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

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 p...

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Published in:PloS one 2008-07, Vol.3 (7), p.e2611-e2611
Main 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
Format: Article
Language:English
Subjects:
Alveolar bone
Biofilms
Cell Biology
Cell Biology/Cell Growth and Division
Clinical trials
Collagen
Defects
Dentistry
Double-Blind Method
Enamel
Fibroblast growth factor 2
Fibroblast Growth Factor 2 - therapeutic use
Fibroblast growth factors
Fibroblasts
Follow-Up Studies
Growth factors
Guided Tissue Regeneration, Periodontal - methods
Gum disease
Health aspects
Health sciences
Hospitals
Humans
Hydroxyapatite
Laboratory animals
Ligaments
Literature reviews
Patients
Periodontal Diseases - drug therapy
Periodontitis
Pharmacology/Drug Development
Phosphatase
Radiography
Randomization
Recombinant Proteins - therapeutic use
Regeneration
Researchers
Statistical analysis
Stem cells
Stimulators
Teeth
Tissue engineering
Treatment Outcome
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Description
Summary: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. 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. 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. ClinicalTrials.gov NCT00514657.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0002611