Long‐Term Prognosis of Periodontal Regeneration With Basic Fibroblast Growth Factor: Over 10 Years Case Series Evaluation

Background In Japan, a 0.3% recombinant protein of human basic fibroblast growth factor (0.3% rhFGF‐2; REGROTH) was approved to manufacture new periodontal regenerative medicine in September 2016. The efficacy of 0.3% rhFGF‐2 for periodontal regeneration was evaluated in multicenter clinical trials. We also participated in a Phase III trial conducted between 2009 and 2013. Some patients still continued to visit our hospital for supportive periodontal therapy (SPT) till March 2025, providing a long‐term prognosis for regenerative therapy using 0.3% rhFGF‐2 alone. Aim We assessed the clinical and radiographic outcomes of five cases that were followed up for >10 years postoperatively with 0.3% rhFGF‐2. Case Description In the clinical trial protocol, periodontal tissue examinations, including the gingival index (GI), probing pocket depth (PPD), bleeding on probing (BOP), mobility, and plaque index (Pl.I), were conducted at baseline and 12, 24, and 36 weeks postoperatively. Additionally, radiographs were obtained using a stent created in advance at baseline and 24 and 36 weeks postoperatively. Following the 36‐week clinical trial, patients continued to receive the periodontal therapy they needed. Of the 33 patients enrolled in the clinical trial at our dental hospital between April 2009 and December 2013, 18 patients received the 0.3% rhFGF‐2. Five of the 18 patients continued to visit our hospital till March 2025. At the latest follow‐up, the mean PPD reduction over more than 10 years was maintained at 4.8 mm, and the mean residual bone volume rate was 71.9%. Conclusion Periodontal regeneration therapy using 0.3% rhFGF‐2 showed sustained new bone augmentation over the long term, comparable to previous regenerative materials.