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FGF-2 stimulates periodontal regeneration: results of a multi-center randomized clinical trial
Authors:Kitamura M  Akamatsu M  Machigashira M  Hara Y  Sakagami R  Hirofuji T  Hamachi T  Maeda K  Yokota M  Kido J  Nagata T  Kurihara H  Takashiba S  Sibutani T  Fukuda M  Noguchi T  Yamazaki K  Yoshie H  Ioroi K  Arai T  Nakagawa T  Ito K  Oda S  Izumi Y  Ogata Y  Yamada S  Shimauchi H  Kunimatsu K  Kawanami M  Fujii T  Furuichi Y  Furuuchi T  Sasano T  Imai E  Omae M  Yamada S  Watanuki M  Murakami S
Affiliation:Department of Periodontology, Division of Oral Biology and Disease Control, Osaka University Dental Hospital, Japan.
Abstract:The efficacy of the local application of recombinant human fibroblast growth factor-2 (FGF-2) in periodontal regeneration has been investigated. In this study, a randomized, double-blind, placebo-controlled clinical trial was conducted in 253 adult patients with periodontitis. Modified Widman periodontal surgery was performed, during which 200 μL of the investigational formulation containing 0% (vehicle alone), 0.2%, 0.3%, or 0.4% FGF-2 was administered to 2- or 3-walled vertical bone defects. Each dose of FGF-2 showed significant superiority over vehicle alone (p < 0.01) for the percentage of bone fill at 36 wks after administration, and the percentage peaked in the 0.3% FGF-2 group. No significant differences among groups were observed in clinical attachment regained, scoring approximately 2 mm. No clinical safety problems, including an abnormal increase in alveolar bone or ankylosis, were identified. These results strongly suggest that topical application of FGF-2 can be efficacious in the regeneration of human periodontal tissue that has been destroyed by periodontitis.
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