NCT01634308

Brief Summary

The purpose of this Clinical study was to evaluate the Efficacy and Safety of bongros-BMP compared to Bio-oss for Regeneration of alveolar bone tissue after Maxillary sinus floor augmentation.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 6, 2012

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

2 years

First QC Date

July 3, 2012

Last Update Submit

July 12, 2012

Conditions

Regeneration of Alveolar Tissue After Maxillary Sinus Floor Augmentation

Study Arms (2)

Novosis(bongros/BMP-2)

EXPERIMENTAL
Drug: Novosis(bongros/BMP-2)

Bio-oss

ACTIVE COMPARATOR
Drug: Bio-oss

Interventions

Novosis(bongros/BMP-2)DRUG
Novosis(bongros/BMP-2)
Bio-ossDRUG
Bio-oss

Sponsors & Collaborators

Study Sites (1)

Dept. of Oral and Maxillofacial Surgery and School of Dentistry, Seoul National University

Seoul, South Korea

Location

Related Publications (1)

  • Kim HJ, Chung JH, Shin SY, Shin SI, Kye SB, Kim NK, Kwon TG, Paeng JY, Kim JW, Oh OH, Kook MS, Yang HJ, Hwang SJ. Efficacy of rhBMP-2/Hydroxyapatite on Sinus Floor Augmentation: A Multicenter, Randomized Controlled Clinical Trial. J Dent Res. 2015 Sep;94(9 Suppl):158S-65S. doi: 10.1177/0022034515594573. Epub 2015 Jul 16.

    PMID: 26185033DERIVED

MeSH Terms

Interventions

Bio-Oss

Study Design

Study Type
interventional
Phase
phase 3
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 6, 2012

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 13, 2012

Record last verified: 2012-07

Locations

KR(1)