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© 2025 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

This study reports the application of a digitally guided presurgical molding protocol using clear aligners in infants with unilateral cleft lip and palate. The method proved feasible and safe, producing significant short-term reductions in cleft width with only mild, transient skin reactions observed. While qualitative improvements in nasal symmetry were observed, objective measures and long-term outcomes have yet to be determined. By leveraging digital planning and simplified appliance delivery, this approach has the potential to broaden access to early cleft care, though scalability and cost-effectiveness require further evaluation.

What are the main findings?

Digital NAM using clear aligners significantly reduced anterior (–5.38 mm) and posterior (–3.39 mm) cleft widths.

Intermolar width increased (+1.23 mm) and intercanine width remained stable, indicating preserved maxillary arch form during treatment.

What is the implication of the main finding?

A digitally planned, low-contact NAM clear aligner protocol can achieve effective presurgical molding with minimal in-office visits.

This model supports broader access to cleft care in underserved and remote populations by enabling caregiver participation and digital workflow scalability.

Background: 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. Objective: 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. Material and Methods: 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. Results: Significant reductions were observed in anterior cleft width (mean decrease: 5.38 mm, 95% CI: –7.58 to –3.18, p < 0.001) and posterior cleft width (mean decrease: 3.39 mm, 95% CI: –4.79 to –1.99, p < 0.001). Intermolar distance increased by 1.23 mm (p = 0.036), while intercanine width remained stable (p = 0.515), indicating preservation of maxillary arch form. Surgeons reported improved nasal symmetry and tissue alignment at the time of lip repair. Conclusions: 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.

Details

Title
Expanding Access to Presurgical Cleft Care: Digital Nasoalveolar Molding with Clear Aligners in a Rural Low-Income Population †
Author
Frazao, Diogo C 1 ; Salgado, Miguel A, C 2 ; Cody, Ryan J 3 ; Kay, Elizabeth M 4 ; Pretti Henrique 5   VIAFID ORCID Logo  ; Dave, Singh G 6 ; Pimenta, Luiz A 7   VIAFID ORCID Logo 

 Department of Science and Technology Applied to Dentistry, Institute of Science/Technology, Universidade Estadual Paulista “Júlio de Mesquita Filho” (Unesp), São José dos Campos, São Paulo 12245-000, Brazil; [email protected] 
 Department of Biosciences and Oral Diagnosis, Institute of Science and Technology, Sao Paulo State University, São Paulo 05508-020, Brazil; [email protected] 
 Department of Orthodontics, School of Dentistry, University of Texas, Houston, TX 78712, USA; [email protected] 
 Chapel Hill Adams School of Dentistry, University of North Carolina, Chapel Hill, NC 27599, USA; [email protected] 
 Department of Orthodontics, Federal University of Minas Gerais, Belo Horizonte 31270-901, Brazil; [email protected] 
 Sleep Medicine, Stanford University, Stanford, CA 94305, USA; [email protected] 
 Division of Prosthodontics, College of Dental Medicine Columbia University, New York, NY 10032, USA 
First page
1231
Publication year
2025
Publication date
2025
Publisher
MDPI AG
e-ISSN
22279067
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3254480148
Copyright
© 2025 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.