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CompletedNCT02714829rhBMP-2Updated Apr 4, 2018

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

An interventional study of Inject BMP and ExcelOS-inject in Alveolar Bone Preservation and Bone Graft, sponsored by BioAlpha Inc.. Completed. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-04-04.

Sponsored by BioAlpha Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Alveolar Bone Preservation
  • Bone Graft

Keywords

  • Injectable Ceramics Bone Graft Substitute Containing rhBMP-2
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In context

Lead sponsor

BioAlpha Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Persons without periodontal disease

Exclusion criteria

Exclusion Criteria:

  • Women who are pregnant or plan to be pregnant within study period
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    Inject BMP

    ExcelOS-inject containing rhBMP-2

    Device: Inject BMP

  • Active comparator
    ExcelOS-inject

    ExcelOS-inject without rhBMP-2

    Device: ExcelOS-inject

Interventions

  • DeviceInject BMP

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

  • DeviceExcelOS-inject

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

06

What researchers measure

Primary outcomes

  1. compared the changed height and standard height by computed tomography.

    Time frame: at 12 weeks after surgery

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Han JJ, Chang AR, Ahn J, Jung S, Hong J, Oh HK, Hwang SJ. Efficacy and safety of rhBMP/beta-TCP in alveolar ridge preservation: a multicenter, randomized, open-label, comparative, investigator-blinded clinical trial. Maxillofac Plast Reconstr Surg. 2021 Dec 20;43(1):42. doi: 10.1186/s40902-021-00328-0. PubMed 34928477 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02714829
Lead sponsor
BioAlpha Inc.
Responsible party
Sponsor
First posted
Mar 22, 2016
Start date
Apr 2016
Primary completion
Sep 2017
Completion
Apr 2018
Last update
Apr 4, 2018

Study contacts

Soon Jung Hwang, Ph.D
principal investigator · Seoul National University Dental Hospital
Jong-Rak Hong, Ph.D
principal investigator · Samsung Medical Center
Hee-Kyun Oh, Ph.D
principal investigator · Chonnam National University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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