This study aims to verify the effectiveness of Trafermin (recombinant human basic fibroblast growth factor) in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
328
Administered to the bone defect during flap operation
Control
Kaken Investigational Site
Nagoya, Aichi-ken, Japan
Kaken Investigational Site
Matsudo, Chiba, Japan
rate of increase in alveolar bone height
Time frame: 36 weeks after administration
clinical attachment level regained
Time frame: 36 weeks after administration
time course of increase rate in alveolar bone height
Time frame: within 36 weeks after administration
time course of clinical attachment level regained
Time frame: within 36 weeks after administration
time course change of periodontal tissue inspection values
Time frame: within 36 weeks after administration
occurrence and level of adverse reaction
Time frame: within 36 weeks after administration
serum anti-Trafermin antibody level
Time frame: within 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Kaken Investigational Site
Fukuoka, Fukuoka, Japan
Kaken Investigational Site
Kitakyushu, Fukuoka, Japan
Kaken Investigational Site
Hiroshima, Hiroshima, Japan
Kaken Investigational Site
Ishikari-Tobetsu, Hokkaido, Japan
Kaken Investigational Site
Sapporo, Hokkaido, Japan
Kaken Investigational Site
Morioka, Iwate, Japan
Kaken Investigational Site
Kagoshima, Kagoshima-ken, Japan
Kaken Investigational Site
Machida, Kanagawa, Japan
...and 11 more locations