title: 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: OBJECTIVE
  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.
  
  
  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 analyzes.
  
  
  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.
  
  
  CONCLUSIONS
  It can be concluded that sinus augmentation with ErhBMP-2 carrying BCP carrier did not enhance bone regeneration compared to the conventional treatment using deproteinized bovine bone at 24 weeks after the surgery.
authors.affiliation: Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University, Seoul, Korea.
authors.forename: Min-Soo
authors.initials: MS
authors.lastname: Kim
authors.affiliation: Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University, Seoul, Korea.
authors.forename: Jung-Seok
authors.initials: JS
authors.lastname: Lee
authors.affiliation: Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University, Seoul, Korea.
authors.forename: Hyun-Ki
authors.initials: HK
authors.lastname: Shin
authors.affiliation: Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University, Seoul, Korea.
authors.forename: Jae-Shin
authors.initials: JS
authors.lastname: Kim
authors.affiliation: Division of Periodontology, Department of Dentistry, School of Medicine, Inha University, Incheon, Korea.
authors.forename: Jeong-Ho
authors.initials: JH
authors.lastname: Yun
authors.affiliation: Department of Periodontology, Research Institute for Periodontal Regeneration, College of Dentistry, Yonsei University, Seoul, Korea.
authors.forename: Kyoo-Sung
authors.initials: KS
authors.lastname: Cho
mesh_terms: D000818:Animals; D001706:Biopsy; D055396:Bone Morphogenetic Protein 2 / Q000494:pharmacology*; D001861:Bone Regeneration / Q000187:drug effects*; D002417:Cattle; D004926:Escherichia coli; D005260:Female; D006801:Humans; D006882:Hydroxyapatites / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D008903:Minerals / Q000494:pharmacology; D011446:Prospective Studies; D011862:Radiography, Panoramic; D011994:Recombinant Proteins / Q000494:pharmacology; D059546:Sinus Floor Augmentation / Q000379:methods*; D014057:Tomography, X-Ray Computed; D016212:Transforming Growth Factor beta / Q000494:pharmacology*
chemical_list: C077540:Bio-Oss; D055396:Bone Morphogenetic Protein 2; D006882:Hydroxyapatites; D008903:Minerals; D011994:Recombinant Proteins; D016212:Transforming Growth Factor beta; C074950:hydroxyapatite-beta tricalcium phosphate; C499469:recombinant human bone morphogenetic protein-2
keywords: bone substitutes; clinical research; clinical trials; growth factors; sinus floor elevation