Relapse-related factors of Le Fort I osteotomy in cleft lip and palate patients: A systematic review and meta-analysis.

A systematic review search was based on the PICOS approach, as follows: population: cleft lip and palate patients; intervention: Le Fort I osteotomy; comparator: different surgical protocols; outcome: stability, recurrence or surgical complications; study designs: only case reports were excluded from the review. No restrictions were placed on language or year of publication. Risk of bias was analyzed, heterogeneity was assessed, and subgroup analysis was performed using a level of significance of 1% (p = 0.01). The search identified 248 citations, from which 29 studies were selected and a total of 797 patients enrolled. The level of agreement between the authors was considered excellent (k = 0.810 for study selection and k = 0.941 for study eligibility). Our results reported a mean maxillary advancement of 5.69 mm, a mean vertical downward/upward of 2.85/-2.02 mm and a mean clockwise rotation of 4.15°. Greater surgical relapse rates were reported for vertical downward movement (-1.13 mm, 39.6%), followed by clockwise rotation (-1.41°, 33.9%), sagittal (-0.99 mm, 17.4%) and vertical upward (0.11 mm, 5.4%) movements. No relevance was found regarding the type of cleft, the type of Le Fort I osteotomy, concomitant bone grafting, surgical overcorrection, postoperative rigid or elastic intermaxillary fixation, or retention splint. Study limitations were heterogeneity and the low number of high-quality studies. In spite of reported high relapse rates, Le Fort I osteotomy for maxillary reposition is the first-choice procedure for selected cleft lip and palate patients in whom extensive maxillary movements are not required, because of its safety and its three-dimensional movement versatility in one-step surgery. Otherwise, distraction osteogenesis should be considered as the gold standard treatment.