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

Not Applicable

Completed

• Conditions: Alveolar Bone Preservation; Bone Graft
• Interventions: Device: Inject BMP; Device: ExcelOS-inject

• Registration Number: NCT02714829
• Lead Sponsor: BioAlpha Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-22
• Study Start: 2016-04
• Primary Completion: 2017-09
• Status Verified: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Persons without periodontal disease

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inject BMP	Inject BMP	ExcelOS-inject containing rhBMP-2
ExcelOS-inject	ExcelOS-inject	ExcelOS-inject without rhBMP-2

Primary Outcome Measures

Name	Time	Method
compared the changed height and standard height by computed tomography.	at 12 weeks after surgery