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

NCT ID: NCT02714829

Last Updated: 2018-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-04-30

Brief Summary

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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

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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.

Conditions

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Alveolar Bone Preservation Bone Graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Inject BMP

ExcelOS-inject containing rhBMP-2

Group Type EXPERIMENTAL

Inject BMP

Intervention Type DEVICE

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

ExcelOS-inject

ExcelOS-inject without rhBMP-2

Group Type ACTIVE_COMPARATOR

ExcelOS-inject

Intervention Type DEVICE

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

Interventions

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Inject BMP

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

Intervention Type DEVICE

ExcelOS-inject

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Persons without periodontal disease

Exclusion Criteria

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

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioAlpha Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Soon Jung Hwang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Dental Hospital

Jong-Rak Hong, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Hee-Kyun Oh, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University

References

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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.

Reference Type DERIVED
PMID: 34928477 (View on PubMed)

Other Identifiers

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ExcelOS 14-01

Identifier Type: -

Identifier Source: org_study_id

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