Design of Unilateral Complete Presurgical Nasoalveolar Molding (PNAM) Corrector Based on Feature Points Extraction of Complex 3D Surface

Cleft lip and palate is a congenital maxillofacial deformity. Unilateral complete cleft lip and palate is one of the most common clinical types. Nasal alveolar molding (PNAM) is a recognized strategy for the treatment of cleft lip and palate. However, the current design of PNAM devices mainly relies on the subjective experience of doctors. The purpose of this paper is to describe the design and manufacture of a new computer-aided design appliance, which can be applied to the presurgical nasoalveolar molding of unilateral complete cleft lip and palate, eliminate individual differences, and improve production efficiency. In this paper, seven feature points on the healthy side and the affected side are extracted by the method of Gaussian curvature and ridge line extraction, and the healthy side rotation and built-in model are designed by using these seven feature points, which can quickly generate eight treatment stages of PNAM. The correction effects of the PNAM appliance designed in this paper were compared with the original maxillary model and the clinical PNAM appliance (hand-made by subjective experience) from the aspects of alveolar fissure width and symmetry. The PNAM appliance designed in this paper can effectively improve the symmetry of patients with unilateral complete cleft lip and palate (morphological similarity: t = 3.250, p = 0.01; length similarity: t = 1.559, p = 0.150) and reduce the width of alveolar cleft (t = 8.330, p < 0.01). This can fully achieve the therapeutic effect of PNAM appliances prepared by experienced doctors and is more efficient. The method based on complex 3D surface feature point extraction can provide the basis for the design and evaluation of a unilateral complete PNAM correction model, improve the design and production efficiency of unilateral complete cleft lip and palate appliance, eliminate the design problems caused by individual differences, and reduce the burden of doctors.