BackgroundTemporo-Mandibular Joint (TMJ) replacement has been used clinically for years. The objective of this study was to evaluate outcomes achieved in patients with two different categories of TMJ prostheses.Material and MethodsAll patients who had a TMJ replacement (TMJR) implanted during the study period from 2006 through 2012 were included in this 3-year prospective study. All procedures were performed using the Biomet Microfixation TMJ Replacement System, and all involved replacing both the skull base component (glenoid fossa) and the mandibular condyle.ResultsFifty-seven patients (38 females and 19 males), involving 75 TMJs with severe disease requiring reconstruction (39 unilateral, 18 bilateral) were operated on consecutively, and 68 stock prostheses and 7 custom-made prostheses were implanted. The mean age at surgery was 52.6±11.5 years in the stock group and 51.8±11.7 years in the custom-made group. In the stock group, after three years of TMJR, results showed a reduction in pain intensity from 6.4±1.4 to 1.6±1.2 (p<0.001), and an improvement in jaw opening from 2.7±0.9 cm to 4.2±0.7 cm (p<0.001). In the custom-made group, after three years of TMJR, results showed a reduction in pain intensity from 6.0±1.6 to 2.2±0.4 (p<0.001), and an improvement in jaw opening from 1.5±0.5 cm to 4.3±0.6 cm (p<0.001). No statistically significant differences between two groups were detected.ConclusionsThe results of this three-year prospective study support the surgical placement of TMJ prostheses (stock prosthetic, and custom-made systems), and show that the approach is efficacious and safe, reduces pain, and improves maximum mouth opening movement, with few complications. As such, TMJR represents a viable technique and a stable long-term solution for cranio-mandibular reconstruction in patients with irreversible end-stage TMJ disease. Comparing stock and custom-made groups, no statistically significant differences were detected with respect to pain intensity reduction and maximum mouth opening improvement. Key words:Temporo-mandibular joint, temporo-mandibular joint replacement, prosthesis, biomaterials, biomedical engineering, computer-aided design and manufacturing.

Purpose This paper aims to propose a functional methodology to produce cranial prostheses in polymeric sheet. Within the scope of rapid prototyping technologies, the single-point incremental forming (SPIF) process is used to demonstrate its capabilities to perform customized medical parts. Design/methodology/approach The methodology starts processing a patient’s computerized axial tomography (CAT) and follows with a computer-aided design and manufacture (CAD/CAM) procedure, which finally permits the successful manufacturing of a customized prosthesis for a specific cranial area. Findings The formability of a series of polymeric sheets is determined and the most restrictive material among them is selected for the fabrication of a specific partial cranial prosthesis following the required geometry. The final strain state at the outer surface of the prosthesis is analysed, showing the high potential of SPIF in manufacturing individualized cranial prostheses from polymeric sheet. Originality/value This paper proposes a complete methodology to design and manufacture polymer customized cranial prostheses from patients’ CATs using the novel SPIF technology. This is an application of a new class of materials to the manufacturing of medical prostheses by SPIF, which to this purpose has been mainly making use of metallic materials so far. Despite the use of polymers to this application is still to be validated from a medical point of view, transparent prostheses can already be of great interest in medical or engineering schools for teaching and research purposes.

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