A Pilot Study on 3D-Printed Impression Trays for Cleft Palate: A Digital Manufacturing Approach

Cleft lip and palate (CLP), affect approximately 1 in 756 births and require comprehensive, individualized treatment strategies. Among the first important interventions is the creation of impression trays for nasoalveolar molding (NAM) plates, which help separate the oral and nasal cavities in newborns. However, traditional tray fabrication methods are labour-intensive, imprecise, and unsuitable for mass production. This study investigates the use of reverse engineering and additive manufacturing (3D printing) to streamline and enhance the production of CLP impression trays. Seventeen tray models were digitally designed using 3D scanning and computer-aided design (CAD) tools and fabricated via stereolithography (SLA) technology using PLA photopolymer resin. The trays had an average consumable usage of 13.09 ml, a weight of 15.04 g, and a production time of approximately 2 hours and 30 minutes per tray. Descriptive statistics and correlation analysis indicated predictable relationships in the fabrication process, particularly between resin usage and tray weight. Batch production further reduces manufacturing times, demonstrating scalability. While CAD/CAM workflows significantly improve accuracy, customization, and reproducibility, challenges such as material optimization and cost barriers persist. Innovations like intraoral scanning hold promise for enhancing patient safety and comfort. This study highlights reverse engineering as an efficient and scalable solution for improving CLP treatment outcomes and clinical practices.