Fast Degradable CalciumPhosphate Cement for Maxillo-Facial Bone Regeneration.

The aim of this preclinical study was to test the applicability of CPC-PLGA-CMC as a bone substitute material for guided bone regeneration (GBR) procedures in a clinically relevant mandibular defect model in mini-pigs. In the study, a predicate device (i.e. BioOss®) was included for comparison. Critical-sized circular mandibular bone defects were created and filled with either CPC-PLGA-CMC without coverage with a GBR membrane or BioOss® covered with a GBR membrane and left to heal for 4 and 12 weeks to obtain temporal insight in material degradation and bone formation. Bone formation increased significantly for both CPC-PLGA-CMC and BioOss® with increasing implantation time. Further, no significant differences were found for bone formation at either 4 or 12 weeks between CPC-PLGA-CMC and BioOss®. Finally, bone substitute material degradation increased significantly for both CPC-PLGA-CMC and BioOss® from 4 to 12 weeks of implantation, showing the highest degradation for CPC-PLGA-CMC (~85%) compared to BioOss® (~12%). In conclusion, this mini-pig study showed that CPC-PLGA-CMC can be used as a bone grafting material and stimulates bone regeneration to a comparable extent as with BioOss® particles. Importantly, CPC-PLGA-CMC degrades faster compared to BioOss®, is easier to apply into a bone defect, and does not need the use of an additional GBR membrane. Consequently, the data support the further investigation of CPC-PLGA-CMC in human clinical trials.