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This study aims to investigate the safety in using Trafermin (recombinant human basic fibroblast growth factor) with periodontal surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental H | Experimental | high volume (0.6mL、0.3% Trafermin) |
|
| Experimental L | Experimental | low volume (0.2mL、0.3% Trafermin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trafermin | Drug | Administered to the bone defect during flap operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum Trafermin level | within 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| occurrence and level of adverse reaction | within 4 weeks | |
| serum anti-Trafermin antibody level | within 4 weeks |
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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 5 | Chiyoda-ku | Japan | ||||
| Kaken Investigational Site 2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18596969 | Result | 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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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C114444 | trafermin |
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| Matsudo |
| Japan |
| Kaken Investigational Site 3 | Ōta-ku | Japan |
| Kaken Investigational Site 1 | Sapporo | Japan |
| Kaken Investigational Site 4 | Shinjuku-ku | Japan |
| Kaken Investigational Site 6 | Suita | Japan |