NCT02714829

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 4, 2018

Status Verified

April 1, 2018

Enrollment Period

1.4 years

First QC Date

March 8, 2016

Last Update Submit

April 3, 2018

Conditions

Alveolar Bone PreservationBone Graft

Keywords

Injectable Ceramics Bone Graft Substitute Containing rhBMP-2

Outcome Measures

Primary Outcomes (1)

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

    at 12 weeks after surgery

Study Arms (2)

Inject BMP

EXPERIMENTAL

ExcelOS-inject containing rhBMP-2

Device: Inject BMP

ExcelOS-inject

ACTIVE COMPARATOR

ExcelOS-inject without rhBMP-2

Device: ExcelOS-inject

Interventions

Inject BMPDEVICE

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

Inject BMP
ExcelOS-injectDEVICE

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

ExcelOS-inject

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons without periodontal disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 34928477DERIVED

Study Officials

  • Soon Jung Hwang, Ph.D

    Seoul National University Dental Hospital

    PRINCIPAL INVESTIGATOR

  • Jong-Rak Hong, Ph.D

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • Hee-Kyun Oh, Ph.D

    Chonnam National University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2016

First Posted

March 22, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2017

Study Completion

April 1, 2018

Last Updated

April 4, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share