Novel 3-D Analysis for the Assessment of Cleft Dimensions on Digital Models of Infants With Unilateral Cleft Lip and Palate.

OBJECTIVE: To present a 3-D standardized analysis of cleft dimensions. MATERIALS: Thirty-one plaster casts of unilateral cleft lip and palate (UCLP) infants were laser scanned. Landmarks and coordinate system were defined. Linear distances and surfaces were measured, and the ratio between cleft and palatal area was calculated (3-D infant cleft severity ratio [3D ICSR]). The digitally measured areas were compared with silicone membranes, adapted to the plaster casts, and analyzed by optic microscopy. MAIN OUTCOME MEASURES: Repeatability, reproducibility, and validity. RESULTS: Bland-Altman plots showed minor bias for anterior cleft width (0.16 mm), arch length (0.23 mm), and palatal surface (-9.18 mm(2)). The random error was maximum 0.78 mm for linear measurements and 12.1 mm(2) for area measurements, reliability of 3D ICSR was 0.99 (intraclass correlation coefficient), differences between measurements on digital and plaster models were less than 2%. CONCLUSIONS: The method offers valid and reproducible 3-D assessment of cleft size and morphology. 3-D infant cleft severity ratio can be used as baseline value for surgical planning and may have a role in predicting dentofacial development.