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Efficacy and Safety of Bongros-BMP Compared to Bio-oss for Regeneration of Alveolar Bone Tissue After Maxillary Sinus Floor Augmentation

NCT ID: NCT01634308

Last Updated: 2012-07-13

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

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Regeneration of Alveolar Tissue After Maxillary Sinus Floor Augmentation

Study Groups

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Novosis(bongros/BMP-2)

Group Type EXPERIMENTAL

Novosis(bongros/BMP-2)

Intervention Type DRUG

Bio-oss

Group Type ACTIVE_COMPARATOR

Bio-oss

Intervention Type DRUG

Interventions

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Novosis(bongros/BMP-2)

Intervention Type DRUG

Bio-oss

Intervention Type DRUG

Eligibility Criteria

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Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bio-alpha Co. LTD.

UNKNOWN

Sponsor Role collaborator

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 26185033 (View on PubMed)

Other Identifiers

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BA05-CP01

Identifier Type: -

Identifier Source: org_study_id