Short-Term Efficacy of Presurgical Vacuum Formed Nasoalveolar Molding Aligners on Nose, Lip, and Maxillary Arch Morphology in Infants With Unilateral Cleft Lip and Palate: A Prospective Clinical Trial

Abstract

Objectives: The purpose of this study was to evaluate the short-term effect of series of preadjusted vacuum formed nasoalveolar molding VF NAM aligners on the morphology of nose, lip, and maxillary arch in infants with unilateral cleft lip and palate (UCLP). Design: Prospective clinical trial. Setting: Unilateral cleft lip and palate patients referred to outpatients’ clinic. Patients: Sixteen nonsyndromic infants with UCLP, less than 2 months of age were included from April 2017 to April 2018. Interventions: All infants received VF NAM therapy. Standardized digital frontal and basilar photographs and 3D digital models were taken before initiation of VF NAM therapy (T1) and after completion of VF NAM therapy (T2). Main Outcome Measure(s): Changes in morphology of the nose, lip, and maxillary arch. Results: Statistical analysis comparing T1 and T2 measurements was performed. Frontal and basilar photographic analysis showed a statistically significant reduction of columella displacement, interlabial gap distance, and nostril width at cleft side (CS), while the nasal height, nostril height at CS, nostril width at noncleft side (NCS), columella deviation angle, nasal tip protrusion, and nostril area at both CS and NCS increased significantly with VF NAM therapy. The nasal width, nostril height at NCS showed no significant change after presurgical VF NAM aligners therapy. The analysis of digital models demonstrated a statistically significant reduction of alveolar cleft width, anterior arch width, arch length, midline deviation, and palatal cleft width, while the posterior arch width and arch perimeter increased significantly with VF NAM therapy. Conclusion: Vacuum formed NAM therapy was effective in reducing the nasoalveolar deformities associated with infants with UCLP and improved the alveolar morphology and nasal symmetry.

The Effects of NAM on the Symmetry of the Face and Maxillary Arch in Babies With Unilateral Cleft

“…This increase can be attributed to the continuous growth of the alveolar ridges, guided by the forces exerted by the devices of this therapy. This result corroborates with some studies found in the literature, 31,32 which demonstrated an increase in the AP in this phase.…”

“…7,33 Uprighting and increasing the extension of the columella before the lip repair surgery favors the surgical procedure, offering better surgical results. 4,5 The findings of this study corroborate with other studies, 7,31 showing; however, small quantitative discrepancies, probably due to differences in methodologies.…”

“…Arch perimeter is considered one of the most important parameters for orthodontic diagnosis and treatment planning. 31 It is defined as the distance from the mesial surface of the first permanent molar around the dental arch to the same point on the opposite side. In this study, using the widths of this concept, we made an analogy to the dental AP to analyze the dimension and changes that occurred in the alveolar arch of babies with cleft lip and palate who used NAM as an early treatment.…”

Novel Digital Workflow for Nasoalveolar Molding and Postoperative Nasal Stent for Infants With Cleft Lip and Palate

“…Al Khateeb et al provided a workflow using vacuum-formed plastics over predicted models. 5 Their research focuses on printing predictive models and using a more readily accessible vacuum forming machine to create the NAM. Our workflow uses predictive modeling but we do not have a need to produce reference models other than for demonstration purposes.…”

“…The impression technique follows the best principles of Al Khateeb et al with the infant fully awake, nearly upright, and allowed to cry freely. 5 In addition, we perform the impression with support of a pediatric anesthesiologist should airway intervention be necessary. The putty is mixed extra-orally for one minute, placed on an appropriate tray, molded intra-orally for 40 seconds, and then removed and left undisturbed for two minutes to complete the setting reaction.…”