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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 88
- Primary Endpoint
- compared the changed height and standard height by computed tomography.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Persons without periodontal disease
Exclusion Criteria
- •Women who are pregnant or plan to be pregnant within study period
Arms & Interventions
Inject BMP
ExcelOS-inject containing rhBMP-2
Intervention: Inject BMP (Device)
ExcelOS-inject
ExcelOS-inject without rhBMP-2
Intervention: ExcelOS-inject (Device)
Outcomes
Primary Outcomes
compared the changed height and standard height by computed tomography.
Time Frame: at 12 weeks after surgery
Secondary Outcomes
No secondary outcomes reported