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Efficacy of rhBMP-2/Hydroxyapatite on Sinus Floor Augmentation: A Multicenter, Randomized Controlled Clinical Trial

 H.J. Kim  ;  J.H. Chung  ;  S.Y. Shin  ;  S.I. Shin  ;  S.B. Kye  ;  N.K. Kim  ;  T.G. Kwon  ;  J.Y. Paeng  ;  J.W. Kim  ;  O.H. Oh  ;  M.S. Kook  ;  H.J. Yang  ;  S.J. Hwang 
 JOURNAL OF DENTAL RESEARCH, Vol.94(9 Suppl) : 158-165, 2015 
Journal Title
Issue Date
Animals ; Biopsy/methods ; Bone Morphogenetic Protein 2/therapeutic use* ; Bone Substitutes/therapeutic use* ; Bone Transplantation/methods ; Cattle ; Female ; Heterografts/pathology ; Heterografts/transplantation ; Humans ; Hydroxyapatites/therapeutic use* ; Male ; Maxillary Sinus/pathology ; Middle Aged ; Osteogenesis/physiology ; Prospective Studies ; Recombinant Proteins/therapeutic use ; Safety ; Single-Blind Method ; Sinus Floor Augmentation/methods* ; Transforming Growth Factor beta/therapeutic use* ; Treatment Outcome
Escherichia coli ; biopsy ; bone morphogenetic protein 2 ; clinical efficacy ; comparative study ; osteogenesis
The aim of this randomized single-blinded active-controlled clinical study was to evaluate the early efficacy of low-dose Escherichia coli-derived recombinant human bone morphogenetic protein 2 (rhBMP-2) soaked with hydroxyapatite granules (BMP-2/H) as compared with an inorganic bovine bone xenograft (ABX) in maxillary sinus floor augmentation. In a total of 127 subjects who were enrolled at 6 centers, maxillary sinus floors were augmented with 1 mg/mL of rhBMP-2 (0.5 to 2.0 mg per sinus) and BMP-2/H (0.5 to 2.0 g; n = 65) or with ABX alone (0.5 to 2.0 g; n = 62). Core biopsies were obtained 3 mo after the augmentation surgery and were analyzed histomorphometrically. The mean new bone formation with BMP-2/H and ABX augmentation was 16.10% ± 10.52% and 8.25% ± 9.47%, respectively. The BMP-2/H group was noninferior to the ABX group; the lower limit of the 1-sided 97.5% confidence interval for the difference between the 2 groups was calculated as 4.33%, which was greater than the prespecified noninferiority margin of -3.75%. An additional test with the Wilcoxon rank-sum test with a 2-sided 5% significance level showed that bone formation between the 2 groups was significantly different (P < 0.0001). The soft tissue and residual graft areas showed no significant differences between the groups. With regard to safety, no significant difference between the 2 groups was observed; there was no significant increase in the amount of rhBMP-2 antibody in the serum after BMP-2/H grafting. Our study suggested that low-dose Escherichia coli-derived rhBMP-2 with hydroxyapatite was effective in early stages for enhanced bone formation after maxillary sinus floor augmentation without harmful adverse events (Clinicaltrials.gov NCT01634308).
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2. College of Dentistry (치과대학) > Dept. of Oral and Maxillofacial Surgery (구강악안면외과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Nam Kyoo(김남규)
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