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

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39 Citations (Scopus)

Abstract

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 gn = 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

Original languageEnglish
Pages (from-to)158S-165S
JournalJournal of Dental Research
Volume94
DOIs
Publication statusPublished - 2015 Sep 24

Bibliographical note

Funding Information:
This study was supported by a research grant for clinical studies from CGBio Inc. / BioAlpha Inc. (Gyeonggi-do, Korea). None of the authors have a financial stake in any company or any of the products related to or cited in this article.

Publisher Copyright:
© International & American Associations for Dental Research.

All Science Journal Classification (ASJC) codes

  • Dentistry(all)

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