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Background  A new distraction osteogenesis assembly system comprising a fully customized CAD/CAM-based fixation unit and ready-made distraction unit was developed. The aim of this study was to introduce our new distraction system and to evaluate its accuracy level in a sampled mandibular distraction osteogenesis.    Methods  Our system consists of a fully customized CAD/CAM-based fixation plate unit with two plates for each moving and anchoring part, and a ready-made distraction unit with attachment slots for fixation plates. The experimental distractions were performed on 3D-printed mandibles for one control and two experimental groups ( N  = 10 for each group). All groups had reference bars on the chin region and teeth to measure distraction accuracy. The control group had the classical ready-made distraction system, and experimental groups 1 and 2 were fitted with our new distraction assembly using a different distractor-positioning guide design. All distracted experimental mandibles were scanned by CT imaging, then superimposed on a 3D simulation to get their discrepancy levels.    Results  The measured 3D distances between the reference landmarks of the surgical simulations and the experimental surgeries for the three groups were significantly different ( p  < 0.0001) by statistical analysis. The errors were greater in the control group (with a total average of 19.18 ± 3.73 mm in 3D distance between the simulated and actual reference points) than those in the two experimental groups (with an average of 3.68 ± 1.41 mm for group 1 and 3.07 ± 1.39 mm for group 2). The customized distraction assembly with 3D-printed bone plate units in group 1 and 2, however, did not show any significant differences between simulated and actual distances ( p  > 0.999).    Conclusion  Our newly-developed distraction assembly system with CAD/CAM plate for the distraction osteogenesis of the mandible produced a greater level of accuracy than that of a conventional distraction device. The system appears to address existing shortcomings of conventional distraction devices, including inaccuracy in vector-controlled movement of the system. However, it also needs to be further developed to address the requirements and anatomical characteristics of specific regions.

Fully-customized distraction assembly for maxillofacial distraction osteogenesis: a novel device and its experimental accuracy verification