FGF-2 stimulates periodontal regeneration: results of a multi-center randomized clinical trial.
The efficacy of the local application of recombinant human fibroblast growth factor-2 (FGF-2) in periodontal regeneration has been investigated. In this study, a randomized, double-blind, placebo-controlled clinical trial was conducted in 253 adult patients with periodontitis. Modified Widman periodontal surgery was performed, during which 200 µL of the investigational formulation containing 0% (vehicle alone), 0.2%, 0.3%, or 0.4% FGF-2 was administered to 2- or 3-walled vertical bone defects. Each dose of FGF-2 showed significant superiority over vehicle alone (p < 0.01) for the percentage of bone fill at 36 wks after administration, and the percentage peaked in the 0.3% FGF-2 group. No significant differences among groups were observed in clinical attachment regained, scoring approximately 2 mm. No clinical safety problems, including an abnormal increase in alveolar bone or ankylosis, were identified. These results strongly suggest that topical application of FGF-2 can be efficacious in the regeneration of human periodontal tissue that has been destroyed by periodontitis.
Department of Periodontology, Division of Oral Biology and Disease Control, Osaka University Dental Hospital, Japan.
M
M
Kitamura
M
M
Akamatsu
M
M
Machigashira
Y
Y
Hara
R
R
Sakagami
T
T
Hirofuji
T
T
Hamachi
K
K
Maeda
M
M
Yokota
J
J
Kido
T
T
Nagata
H
H
Kurihara
S
S
Takashiba
T
T
Sibutani
M
M
Fukuda
T
T
Noguchi
K
K
Yamazaki
H
H
Yoshie
K
K
Ioroi
T
T
Arai
T
T
Nakagawa
K
K
Ito
S
S
Oda
Y
Y
Izumi
Y
Y
Ogata
S
S
Yamada
H
H
Shimauchi
K
K
Kunimatsu
M
M
Kawanami
T
T
Fujii
Y
Y
Furuichi
T
T
Furuuchi
T
T
Sasano
E
E
Imai
M
M
Omae
S
S
Yamada
M
M
Watanuki
S
S
Murakami
D000328:Adult; D016301:Alveolar Bone Loss / Q000000981:diagnostic imaging / Q000601:surgery; D000539:Alveolar Process / Q000187:drug effects; D003774:Dental Plaque Index; D004311:Double-Blind Method; D005260:Female; D016222:Fibroblast Growth Factor 2 / Q000008:administration & dosage / Q000627:therapeutic use*; D005500:Follow-Up Studies; D005881:Gingiva / Q000473:pathology; D005884:Gingival Hemorrhage / Q000145:classification; D005889:Gingival Recession / Q000145:classification; D016557:Guided Tissue Regeneration, Periodontal / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017622:Periodontal Attachment Loss / Q000145:classification; D010512:Periodontal Index; D010513:Periodontal Ligament / Q000187:drug effects; D010514:Periodontal Pocket / Q000145:classification; D010518:Periodontitis / Q000601:surgery*; D010919:Placebos; D011859:Radiography; D011994:Recombinant Proteins; D013524:Surgical Flaps; D014086:Tooth Mobility / Q000145:classification; D016896:Treatment Outcome
D010919:Placebos; D011994:Recombinant Proteins; D016222:Fibroblast Growth Factor 2