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

• Published in: Journal of dental research Vol. 94; no. 9_suppl; pp. 158S - 165S
• Main Authors: Kim, H.J., Chung, J.H., Shin, S.Y., Shin, S.I., Kye, S.B., Kim, N.K., Kwon, T.G., Paeng, J.Y., Kim, J.W., Oh, O.H., Kook, M.S., Yang, H.J., Hwang, S.J.
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.09.2015
• Subjects: 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; biopsy; comparative study; bone morphogenetic protein 2; clinical efficacy; osteogenesis; Escherichia coli
• ISSN: 0022-0345; 1544-0591
• DOI: 10.1177/0022034515594573

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).