title: Periodontal tissue regeneration using fibroblast growth factor-2: randomized controlled phase II clinical trial.
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.
  
  
  RESULTS
  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 > or = 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 microL 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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00514657.
authors.affiliation: Osaka University Dental Hospital, Suita, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kitamura
authors.forename: Keisuke
authors.initials: K
authors.lastname: Nakashima
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Kowashi
authors.forename: Takeo
authors.initials: T
authors.lastname: Fujii
authors.forename: Hidetoshi
authors.initials: H
authors.lastname: Shimauchi
authors.forename: Takashi
authors.initials: T
authors.lastname: Sasano
authors.forename: Toshi
authors.initials: T
authors.lastname: Furuuchi
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Fukuda
authors.forename: Toshihide
authors.initials: T
authors.lastname: Noguchi
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Shibutani
authors.forename: Yukio
authors.initials: Y
authors.lastname: Iwayama
authors.forename: Shogo
authors.initials: S
authors.lastname: Takashiba
authors.forename: Hidemi
authors.initials: H
authors.lastname: Kurihara
authors.forename: Masami
authors.initials: M
authors.lastname: Ninomiya
authors.forename: Jun-ichi
authors.initials: J
authors.lastname: Kido
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Nagata
authors.forename: Takafumi
authors.initials: T
authors.lastname: Hamachi
authors.forename: Katsumasa
authors.initials: K
authors.lastname: Maeda
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Hara
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Izumi
authors.forename: Takao
authors.initials: T
authors.lastname: Hirofuji
authors.forename: Enyu
authors.initials: E
authors.lastname: Imai
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Omae
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Watanuki
authors.forename: Shinya
authors.initials: S
authors.lastname: Murakami
mesh_terms: D004311:Double-Blind Method; D016222:Fibroblast Growth Factor 2 / Q000627:therapeutic use*; D005500:Follow-Up Studies; D016557:Guided Tissue Regeneration, Periodontal / Q000379:methods*; D006801:Humans; D010510:Periodontal Diseases / Q000188:drug therapy*; D011994:Recombinant Proteins / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D016222:Fibroblast Growth Factor 2