A pilot study: Clinical efficacy of novel polycaprolactone-tricalcium phosphate membrane for guided bone regeneration in rabbit calvarial defect model

In this pilot study, we aim to investigate the clinical efficacy of a novel polycaprolactone-tricalcium phosphate (PCL-TCP) membrane for guided bone regeneration (GBR) in an in vivo model. Eight rabbits, each with two surgically created calvarial defects were reconstructed using a bovine particulate bone substitute, then covered with a mechanical barrier using a PCL-TCP or collagen membrane, or left uncovered without any membrane. The rabbits were sacrificed at 1 and 2 months and the reconstructed defects were harvested for histology and histomorphometry evaluations. Results showed no statistical significance in percentage bone area fraction (BAF%) between the PCL-TCP and collagen membranes at 1 and 2 months. The BAF% of the PCL-TCP membrane group was statistically higher at 2 months compared to 1 month (p<.05); the BAF% in the collagen membrane group did not increase significantly from the first to second months (p>.05). We postulate that this is attributed to the greater stiffness and slower degradation of PCL-TCP. We conclude that the novel PCL-TCP membrane is as effective as the commercially available collagen membrane as a mechanical barrier for GBR, with good handling characteristics. Future work should explore variations in PCL-TCP composition to further improve its usability and rate of desired degradation.