Status:
COMPLETED
Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)
Lead Sponsor:
Kaken Pharmaceutical
Conditions:
Periodontitis
Alveolar Bone Loss
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT00734708
Start Date
August 1 2008
Last Update
June 15 2012
Active Locations (21)
Enter a location and click search to find clinical trials sorted by distance.
1
Kaken Investigational Site
Nagoya, Aichi-ken, Japan
2
Kaken Investigational Site
Matsudo, Chiba, Japan
3
Kaken Investigational Site
Fukuoka, Fukuoka, Japan
4
Kaken Investigational Site
Kitakyushu, Fukuoka, Japan