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

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.