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.
Highlights
Additive manufacturing (AM), widely known as 3D printing, refers to the processes of making three-dimensional (3D) objects by adding materials layer-upon-layer
Being different from the review mentioned above, the present review is aimed at comparing patient-specific surgical guides (PSGs) for mandibular surgery and temporomandibular joint (TMJ) patient-specific implants (PSIs) fabricated by applying different AM techniques and the conventional manufacturing methods based on some of the relevant clinical evidence reported in the literature
The data published on its application to TMJ PSIs and PSGs for mandibular surgery are often incomplete in relevant clinical outcomes
Summary
Additive manufacturing (AM), widely known as 3D printing, refers to the processes of making three-dimensional (3D) objects by adding materials layer-upon-layer. Comparisons in clinical outcomes are necessary with respect to the accuracy and efficiency that different manufacturing methods are able to offer (i.e., AM versus non-AM techniques) for the fabrication of PSGs for mandibular surgery and TMJ PSIs. In 2016, Tack et al (2016) published a systematic review on 3D printing applied in the surgery of human medicine, which included clinical trials and case studies on more than three patients. Being different from the review mentioned above, the present review is aimed at comparing PSGs for mandibular surgery and TMJ PSIs fabricated by applying different AM techniques and the conventional manufacturing methods based on some of the relevant clinical evidence reported in the literature In this connection, we first describe the cur rent applications of different AM and non-AM techniques in the fabri cation of these medical devices. We suggest the most important clinical parameters that need to be addressed in the future for the design and implementation of PSGs for mandibular sur gery and TMJ PSIs
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