Background: This is the first randomized controlled study aiming to compare the postoperative clinical morbidities in cleft lip and palate patients treated with distraction osteogenesis versus conventional orthognathic surgery.
Methods: Twenty-nine cleft lip and palate patients with moderate maxillary hypoplasia requiring a maxillary Le Fort I advancement of 4 to 10 mm were randomized into two groups for either internal maxillary distractors or immediate fragment transposition using miniplates and screw fixation. Clinical morbidities were recorded using standardized questionnaires. Skeletal and dental relapses were assessed using lateral cephalometric landmarks.
Results: In the distraction group, two of 15 patients developed infection around the distractors and one patient had an occlusal relapse. Among the 14 patients who received conventional orthognathic surgery, the complications included intraoperative hemorrhage (n = 1), plate exposure leading to sinusitis (n = 1), and occlusal relapse (n = 1). In the skeletal relapses of the osteotomy group, a statistically significant vertical relapse of the A point was noted during the second to twelfth weeks when compared with the distraction group. A statistically significant horizontal relapse of the A and P points during the eighth to twelfth weeks was noted when the osteotomy group was compared with the distraction group.
Conclusions: There were no major differences in the clinical morbidities between the osteotomy and distraction groups. Distraction provided better skeletal stability, whereas there was a significant amount of skeletal relapse in the first 12 weeks after conventional cleft maxillary osteotomy.