Cleft lip and palate (CLP) is a common birth defect. The prevalence of CLP globally is between 1 in 5-700 live births making it more common that neural tube defects or Down’s syndrome. CLP treatment is prolonged and maxillary hypoplasia is a common clinical problem. Typically, this has been treated using orthognathic surgery, but distraction osteogenesis is increasingly being used in the treatment of craniofacial anomalies.
The aim of this review was to assess 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.
Searches were conducted in the Cochrane Oral Health’s Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, LILACS BIREME Virtual Health Library (Latin American and Caribbean Health Science Information database), the US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform with no restrictions on date or language.
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 were considered. Two reviewers selected studies and independently extracted data and assessed risk of bias and standard Cochrane analysis methods were used.
- 6 publications related to a single trial involving 47 patients were included.
- The trial was considered to at high risk of bias.
- Both maxillary distraction osteogenesis and orthognathic surgery produced notable hard and soft tissue improvements.
- The distraction group demonstrated a greater maxillary advancement, (advancement of Subspinale A-point) a mean difference of 4.40 mm (95% CI 0.24 to 8.56) was recorded 2 years postop.
- 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.
- 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.
The authors concluded: –
This 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.
This Cochrane review update (Dental Elf -11th Oct 2016) found no new completed trials or ongoing trial registrations of these two techniques for the treatment of maxillary hypoplasia in CLP patients. Given that the single reported trial was reported 10 years ago this is perhaps disappointing. However the researches did note that the design and conduct of trials is challenging and suggest that potential trialists should consider the IDEAL recommendations for evaluating surgical interventions.
The reviewers indicate that they identified several clinical studies of these interventions the majority being retrospective studies, case series or case reports but they highlight the need for high quality RCTs.
Kloukos D, Fudalej P, Sequeira-Byron P, Katsaros C. Maxillary distraction osteogenesis versus orthognathic surgery for cleft lip and palate patients. Cochrane Database of Systematic Reviews 2018, Issue 8. Art. No.: CD010403. DOI: 10.1002/14651858.CD010403.pub3.
Dental Elf -11th Oct 2016