Efficacy and safety of rhBMP/β-TCP in alveolar ridge preservation: a multicenter, randomized, open-label, comparative, investigator-blinded clinical trial

Abstract

Background The aim of this multicenter, randomized, open-label, comparative, investigator-blinded study was to investigate the efficacy and safety of recombinant human bone morphogenetic protein 2 (rhBMP-2) combined with β-TCP (rhBMP-2/β-TCP) in alveolar ridge preservation. Materials and methods Eighty-four subjects from three centers were enrolled in this clinical trial. After tooth extraction, rhBMP-2/β-TCP (n = 41, test group) or β-TCP (n = 43, control group) were grafted to the extraction socket with an absorbable barrier membrane for alveolar ridge preservation. Using computed tomography images obtained immediately after and 12 weeks after surgery, changes in the alveolar bone height and width were analyzed for each group and compared between the two groups. Results Both the test and control groups showed a significant decrease in alveolar bone height in the 12 weeks after surgery (both groups, p < 0.0001). However, the test group exhibited a significantly lower decrease in alveolar bone height than the control group (p = 0.0004). Alveolar bone width also showed significantly less resorption in the test group than in the control group for all extraction socket levels (ESL) (p = 0.0152 for 75% ESL; p < 0.0001 for 50% ESL; p < 0.0001 for 25% ESL). There were no statistically significant differences in the incidence of adverse events between the two groups. No severe adverse events occurred in either group. Conclusions The results of this study suggest that rhBMP-2/β-TCP is a safe graft material that provides a high alveolar bone preservation effect in patients receiving dental extraction. Trial registration Clinicaltrials.gov, NCT02714829, Registered 22 March 2016

Transpedicular injection of rhBMP-2 with β-tricalcium phosphate to reduce the proximal junctional kyphosis after adult spinal deformity correction: preliminary study

“…Third, β-TCP is a radiopaque material that may remain unabsorbed in postoperative CT scans six months after surgery. However, a recent study utilizing the same combination of rhBMP-2 and β-TCP for alveolar bone augmentation demonstrated increased radiolucency in the radiograph at three months after implantation as compared to the immediate postoperative radiograph 29 . Hence, we do not believe that β-TCP can lead to overestimation when measuring HU.…”

Long-Term Changes in Adipose Tissue in the Newly Formed Bone Induced by Recombinant Human BMP-2 In Vivo

“…Currently, rhBMP-2 is widely used in the oral and maxillofacial regions for the repair of bone defects, treatment of medication-related osteonecrosis of the jaw, and alveolar bone augmentation for implant installation [ 14 , 20 , 21 ]. In implant dentistry, rhBMP-2 is used for alveolar bone regeneration with various bone scaffolds to guide bone regeneration, maxillary sinus bone augmentation, and alveolar ridge preservation [ 22 , 23 ].…”

“…Bone grafting surgery for implant installation has been widely performed in patients with alveolar BV deficiency [ 37 ]. Popularly used with bone grafting material, rhBMP-2 successfully induces new bone regeneration in guided bone regeneration (GBR), maxillary sinus augmentation, and bone defects after cyst enucleation [ 23 , 38 ]. When used with hydroxyapatite granules, rhBMP-2 induces significantly higher bone formation than bovine bone xenografts alone in maxillary sinus augmentation [ 6 ].…”

Relevant Properties and Potential Applications of Sericin in Bone Regeneration

“…Among the genes studied, bone morphogenetic protein-2 (BMP-2) has shown increased expression upon administration of the silk mat-derived solution [ 36 ]. BMP-2 is a potent osteogenic protein [ 37 ]. It is hypothesized that a protein present in this solution may stimulate macrophages to secrete BMP-2.…”