenerate a new autologous disc, however, PGS+PCL was safe, demonstrated rapid resorption, and was capable to prevent condyle degenerative changes.

Comparison in clinical performance of surgical guides for mandibular surgery and temporomandibular joint implants fabricated by additive manufacturing techniques

Additive manufacturing (AM) offers great design freedom that enables objects with desired unique and complex geometry and topology to be readily and cost-effectively fabricated. The overall benefits of AM are well known, such as increased material and resource efficiency, enhanced design and production flexibility, the ability to create porous structures and on-demand manufacturing. When AM is applied to medical devices, these benefits are naturally assumed. However, hard clinical evidence collected from clinical trials and studies seems to be lacking and, as a result, systematic assessment is yet difficult. In the present work, we have reviewed 23 studies on the clinical use of AM patient-specific surgical guides (PSGs) for the mandible surgeries (n = 17) and temporomandibular joint (TMJ) patient-specific implants (PSIs) (n = 6) with respect to expected clinical outcomes. It is concluded that the data published on these AM medical devices are often lacking in comprehensive evaluation of clinical outcomes. A complete set of clinical data, including those on time management, costs, clinical outcomes, range of motion, accuracy of the placement with respect to the pre-operative planning, and extra complications, as well as manufacturing data are needed to demonstrate the real benefits gained from applying AM to these medical devices and to satisfy regulatory requirements.

Outcomes and Survivorship of Biomet Microfixation Total Joint Replacement System: Results From an FDA Postmarket Study

In February 2011, the Food and Drug Administration issued a postmarket surveillance order to all manufacturers of temporomandibular joint (TMJ) implants in the United States. The objective of the present study was to measure implant subsequent surgical intervention (SSI) among patients who had undergone TMJ reconstruction with the Biomet TMJ replacement system (Zimmer Biomet, Warsaw, IN). A prospective observational study was conducted by sending a questionnaire to patients who had received a Biomet TMJ replacement system from 1995 to 2010 in the United States. The questionnaire was sent annually from 2012 to 2015. The primary endpoint was the SSIs. SSIs included both device removal and reoperations. Kaplan-Meier survival analysis was used to determine the survivorship, and Cox proportional hazard regression analysis was performed to evaluate the preoperative diagnosis and SSI. The mean age at implantation was 46.6±12.5years, with a gender distribution of 86.1% female. Data from 499 joints in 319 subjects were collected as a part of the survey. The mean follow-up time was 8.6±3.9years (range, 2-20years). The first SSI frequency was 11.2% (4.2% removal rate and 7.0% reoperation rate). The survivorship rate (Kaplan-Meier) was 96% at 3years, 94% at 5years, and 86% at 10years. The mean interval to failure using a survival function to determine the time to SSI (Greenwood's formula) was 13.5±0.193years. The most common causes of SSI included adhesion removal (2.6%; 13 of 498), heterotopic bone/ankylosis (2.0%; 10 of 498), and infection (1.6%; 8 of 498). The results from the present study are consistent with the reported survivorship rates for other orthopedic devices (5-year survival for total hip or knee arthroplasty, 95.9 and 97.2%, respectively). The etiology of SSIs in the Biomet TMJ replacement system was primarily secondary to biologic failure (ie, adhesions, heterotopic bone, and infection).

Computational characterization of the porous-fibrous behavior of the soft tissues in the temporomandibular joint.

The prevalence and severity of temporomandibular joint (TMJ) disorders have led to growing research interest in the development of new biomaterials and medical devices for TMJ implant designs. In computational designs, however, the time and stretch direction dependences of the TMJ soft tissues behavior are not considered and they are frequently based on measurements taken from non‐human species or from joints that differ markedly from the human TMJ. The aim of this study was to accurately characterize the porous‐fibrous properties of the TMJ soft tissues by simulating previously published experimental tests, to assist professionals in the design of new TMJ implants. To that end, material parameters were determined assuming a uniform fiber orientation throughout the entire sample. This assumption was then tested by comparing these results with those of considering multiple regions and distinct fiber orientations in each sample. Our findings validated the use of a transversely isotropic hyperelastic material model to characterize the direction dependent behavior of TMJ soft tissues and its combination with porous hyperfoam material models to mimic the compressive response of the TMJ disc. In conclusion, constitutive model proposed accurately reproduce the mechanical response of the TMJ soft tissues at different strain rates and stretch directions.

Custom-made Temporomandibular Joint Prosthesis: Computer Aided Modeling and Finite Elements Analysis

Temporomandibular Joint (TMJ) is a bilateral joint that works to perform the main activities of speaking and chewing. Because of this cyclic loading, TMJ disorders are common and greatly affect the quality of life. For this reason, it becomes necessary to replace the non-functioning joint with a prosthetic device. Since the 1930s, different TMJ implants have been developed to restore the correct functioning of TMJ and improve patient quality of life. TMJ prosthesis is a two-component replacement device composed of a condyle, placed t mandible extremities, and a glenoid fossa, localized in temporal bone and these are fixed to healthy bone by screw. In recent years, thanks to technological advancement, TMJ replacement devices can be developed starting from specific tomographic data of each patient, calling them as custom-made prosthesis. The customization process is a computational process of Computer Aided Modeling (CAM) and Computer Aided Design (CAD). It starts from tomographic data to create a tridimensional model of patient mandible and skull, then, based on computational model, TMJ prosthesis is designed and finally it is fabricated by additive manufacture. Follow-up data available in literature show that the main unresolved problem of TMJ prostheses is a kinematics that is still different from the natural one, resulting in hypomobility of implanted condyle compared to the natural one. In this panorama, this study aims to show TMJ CAM customization process and to evaluate mechanical and kinematic response of a unilateral TMJ custom-made prosthesis through Finite Elements Analysis (FEA) with Ansys software. Bilateral bite to incisors and unilateral bite to molar are simulated and mechanical stress and strain generated are evaluated.

Use of Ferrule Rings as Stress Dissipators in Temporomandibular Joint Intramedullary Implants: A Finite Element Analysis Study.

The use of temporomandibular joint (TMJ) implants is considered to be a reliable treatment for some TMJ disorders when TMJ anatomical integrity is compromised. Among all of the designs proposed for these devices, intramedullary approaches are relatively new, and they may offer several advantages compared to those of past models with a lateral approach. In this report, we use finite element analysis (FEA) to calculate stress forces of a TMJ implant featuring a ferrule ring, which is frequently used in engineering as a stress distractor to reduce the splinter effect. Our analysis suggests that the addition of a ferrule ring in the TMJ implant helps to reduce von Mises stresses in the device and displacement forces in the volume and surface of the implant. These results suggest that including a ferrule ring in a TMJ implant may contribute to the stability and outcome of a TMJ implant by reducing component stress and displacement forces.

Adverse Local Tissue Responses to Failed Temporomandibular Joint Implants

The purpose of this study was to determine whether failed alloplastic temporomandibular joint replacement (TMJR) devices can elicit the aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL) reaction seen in some patients with metal-on-metal hip arthroplasties. This study involved analysis of paraffin-embedded sections of peri-implant tissue from failed TMJ implant cases obtained from 3 independent sources. Hematoxylin and eosin staining, conventional and polarized light microscopy, back-scattered electron imaging, and energy-dispersive x-ray analysis were used. Immunohistochemical methods were used to identify T and B lymphocytes and macrophages. The total TMJR device specimens showed primary macrophage and lymphocytic responses similar to responses reported previously for failed total hip implants, including ALVAL. No chronic or acute inflammation was apparent in the failed hemiarthroplasty TMJR cases. In this limited preliminary study, the local tissue responses to the failed TMJR implants showed similar primary macrophage and lymphocyte responses to previously reported failed metal-on-metal and metal-on-polyethylene orthopedic total joint replacement devices. No such local inflammatory responses were seen with the failed TMJR hemiarthroplasty devices.

Examination of failed retrieved temporomandibular joint (TMJ) implants

In the management of end-stage temporomandibular joint disorders (TMD), surgeons must often resort to alloplastic temporomandibular joint (TMJ) total joint replacement (TJR) to increase mandibular function and form, as well as reduce pain. Understanding wear and failure mechanisms of TMJ TJR implants is important to their in vivo longevity. However, compared to orthopedic TJR devices, functional wear of failed TMJ TJR implants has not been examined. Not only do wear and corrosion influence TJR implant in vivo longevity, but so does reactivity of peri-implant tissue to these two events. The aim of this study was to examine and report on the wear of retrieved, failed metal-on-metal (MoM), metal-on-polymer (MoP), and titanium-nitride coated (TiN Coated) TMJ TJR implant components.A total cohort of 31 TMJ TJR devices were studied of which 28 were failed, retrieved TMJ TJRs, 3 were never implanted devices that served as controls. The mean time from implantation to removal was 7.24years (range 3–15), SD 3.01. Optical microscopy, White Light Interferometry (WLI), Scanning Electron Microscopy (SEM), and Raman spectroscopy were utilized to characterize the surfaces of the devices. Data was acquired and evaluated by analyzing alloy microstructure. Substantial surface damage was observed between the articulating areas of the condylar head and the glenoid fossa components. Damage included pitting corrosion, evidence of deposited corrosion products, specific wear patterns, hard phases, surface depressions, and bi-directional scratches. Electrochemical analysis was performed on the MoM Control, retrieved, failed MoM, and TiN Coated devices. Electrochemical tests consisted of open circuit potential (OCP) and electrochemical impedance spectroscopy (EIS) tests conducted using the condylar head of the retrieved failed devices. EIS confirmed material properties as well as corrosion kinetics in vivo help to mitigate corrosion as reflected by the Raman spectroscopy results. In summary, this study demonstrated the role of wear and corrosion interactions on the early failure of TMJ TJR devices.Since the materials employed in most orthopedic TJR devices are similar to those used in TMJ TJR implants, studies such as this can provide data that will improve future embodiment paradigms for both. Further studies will include in vitro investigation of corrosion kinetics and the underlying tribocorrosion mechanism of TMJ TJR devices. Statement of SignificanceAn attempt is made in this study, to examine the retrieved TMJ implants and conduct surface and electrochemical analysis; further a translation research approach is employed to compare the observations from the total hip replacement (THR) retrievals. A total cohort of 31 TMJ TJR devices were studied of which 28 were failed, retrieved TMJ TJRs, 3 were never implanted devices that served as controls. Data was acquired and evaluated by analyzing alloy microstructure. Substantial surface damage was observed between the articulating areas of the condylar head and the glenoid fossa components. Electrochemical analysis was performed on the MoM Control, retrieved, failed MoM, and TiN Coated devices. This study demonstrated the role of wear and corrosion interactions on the early failure of TMJ TJR devices. Since the materials employed in most orthopedic TJR devices are similar to those used in TMJ TJR implants, a comparison study was conducted.

Load transfer in Christensen® TMJ in alloplastic total joint replacement for two different mouth apertures

This study analyses load transfer in the fossa component based on two numerical models of total temporomandibular joint (TMJ) implants for two mouth openings. The TMJ articulation is a very complex system with muscles, ligaments and cartilage. Until now, studies of TMJ implants have analysed only condylar behaviour.The finite element models were constructed based on CT scans of a cadaveric mandible and cranium, considering the bone geometry and position. The influence of five principal muscle actions was simulated for two mouth positions, 5 mm and 15 mm openings at the incisive tooth support. Strain distributions into the surrounding bone tissue were analysed in both models in the condyle and fossa components.The results demonstrate that in Christensen® TJR of the temporomandibular joint the fossa component is the more critical part, presenting more stress near the screw holes and contact regions with the cranium. The most critical region is around the first two screws and the least critical is in the condyle component.For the mandible condyle reconstructed with a Christensen® prosthesis, the 15 mm mouth opening was more critical, as compression was increased, but for the fossa component the most critical situation occurred with the 5 mm opening. The micromovements observed suggest that the number of screws could be reduced to increase osteointegration of screws in the mandible condyle.

Evaluación clínica de pacientes con prótesis total de articulación temporomandibular

IntroductionThe temporomandibular joint (TMJ) can be affected by injuries that alter its morphology and compromise its normal function, and in some cases leading to the need for surgery to resect it and rebuild it. The reconstruction of the TMJ bone articular defects has been a challenge for the maxillofacial surgeon. It can be achieved by using alloplastic materials. Among these, we highlight the total temporomandibular joint prosthesis, developed until achieving its current form and composition, and which has led to the establishment of clear protocols for its use. Among these, we highlight the W.Lorenz™ prosthesis with a high technology and specific details that lead to an increased clinical and functional improvement. ObjectiveTo study the important clinical and functional aspects observed in surgically treated patients. Materials and MethodsThis study evaluated 15 patients between 24 to 44 years, who underwent TMJ replacement surgery with 23 TMJ implants, 8 bilateral and 7 unilateral, between the years 2000 to 2008. All surgeries were performed by the same surgeon. ResultsA large increase in functional improvement was observed, particularly in the cases of TMJ ankylosis. ConclusionsMany more studies and monitoring should be conducted to establish, especially in the long term, that these prostheses offer the stomatognathic system an effective and durable physiology.

Theoretical assessment of an intramedullary condylar component versus screw fixation for the condylar component of a hemiarthroplasty alloplastic TMJ replacement system

Virtual design gives flexibility to explore constructive solutions or structures. It enables analysis that would often be impossible even if expensive real prototypes were available. Simulations using finite element models allow access to the stress and strain tensor or to the deformation tensor within an implant or a tissue which is impossible experimentally, even in vitro.This study is based on two numerical models of temporomandibular joint (TMJ) implants, comparing two bone-implant connections: an external connection performed with surgical screws (commercial model) and an internal connection carried out by penetration into the intramedullary space. The finite element models were constructed based on a cadaveric mandible and considering the five principal muscles in action.Strain distributions into the surrounding bone tissue are analysed and in both models they show significant differences at the external surface of the mandible in displacements. However, while the intramedullary fixation increases strains in the cancellous tissue, the study shows that strain distribution is mainly influenced by the number and distribution of screws in commercial solution.

Enhancement of biomechanical behavior on osseointegration of implant with SLAffinity

The purpose of this study was to investigate stresses resulting from different thicknesses of hydroxyapatite- and titanium dioxide (TiO(2))-treated layers at the interface between temporomandibular joint (TMJ) implants and bones using three-dimensional finite element models. For ensuring osseointegration of implant treatment, one must examine the stresses of interface between implant and bone tissue. Treated layers on TMJ implants are a very important factor in clinical application. Several studies have investigated finite element models for TMJs, but few have examined a model for TMJ implants with treated layers. In this study, TMJ models were reconstructed using computer tomography data, and the effects of treated layer thickness on the stress field during jaw movement were investigated; this index has not yet been reported with respect to TMJ implant. The maximum stresses in the bone occurred at the position of the first screw. Data analysis indicated a greater decrease in this stress in the case of using TMJ implants with TiO(2)-treated layers, and the stresses decreased with increasing layer thicknesses. Results confirmed that the treated layers improve biomechanical properties of the TMJ implants and release abnormal stress concentration in them. The results of our study offer the potential clinical benefit of inducing superior biomechanical behavior in TMJ implants.

Alloplastic total temporomandibular joint replacement

Temporomandibular joint (TMJ) prosthesis have been hesitated to use because of bitter memories about Proplast-Teflon interpositional TMJ implants. Many clinicians, however, are trying to use total TMJ prosthesis with getting continuous long-term follow-up results. Alloplastic total TMJ replacement have been applied to much more patients who have failed previous TMJ prostheses or TMJ implants, fibrous/bony ankylosis, severe osteoarthritis, degenerative joint disease, idiopathic condylar resorption, condyle loss by trauma or tumor resection, and other bony destructive diseases. Nowadays three types of total TMJ prosthesis are widely used. In this article, indications, types of prosthesis, safety and stability would be demonstrated with a case report.

A Mastication Mechanism Designed for Testing Temporomandibular Joint Implants

The development of temporomandibular joint implants has involved simplified mechanical tests that apply pure vertical forces or pure rotational movements to the implant. The aim of this study was to develop a biological based mastication mechanism and conduct preliminary testing of a novel temporomandibular joint implant. The mechanism was designed to mimic temporomandibular joint loads by performing compression and anterior/posterior translation. Pilot testing was performed on six implant/joint specimens for seven consecutive hours, completing approximately 22,000 cycles at a frequency of approximately 1 Hz. Each cycle had a joint compression phase (67.3 N over 0.15 s) followed by a translation phase (8.67 N over 0.43 s) that was similar to joint loads/motions that have been reported in vivo. This new mastication mechanism incorporates both anatomical and mechanical variability. The use of biological specimens is an important approach that can help bridge the gap between traditional synthetic implant materials/mechanical testing andin vivotesting.

A mastication mechanism designed for testing temporomandibular joint implants

The development of temporomandibular joint implants has involved simplified mechanical tests that apply pure vertical forces or pure rotational movements to the implant. The aim of this study was to develop a biological based mastication mechanism and conduct preliminary testing of a novel temporomandibular joint implant. The mechanism was designed to mimic temporomandibular joint loads by performing compression and anterior/posterior translation. Pilot testing was performed on six implant/joint specimens for seven consecutive hours, completing approximately 22,000 cycles at a frequency of approximately 1 Hz. Each cycle had a joint compression phase 67.3 N over 0.15 s followed by a translation phase 8.67 N over 0.43 s that was similar to joint loads/motions that have been reported in vivo. This new mastication mechanism incorporates both anatomical and mechanical variability. The use of biological specimens is an important approach that can help bridge the gap between traditional synthetic implant materials/mechanical testing and in vivo testing.

Bone microenvironment associated to wear debris in temporomandibular joint implants: pre-clinical model in mice

Aseptic osteolysis is a main cause of loosening of orthopaedic implant failures. The wear debris derived from polymers (UHWMPE) and/or metals of implants (Ti) elicit primary inflammatory and secondary osteolytic responses. In total temporomandibular joint (TMJ) reconstruction with implants, foreign body reactions are reported and are the major cause of failure in the metal-on-metal and Teflon® or Proplast®-on-metal prosthesis, leading a revision surgery. A new generation of implants replaced Teflon® by UHWMPE in the fossa component with acceptable clinical results in long term follow-up (14 years).

A comparison of stress distributions for different surgical procedures, screw dimensions and orientations for a Temporomandibular joint implant

Finite element analysis is a useful analytical tool for the design of biomedical implants. The aim of this study was to investigate the behavior of temporomandibular joint implants with multiple design variables of the screws used for fixation of the implant. A commercially available implant with full mandible was analyzed using a finite element software package. The effects of different design variables such as orientation, diameter and stem length of the screws on the stress distribution in bone for two different surgical procedures were investigated. Considering the microstrain in bone as a principal factor, the acceptable ranges for screw diameter and length were determined. Parallel orientation of the screws performed better from a stress point of view when compared to the zig-zag orientation. Sufficient contact between the implant collar and mandibular condyle was shown to reduce the peak stresses which may lead to long term success. The distance between screw holes in the parallel orientation was much closer when compared to the zig-zag orientation. However, the stresses in bone near the screw hole area for the parallel orientation were within acceptable limits.