NCT02714829

Clinical Study of Injectable Ceramics Bone Graft Substitute Containing rhBMP-2

Clinical Study to Evaluate Efficacy and Safety of "Inject BMP(Beta-TCP Containing rhBMP-2)" for Socket Preservation After Extraction of a Single-rooted Tooth: A Randomized, Outcomes Assessor-Blinded, Multi-center, Prospective Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: BioAlpha Inc. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, outcomes assessor-blinded, randomized study to evaluate the efficacy and safety of "Inject BMP(Injectable Ceramics Bone Graft Substitute Containing rhBMP-2)" for socket preservation after extraction of a single-rooted tooth, compared to ExcelOS-inject(Injectable Ceramics Bone Graft Substitute).

Detailed description

Inject BMP is Injectable Ceramics Bone Graft Substitute(ExcelOS-inject) containing rhBMP-2. Recombinant human Bone morphogenetic protein 2 (rhBMP-2) stimulates the production of bone.

Conditions

• Alveolar Bone Preservation
• Bone Graft

Interventions

Type	Name	Description
DEVICE	Inject BMP	Injection of ExcelOS-inject(beta-TCP) containing rhBMP-2.
DEVICE	ExcelOS-inject	Injection of ExcelOS-inject(beta-TCP) without rhBMP-2.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-09-01
• Completion: 2018-04-01
• First posted: 2016-03-22
• Last updated: 2018-04-04