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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaken Pharmaceutical

Criteria

Inclusion Criteria:

• Probing pocket depth 4mm or deeper

• Vertical intrabony defect 3 mm or deeper from radiographs at baseline

• Mobility of tooth 2 degree or less

Exclusion Criteria:

• Using an investigational drug within the past 24 months

• Coexisting malignant tumour or history of the same

• Coexisting diabetes (HbA1C 6.5% or more)

• Taking bisphosphonates

• Coexisting gingival overgrowth or history of the same