Smartphone and AI Workflow for 3D Printed Plate for Presurgical Therapy in Cleft Lip and Palate: Retrospective Evaluation of Outcomes

Objective To explore clinical feasibility of smartphone and AI-assisted workflow for presurgical orthopedic therapy in newborns with unilateral cleft lip and palate (UCLP). Design Retrospective exploratory cohort study. Setting A tertiary craniofacial center. Patients Twenty consecutive (13 females, 7 males) with non-syndromic complete UCLP treated 2022–2024. Interventions Passive presurgical plates fabricated through smartphone scanning of impressions, AI-assisted automated plate design and 3D printing. Main Outcome Measures Clinical outcomes (treatment duration, visits, complications) and morphological changes (anterior cleft width, cleft area, IMT angle, maxillary segment areas). Results Therapy began at 10.8 ± 5.7 days, lasted 113.5 ± 15.6 days and required a mean of five visits. Anterior cleft width and cleft area reduced 56.8% and 40.8% with significant maxillary segment growth. Conclusions Smartphone and AI assisted workflows showed feasibility of safe, efficient presurgical plate fabrication and therapy, streamlining production and accessibility while reducing procedural burden. The findings remain preliminary and should be interpreted with caution.