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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714829
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Alveolar Bone Preservation Bone Graft Device: Inject BMP Device: ExcelOS-inject Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : April 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: Inject BMP
ExcelOS-inject containing rhBMP-2
Device: Inject BMP
Injection of ExcelOS-inject(beta-TCP) containing rhBMP-2.

Active Comparator: ExcelOS-inject
ExcelOS-inject without rhBMP-2
Device: ExcelOS-inject
Injection of ExcelOS-inject(beta-TCP) without rhBMP-2.




Primary Outcome Measures :
  1. compared the changed height and standard height by computed tomography. [ Time Frame: at 12 weeks after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persons without periodontal disease

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714829


Sponsors and Collaborators
BioAlpha Inc.
Investigators
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Principal Investigator: Soon Jung Hwang, Ph.D Seoul National Uinversity Dental Hospital
Principal Investigator: Jong-Rak Hong, Ph.D Samsung Medical Center
Principal Investigator: Hee-Kyun Oh, Ph.D Chonnam National University
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Responsible Party: BioAlpha Inc.
ClinicalTrials.gov Identifier: NCT02714829    
Other Study ID Numbers: ExcelOS 14-01
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioAlpha Inc.:
Injectable Ceramics Bone Graft Substitute Containing rhBMP-2