Efficacy and safety of autologous adipose-derived stem cells combined with platelet-rich plasma for periodontal regeneration: a multicenter, randomized, open-label, parallel-group comparative trial

Introduction: Periodontitis is a chronic inflammatory disease caused by dental biofilm that destroys the periodontal tissues supporting the teeth. We aimed to evaluate the efficacy and safety of co-transplantation of autologous adipose-derived mesenchymal stem cells (ASCs) with platelet-rich plasma (PRP) compared to enamel matrix derivative (EMD) for regenerating periodontal tissue damaged by chronic periodontitis. Methods: In this multicenter, randomized, open-label, parallel-group phase II therapeutic equivalence trial, we assessed the effects of ASCs with PRP versus EMD on alveolar bone height and width, as well as other periodontal indices. Measurements of primary and secondary endpoints and periodontal tissue indices were performed at baseline, the day of transplantation, and at 12, 24, and 36 weeks post-transplantation. Data were analyzed using Student's t-test. Results: Of the 21 patients initially recruited, 9 in the ASCs + PRP group and 6 in the EMD group completed the study. The ASCs + PRP treatment demonstrated greater regenerative potential than that of EMD, with a significantly higher alveolar bone height at 36 weeks post-treatment. Patients receiving ASCs + PRP treatment showed a statistically higher mean height of new alveolar bone in the transplanted area than those in the EMD group. Clinical attachment levels improved significantly from baseline at 12, 24, and 36 weeks in the ASCs + PRP group; however, no significant difference in clinical attachment gain was observed between the two groups. Adverse events in the ASCs + PRP group were neither related to the implantation site nor to the treatment. Conclusions: Co-transplantation of ASCs with PRP is a safe and effective approach for periodontal regeneration, offering a promising therapeutic strategy for the treatment of periodontitis.