Cochrane · intervention · CD008050
Secondary bone grafting for alveolar cleft in children with cleft lip or cleft lip and palate
Guo, J, Li, C, Zhang, Q, et al. · Cochrane Database of Systematic Reviews · 2011 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
15
current version
GRADE rated
0
No studies
2
Included studies
2
as reported
No studies 2 · 13.3%Ungraded 13 · 86.7%Very low 0 · 0%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 | Patients with the diagnosis of unilateral cleft lip and/or palate and bilateral cleft lip and/or palate involving the alveolar process (complete or incomplete alveolar cleft types; cleft types involving a Simonart band); patients greater than 5 years of age. Exclusion: edentulous premaxilla; atypical or non-described cleft diagnoses; associated syndromic conditions. | Skeletally mature unilateral cleft lip and palate patients with an alveolar cleft defect, mean age 16.1 years (n=21); unilateral or bilateral cleft lip and palate patients aged 7 to 16 years (n=27) |
| Intervention | Any form of secondary alveolar bone grafting (undertaken in patients greater than 5 years of age); comparisons included variations in timing, donor sites, bone substitutes and technique. | InFuse bone graft (collagen matrix) impregnated with rhBMP-2 (n=9); Traditional iliac bone grafting plus fibrin glue (n=13) |
| Comparison | Variations in timing, donor sites, bone substitutes and technique (a different secondary bone grafting method) | Traditional iliac crest cancellous bone graft (n=12); Traditional iliac bone grafting alone (n=14) |
| Outcomes | Primary: Bone graft healing (alveolar ridge and augmentation of the nasal alar base) by radiographic assessment (2D and 3D images) and clinical assessment. Secondary: Morbidity of donor site; successful rate of insertion of an implant or integration of denture in the alveolar cleft region; rate of tooth eruption in the line of the alveolar cleft; gingival health; quality of life after surgery (e.g. postoperative pain, outpatient procedure, length of hospital stay); adverse events of secondary bone grafting. | Clinical assessment: alveolar ridge healing (n=21); Clinical assessment: nasal alar base augmentation (n=21); Radiographic assessment: Panorex scan (n=21); Radiographic assessment: three-dimensional CT scan (n=21); Radiographic assessment: periapical film (n=21); Length of hospital stay (n=21); Number discharged on same day as surgery (n=21); Postoperative complication: oronasal fistula (n=21); Postoperative complication: loss of bone graft (n=21); Radiographic assessment: coronal bone volume (n=27); Radiographic assessment: coronal bone density (n=27); Postoperative complication: wound infection (n=27); Postoperative complication: dehiscence (n=27) |
| Study designs | Only randomized controlled clinical trials (RCTs) | 2 parallel-group randomized controlled trials (both assessed at high risk of bias) |
| Timing | Not specified | Radiographic follow-up at 1 year (Dickinson 2008); follow-up at least 3 months (Segura-Castillo 2005) |
Search date: 2011-02. Databases: Cochrane Oral Health Group's Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (OVID); EMBASE (OVID); Chinese Biomedical Literature Database (CBM); WHO International Clinical Trials Registry Platform
Questions and results
Current version onlyArtificial bone graft: InFuse (collagen matrix) impregnated with rhBMP-2 vs Traditional iliac crest cancellous bone graft
Population: Skeletally mature patients with unilateral cleft lip and palate and an alveolar cleft defect (>5 years; mean age 16.1 years)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Length of hospital stay (days) | MD -1.40 [-1.92, -0.88] | 1 study · 21 participants | Ungraded |
Postoperative complication: persistent oronasal fistula | RR 0.19 [0.01, 3.23] | 1 study · 21 participants | Ungraded |
Radiographic assessment: three-dimensional CT scan (0 to 3 grading scale) 1 year | MD 0.90 [0.41, 1.39] | 1 study · 21 participants | Ungraded |
Clinical assessment: alveolar ridge healing (0 to 3 grading scale) | MD 0.90 [0.64, 1.16] | 1 study · 21 participants | Ungraded |
Number of participants discharged on the same day as surgery | RR 20 | 1 study · 21 participants | Ungraded |
Radiographic assessment: periapical film (0 to 3 grading scale) 1 year | MD 0.60 [0.30, 0.90] | 1 study · 21 participants | Ungraded |
Clinical assessment: nasal alar base augmentation (0 to 3 grading scale) | MD 0.20 [-0.01, 0.41] | 1 study · 21 participants | Ungraded |
Radiographic assessment: Panorex scan (0 to 3 grading scale) 1 year | MD 0.90 [0.41, 1.39] | 1 study · 21 participants | Ungraded |
Postoperative complication: (partial) loss of bone graft | RR 0.12 [0.01, 1.89] | 1 study · 21 participants | Ungraded |
Traditional iliac bone graft plus fibrin glue vs Traditional iliac bone graft alone
Population: Patients aged 7 to 16 years with unilateral or bilateral cleft lip and palate (alveolar cleft)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Radiographic assessment: coronal bone volume (cm3) At least 3 months | MD 42.62 [20.99, 64.25] | 1 study · 27 participants | Ungraded |
Postoperative complication: wound infection At least 3 months | RR 3.23 [0.14, 100] | 1 study · 27 participants | Ungraded |
Radiographic assessment: coronal bone density (Hounsfield units) At least 3 months | MD 150.89 [3.45, 298.33] | 1 study · 27 participants | Ungraded |
Postoperative complication: wound dehiscence At least 3 months | RR 0.36 [0.04, 3.03] | 1 study · 27 participants | Ungraded |
Secondary alveolar bone grafting performed at one timing (e.g. early secondary grafting) vs Secondary alveolar bone grafting performed at a different / optimal timing (e.g. late secondary grafting)
Population: Patients greater than 5 years of age with unilateral or bilateral cleft lip and/or palate involving the alveolar process (complete or incomplete alveolar cleft)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | Furthermore, no RCTs were found to study the optimal timing ... with secondary bone grafting surgery. This systematic review has not been able to report all the objectives described in the protocol. | 0 studies | No studies |
Secondary alveolar bone grafting with a given sequence of orthodontic treatment (e.g. orthodontics before grafting) vs Secondary alveolar bone grafting with a different sequence of orthodontic treatment (e.g. orthodontics after grafting)
Population: Patients greater than 5 years of age with unilateral or bilateral cleft lip and/or palate involving the alveolar process (complete or incomplete alveolar cleft)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | No RCTs were found to study ... the sequence of orthodontic treatment with secondary bone grafting surgery. | 0 studies | No studies |
Any form of secondary alveolar bone grafting (undertaken in patients greater than 5 years); variations in timing, technique, donor site or bone substitute vs A different secondary alveolar bone grafting method (variation in timing, technique, donor site or bone substitute)
Population: Patients greater than 5 years of age with cleft lip and alveolar process, unilateral or bilateral cleft lip and palate involving the alveolar process (complete or incomplete alveolar cleft; including cleft types involving Simonart's bands)
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | Protocol only (2009): no studies yet included. Planned objective: to compare the effectiveness of different secondary bone grafting methods (timing, technique, source of graft). A 'Summary of findings table' was… | NR | No studies |