Randomized Placebo-Controlled and Controlled Non-Inferiority Phase III Trials Comparing Trafermin, a Recombinant Human Fibroblast Growth Factor 2, and Enamel Matrix Derivative in Periodontal Regeneration in Intrabony Defects

Masahiro Kitamura, Motoki Akamatsu, Masamitsu Kawanami, Yasushi Furuichi, Takeo Fujii, Mari Mori, Kazushi Kunimatsu, Hidetoshi Shimauchi, Yorimasa Ogata, Matsuo Yamamoto, Taneaki Nakagawa, Shuichi Sato, Koichi Ito, Takefumi Ogasawara, Yuichi Izumi, Kazuhiro Gomi, Kazuhisa Yamazaki, Hiromasa Yoshie, Mitsuo Fukuda, Toshihide NoguchiShogo Takashiba, Hidemi Kurihara, Toshihiko Nagata, Takafumi Hamachi, Katsumasa Maeda, Makoto Yokota, Ryuji Sakagami, Yoshitaka Hara, Kazuyuki Noguchi, Toshi Furuuchi, Takashi Sasano, Enyu Imai, Masatoshi Ohmae, Hayuru Koizumi, Mitsuru Watanuki, Shinya Murakami

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

We investigated the efficacy, safety, and clinical significance of trafermin, a recombinant human fibroblast growth factor (rhFGF)-2, for periodontal regeneration in intrabony defects in Phase III trials. Study A, a multicenter, randomized, double-blind, placebo-controlled study, was conducted at 24 centers. Patients with periodontitis with 4-mm and 3-mm or deeper probing pocket depth and intrabony defects, respectively, were included. A total of 328 patients were randomly assigned (2:1) to receive 0.3% rhFGF-2 or placebo, and 323 patients received the assigned investigational drug during flap surgery. One of the co-primary endpoints, the percentage of bone fill at 36 weeks after drug administration, was significantly greater in the rhFGF-2 group at 37.131% (95% confidence interval [CI], 32.7502 to 41.5123; n=208) than it was in the placebo group at 21.579% (95% CI, 16.3571 to 26.8011; n=100; p

Original languageEnglish
JournalJournal of Bone and Mineral Research
DOIs
Publication statusAccepted/In press - 2015

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Keywords

  • Cell/tissue signaling
  • Clinical trials
  • Cytokines
  • Dental biology
  • Endocrine pathways

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Kitamura, M., Akamatsu, M., Kawanami, M., Furuichi, Y., Fujii, T., Mori, M., Kunimatsu, K., Shimauchi, H., Ogata, Y., Yamamoto, M., Nakagawa, T., Sato, S., Ito, K., Ogasawara, T., Izumi, Y., Gomi, K., Yamazaki, K., Yoshie, H., Fukuda, M., ... Murakami, S. (Accepted/In press). Randomized Placebo-Controlled and Controlled Non-Inferiority Phase III Trials Comparing Trafermin, a Recombinant Human Fibroblast Growth Factor 2, and Enamel Matrix Derivative in Periodontal Regeneration in Intrabony Defects. Journal of Bone and Mineral Research. https://doi.org/10.1002/jbmr.2738