Soft tissue changes from maxillary distraction osteogenesis versus orthognathic surgery in patients with cleft lip and palate--a randomized controlled clinical trial.

Purpose: The objective of this randomized controlled clinical trial was to compare the soft tissue changes after maxillary advancement using conventional orthognathic surgery (CO) and distraction osteogenesis (DO) in patients with cleft lip and palate (CLP).

Materials And Methods: The study group of 39 CLP patients with maxillary hypoplasia underwent either CO or DO with 4 to 10 mm of maxillary advancement. Lateral cephalographs were taken preoperatively and postoperatively at regular intervals. A series of skeletal, dental, and soft tissue landmarks was used to evaluate the changes in the soft tissue and the correlation of hard and soft tissue changes and ratios.

Results: Significant differences were found between the CO and DO patients at A point in both maxillary advancement and downgrafting in the early follow-up period. On soft tissue landmarks of pronasale, subnasale, and labial superius, significant differences were found between the 2 groups at 6 months postoperatively only with maxillary advancement. There was better correlation of hard and soft tissue changes with maxillary advancement. The nasal projection was significantly different between the 2 groups at the early and intermediate period. There was much more consistent hard to soft tissue ratios in maxillary advancement with DO than with CO.

Conclusions: Both CO and DO can induce significant soft tissue changes of the upper lip and nose, particularly with maxillary advancement. DO generates more consistent hard to soft tissue ratios.