Effectiveness of a Novel 3D-Printed Nasoalveolar Molding Appliance (D-NAM) on Improving the Maxillary Arch Dimensions in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial

Objective: The aim of the current study was to introduce and measure the effectiveness of a new 3D-printed nasoalveolar molding (D-NAM) appliance on improving the maxillary arch dimensions (MADs) in infants with unilateral complete cleft lip and palate (UCLP) before surgical lip repair. Design: A prospective, balanced, randomized, parallel groups, single-blinded, controlled trial. Setting: All the steps of the current study were carried in the Department of Orthodontics, Cairo University in Egypt. Participants: Thirty-four, nonsyndromic infants with UCLP. Interventions: The eligible infants were randomly assigned into either no-treatment (control) or to the new D-NAM groups. In D-NAM group, the maxillary models were 3D scanned into virtual models onto which segmentation and alveolar segments approximation were performed. Approximation movements were divided into 3 models representing 3 activation steps. On each of these models, virtual appliance construction was performed followed by 3D printing of the appliance. Nasal stent was added manually to the appliances of the second and third steps. Horizontal tapes were applied to infants in the D-NAM group only. Main Outcomes Measures: A Blinded assessors carried all the MADs measurements virtually on digital models collected at the beginning (T1) and after (T2) treatment. Results: Clinically and/or statistically significant improvements in all the measured MADs were recorded in D-NAM group at T2 before surgical lip repair in comparison to control group. Conclusions: The introduced D-NAM/3D-printed appliance is a simple and efficient technique to improve the MADs in infants with UCLP before surgical lip repair.