JOURNAL OF BIOMEDICAL MATERIALS RESEARCH PART A, vol.96A, no.1, pp.230-238, 2011 (SCI-Expanded)
We report results from an initial small animal study designed to provide information on the biocompatibility of a novel biodegradable composite designed for craniomaxillofacial reconstruction. Rat calvarium was chosen as a clinically analogous model, which allowed comparison between experimental groups (PCL alone, PCL/phosphate glass, or PCL/bioglass implants) and control groups (empty defects or bone grafted defects). All animals recovered well from surgery and no clinical complications were observed. Histological assessment indicated a lack of inflammatory response. The amount of new bone formation at the dural aspect of the implant was statistically significantly higher in the PCL/phosphate glass group than the other experimental groups. This study confirms, in a clinically analogous model, the promise of the novel PCL/phosphate glass composite material. Work is planned toward manufacturing scale up and clinical trials. (C) 2010 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 96A: 230-238, 2011.