Digital Design and Clinical Application of an Intraoral Archwire Distraction Appliance for Maxillary Distraction in Patients With Cleft Lip and Palate.

This study presents the digital design and clinical application of the Archwire Distraction Appliance (AWDA), a cost-effective intraoral distraction method developed for patients with cleft lip and palate. The AWDA provides an alternative approach to existing extraoral and intraoral distraction systems by enabling segmental maxillary advancement in both sagittal and horizontal planes. To our knowledge, this study is the first to describe a fully digital workflow for the design and fabrication of an archwire-based intraoral distraction appliance for patients with cleft lip and palate. In this study, the digital design workflow of the AWDA is described in detail. The attachments required for the appliance and the reference planes necessary for accurate attachment positioning were designed using Meshmixer software, whereas the appliance itself was designed and customized using 3Shape Appliance Designer. The digital workflow, appliance fabrication, surgical protocol, and clinical outcomes are also presented. AWDA may provide important functional and esthetic advantages in selected patients with cleft lip and palate requiring segmental maxillary advancement. Nevertheless, careful case selection, periodontal evaluation, and long-term follow-up remain essential for achieving predictable and stable outcomes.