Abstract
OBJECTIVES: To assess the efficacy and safety of a cell-based therapy for 3D bone augmentation of severe alveolar bone defects prior to dental implant placement. MATERIALS AND METHODS: A Phase 2 randomized controlled clinical trial evaluated the safety and efficacy of a cell therapy using expanded autologous iliac crest-derived mesenchymal cells seeded on a synthetic bioabsorbable bone substitute covered with a non-resorbable membrane. The control group received an autogenous bone block graft. After 5 months, CBCT scans were compared to measure the bone volume changes achieved after the regenerative surgery. Subsequently, dental implants were placed in the regenerated areas. RESULTS: A total of 48 patients were included and randomized (36 patients in the test group and 12 in the control group). However, seven patients did not reach the minimum required number of expanded MSCs and were therefore unable to be treated. The tested intervention demonstrated significantly greater gains in bone volume, with a mean difference of 480.01 mm(3) (p = 0.032). Similarly, the mean change in bone crest volume from baseline to 5 months was notably higher in the test group (1066.91 mm(3)) compared to the control group (586.9 mm(3)). Adverse reactions and patient morbidity were minor in both groups. Implants were placed on the regenerated bone, and all were integrated successfully in both groups. CONCLUSIONS: The cell-based therapy resulted in significant changes in bone volume compared to the control treatment, enabling dental implants in all patients. The procedure was associated with minimal adverse effects and patient morbidity. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03373052, NCT04297813.