Periodontal regeneration by leukocyte and platelet-rich fibrin with autogenous bone graft versus enamel matrix derivative with autogenous bone graft in the treatment of periodontal intrabony defects: A randomized non-inferiority trial

Background: Aim of the present study was to ascertain if a combination of leukocyte and platelet-rich fibrin (L-PRF) + autogenous bone graft (ABG) may be a clinically “non-inferior” treatment modality as compared with the association of enamel matrix derivative (EMD) with ABG in the management of intrabony defects (IBDs). Methods: A total of forty-four patients, exhibiting at least one unfavorable intraosseous defect, were treated by L-PRF associated with ABG (22 patients; test group) or EMD+ABG (control group) in each defect. At baseline and 12 months, a complete clinical and radiographic examination was done. Pre- and post-therapy clinical (probing pocket depth [PPD], clinical attachment level [CAL], gingival recession [GR]) and radiographic (defect Bone level [(DBL)] parameters for the different treatments were compared. To guarantee the test treatment's efficacy 1mm was chosen as non-inferiority margin; for clinical relevance, a second non-inferiority margin = 0.5 mm was set. Results: Clinical and radiographic parameters significantly improved 12 months after surgery in both test and control sites, without inter-groups differences for each measurement. The control group – test group differences for the parameters CAL gain −0.248 mm (−0.618 to 0.122), PPD Reduction −0.397 mm (−0.810 to 0.015), GR Change 0.059 mm (−0.300 to 0.418), DBL Gain −0.250 mm (−0.746 to 0.246) were all within the non-inferiority margin of 0.5 mm. Conclusion: Our results suggest that the L-PRF+ABG combined treatment of non-contained IBDs produces non-inferior results in terms of CAL gain, PPD reduction, GR increase and DBL gain in comparison with the EMD+ABG combination.