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The present clinical trial clarified that basic fibroblast growth factor-2 (FGF-2) can induce regeneration of periodontal tissue lost by progression of periodontitis and evaluated the safety of such induction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P | Placebo Comparator |
| |
| L | Experimental | low dose (0.03 %) |
|
| M | Experimental | medium dose (0.1 %) |
|
| H | Experimental | high dose (0.3 %) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trafermin (genetical recombinant of human basic Fibroblast Growth Factor) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| rate of increase in alveolar bone height | 36 weeks after administration | |
| clinical attachment level (CAL) regained | 36 weeks after administration |
| Measure | Description | Time Frame |
|---|---|---|
| time course of rate of increase in alveolar bone height | within 36 weeks after administration | |
| time course of CAL regained | within 36 weeks after administration | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Makoto Tamura, Ph.D | Kaken Pharmaceutical Co., Ltd. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18596969 | Derived | 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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| the other periodontal inspections (PD, BOP, GI etc.) |
| within 36 weeks after administration |