3D printed customized facemask for early treatment of Class III malocclusion: a two-center case series feasibility study.

Background: This prospective two-center case series feasibility study aimed to investigate the potential of a novel maxillary protraction facemask customized to the patients' anatomy recorded with 3D face scanning and then produced by digital design and additive manufacturing.
Methods: Ten subjects (5 females and 5 males, average age 7.7±1.0 years) with Class III malocclusion were treated with a rapid maxillary expander (RME) and a Petit-type facemask (FM), whose components were digitally designed on a 3D scan of the patient's face. Subjects' face scans were obtained either with a tablet or with face scanner. FM components were modelled with a 3D software. The pads were 3D printed in biocompatible resin, and the bar was printed in stainless steel. A questionnaire investigating the patients' experience was filled in after the first week of treatment and after 3, 6, and 9 months.
Results: The customized FM showed an excellent adaptation to the anatomy of the face. No severe complications were reported during the 9 months of appliance wearing. Some reversible episodes of skin irritation were reported below the pads, mainly in the chin area. The reported time wearing ranged between 8.2±2.3 and 9.5±1.2 hours per day, mainly at night. Reported pain was overall low (maximum after 1 week with an average value of 1.9±1.7 on a visual analog scale [VAS] 0-10) and patients' satisfaction was adequate at the end of the facemask wear after 9 months (8.7±1.4 on a VAS 0-10).
Conclusions: The customized FM was overall well accepted by the patients and represents a valid alternative to conventional ones.