Periodontal regeneration using a xenogeneic bone substitute seeded with autologous periodontal ligament‐derived mesenchymal stem cells: A 12‐month quasi‐randomized controlled pilot clinical trial

Aim To evaluate the safety and efficacy of autologous periodontal ligament‐derived mesenchymal stem cells (PDL‐MSCs) embedded in a xenogeneic bone substitute (XBS) for the regenerative treatment of intra‐bony periodontal defects. Material and Methods This quasi‐randomized controlled pilot phase II clinical trial included patients requiring a tooth extraction and presence of one intra‐bony lesion (1–2 walls). Patients were allocated to either the experimental (XBS + 10 × 106 PDL‐MSCs/100 mg) or the control group (XBS). Clinical and radiographical parameters were recorded at baseline, 6, 9 and 12 months. The presence of adverse events was also evaluated. Chi‐square, Student's t test, Mann–Whitney U, repeated‐measures ANOVA and regression models were used. Results Twenty patients were included. No serious adverse events were reported. Patients in the experimental group (n = 9) showed greater clinical attachment level (CAL) gain (1.44, standard deviation [SD] = 1.87) and probing pocket depth (PPD) reduction (2.33, SD = 1.32) than the control group (n = 10; CAL gain = 0.88, SD = 1.68, and PPD reduction = 2.10, SD = 2.46), without statistically significant differences. Conclusion The application of PDL‐MSCs to XBS for the treatment of one‐ to two‐wall intra‐bony lesions was safe and resulted in low postoperative morbidity and appropriate healing, although its additional benefit, when compared with the XBS alone, was not demonstrated.