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

ObjectiveTo explore clinical feasibility of smartphone and AI-assisted workflow for presurgical orthopedic therapy in newborns with unilateral cleft lip and palate (UCLP).DesignRetrospective exploratory cohort study.SettingA tertiary craniofacial center.PatientsTwenty consecutive (13 females, 7 males) with non-syndromic complete UCLP treated 2022-2024.InterventionsPassive presurgical plates fabricated through smartphone scanning of impressions, AI-assisted automated plate design and 3D printing.Main Outcome MeasuresClinical outcomes (treatment duration, visits, complications) and morphological changes (anterior cleft width, cleft area, IMT angle, maxillary segment areas).ResultsTherapy 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.ConclusionsSmartphone 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.