Maxillary distraction osteogenesis versus orthognathic surgery for cleft lip and palate patients.

Cochrane Database Syst Rev. 2016 Sep 30;9(9):CD010403. doi: 10.1002/14651858.CD010403.pub2.

Kloukos D(1), Fudalej P, Sequeira-Byron P, Katsaros C.

Author information:

(1)Department of Orthodontics and Dentofacial Orthopedics, School of Dental

Medicine, University of Bern, Freiburgstrasse 7, Bern, Switzerland, 3010.

Update in

Cochrane Database Syst Rev. 2018 Aug 10;8:CD010403.

BACKGROUND: Cleft 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.

OBJECTIVES: To 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 METHODS: We searched the following electronic databases: Cochrane Oral

Health’s Trials Register (to 16 February 2016), the Cochrane Central Register of

Controlled Trials (CENTRAL) (the Cochrane Library, 2016, Issue 1), MEDLINE Ovid

(1946 to 16 February 2016), Embase Ovid (1980 to 16 February 2016), LILACS

BIREME (1982 to 16 February 2016), the US National Institutes of Health Ongoing

Trials Register (ClinicalTrials.gov) (to 16 February 2016), and the World Health

Organization (WHO) International Clinical Trials Registry Platform (to 16

February 2016). There were no restrictions regarding language or date of

publication in the electronic searches. We performed handsearching of six

speciality journals and we checked the reference lists of all trials identified

for further studies.

SELECTION CRITERIA: We 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 ANALYSIS: Two 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 RESULTS: We 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’ CONCLUSIONS: 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.

DOI: 10.1002/14651858.CD010403.pub2

PMCID: PMC6452788
PMID: 27689965

Conflict of interest statement: Dimitrios Kloukos: none known Piotr Fudalej:

none known Patrick Sequeira‐Byron: none known Christos Katsaros: none known The

participating review authors declare that there is no financial conflict of

interest and that they do not have any associations with industry regarding the

subject of this review.