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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02714829
Acronym
rhBMP-2
Enrollment
88
Registered
2016-03-22
Start date
2016-04-30
Completion date
2018-04-30
Last updated
2018-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Bone Preservation, Bone Graft

Keywords

Injectable Ceramics Bone Graft Substitute Containing rhBMP-2

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.

Interventions

Injection of ExcelOS-inject(beta-TCP) containing rhBMP-2.

DEVICEExcelOS-inject

Injection of ExcelOS-inject(beta-TCP) without rhBMP-2.

Sponsors

BioAlpha Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Persons without periodontal disease

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
compared the changed height and standard height by computed tomography.at 12 weeks after surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026