Efficacy and Safety of Bongros-BMP Compared to Bio-oss for Regeneration of Alveolar Bone Tissue After Maxillary Sinus Floor Augmentation

Phase 3 Completed Daewoong Pharmaceutical Co. LTD. Bio-alpha Co. LTD. · collab

Summary

The purpose of this Clinical study was to evaluate the Efficacy and Safety of bongros-BMP compared to Bio-oss for Regeneration of alveolar bone tissue after Maxillary sinus floor augmentation.

Timeline

Start: 2010-06
Primary completion: 2012-06
Completion: 2012-06

Outcome

Met primary endpoint

paper The BMP-2/H group was noninferior to the ABX group; PMID 26185033 ↗

paper which was greater than the prespecified noninferiority margin of -3.75%. PMID 26185033 ↗

Publications

Kim HJ, Chung JH, Shin SY, Shin SI, Kye SB, Kim NK, Kwon TG, Paeng JY, Kim JW, Oh OH, Kook MS, Yang HJ, Hwang SJ. Efficacy of rhBMP-2/Hydroxyapatite on Sinus Floor Augmentation: A Multicenter, Randomized Controlled Clinical Trial. J Dent Res. 2015 Sep;94(9 Suppl):158S-65S. doi: 10.1177/0022034515594573. Epub 2015 Jul 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bio-oss	Other / unclassified	—	—
Subject	rhBMP-2	Protein / enzyme biologic	1 mg/ml	—

Indications

No indication recorded.