Multi-centre, randomized clinical trial on the efficacy and safety of recombinant human platelet-derived growth factor with β-tricalcium phosphate in human intra-osseous periodontal defects

P>Aim The objective of the study was to evaluate the safety and efficacy of a formulation containing recombinant human platelet-derived growth factor (rhPDGF-BB) and beta-tricalcium phosphate (beta-TCP) in patients with periodontal defects and to compare it with those of beta-TCP alone. Materials and Methods In this double-blind, prospective, parallel, active-controlled, randomized, multi-centre clinical trial, 54 patients with periodontal osseous defects were randomly assigned to rhPDGF-BB+beta-TCP or beta-TCP. Following periodontal surgery, respective implantation was performed. The primary and secondary end points of treatment were evaluated at the third and the sixth month. Results Among the outcome measures, the extent of linear bone growth (p < 0.01) and per cent bone fill (p < 0.004) at the sixth month over baseline were significantly higher in the rhPDGF-BB+beta-TCP group when compared with the beta-TCP group. Similarly, it also resulted in significantly higher area under the curve clinical attachment level gain at 0-6 months (p < 0.01), CAL gain and greater reduction in probing depth at the third and the sixth month than that with beta-TCP treatment alone. The incidence of adverse events was similar in both the groups and no serious adverse events were reported in any of the patients. Conclusions rhPDGF-BB+beta-TCP is safe and effective in the treatment of periodontal defects. It increases bone formation and soft tissue healing (clinicaltrials.gov, number NCT00496847; CTRI No.: CTRI/2008/091/000152).