Phase 3 Clinical Trial of Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2(Trafermin)
NCT ID: NCT00734708
Last Updated: 2012-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
328 participants
INTERVENTIONAL
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
positive drug (0.3% Trafermin contained)
Trafermin (genetical recombination)
Administered to the bone defect during flap operation
P
control
Placebo
Control
Interventions
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Trafermin (genetical recombination)
Administered to the bone defect during flap operation
Placebo
Control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Vertical intrabony defect 3 mm or deeper from radiographs at baseline
* Mobility of tooth 2 degree or less
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Kaken Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Chikara Ieda
Role: STUDY_DIRECTOR
Kaken Pharmaceutical Co., Ltd.
Locations
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Kaken Investigational Site
Nagoya, Aichi-ken, Japan
Kaken Investigational Site
Matsudo, Chiba, Japan
Kaken Investigational Site
Fukuoka, Fukuoka, Japan
Kaken Investigational Site
Kitakyushu, Fukuoka, Japan
Kaken Investigational Site
Hiroshima, Hiroshima, Japan
Kaken Investigational Site
Ishikari-Tobetsu, Hokkaido, Japan
Kaken Investigational Site
Sapporo, Hokkaido, Japan
Kaken Investigational Site
Morioka, Iwate, Japan
Kaken Investigational Site
Kagoshima, Kagoshima-ken, Japan
Kaken Investigational Site
Machida, Kanagawa, Japan
Kaken Investigational Site
Yokohama, Kanagawa, Japan
Kaken Investigational Site
Sendai, Miyagi, Japan
Kaken Investigational Site
Nagasaki, Nagasaki, Japan
Kaken Investigational Site
Niigata, Niigata, Japan
Kaken Investigational Site
Okayama, Okayama-ken, Japan
Kaken Investigational Site
Suita, Osaka, Japan
Kaken Investigational Site
Tokushima, Tokushima, Japan
Kaken Investigational Site
Bunkyo-ku, Tokyo, Japan
Kaken Investigational Site
Chiyoda-ku, Tokyo, Japan
Kaken Investigational Site
Ōta-ku, Tokyo, Japan
Kaken Investigational Site
Sinjyuku-ku, Tokyo, Japan
Countries
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References
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Kitamura M, Nakashima K, Kowashi Y, Fujii T, Shimauchi H, Sasano T, Furuuchi T, Fukuda M, Noguchi T, Shibutani T, Iwayama Y, Takashiba S, Kurihara H, Ninomiya M, Kido J, Nagata T, Hamachi T, Maeda K, Hara Y, Izumi Y, Hirofuji T, Imai E, Omae M, Watanuki M, Murakami S. Periodontal tissue regeneration using fibroblast growth factor-2: randomized controlled phase II clinical trial. PLoS One. 2008 Jul 2;3(7):e2611. doi: 10.1371/journal.pone.0002611.
Other Identifiers
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KCB-1D-03
Identifier Type: -
Identifier Source: org_study_id
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