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

April 3, 2018 updated by: BioAlpha Inc.

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persons without periodontal disease

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
compared the changed height and standard height by computed tomography.
Time Frame: at 12 weeks after surgery
at 12 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioAlpha Inc.

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (Estimate)

March 22, 2016

Study Record Updates

Last Update Posted (Actual)

April 4, 2018

Last Update Submitted That Met QC Criteria

April 3, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ExcelOS 14-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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