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

This study has been completed.
Information provided by (Responsible Party):
Kaken Pharmaceutical Identifier:
First received: August 13, 2008
Last updated: June 14, 2012
Last verified: June 2012
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.

Condition Intervention Phase
Alveolar Bone Loss
Periodontal Attachment Loss
Drug: Trafermin (genetical recombination)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Kaken Pharmaceutical:

Primary Outcome Measures:
  • rate of increase in alveolar bone height [ Time Frame: 36 weeks after administration ]
  • clinical attachment level regained [ Time Frame: 36 weeks after administration ]

Secondary Outcome Measures:
  • time course of increase rate in alveolar bone height [ Time Frame: within 36 weeks after administration ]
  • time course of clinical attachment level regained [ Time Frame: within 36 weeks after administration ]
  • time course change of periodontal tissue inspection values [ Time Frame: within 36 weeks after administration ]
  • occurrence and level of adverse reaction [ Time Frame: within 36 weeks after administration ]
  • serum anti-Trafermin antibody level [ Time Frame: within 4 weeks ]

Enrollment: 328
Study Start Date: August 2008
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
positive drug (0.3% Trafermin contained)
Drug: Trafermin (genetical recombination)
Administered to the bone defect during flap operation
Other Name: KCB-1D
Placebo Comparator: P
Drug: Placebo


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00734708

Kaken Investigational Site
Nagoya, Aichi, Japan
Kaken Investigational Site
Matsudo, Chiba, Japan
Kaken Investigational Site
Kitakyusyu, Fukuoka, Japan
Kaken Investigational Site
Ishikari-Tobetsu, Hokkaido, Japan
Kaken Investigational Site
Sapporo, Hokkaido, Japan
Kaken Investigational Site
Morioka, Iwate, Japan
Kaken Investigational Site
Machida, Kanagawa, Japan
Kaken Investigational Site
Yokohama, Kanagawa, Japan
Kaken Investigational Site
Sendai, Miyagi, Japan
Kaken Investigational Site
Suita, Osaka, Japan
Kaken Investigational Site
Bunkyo-ku, Tokyo, Japan
Kaken Investigational Site
Chiyoda-ku, Tokyo, Japan
Kaken Investigational Site
Ota-ku, Tokyo, Japan
Kaken Investigational Site
Sinjyuku-ku, Tokyo, Japan
Kaken Investigational Site
Fukuoka, Japan
Kaken Investigational Site
Hiroshima, Japan
Kaken Investigational Site
Kagoshima, Japan
Kaken Investigational Site
Nagasaki, Japan
Kaken Investigational Site
Niigata, Japan
Kaken Investigational Site
Okayama, Japan
Kaken Investigational Site
Tokushima, Japan
Sponsors and Collaborators
Kaken Pharmaceutical
Study Director: Chikara Ieda Kaken Pharmaceutical Co., Ltd
  More Information

Responsible Party: Kaken Pharmaceutical Identifier: NCT00734708     History of Changes
Other Study ID Numbers: KCB-1D-03
Study First Received: August 13, 2008
Last Updated: June 14, 2012

Additional relevant MeSH terms:
Alveolar Bone Loss
Periodontal Attachment Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy processed this record on May 22, 2017