The Use of Presurgical Lip-Alveolus-Nose Approximation in Early Infant Orthopedics: A Clinical Case Series

Background and Objectives: Presurgical infant orthopedics aims to reduce cleft severity and facilitate primary surgical repair during the early neonatal period, when increased tissue plasticity enhances molding. Nasoalveolar molding is widely used but requires intraoral appliances, laboratory support, specialized training, and frequent follow-up visits, which may limit accessibility and adherence. This case series reports the clinical application of presurgical lip-alveolus-nose approximation (PLANA), an extraoral technique for early presurgical cleft management, and describes the clinical changes observed during treatment in four infants. Materials and Methods: A prospective case series conducted in neonates with non-syndromic unilateral or bilateral cleft lip and/or palate referred within the first 10 days of life to the Alabama Cleft Center. Treatment consisted of a prefabricated silicone nasal aligner combined with hydrocolloid lip adhesive taping. No intraoral plates or dental impressions were used. Devices were worn 20 to 22 h daily. Follow up occurred every 2 to 4 weeks, with remote monitoring used when appropriate. Qualitative clinical observations focused on apparent changes in nasal symmetry, columellar length, septal alignment, nasal tip projection, premaxillary position, nostril dimensions, alar base width, cleft width, and lip approximation, as well as feeding tolerance, skin tolerance, and treatment adherence. These observations were assessed qualitatively through serial clinical examinations and clinical photographs; no standardized quantitative morphometric measurements were performed. Results: Four infants with complete unilateral or bilateral cleft lip and palate received PLANA treatment. Serial clinical examinations and photographs documented qualitative changes in nasolabial morphology over the course of treatment in all four patients. Qualitative clinical assessment of serial photographs and examinations suggested greater apparent nasal symmetry, apparent columellar elongation, more central-appearing nasal alignment, increased apparent nasal tip projection, apparent cleft-width reduction, and progressive lip approximation. In unilateral clefts, changes were observed in both the cleft and non-cleft nasal sides, while bilateral clefts demonstrated changes in nasal morphology bilaterally. No device-related complications or clinically significant skin intolerance were documented during the reported treatment periods. Parent-reported device wear was approximately 20-22 h per day. Conclusions: In this four-patient prospective descriptive case series, PLANA was applied clinically, with no clinically significant treatment-related complications documented during the reported treatment periods. Serial clinical observations suggested changes in nasolabial morphology during treatment. Given the small sample size, absence of a contemporaneous control group, and qualitative nature of the assessments, these findings should be interpreted as preliminary and hypothesis-generating rather than as evidence of treatment efficacy or comparative effectiveness. Larger prospective, multicenter comparative studies incorporating standardized quantitative measurements, objective adherence assessment, and long-term surgical and aesthetic outcomes are needed to evaluate the effectiveness, reproducibility, and clinical applicability of the PLANA approach.