• Dimitrios Kloukos, Piotr Fudalej, Patrick Sequeira-Byron, and Christos Katsaros.
• Department of Orthodontics and Dentofacial Orthopedics, School of Dental Medicine, University of Bern, Freiburgstrasse 7, Bern, Switzerland, 3010.
• Cochrane Db Syst Rev. 2018 Aug 10; 8: CD010403.

BackgroundCleft lip and palate is one of the most common birth defects and can cause difficulties with feeding, speech and hearing, as well as psychosocial problems. Treatment of orofacial clefts is prolonged; it typically commences after birth and lasts until the child reaches adulthood or even into adulthood. Residual deformities, functional disturbances, or both, are frequently seen in adults with a repaired cleft. Conventional orthognathic surgery, such as Le Fort I osteotomy, is often performed for the correction of maxillary hypoplasia. An alternative intervention is distraction osteogenesis, which achieves bone lengthening by gradual mechanical distraction. This review is an update of the original version that was published in 2016.ObjectivesTo provide evidence regarding the effects and long-term results of maxillary distraction osteogenesis compared to orthognathic surgery for the treatment of hypoplastic maxilla in people with cleft lip and palate.Search MethodsCochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 15 May 2018), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2018, Issue 4), MEDLINE Ovid (1946 to 15 May 2018), Embase Ovid (1980 to 15 May 2018), and LILACS BIREME Virtual Health Library (Latin American and Caribbean Health Science Information database; from 1982 to 15 May 2018). The US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases.Selection CriteriaWe included randomised controlled trials (RCTs) comparing maxillary distraction osteogenesis to conventional Le Fort I osteotomy for the correction of cleft lip and palate maxillary hypoplasia in non-syndromic cleft patients aged 15 years or older.Data Collection And AnalysisTwo review authors assessed studies for eligibility. Two review authors independently extracted data and assessed the risk of bias in the included studies. We contacted trial authors for clarification or missing information whenever possible. All standard methodological procedures expected by Cochrane were used.Main ResultsWe found six publications involving a total of 47 participants requiring maxillary advancement of 4 mm to 10 mm. All of them related to a single trial performed between 2002 and 2008 at the University of Hong Kong, but not all of the publications reported outcomes from all 47 participants. The study compared maxillary distraction osteogenesis with orthognathic surgery, and included participants from 13 to 45 years of age.Results and conclusions should be interpreted with caution given the fact that this was a single trial at high risk of bias, with a small sample size.The main outcomes assessed were hard and soft tissue changes, skeletal relapse, effects on speech and velopharyngeal function, psychological status, and clinical morbidities.Both interventions produced notable hard and soft tissue improvements. Nevertheless, the distraction group demonstrated a greater maxillary advancement, evaluated as the advancement of Subspinale A-point: a mean difference of 4.40 mm (95% CI 0.24 to 8.56) was recorded two years postoperatively.Horizontal relapse of the maxilla was significantly less in the distraction osteogenesis group five years after surgery. A total forward movement of A-point of 2.27 mm was noted for the distraction group, whereas a backward movement of 2.53 mm was recorded for the osteotomy group (mean difference 4.8 mm, 95% CI 0.41 to 9.19).No statistically significant differences could be detected between the groups in speech outcomes, when evaluated through resonance (hypernasality) at 17 months postoperatively (RR 0.11, 95% CI 0.01 to 1.85) and nasal emissions at 17 months postoperatively (RR 3.00, 95% CI 0.14 to 66.53), or in velopharyngeal function at the same time point (RR 1.28, 95% CI 0.65 to 2.52).Maxillary distraction initially lowered social self-esteem at least until the distractors were removed, at three months postoperatively, compared to the osteotomy group, but this improved over time and the distraction group had higher satisfaction with life in the long term (two years after surgery) (MD 2.95, 95% CI 014 to 5.76).Adverse effects, in terms of clinical morbidities, included mainly occlusal relapse and mucosal infection, with the frequency being similar between groups (3/15 participants in the distraction osteogenesis group and 3/14 participants in the osteotomy group). There was no severe harm to any participant.Authors' ConclusionsThis review found only one small randomised controlled trial concerning the effectiveness of distraction osteogenesis compared to conventional orthognathic surgery. The available evidence is of very low quality, which indicates that further research is likely to change the estimate of the effect. Based on measured outcomes, distraction osteogenesis may produce more satisfactory results; however, further prospective research comprising assessment of a larger sample size with participants with different facial characteristics is required to confirm possible true differences between interventions.

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