Premaxilla Manipulation Technique for Molding Deviated and Rotated Premaxilla in Bilateral Cleft Lip Palate Neonates: A Preliminary Study.

ObjectiveTo assess the efficacy of the premaxilla manipulation technique (PMT) for fast correction of deviated and rotated premaxilla.DesignProspective cohort study with repeated measures.SettingTertiary cleft and craniofacial center within an academic institution/hospital.PatientsNine non-syndromic neonates with bilateral cleft lip and palate (BCLP) presenting for management of deviated, rotated, and protruded premaxilla.InterventionsNasoalveolar molding (NAM) therapy after one-step PMT during impression-taking.Main Outcome MeasuresResolution of deviation, rotation, and protrusion of the premaxilla measured by angular photogrammetry using ImageJ software on standardized photographs taken at 4 different timepoints, T0 (beginning), T1 (1-2 weeks), T2 (1 month), and T3 (before cheiloplasty).ResultsNo adverse events occurred during NAM therapy (mean duration: 80.85 ± 24.18 days), which began at a mean infant age of 17.5 ± 8.19 days. Reliability of photogrammetry was high (intraclass correlation coefficient r = 0.890, P < .001). Premaxillary deviation and rotation demonstrated significant immediate correction by T1 (12 ± 6.09 days), decreasing from 18.28° to -2.43° and 19.34° to 3.56°, respectively (both False Discovery Rate-adjusted P = .015), and stabilizing thereafter. Conversely, premaxillary protrusion exhibited a continuous, stepwise reduction across all intervals, decreasing significantly from 40.16° at T0 to 32.27° at T1 (P = .012) and continued to improve significantly through T3.ConclusionsThe PMT suggests potential effectiveness in correcting the premaxillary deviation and rotation in infants with BCLP. The limitations of small sample size due to the preliminary nature of the study and 2D photogrammetry call for a long-term clinical trial comparing techniques utilizing 3D imaging.