Clinical Outcome of Periodontal Tissue Regeneration Therapy by Administration of Basic Fibroblast Growth Factor (FGF-2)

Abstract

 Purpose: In December 2016, the periodontal regenerative medicine REGROTH (Kaken Pharmaceutical, Tokyo, Japan), the whole active ingredient of which is basic fibroblast growth factor (FGF-2), was launched. In this study, we evaluated the clinical outcome of periodontal tissue regeneration therapy using REGROTH at Osaka University Dental Hospital (Department of Periodontology).

 Methods: 131 teeth from 94 patients (28 men and 66 women), who had been diagnosed with periodontitis and treated with REGROTH (140 sites), were registered. The patients underwent initial preparation, flap surgery combined with REGROTH and then supportive periodontal therapy (SPT) or maintenance. Each test site demonstrated a vertical bone defect with a probing depth (PD) of 4 mm or more and a bone defect depth of 3 mm or more. In this study, the therapeutic effect of REGROTH was evaluated by measuring the tooth mobility, PD, bleeding on probing (BOP) and new bone formation rate (radiographic analysis) before and after the administration of REGROTH.

 Results: The average value of PD at the test site was 6.00±1.50 mm before surgery, and decreased to 3.81±1.31 mm at 3-5 months after surgery, and 3.54±1.07 mm at 9 months or more after surgery. BOP was observed in 70% of the test site before surgery, and decreased to approximately 20% at 3-5 months after surgery, and remained a low value thereafter. The average value of new bone formation gradually increased over time: 24.4±24.5% at 3-5 months after surgery, 35.7±24.3% at 6-8 months after surgery and 49.4±27.6% at 9 months or more after surgery.

 Conclusion: Clinical outcome of periodontal tissue regeneration by REGROTH therapy at Osaka University Dental Hospital was equal to or greater than that of the phase III clinical trial during the development of REGROTH.