Digital fabrication of nasoalveolar molding devices for the treatment of infants with cleft lip and palate

Aim: To develop a fully digital workflow for fabricating nasoalveolar molding (NAM) appliances for the treatment of infants born with cleft lip and palate, integrating commercially available intraoral scanning, computer-aided design/computer-aided manufacturing, and three-dimensional (3D) printing tools. Materials and Methods: Digital models were obtained using direct intraoral scanning and from scans of plaster models poured from conventional impressions of three infants with cleft lip and palate. The models were digitally superimposed to assess dimensional accuracy. Digital models were manipulated in MeshMixer software to simulate sequential NAM adjustments, which were then compared to those of a conventionally fabricated appliance. NAM appliances were digitally designed in 3Shape and SolidWorks software and fabricated using SprintRay and Stratasys 3D printers with material customization for intraoral and nasal components. Results: Superimposition analysis demonstrated high dimensional accuracy of intraoral scans with deviations of <0.5 mm in clinically relevant areas. Virtual model manipulation successfully replicated clinical NAM adjustments with systematic modifications ranging from 0.5 mm to 2.0 mm. Quantitative comparison between conventional and digital adjustments revealed similar magnitudes of change. The fully digital workflow allowed for predictable appliance fabrication of 3D-printed NAM appliances with satisfactory fit and function. Conclusion: A fully digital workflow for NAM appliance fabrication was successfully developed, demonstrating high accuracy, reproducibility, and feasibility using commercially available technologies. This approach eliminates the need for conventional impressions, streamlines appliance fabrication, and provides a systematic method for digital NAM adjustments, offering a promising alternative to traditional techniques.