Periodontal Tissue Regeneration Using Fibroblast Growth Factor-2: Randomized Controlled Phase II Clinical Trial

被引：148

作者：

Kitamura, Masahiro ^{[1
]}

Nakashima, Keisuke ^{[2
]}

Kowashi, Yusuke ^{[2
]}

Fujii, Takeo ^{[3
]}

Shimauchi, Hidetoshi ^{[4
]}

Sasano, Takashi ^{[4
]}

Furuuchi, Toshi ^{[4
]}

Fukuda, Mitsuo ^{[5
]}

Noguchi, Toshihide ^{[5
]}

Shibutani, Toshiaki ^{[6
]}

Iwayama, Yukio ^{[6
]}

Takashiba, Shogo ^{[7
]}

Kurihara, Hidemi ^{[8
]}

Ninomiya, Masami ^{[9
]}

Kido, Jun-ichi ^{[9
]}

Nagata, Toshihiko ^{[9
]}

Hamachi, Takafumi ^{[10
]}

Maeda, Katsumasa ^{[10
]}

Hara, Yoshitaka ^{[11
]}

Izumi, Yuichi ^{[12
]}

Hirofuji, Takao ^{[13
]}

Imai, Enyu ^{[14
]}

Omae, Masatoshi ^{[15
]}

Watanuki, Mitsuru ^{[16
]}

Murakami, Shinya ^{[1
]}

机构：

[1] Osaka Univ, Dent Hosp, Suita, Osaka, Japan

[2] Hlth Sci Univ Hokkaido, Dent Hosp, Ishikari, Hokkaido, Japan

[3] Hlth Sci Univ Hokkaido, Med & Dent Clin, Sapporo, Hokkaido, Japan

[4] Tohoku Univ, Dent Hosp, Sendai, Miyagi, Japan

[5] Aichi Gakuin Univ, Dent Hosp, Nagoya, Aichi, Japan

[6] Asahi Univ, Dent Hosp, Mizuho, Japan

[7] Okayama Univ, Dent Hosp, Okayama, Japan

[8] Hiroshima Univ, Dent Hosp, Hiroshima, Japan

[9] Tokushima Univ, Dent Hosp, Tokushima, Japan

[10] Kyushu Univ, Dent Hosp, Fukuoka, Japan

[11] Nagasaki Univ Hosp, Attached Sch Dent, Nagasaki, Japan

[12] Kagoshima Univ, Dent Hosp, Kagoshima, Japan

[13] Fukuoka Dent Coll Hosp, Fukuoka, Japan

[14] Osaka Univ Hosp, Suita, Osaka, Japan

[15] Izumisano Municipal Hosp, Rinku Gen Med Ctr, Izumisano, Japan

[16] Kaken Pharm Co Ltd, Tokyo, Japan

来源：

PLOS ONE | 2008年 / 3卷 / 07期

关键词：

D O I：

10.1371/journal.pone.0002611

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

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 containing 0.1% FGF-2; and Group H, given HPC containing 0.3% FGF-2. Each patient underwent flap operation during which we administered 200 mu L 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 attributable 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.

引用

页数：11

共 37 条

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