Reliability and validity of a modified lateral cephalometric analysis for evaluation of craniofacial morphology and growth in patients with clefts.

In previous intercenter studies on craniofacial morphology in patients with unilateral cleft lip and palate, probable surgical-induced changes in mandibular morphology and spatial position related to posterior vertical maxillary morphology were identified by our group. These changes could not be detected in other cephalometric cleft studies because posterior vertical maxillary height and vertical mandibular ramus length were not measured simultaneously. This study presents a modified digital lateral cephalometric hard and soft tissue analysis (Onyx Ceph software, version 2.5.6.; Image Instruments GmbH, Chemnitz, Germany) to evaluate craniofacial morphology and growth patterns in patients with clefts. Forty controls without clefts were used to evaluate the accuracy, reliability, and validity of this analysis for future cleft research. Measurement error according to the method of Bland and Altman was less than 1.00 degrees and 1.00 mm, whereas squared correlation coefficients (r) according to the method of Sackett et al showed a high reliability. Method comparison tests according to the method of Bland and Altman clearly showed that the modified digital cephalometric analysis ("test") was valid for future cleft research compared with the "gold standard" (conventional cephalometry).