3-Dimensional Evaluation of Two PNAM Techniques (Modified Grayson & AlignerNAM) on Facial Soft Tissue Morphology: A Randomised Clinical Trial

Abstract

Objective Evaluate facial changes after Presurgical Naso-Alveolar Molding (PNAM) in unilateral cleft lip and palate (UCLP) patients treated with Modified Grayson Technique and AlignerNAM (with DynaCleft nasal elevator) using a 3D facial scan. Design Randomised clinical trial. Setting Institutional study. Participants: 20 UCLP patients allocated to two groups (10 patients each). Interventions Group A patients underwent PNAM with Modified Grayson Technique and Group B patients underwent AlignerNAM (with DynaCleft nasal elevator). Their 3D facial scans were obtained by using an iOSbased application (Bellus3D FaceApp) mounted on a novel frame. These .stl files were analysed using 3D software (GOM INSPECT) at three-time intervals; before intervention (T0), after intervention (T1) and one month after lip repair surgery (T2). Main Outcome Measure(s) Changes in facial and nasolabial morphology. Results Both techniques brought significant improvement in the columellar length, nasal tip projection, columella angle, nasal tip angle and a significant reduction in cleft width. At T1, a statistically significant difference in angular and linear measurements was present in both groups. At T2, no statistically significant difference in linear parameters was observed between the two groups except for the outer lateral height of the non-cleft side, basal lateral height of the non-cleft side, and philtrum width. Similar pattern was observed in angular measurements with no statistically significant difference between the two groups except in nasolabial angle, anterior nasal base triangle III, and anterior nasal root triangle. Conclusions Aligner NAM and Modified Grayson technique are equally effective PNAM methods with similar clinical results in nasolabial morphology after lip repair surgery.