Preclinical evaluation of injectable bone substitute materials.
PURPOSE The purpose of this project was to study the effect of chitosan bead encapsulating calcium sulfate, which provides a sustained release of chitosan and calcium sulfate after implantation, on early bony consolidation in distraction osteogenesis of a dog model. MATERIALS AND METHODS Forty-five dogs were used for this study. An external distraction device was applied to the mandibular body after a vertical osteotomy and mandibular distraction was initiated 5 days after the operation at a rate of 1 mm/day up to a 10-mm distraction. The experimental group was divided into a control group (I), hyaluronic acid group (II), chitosan group (III), calcium sulfate group (IV), and chitosan bead encapsulating calcium sulfate group (V). Normal saline was injected in group I. In group II, 1 mL of hyaluronic acid solution was injected into the distracted region. In group III, 1 mL of injectable solution of chitosan mixed with hyaluronic acid was implanted. In group IV, 1 mL of injectable solution of calcium sulfate mixed with hyaluronic acid was implanted. In group V, an injectable form of powdered chitosan bead encapsulating calcium sulfate mixed with 1 mL volume of hyaluronic acid was implanted. RESULTS Bone mineral density was 12% of the contralateral normal mandible at 3 weeks, 23.4% at 6 weeks in group I, 15% at 3 weeks, 29.1% at 6 weeks in group II, 16% at 3 weeks and 32% at 6 weeks in group III, 30.4% at 3 weeks and 52.8% at 6 weeks in group IV, and 33.6% at 3 weeks and 55% at 6 weeks in group V with statistical significance (P < .005). The mean 3-point failure load was compared with the intact contralateral mandible and noted to be 12% in the control group, 16% in group II, 18% in group III, 34.3% in group IV, and 31.7% in group V. Difference of mean percentages between one group and another was statistically significant (P < .005). In the histologic findings, new bone was generated in all groups. In groups IV and V, the formation of active woven bone was observed throughout the distracted region at 6 weeks. The amount of new bone formation in the distracted zone was in the order of group IV and V, III and II, and the control group. CONCLUSIONS These findings suggest that chitosan bead encapsulating calcium sulfate appears to facilitate early bony consolidation in distraction osteogenesis.