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

Abstract

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.

Correlation between cleft width and dental arch symmetry in cleft lip and palate: a longitudinal study

“…These findings are in line with those of other authors who have demonstrated the difference in palate symmetry before cheiloplasty. 5,15,22 The analyses indicate improvement of palate symmetry between I-T' and I-T, at T2, due to the growth of the posterior region of the palate. 16 These data were consistent with the increase in parameters C'-T' and C-T and were congruous with those of other authors.…”

“…Considering that palate width is a negative predictor of palate development, 5,11,15,23,27 we emphasize the importance of further evaluation of cleft palate width. The proposal of a cleft width classification would contribute to determining the influence of cleft width on palate growth and treatment protocols.…”

“…Numerous parameters can influence the symmetry of dental arches. 5,11,14,15 However, this study focused on the understanding of cleft width, considering the lack of width classifications.…”

“…5,13 Palate asymmetry in children with craniofacial anomalies is correlated with factors such as orofacial cleft phenotype classification, treatment protocol, cleft length, and cleft width. 6,11,14,15 However, the literature lacks studies on the influence of cleft width before and after surgical repairs. Moreover, no study so far has explained which cleft width (anterior, middle, or posterior) would play a role in dental arch symmetry in children.…”

3D printing for surgical planning in bone grafts for cleft-palate: a case report

“…14,15 El-Ghafour et al and also Shen et al presented the application of molding appliance that improved the maxillary arch. 16,17 To our knowledge no previous description of 3D printing was published earlier.…”