Periodontal tissue regeneration using fibroblast growth factor-2: randomized controlled phase II clinical trial.
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.
Kitamura
Masahiro
M
Osaka University Dental Hospital, Suita, Japan.
Nakashima
Keisuke
K
Kowashi
Yusuke
Y
Fujii
Takeo
T
Shimauchi
Hidetoshi
H
Sasano
Takashi
T
Furuuchi
Toshi
T
Fukuda
Mitsuo
M
Noguchi
Toshihide
T
Shibutani
Toshiaki
T
Iwayama
Yukio
Y
Takashiba
Shogo
S
Kurihara
Hidemi
H
Ninomiya
Masami
M
Kido
Jun-ichi
J
Nagata
Toshihiko
T
Hamachi
Takafumi
T
Maeda
Katsumasa
K
Hara
Yoshitaka
Y
Izumi
Yuichi
Y
Hirofuji
Takao
T
Imai
Enyu
E
Omae
Masatoshi
M
Watanuki
Mitsuru
M
Murakami
Shinya
S
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
D011994:Recombinant Proteins; D016222:Fibroblast Growth Factor 2