Objective: The aim is to compare between the clinical effectiveness of nasoalveolar molding (NAM) versus the computer-aided design NAM (CAD/NAM) in patients with bilateral clefts. Design: The trial is a randomized comparative trial with 1:1 allocation ratio. Participants: Thirty infants with bilateral complete cleft lip and palate were recruited. Interventions: Patients were randomized between NAM and CAD/NAM groups. The treatment steps described by Grayson were followed for the NAM group. In the CAD/NAM group, digitized maxillary models were made to create series of modified virtual models which were used to fabricate the molding plates using 3-dimensional printing technology. The nasal stents were then added to the plates following Grayson method. The study lasted for 4 months. Main Outcomes: The primary outcome was to evaluate the changes in the intersegment cleft gap. Secondary outcomes included the analysis of the maxillary arch in transverse, anteroposterior, and vertical dimensions as well as the premaxillary deviation and rotation. Chair side time was assessed for both methods. Results: Both modalities decreased the intersegment cleft gap. The CAD/NAM plates caused more reduction in the total arch length by 1.99 mm (−3.79 to 0.19, P = .03) as compared to the NAM treatment. No differences were found between groups in the transverse and vertical maxillary arch changes. Conclusions: Both interventions were effective in narrowing the cleft gap. Similar maxillary changes were found in both groups. The CAD/NAM modality required less chair side time compared to the NAM treatment.
Development of a Novel, Low-Cost, High-fidelity Cleft Lip Repair Surgical Simulator Using Computer-Aided Design and 3-Dimensional Printing