Periodontal Surgery Using rhFGF-2+DBBM: A 12-month Case Series

Objectives: The novel regenerative therapy using trafermin, a recombinant human fibroblast growth factor-2 (rhFGF-2) received a formal pharmaceutical approval in Japan in 2016. The purpose of this case series study was to evaluate clinical outcomes following application of rhFGF-2 in combination with deproteinized bovine bone mineral (DBBM) in the treatment of intrabony defects.
Methods: Five intrabony defects in 3 chronic periodontitis patients were evaluated. They had sites with probing depth (PD) > 4 mm and intrabony defects > 3 mm in depth after initial periodontal therapy. Full-thickness flap was elevated to expose the defects, and 0.3% rhFGF-2 (Regroth Dental Kit) + DBBM (Bio-Oss) was applied after debridement. Clinical and radiographic parameters and a patient-reported outcome measure (PROM) were evaluated.
Results: Postoperative healing was uneventful in all cases, and no significant adverse events were noted. At 12 months, a significant improvement in clinical attachment level (CAL) and PD from baseline value was observed (p < 0.05). CAL significantly decreased from 6.6 ± 0.5 mm to 4.5 ± 1.1 mm post-surgery. PD decreased from 5.6 ± 0.9 mm to 2.9 ± 0.5 mm. A significant change in radiographic bone fill was noted (from 44.3% to 54.8%).
No significant change in PROM from baseline was observed at 12 months.
Conclusions: At 12 months, the use of rhFGF-2+DBBM yielded significant improvements in clinical parameters when compared to baseline measurements. It is suggested that the combination therapy is clinically effective in the treatment of intrabony defects.