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 β-tricalcium phosphate (β-TCP) in patients with periodontal defects and to compare it with those of β-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+β-TCP or β-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+β-TCP group when compared with the β-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 β-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+β-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).
RCT Entities:
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 β-tricalcium phosphate (β-TCP) in patients with periodontal defects and to compare it with those of β-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+β-TCP or β-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+β-TCP group when compared with the β-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 β-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+β-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).
Authors: Myron Nevins; Richard T Kao; Michael K McGuire; Pamela K McClain; James E Hinrichs; Bradley S McAllister; Michael S Reddy; Marc L Nevins; Robert J Genco; Samuel E Lynch; William V Giannobile Journal: J Periodontol Date: 2012-05-21 Impact factor: 6.993
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