Assessment of clinical outcomes with an adhesive based Nasoalveolar Molding (NAM) appliance in infants with Unilateral Cleft Lip and Palate

Abstract

AbstractAim: The aim of this study was to measure the amount of alveolar cleft closure and corresponding soft tissue changes attained with an adhesive based (NAM) technique in infants with unilateral cleft lip and palate (UCLP). Methods: In this retrospective cohort study, records of seventy-seven patients with unilateral cleft lip and palate that met the inclusion criteria were identified. Forty-four of these participants had corresponding facial photographs of sufficient quality to assess soft tissue outcomes. The casts of the participants were converted into STL files using an i-Tero element® scanner and analyzed on OrthoCAD® software. For the hard tissue outcomes anterior inter cleft distance and posterior inter arch widths were measured at start of treatment and after treatment was completed. The difference between these measurements at start and finish were computed. For the soft tissue outcomes, the columella deviation angle was measured on cropped photographs at start and finish using GIMP software, and the differences between them were computed. Results: Intra class correlation coefficient (ICC) was utilized to determine within operator agreement and Bland Altman Plots were used to demonstrate the intra operator agreement. Both were deemed high and within 1 degree and 0.5mm for the measurements. Spearman correlation coefficient (R) was -0.58 for the anterior inter cleft distance and -0.41 for posterior inter arch width. Median reduction in anterior inter cleft distance was 4.75mm. Median increase in posterior inter arch width was 1.2mm and median improvement in columella position was 31.2 degrees. Conclusions: The adhesive based NAM technique employed in the present study is an effective method for conducting NAM therapy in infants with cleft lip and palate.