Since the discovery in 1969 of a man-made surface-active material that would bond to bone, a range of materials with the same ability has been developed. These include glass, glass-ceramic, and ceramic materials which have a range of reaction rates and from which it should be possible to select a surface-active material for a specific application. The available materials and their similarities, differences, and current clinical applications are reviewed.
Evidence for the lack of toxicity of various bioglass formulations has been deduced from studies carried out, both in vivo and in vitro, in several different centers. Recent studies of the authors, described here, include testing of solid bioglass implants in the soft tissues of rats and rabbits for time periods of up to eight weeks. Two new techniques are described for the toxicological testing of particulate biomaterials. These tests, which involve rat peritoneal macrophages in culture and a mouse pulmonary biomaterial embolus model, indicate the biocompatibility of bioglass powders. Thus, the surface activity so critical in bone adhesion is without toxic effect in non-osseous tissues in contact with solid bioglass implants. Should wear occur and produce particulate bioglass, the material should be eliminated without consequence.
The hypothesis that bioactive glass particulate increases the rate of bone proliferation over that of synthetic hydroxyapatite and bioactive glass-ceramic was tested in these experiments. Three types of bioactive particles-45S5 Bioglass(R), synthetic hydroxyapatite, and A-W glass-ceramic-were implanted in 6-mm-diameter holes drilled in the femoral condyles of mature rabbits. Bone growth rate was measured using an image processor. 45S5 Bioglass(R) produced bone more rapidly than either A-W glass-ceramic or hydroxyapatite. At the later time periods, 45S5 Bioglass(R) was resorbed more quickly than A-W glass-ceramic. Synthetic hydroxyapatite was not resorbed at all. Backscattered electron imaging suggested that the resorption process occurred by solution-mediated dissolution, which produced chemical changes in the enclosed particulate. It was concluded that the rate of bone growth correlates with the rate of dissolution of silica as the particles resorb.
Four bioactive ceramic materials currently recommended for regeneration of osseous tissues in treatment of periodontal disease have been compared with Bioglass particulates, of equivalent size in two compositions, in a monkey model. Both Bioglass materials were found to be easily manipulated, were haemostatic and osteoproductive allowing restoration of both alveolar bone and periodontal ligament. Epithelial downgrowth was inhibited and epithelial attachment was close to the preimplantation level. The other materials were slower to act and epithelial downgrowth was to the same level as in unfilled control defects.
Various bioceramic materials were implanted into 6-mm-diameter holes made in the femoral condyles of mature Japanese white rabbits using different-sized granules to find an optimal material and granule diameter for use as a bone graft. Bioceramics include a bioinert ceramic (Alumina), surface-bioactive ceramics [hydroxyapatite (HAp) and Bioglass(R)], and resorbable bioactive ceramics [alphatricalcium phosphate (alpha-TCP), beta-TCP, tetracalcium phosphate (TeCP), Te. DCPD, Te. DCPA, and low-crystalline HAp]. Granule sizes were 100-300, 10, and 1-3 microm. Bone growth behavior varied with the kind of bioceramic and the size used. For surface-bioactive ceramics, 45S5 Bioglass(R) led to more rapid bone proliferation than synthetic HAp. In resorbable bioactive ceramics, the order of resorption was: low-crystalline HAp and OCP > TeCP, Te DCPD, Te DCPA > alpha-TCP, beta-TCP. In terms of biocompatibility, alpha-TCP was better than beta-TCP.
We compared the gross behavior of and microscopic response to implant materials currently in clinical use for facial bone augmentation at different sites in dogs. Materials evaluated include porous polytetrafluoroethylene carbon (Proplast), large-pore high-density polyethylene (Medpor), solid medical-grade silicone rubber (Silastic), polyamide mesh (Supramid), and autogenous rib bone. The subjects were 12 mixed-breed dogs and the materials were implanted directly on bone with periosteum removed at one of three sites in the dog's face (malar eminence, nasal dorsum, and chin). Animals were killed 3 months after surgery and stability of the implants was graded by manual manipulation. Blocks of tissue, including the study materials and underlying bone, were examined microscopically after sectioning. Stability results are tabulated and histologic appearance is described by site for each material evaluated. These data demonstrate marked variability of stability and cellular response depending on the site of implantation. From these data one may conclude that the site of implantation and implant movement are essential factors in determining the nature of the tissue response and fate of an implant. Solid and porous alloplastic materials show an acceptable tissue response, but neither demonstrates the ability to consistently provide an implant that is stable on underlying bone.
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