Stability of Recombinant Human Platelet-Derived Growth Factor-BB- Regenerated Periodontal Defects: Sixty-Month Clinical and Radiographic Observations.

Abstract

The availability of recombinant human platelet-derived growth factor-BB (rhPDGF-BB) plus β-tricalcium phosphate (β-TCP) for periodontal therapeutic use resulted from a large-scale, prospective, masked, randomized clinical trial. This pivotal trial indicated that this combination can safely and effectively be used to treat advanced periodontal osseous defects. Previous reports demonstrated significant gain in clinical attachment level, linear bone gain, and percentage bone fill after 6 months. Subsequent evaluation of selected cases 24 months after treatment indicated the clinical gains were maintainable. Furthermore, there appeared to be substantial increase in linear bone gain and percentage bone fill. Radiographically, there was increased radiopacity and bone trabeculation, suggesting bone maturation. This report presents representative cases from the rhPDGF-BB plus β-TCP pivotal clinical trial after 60 months. Maximal regenerative results were achieved after 12 months and maintained ≥5 years. Sites treated with rhPDGF-BB plus β-TCP were generally healthy, with no evidence of ankylosis, root resorption, or abnormal tissue reaction. However, a limited number of cases deteriorated, suggesting that smoking and poor self/supportive care compliance can adversely affect periodontal regenerative results. The use of rhPDGF-BB plus β-TCP was safe and effective in the treatment of periodontal osseous defects. The regenerated results are maintainable ≥5 years, with adverse events attributable to the treatment.