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Background: Distraction osteogenesis (DO) is rapidly becoming a mainstream surgical technique for correction of maxillary deficiency. The aim of this study was to compare the effectiveness of a newly designed tooth-borne osteogenic distraction device with conventional Le Fort 1 osteotomy in maxillary advancement of cleft lip and palate patients., Methods: The DO group consisted of 10 subjects (7 males, 3 females) with a mean age of 21.2 (SD 4.2) years. In these patients, the newly designed distraction device which exerted force anteroposteriorly was cemented after mobilization of the maxilla. After a latency period of 7 days, the distractor was activated twice daily by a total amount of 0.5 mm per day. The activation was continued for 3 weeks. After an 8-week consolidation period, the distraction appliance was removed. Cephalograms of DO patients were obtained at the start of distraction and at the end of consolidation. The Le Fort 1 group consisted of 11 subjects (6 males, 5 females) with a mean age of 22.3 (SD 3.7) years. Pre and postsurgery lateral cephalograms were obtained. t-test and paired t-test were used to evaluate the data., Results: At the end of treatment, the SNA angle of Le Fort 1 patients increased by 5.5° (SD 2.3) (P<0.001) and the SNA angle of DO patients increased by 3.4° (SD 2) (P<0.001)., Conclusions: Current evidence suggests that both conventional Le Fort 1 and tooth-borne osteogenic distraction device can effectively advance the maxilla forward in patients with cleft lip.