In vitro change in mechanical strength of beta-tricalcium phosphate/copolymerized poly-L-lactide composites and their application for guided bone regeneration.

Novel composites of bioactive beta-tricalcium phosphate [Ca(3)(PO(4))(2)] and biodegradable copolymerized poly-L-lactide (CPLA) were prepared by a heat-kneading method. The mechanical and chemical changes of the composites were evaluated in vitro by soaking in physiological saline and Dulbecco's phosphate buffered saline. When soaked in physiological saline, the 3-point mechanical strength decreased rapidly from 60 to 30 MPa in the initial 4 weeks and then gradually reached a plateau; the initial decrease in the mechanical strength was ascribed to the dissolution of beta-tricalcium phosphate from the surface. The mechanical properties evident at 8-12 weeks were sufficient for the composites to be used as a biodegradable material for regeneration of bone because the hydrolysis of CPLA was inhibited in both physiological saline and phosphate-buffered saline as a result of a pH-buffering effect. Composite membranes 250-microm thick were used to regenerate large bone defects in beagle dogs: 10 x 10 x 10 mm(3) in volume in the mandible and 20 mm in length in the tibia. The afflicted areas covered with the composite membranes were almost perfectly filled with new bone 12 weeks after the operation, whereas those covered with a CPLA membrane or without any membranes were invaded by soft tissue.