Can Use of Rigid Fixation After Consolidation Increase Stability in Cleft Patients Following Distraction Osteogenesis?

Abstract

The stability of distraction osteogenesis (DO) is an important issue in maxillary advancement for patients with cleft lip and palate (CLP). The aim of this study was to evaluate postoperative stability in patients with and without internal fixation after removing maxillary distraction devices. This randomized clinical trial assessed patients with CLP who needed maxillary advancement greater than 6mm; they were randomly assigned to 1 of 2 groups. In group 1, distraction devices were removed 3months after distraction and then 4L miniplates were placed bilaterally in the maxilla. In group 2 (controls), no miniplates were placed after removing the distraction devices. Lateral cephalograms taken on 3 occasions (preoperatively, immediately after removing the distraction device, and after 18months) were used to determine vertical and horizontal changes at the A point. Twenty-two patients (n=11 per group) were included. There was no significant difference between groups for horizontal relapse (P=.79). The results showed no significant difference for vertical relapse between the 2 groups (P=.11). The Pearson correlation test showed a correlation between the amount of advancement and horizontal relapse at the A point in group 1 (P=.01) and group 2 (P=.001). In group 1, for every 1-mm maxillary advancement, a 0.36-mm relapse was seen (B=0.36, P=.01). In group 2, for every 1-mm maxillary advancement, a 0.43-mm relapse was seen (B=0.43, P=.001). According to these results, rigid fixation after consolidation did not increase stability in patients with CLP after DO.