OBJECTIVES: To examine hard and soft tissue changes in unilateral cleft lip and palate patients (UCLP) following maxillary distraction osteogenesis with the rigid external distraction (RED) device. MATERIAL and METHODS: Twelve Japanese non-syndromic UCLP (4 males and 8 females) who underwent maxillary distraction osteogenesis (mean maxillary advancement: 11.8 mm) at the mean age of 16.4 years for severe maxillary hypoplasia were used as subjects. Hard and soft tissue changes were analyzed using serial sets of cephalograms taken at following stages; 1) shortly before osteotomy, 2) immediately after distraction, 3) 6 months and 4) 1 year post-surgery. A paired t-test identified significant hard and soft tissue changes following surgery. Pearson correlation analysis and stepwise regression analysis were used to identify hard tissue changes relative to the maxillary advancement as well as soft tissue changes for hard tissue changes. RESULTS: Significant dental compensation such as inclination and elongation of maxillary anterior and molar teeth was found together with significant mandibular rotation in accordance to the maxillary advancement. Dental compensation was significantly related to mandibular rotation and design of oral appliance. In the 6 months follow-up period, significant skeletal and dental relapse was found, but not significant from 6 to 12 months follow-up period. Maxillary relapse was significantly related to the amount of changes produced by distraction and the severity of initial maxillary hypoplasia, while mandibular relapse was significantly related to maxillary skeletal and dental relapse. Remarkable improvement of the soft tissue profile was found due to the decreased frontonasal angle and increased nasal tip angle, which was significantly related to the hard tissue changes. CONCLUSION: Maxillary distraction osteogenesis using the RED system is a valuable surgical approach to improve facial dysmorphology in this disorder. However, more reinforced dental anchorage would be desirable to reduce dental compensation associated with this procedure.

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