NCT00734708

Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 328 (actual)
• Sponsor: Kaken Pharmaceutical · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.

Conditions

• Periodontitis
• Alveolar Bone Loss
• Periodontal Attachment Loss

Interventions

Type	Name	Description
DRUG	Trafermin (genetical recombination)	Administered to the bone defect during flap operation
DRUG	Placebo	Control

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-03-01
• First posted: 2008-08-14
• Last updated: 2012-06-15

Locations

21 sites across 1 country: Japan