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

Bone Graft Clinical Trial

— rhBMP-2  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714829
• Other study ID #: ExcelOS 14-01
• Status: Completed
• Phase: N/A
• First received: March 8, 2016
• Last updated: April 3, 2018
• Start date: April 2016
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: BioAlpha Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Persons without periodontal disease

Exclusion Criteria:

• Women who are pregnant or plan to be pregnant within study period

Related Conditions & MeSH terms

• Alveolar Bone Preservation
• Bone Graft

Intervention

Device:
• Inject BMP
Injection of ExcelOS-inject(beta-TCP) containing rhBMP-2.
• ExcelOS-inject
Injection of ExcelOS-inject(beta-TCP) without rhBMP-2.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioAlpha Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compared the changed height and standard height by computed tomography.		at 12 weeks after surgery