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

Phase 3

Completed

• Conditions: Periodontitis; Alveolar Bone Loss; Periodontal Attachment Loss
• Interventions: Drug: Placebo; Drug: Trafermin (genetical recombination)

• Registration Number: NCT00734708
• Lead Sponsor: Kaken Pharmaceutical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2010-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-14
• Last Update Posted: 2012-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P	Placebo	control
A	Trafermin (genetical recombination)	positive drug (0.3% Trafermin contained)

Primary Outcome Measures

Name	Time	Method
clinical attachment level regained	36 weeks after administration
rate of increase in alveolar bone height	36 weeks after administration

Secondary Outcome Measures

Name	Time	Method
time course of increase rate in alveolar bone height	within 36 weeks after administration
time course of clinical attachment level regained	within 36 weeks after administration
time course change of periodontal tissue inspection values	within 36 weeks after administration
occurrence and level of adverse reaction	within 36 weeks after administration
serum anti-Trafermin antibody level	within 4 weeks

Trial Locations

Locations (1)

Kaken Investigational Site; 🇯🇵 Tokushima, Japan