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Periodontal tissue regeneration using fibroblast growth factor -2:Randomized controlled phase II clinical trial

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Title: Periodontal tissue regeneration using fibroblast growth factor -2:Randomized controlled phase II clinical trial
Authors: Kitamura, Masahiro / Nakashima, Keisuke / Kowashi, Yusuke / Fujii, Takeo / Shimauchi, Hidetoshi / Sasano, Takashi / Furuuchi, Toshi / Fukuda, Mitsuo / Noguchi, Toshihide / Shibutani, Toshiaki / Iwayama, Yukio / Takashiba, Shogo / Kurihara, Hidemi / Ninomiya, Masami / Kido, Jun-ichi / Nagata, Toshihiko / Hamachi, Takafumi / Maeda, Katsumasa / Hara, Yoshitaka / Izumi, Yuichi / Hirofuji, Takao / Imai, Enyu / Omae, Masatoshi / Watanuki, Mitsuru / Murakami, Shinya
Issue Date: 2-Jul-2008
Publisher: the Public Library of Science (PLoS)
Citation: PLoS ONE, 3(7), e2611; 2008
Abstract: Background: The options for medical use of signaling molecules as stimulators of tissue regeneration are currently limited. Preclinical evidence suggests that fibroblast growth factor (FGF)-2 can promote periodontal regeneration. This study aimed to clarify the activity of FGF-2 in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation. Methodology/Principal Findings: We used recombinant human FGF-2 with 3% hydroxypropylcellulose (HPC) as vehicle and conducted a randomized double-blinded controlled trial involving 13 facilities. Subjects comprised 74 patients displaying a 2- or 3-walled vertical bone defect as measured ?3 mm apical to the bone crest. Patients were randomly assigned to 4 groups: Group P, given HPC with no FGF-2; Group L, given HPC containing 0.03% FGF-2; Group M, given HPC cotaining 0.1% FGF-2; and Group H, given HPC Containing 0.3% FGF-2. Each patient underwent flap operation during which we administered 200 μL of the appropriate investigational drug to the bone defect. Before and for 36 weeks following administration, patients underwent periodontal tissue inspections and standardized radiography of the region under investigation. As a result, a significant difference (p = 0.021) in rate of increase in alveolar bone height was identified between Group P (23.92%) and Group H (58.62%) at 36 weeks. The linear increase in alveolar bone height at 36 weeks in Group P and H was 0.95 mm and 1.85 mm, respectively (p = 0.132). No serious adverse events attribute to the investigational drug were identified. Conclusions: Although no statistically significant differences were noted for gains in clinical attachment level and alveolar bone gain for FGF-2 groups versus Group P, the significant difference in rate of increase in alveolar bone height (p = 0.021) between Groups P and H at 36 weeks suggests that some efficacy could be expected from FGF-2 in stimulating regeneration of periodontal tissue in patients with periodontitis.
URI: http://hdl.handle.net/10069/20060
ISSN: 19326203
DOI: 10.1371/journal.pone.0002611
PubMed ID: 18596969
Rights: (c)2008 Kitamura et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Type: Journal Article
Text Version: publisher
Appears in Collections:Articles in academic journal

Citable URI : http://hdl.handle.net/10069/20060

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