Higher Dosages of BMP-2 in Alveolar Cleft Repair Result in Higher Rates of Postoperative Nasal Stenosis

Abstract

PLASTIC SURGERY 2015, Abstract Supplement 4 Figure 1. Mean density of iliac bone grafts and BMP/DBM grafts at 6-9 months were identical: 1.38 g/cc (SD: 0.28). A one tailed ANOVA test comparing means showed no statistical significance (p=0.999).Figure 2. At 6-9 months, patients with BMP/DBM grafts had an average of 31.6% bone fill (95% CI: 24.2-38.5%) vs. 32.5% (95% CI: 22.1-42.9%) in the iliac bone population. No difference between means (p= 0.836). CONCLUSIONS:Here we demonstrate that BMP/DBM is equivalent at 6-9 months to iliac crest grafts, in terms of bone fill within the alveolar cleft site and overall regenerated bone density. These CBCT data contradict the conclusions that are drawn from occlusal radiographs alone; complete bony reconstitution as measured by the Bergland scale on 2D radiographs is unlikely to correlate with true obliteration of the cleft site, as the postoperative CBCT images at 6-9 months show significant bone gaps within the space. This study is the first to apply 3D imaging to understand bone regeneration in the context of secondary alveolar cleft repair.

Deciduous Dental Pulp Stem Cells for Maxillary Alveolar Reconstruction in Cleft Lip and Palate Patients

“…Several studies have shown successful rhBMP-2induced bone formation in the craniofacial skeleton [5][6][7]. However, in spite of some exciting data from these human reports, major complications, adverse events, and reoperations have increasingly been attributed to the "off-label" use of rhBMP-2 in spine surgery, including heterotopic ossifica-tion, osteolysis, increased neurological deficits, and cancer, [9,10,24,25] and for maxillofacial surgery, Neovius et al and Goss et al reported severe swelling, while high rates of postoperative nasal stenosis were described in cleft children [8,11]. Because of this, a second FDA warning was issued against the use of this product in the pediatric population out of concern for insufficient data to demonstrate longterm efficacy or safety in children.…”

“…However, the lack of bioactivity, biomechanical weaknes, and susceptibility to infection are still detrimental to the use of most of them; [3] and even for bone morphogenetic proteins, recently suggested as an effective alternative [4][5][6][7], significant restraints concerning high costs and severe adverse events have emerged [8][9][10][11].…”

Clinical Application of Stem Cell Therapy in Reconstructing Maxillary Cleft Alveolar Bone Defects: A Systematic Review of Randomized Clinical Trials

“…In addition to the lengthy operative time and stay in the hospital, there is a risk of intraoperative blood loss, postoperative pain, and high cost [ 19 ]. On the other hand, rhBMP-2 adverse effects involved severe swelling in maxillofacial surgery and postoperative nasal stenosis in cleft children [ 29 - 30 ]. As a result, the Food and Drug Administration (FDA) warning was issued against the utilization of it in the pediatric population due to a lack of evidence that confirms long-term effectiveness or safety in children [ 19 ].…”