Comparison in clinical performance of surgical guides for mandibular surgery and temporomandibular joint implants fabricated by additive manufacturing techniques. (July 2021)

• Record Type: Journal Article
• Authors: Oldhoff, M.G.E.; Mirzaali, M.J.; Tümer, N.; Zhou, J.; Zadpoor, A.A.
• Is Part Of: Journal of the mechanical behavior of biomedical materials. Volume 119(2021)
• Publication Date: 2021-07
• Subjects: Additive manufacturing -- Temporomandibular joint -- Surgical guides -- Patient-specific implants; Biomedical materials -- Periodicals; Biomedical materials -- Mechanical properties -- Periodicals; Biomedical materials; Biomedical materials -- Mechanical properties; Periodicals; Electronic journals; 610.28
• DOI: 10.1016/j.jmbbm.2021.104512
• Languages: English
• ISSNs: 1751-6161

Abstract

Abstract: 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.