Background: In order to overcome the geometrical and physical limitations of conventional rotating and piezosurgery instruments used to perform bone osteotomies, as well as the difficulties in translating digital planning to the operating room, a stand-alone robot-guided laser system has been developed by Advanced Osteotomy Tools, a Swiss start-up company. We present our experiences of the first-in-man use of the Cold Ablation Robot-guided Laser Osteotome (CARLO^®). Methods: The CARLO^® device employs a stand-alone 2.94-µm erbium-doped yttrium aluminum garnet (Er:YAG) laser mounted on a robotic arm. A 19-year-old patient provided informed consent to undergo bimaxillary orthognathic surgery. A linear Le Fort I midface osteotomy was digitally planned and transferred to the CARLO^® device. The linear part of the Le Fort I osteotomy was performed autonomously by the CARLO^® device under direct visual control. All pre-, intra-, and postoperative technical difficulties and safety issues were documented. Accuracy was analyzed by superimposing pre- and postoperative computed tomography images. Results: The CARLO^® device performed the linear osteotomy without any technical or safety issues. There was a maximum difference of 0.8 mm between the planned and performed osteotomies, with a root-mean-square error of 1.0 mm. The patient showed normal postoperative healing with no complications. Conclusion: The newly developed stand-alone CARLO^® device could be a useful alternative to conventional burs, drills, and piezosurgery instruments for performing osteotomies. However, the technical workflow concerning the positioning and fixation of the target marker and the implementation of active depth control still need to be improved. Further research to assess safety and accuracy is also necessary, especially at osteotomy sites where direct visual control is not possible. Finally, cost-effectiveness analysis comparing the use of the CARLO^® device with gold-standard surgery protocols will help to define the role of the CARLO^® device in the surgical landscape.

The aim of the study was to assess the clinical applicability of robot guided laser osteotomy for clinical application. This is the initial report on 14 consecutive patients requiring an orthognathic procedure with a midface osteotomy (no restrictions made on the surgical indication itself) who have undergone surgery by means of the Cold Ablation Laser Osteotome CARLO® (AOT Advanced Osteotomy Tools, Basle, Switzerland), which is an integrated system, functionally comprising: an Er:YAG laser source, intended to perform osteotomies using cold laser ablation, a robot arm that controls the position of the laser source, an optical tracking device that provides a continuous and accurate measurement of the position of the laser source and of reference elements attached to instruments or bones, a navigation system (software) that is able to read preoperatively defined planned osteotomies, and - under the control of a surgeon - performs the planned osteotomies. Safety was assessed by unimpaired postoperative healing and the absence of device related injuries; performance was assessed as ability to cut the maxilla along the preoperatively planned cutting path with a rage of accuracy of 2mm. Cold ablation robot-guided laser osteotomy could successfully be performed in 14 consecutive patients. No intraoperative complications or technical failure occurred. All osteotomies were within an average deviation of 0.80 mm (±0.26 mm) of the virtually preplanned location. The registration procedure to set up the robot at the beginning of the operation required a mean time of 4.6 min (±5.3min). In this report we describe the effective and successful routine use of Cold ablation robot-guided laser osteotomy in an actual clinical setting. It is a promising technical innovation that has the potential to set new standards for accuracy and safety in orthognathic surgery.

Cleft lip and palate are one of the most common congenital craniofacial malformations. As an initial treatment, presurgical orthopedics is considered standard treatment at many cleft centers. Digital impressions are becoming feasible in cleft care. Computer-aided design (CAD) and three-dimensional (3D) printing are manufacturing standards in dentistry. The assimilation of these technologies has the potential to alter the traditional workflow for the fabrication of customized presurgical orthopedic plates. We present a digital workflow comprising three steps: 3D digital image acquisition with an intraoral scanner, open-source CAD modeling, and point-of-care 3D printing for the fabrication of personalized passive presurgical plates for newborns with cleft lip and palate. The digital workflow resulted in patient-related benefits, such as no risk of airway obstruction with quicker data acquisition (range 1–2.5 min). Throughput time was higher in the digital workflow 260–350 min compared to 135 min in the conventional workflow. The manual and personal intervention time was reduced from 135 min to 60 min. We show a clinically useful digital workflow for presurgical plates in cleft treatment. Once care providers overcome procurement costs, digital impressions, and point-of-care 3D printing will simplify these workflows and have the potential to become standard for cleft care.