Evaluation of Facial Esthetics Following NAM Versus CAD/NAM in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial.

OBJECTIVE: The aim is to compare the facial esthetics following nasoalveolar molding (NAM) versus computer-aided design NAM (CAD/NAM) in patients with bilateral cleft lip/palate (CLP). DESIGN: The trial is a randomized comparative trial with a 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 a 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 intraoral plates following the Grayson method. The study lasted for 4 months. MAIN OUTCOMES: The assessment of the changes observed in the interlabial gap and nasolabial esthetics was done using standardized 2-dimensional photographs. The correlation between dental arch changes and extraoral facial esthetics was studied. RESULTS: Both modalities showed improvement in nasolabial esthetics before the lip surgery. No statistically significant difference was found between NAM and CAD/NAM groups in any of the assessed variables. CONCLUSIONS: Both interventions were effective in the management of infants with bilateral CLP.