Prospective randomized controlled trial of sinus grafting using Escherichia-coli-produced rhBMP-2 with a biphasic calcium phosphate carrier compared to deproteinized bovine bone

Abstract

Aim: This study compared the effects of Escherichia-coli-produced recombinant human bone morphogenetic protein 2 (ErhBMP-2) with a biphasic calcium phosphate (BCP) carrier to those of deproteinized bovine bone in human maxillary sinus floor augmentation.Materials and Methods: Screening for this clinical trial selected 56 sites that provided informed consent to participate, of which 46 were ultimately enrolled and 41 were finally included in the study. The sites were divided into two groups using a random-number table, and the material was applied. A trephine biopsy was performed after 24 weeks, and implants wider than the biopsy site were inserted. Computed tomography and plain panoramic images were obtained immediately and then again at 24 weeks after the surgery. Radiographic images were reconstructed to allow measurement of the linear and volumetric changes. The biopsy samples were processed for histologic and histometric analyses.Results: All sites healed uneventfully with no complications. Radiographic analysis revealed a tendency for the volume to increase, but the difference was not statistically significant in either group. Comparison of volumetric changes between the two groups also revealed no significant difference. Moreover, none of the histometric parameters differed significantly between the groups, although different healing patterns were observed on histologic analysis.Conclusion: It can be concluded that the efficacy of ErhBMP-2 with a BCP carrier is comparable to that of deproteinized bovine bone for maxillary sinus floor augmentation. ErhBMP-2 did not enhance bone regeneration compared to conventional grafting biomaterial at 24 weeks after sinus augmentation.