Effect of Presurgical Orthodontic Molding Using Nasoalveolar Molding Versus Passive Alveolar Molding on Newborns With Unilateral Cleft Lip and Palate

What this Trial Is About

Orofacial clefts are common birth deformities that include isolated cleft palate, cleft lip, or cleft lip palate. Newborns with unilateral complete cleft lip and palate UCLP often have significant facial asymmetries, such as a wide and flat nose wing and deviation of the noses columella and philtrum to the non-cleft side. Since these asymmetries may persist after surgical lip closure, presurgical orthodontic treatments are important to improve nose symmetry and create better conditions for surgery. This study compares two presurgical orthodontic approaches for newborns with UCLP to better understand their effects on facial growth and symmetry during the first year of life. The study evaluates two treatments Nasoalveolar Molding NAM and passive Alveolar Molding pAM. Both begin within the first week after birth with a palate plate inserted. NAM includes an added nasal stent after one week to encourage nasal growth and shape adjustment, while pAM uses the palate plate without the stent. Treatments continue until surgical lip closure at 6 to 7 months, followed by use of a nostril retainer and further treatment until palate closure at 10 to 12 months. Newborns are randomly assigned to either the NAM group or the pAM group. Participants will be assessed at specific points from birth through the first two years of life. Measurements include nostril width, nasal shape and symmetry, cleft width, maxillary growth, facial asymmetries, and facial perception. Primary outcomes focus on changes in columella deviation angle and nostril width from birth to surgical lip closure. Secondary outcomes track nasal and alveolar development, symmetry, and facial dynamics up to one year after palate closure. The study aims to provide detailed insight into how these treatments influence facial growth and symmetry in infants with UCLP.

Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate