ORAL HEALTH EVIDENCE-BASED PRACTICE PROGRAM
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Title Alveolar Bone Grafting With rhBMP2 May Benefit Patients Undergoing Surgical Correction of Cleft Lip/Palate
Clinical Question In Cleft lip/palate patients with alveolar clefting, does the use of rhBMP2 for secondary grafting provide as good or better outcomes compared to autogenous grafting from the iliac crest?
Clinical Bottom Line The use of rhBMP-2 could be a promising alternative to autogenous iliac crest grafting for secondary bone alveolar cleft grafts in children with cleft lip/palate. (See Comments on the CAT below)
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 18176223Dickinson/2008Adolescents with alveolar cleftingRandomized Controlled Trial
Key results21 Patients were enrolled in the study. 9 were in the experimental group (BMP2) and 12 were in the control group (iliac crest). Mean age of patients was between 15.9-16.4y. After a 6 week and one year follow up, 1/9 patients in BMP2 group had wound healing complications compared to 5/12 for the iliac crest group. Radiographically: BMP2 group showed enhanced mineralization with both Panorex and 3-D computed tomography at 2.9 compared to 2.0 (p<0.05). Mineralization was graded on a scale from 0 to 3 with 2=50-75% bone mineralization within the defect and 3=75-100%. Additionally, BMP2 group had a larger percentage alveolar defect filled with new bone (95%) compared to iliac crest group at 63% ( p<0.01). Post operative pain was also less for the BMP2 group and cost of procedure was approximately $11,100 for BMP2 group compared to $21,800 for iliac crest group.
#2) 20163243Alonso/2010Alveolar cleft patients age 8-12 yRandomized Controlled Trial
Key resultsEach group had 8 patients randomly assigned to either iliac crest graft group or rhBMP-2 graft. Morbidity: Iliac crest: (87.5%) stated significant donor-site pain 2 weeks post op while rhBMP-2: (37.5%) developed significant swelling early post op which resolved. Bone height measurement: At a 1 year follow up, the iliac crest group had a mean cleft-side height: (13.9 mm 86.8%), compared to rhBMP-2 (10.2 mm, 65%) (p<0.01). Bone filling percentage: A significant difference was noted at 6 months between the iliac crest group (79.4%) compared to the rhBMP-2 group (59.6%)(P<0.01), but at 12 months this difference was not statistically significant with the iliac crest group (80.2%) compared to rhBMP2 (74.4%).
Evidence Search (("bone transplantation"[MeSH Terms] OR ("bone"[All Fields] AND "transplantation"[All Fields]) OR "bone transplantation"[All Fields] OR ("bone"[All Fields] AND "grafting"[All Fields]) OR "bone grafting"[All Fields]) AND ("cleft lip"[MeSH Terms] OR ("cleft"[All Fields] AND "lip"[All Fields]) OR "cleft lip"[All Fields])) AND ("humans"[MeSH Terms] AND Randomized Controlled Trial[ptyp])
Comments on
The Evidence
At this time, there are limited data and clinical trials involving only small numbers of patients on the use of rhBMP-2 as an alternative to autogenous iliac crest bone for secondary bone alveolar cleft grafting. Both the Dickinson and Alonso articles show that rhBMP-2 can be successful, but more evidence is needed to consider the use of rhBMP-2 as the standard of care for secondary bone alveolar cleft grafting. One positive aspect for rhBMP-2 is that it eliminates donor site morbidity and decreases length of hospital stay.
Applicability The principal aim in secondary alveolar bone grafting is to unify the maxilla and create and osseous environment that will support tooth eruption into the arch (Eppley 2000). This is typically done in a patient’s transitional dention prior to eruption of permanent maxillary canine. The techniques could be used by oral maxillofacial surgeons, head and neck surgeons or any other provider involved in the treatment of secondary bone grafting for alveolar clefts in children with cleft lip/palate.
Specialty/Discipline (Oral Surgery) (Orthodontics) (Pediatric Dentistry)
Keywords Cleft lip, cleft palate, secondary alveolar grafting, rhBMP-2
ID# 2158
Date of submission: 10/08/2011spacer
E-mail villarreald7@uthscsa.edu
Author Demitri Villarreal
Co-author(s)
Co-author(s) e-mail
Faculty mentor/Co-author Guy Huynh-Ba, DDS
Faculty mentor/Co-author e-mail HuynhBa@uthscsa.edu
Basic Science Rationale
(Mechanisms that may account for and/or explain the clinical question, i.e. is the answer to the clinical question consistent with basic biological, physical and/or behavioral science principles, laws and research?)
post a rationale
None available
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Comments on the CAT
(FOR PRACTICING DENTISTS' and/or FACULTY COMMENTS ON PUBLISHED CATs)
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by Ejvis Lamani (San Antonio, TX) on 07/05/2012
On July 5th, 2012 I conducted a PubMed search on this topic and found a Systematic Review (PubMed# 21465220) and a Meta-Analysis (PubMed# 21678372). They were both published in June 2011 and agree that more Randomized Clinical Trials are needed. However, while the first review (21465220) found that in skeletally matured patients BMP2 treatments favored better bone quality as well as the advantages mentioned in the above CAT, the Cochrane review (21678372) concluded that there was high risk of bias and thus insufficient evidence to recommend the bone graft substitute impregnated with BMP-2 versus the traditional iliac graft.
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