NCT00496847

Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect

Study on the Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect - A Double-blind, Controlled, Randomised,Parallel,Multi-centre Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Virchow Group · Industry
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Intrabony Periodontal Defect

Interventions

Type	Name	Description
DRUG	PERIOGEN	Implantation of rhPDGF-BB (0.3 mg/ml) + β-TCP (0.5 g)
DRUG	Beta TCP alone	Implantation of β-TCP (0.5 g) alone

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-08-01
• Completion: 2009-08-01
• First posted: 2007-07-04
• Last updated: 2014-12-16

Locations

1 site across 1 country: India