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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | positive drug (0.3% Trafermin contained) |
|
| P | Placebo Comparator | control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trafermin (genetical recombination) | Drug | Administered to the bone defect during flap operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| rate of increase in alveolar bone height | 36 weeks after administration | |
| clinical attachment level regained | 36 weeks after administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chikara Ieda | Kaken Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaken Investigational Site | Nagoya | Aichi-ken | Japan | |||
| Kaken Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18596969 | Background | 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. |
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| Placebo | Drug | Control |
|
| 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 |
| 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 |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D016301 | Alveolar Bone Loss |
| D017622 | Periodontal Attachment Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| C114444 | trafermin |
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