Expanding Access to Presurgical Cleft Care: Digital Nasoalveolar Molding with Clear Aligners in a Rural Low-Income Population

Abstract

<b>Background:</b> Presurgical nasoalveolar molding (NAM) improves outcomes in infants with cleft lip and palate by guiding alveolar segment alignment and enhancing nasal symmetry prior to primary lip repair. However, traditional NAM protocols require frequent clinical visits and specialized expertise, limiting access for families in rural and low-resource settings. <b>Objective</b>: This retrospective clinical study evaluated the feasibility and clinical outcomes of a digitally guided NAM approach using thermoformed clear aligners in infants with unilateral complete cleft lip and palate. <b>Material and Methods:</b> Twenty-five neonates residing in rural regions were treated over a 20-week pre-surgical period using a digital workflow that included intraoral scanning, 3D model design, and sequential aligner fabrication. The protocol minimized the number of in-office visits while engaging caregivers in home-based appliance management. Anatomical changes were assessed using 3D models at baseline and at treatment completion. <b>Results:</b> Significant reductions were observed in anterior cleft width (mean decrease: 5.38 mm, 95% CI: -7.58 to -3.18, <i>p</i> &lt; 0.001) and posterior cleft width (mean decrease: 3.39 mm, 95% CI: -4.79 to -1.99, <i>p</i> &lt; 0.001). Intermolar distance increased by 1.23 mm (<i>p</i> = 0.036), while intercanine width remained stable (<i>p</i> = 0.515), indicating preservation of maxillary arch form. Surgeons reported improved nasal symmetry and tissue alignment at the time of lip repair. <b>Conclusions:</b> This digitally planned NAM clear aligner protocol demonstrated clinical feasibility and effectiveness in reducing cleft width during the pre-surgical period. Findings should be interpreted with caution, given the retrospective design, lack of a control group, and absence of objective nasal outcome measures. Further studies are recommended to assess long-term outcomes and broader implementation potential.