Cochrane · intervention · CD010403
Maxillary distraction osteogenesis versus orthognathic surgery for cleft lip and palate patients
Kloukos, D, Fudalej, P, Sequeira‐Byron, P, et al. · Cochrane Database of Systematic Reviews · 2018 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
9
current version
GRADE rated
6
No studies
0
Included studies
1
as reported
No studies 0 · 0%Ungraded 3 · 33.3%Very low 6 · 66.7%Low 0 · 0%Moderate 0 · 0%High 0 · 0%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Adolescents or adults, 15 years of age or older, with an established diagnosis of complete cleft lip and alveolar process, complete unilateral cleft lip and palate, and complete bilateral cleft lip and palate (involving the alveolar process). Excluded participants with syndromic conditions, atypical clefts (e.g. midline) or unclear diagnosis regarding the type of cleft. | 47 participants (one trial, six publications), aged 13 to 45 years, requiring maxillary advancement of 4 mm to 10 mm; University of Hong Kong (2002 to 2008) |
| Intervention | Maxillary distraction osteogenesis | Maxillary (internal) distraction osteogenesis (n=25) |
| Comparison | Orthognathic surgery (conventional Le Fort I osteotomy) | Conventional Le Fort I osteotomy (n=22) |
| Outcomes | Primary: 1. Midfacial soft and hard tissue changes (lateral cephalometric radiography and/or photographic superimposition); transversal maxillary changes (anteroposterior cephalometric radiography or digital cast models). 2. Surgical relapse/stability (lateral cephalographs at different postoperative times). 3. Perceptual speech assessment (articulation; resonance [hypernasality and hyponasality]; nasal emission). Secondary: 1. Instrumental assessment of velopharyngeal function (nasoendoscopy/videonasopharyngoscopy/videofluoroscopy). 2. Patient-reported outcomes: self-esteem and psychological adjustment (validated questionnaires). 3. Adverse effects or clinical morbidities (e.g. mucosal infection, sinusitis, transection of vessels). | Maxillary advancement / hard tissue changes (n=39); Midfacial soft tissue changes (n=39); Long-term skeletal relapse/stability (n=16 at 5 years); Speech: resonance and nasal emission (n=22); Velopharyngeal function (n=21); Psychological status: SWLS, CFSEI, SADS (n=30); Clinical morbidities (n=29) |
| Study designs | Randomised controlled trials (RCTs); non-randomised or quasi-randomised controlled trials were not eligible | One RCT at high risk of bias (n=1) |
| Timing | Not specified | Follow-up varied: 6 months, 1 year and 2 years (soft/hard tissue, psychological status), 17 months (speech, velopharyngeal function), 12 months (clinical morbidities) and up to 5 years (skeletal relapse) |
Search date: 2018-05. Databases: Cochrane Oral Health's Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE Ovid; Embase Ovid; LILACS BIREME; ClinicalTrials.gov; WHO International Clinical Trials Registry Platform
Questions and results
Current version onlyMaxillary distraction osteogenesis vs Orthognathic surgery (conventional Le Fort I osteotomy)
Population: Adolescents or adults (15 years or older) with an established diagnosis of complete cleft lip and alveolar process, or complete unilateral or bilateral cleft lip and palate (involving the alveolar process); non-syndromic, requiring surgical correction of maxillary hypoplasia
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Long-term skeletal relapse/stability (horizontal movement of A-point) 5 years (long-term) | MD 4.80 [0.41, 9.19] | 1 study · 16 participants | Very low Downgraded: risk of bias, indirectness |
Psychological status: social self-esteem (Culture-Free Self-Esteem Inventory subset); also general self-esteem and Social Avoidance and Distress Scale up to 2 years (significant at 3 months) | Results text (Ungraded; not in SoF): social self-esteem (subset of the Culture-Free Self-Esteem Inventory, CFSEI) - DO participants had lower social self-esteem in the first three months postoperatively, with a… | 1 study · 30 participants | Ungraded |
Midfacial soft tissue changes (facial profile landmarks: pronasale, subnasale, stomion superius, labrale superius) 2 years | Results text (Ungraded; not in SoF): both groups showed notable positive soft tissue changes of the upper lip and nose after maxillary advancement (39 participants). Between-group soft tissue differences at 2 years… | 1 study · 39 participants | Ungraded |
Clinical morbidities (adverse effects) 12 months | SoF (Very Low): Clinical morbidities assessed with questionnaires, follow-up 12 months; risk with orthognathic surgery 3/14; risk with maxillary distraction osteogenesis 3/15; relative effect -; 29 participants (1… 3/14 (orthognathic surgery) vs 3/15 (maxillary distraction osteogenesis) | 1 study · 29 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Speech: resonance (hypernasality) (deterioration/improvement) 17 months (mean) | RR 0.11 [0.01, 1.85] 364 per 1000 (deteriorated participants with orthognathic surgery) vs 40 per 1000 | 1 study · 22 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Velopharyngeal function (complete velopharyngeal closure; deterioration/improvement) 17 months (mean) | RR 1.28 [0.65, 2.52] 545 per 1000 (participants with complete velopharyngeal closure, orthognathic surgery) vs 425 per 1000 | 1 study · 21 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Psychological status: satisfaction with life (Satisfaction With Life Scale, SWLS) 2 years | MD 2.95 [0.14, 5.76] | 1 study · 30 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Maxillary advancement (midfacial hard tissue change; Subspinale A-point) 2 years | MD 4.40 [0.24, 8.56] | 1 study · 39 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Speech: nasal emission 17 months | RR 3.00 [0.14, 66.53] | 1 study · 22 participants | Ungraded |
Maxillary distraction osteogenesis vs Orthognathic surgery (conventional Le Fort I osteotomy)
Population: Adolescents or adults (15 years or older) with an established diagnosis of complete cleft lip and alveolar process, or complete unilateral or bilateral cleft lip and palate (involving the alveolar process); non-syndromic, requiring surgical correction of maxillary hypoplasia
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Speech: nasal emission 17 months | RR 3.00 [0.14, 66.53] | 1 study · 22 participants | Ungraded |
Psychological status: social self-esteem (Culture-Free Self-Esteem Inventory subset); also general self-esteem and Social Avoidance and Distress Scale up to 2 years (significant at 3 months) | Results text (Ungraded; not in SoF): social self-esteem (subset of the Culture-Free Self-Esteem Inventory, CFSEI) - DO participants had lower social self-esteem in the first three months postoperatively, with a… | 1 study · 30 participants | Ungraded |
Clinical morbidities (adverse effects) 12 months | SoF (Very Low): Clinical morbidities assessed with questionnaires, follow-up 12 months; risk with orthognathic surgery 3/14; risk with maxillary distraction osteogenesis 3/15; relative effect -; 29 participants (1… 3/14 (orthognathic surgery) vs 3/15 (maxillary distraction osteogenesis) | 1 study · 29 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Midfacial soft tissue changes (facial profile landmarks: pronasale, subnasale, stomion superius, labrale superius) 2 years | Results text (Ungraded; not in SoF): both groups showed notable positive soft tissue changes of the upper lip and nose after maxillary advancement (39 participants). Between-group soft tissue differences at 2 years… | 1 study · 39 participants | Ungraded |
Maxillary advancement (midfacial hard tissue change; Subspinale A-point) 2 years | MD 4.40 [0.24, 8.56] | 1 study · 39 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Velopharyngeal function (complete velopharyngeal closure; deterioration/improvement) 17 months (mean) | RR 1.28 [0.65, 2.52] 545 per 1000 (participants with complete velopharyngeal closure, orthognathic surgery) vs 425 per 1000 | 1 study · 21 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Speech: resonance (hypernasality) (deterioration/improvement) 17 months (mean) | RR 0.11 [0.01, 1.85] 364 per 1000 (deteriorated participants with orthognathic surgery) vs 40 per 1000 | 1 study · 22 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Long-term skeletal relapse/stability (horizontal movement of A-point) 5 years (long-term) | MD 4.80 [0.41, 9.19] | 1 study · 16 participants | Very low Downgraded: risk of bias, indirectness |
Psychological status: satisfaction with life (Satisfaction With Life Scale, SWLS) 2 years | MD 2.95 [0.14, 5.76] | 1 study · 30 participants | Very low Downgraded: risk of bias, imprecision, indirectness |
Maxillary distraction osteogenesis vs Orthognathic surgery (conventional Le Fort I osteotomy)
Population: Adolescents or adults (15 years or older) with an established diagnosis of complete cleft lip and alveolar process, or complete unilateral or bilateral cleft lip and palate (involving the alveolar process); non-syndromic, requiring surgical correction of maxillary hypoplasia
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Midfacial soft and hard tissue changes (lateral cephalometric radiography and/or photographic superimposition); transversal maxillary changes | no estimate extracted | NR | No studies |
Instrumental assessment of velopharyngeal function (nasoendoscopy / videonasopharyngoscopy / videofluoroscopy) | no estimate extracted | NR | No studies |
Adverse effects / clinical morbidities (e.g. mucosal infection, sinusitis, transection of vessels) | no estimate extracted | NR | No studies |
Surgical relapse/stability (lateral cephalographs taken at different postoperative times) | no estimate extracted | NR | No studies |
Self-esteem and psychological adjustment (validated questionnaires) | no estimate extracted | NR | No studies |
Perceptual speech assessment (articulation; resonance [hypernasality and hyponasality]; nasal emission) | no estimate extracted | NR | No studies |