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Sponsored by: |
Virchow Group |
Information provided by: | Virchow Group |
ClinicalTrials.gov Identifier: | NCT00496847 |
PERIOGEN, containing rhPDGF and -beta-TCP, promotes gingival healing and corrects periodontal defects. This study will test the safety and efficacy of PERIOGEN in the treatment of periodontal disease
Condition | Intervention | Phase |
Periodontal Defects |
Drug: PERIOGEN (rhPDGF-beta-TCP) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study on the Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect - A Double-Blind, Controlled, Randomised,Parallel,Multi-Centre Study |
Estimated Enrollment: | 60 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | September 2008 |
Sixty eligible patients with periodontal defect will randomly receive either beta-TCP implantation (control group) or PERIOGEN implantation, containing beta-TCP and rhPDGF (drug group). The specified primary and secondary end points related to efficacy and safety will be assessed during 6 months study period.
Ages Eligible for Study: | 25 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hemanth Nandigala, MBBS | 91+4023800924 ext 23 | hemanth@virchows.com |
Contact: TC Raghuram, MD, PhD | 91+4023800924 ext 28 | tcraghuram@yahoo.com |
India, Andhra pradesh | |||||
Sri Sai Dental college of surgery, Vikarabad, | Not yet recruiting | ||||
RR Dist, Andhra pradesh, India, 501101 | |||||
Principal Investigator: A Jayakumar, MDS |
Virchow Group |
Principal Investigator: | A Jayakumar, MDS | Sri Sai Dental college of surgery, Vikarabad, RR Dist, AP, India. |
Study ID Numbers: | VB023/07 |
First Received: | July 3, 2007 |
Last Updated: | July 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00496847 |
Health Authority: | India: Ministry of Health |
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