Objectives: The aim of this pilot study was to illustrate the feasibility of a full digital workflow to design and manufacturing a consecutive series of customized nasoalveolar molding (NAM) appliances in advance for presurgical unilateral and bilateral cleft lip and palate (CLP) treatment. Methods: The full digital workflow consisted of acquisition of 3D image data of an infant's maxilla by using intraoral scanner (TRIOS; 3Shape, Copenhagen, Denmark); the initial data were imported into an appropriate computer-aided design (CAD) software environment, the digital model was virtual modified to achieve a harmonic alveolar arch, and generated a consecutive of digital models of each movement stage; the digital model of NAM appliance was designed based on the virtual modified model; bio-compatible material MED610 was used to manufacturing the real NAM appliances by 3D printing. A consecutive series of NAM appliances was delivered to CLP infant before lip surgery. Results: Intraoral scanning was harmless and safer than conventional impression technique for CLP infants. The CAD/3D printing procedures allowed a series of NAM appliances to be designed and manufactured in advance. The clinical results showed that this full digital workflow was efficient, viable and able to estimate the treatment objective. By the end of presurgical NAM treatment, the malposition alveolar segments had been aligned normally, the surrounding soft tissues repositioned. Conclusions: The full digital workflow presented has provided the potential for presurgical NAM treatment of infants with cleft lip and palate. Intraoral scanning served as a starting point, so subsequent virtual treatment planning and CAD/3D printing procedures could realize the full digital workflow, a whole series of customized NAM appliances was manufactured in advance. This method brings the benefits of safety, affectivity and time-saving.
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