Periodontal disease causes the destruction of the supporting structures of teeth including alveolar bone, functioning tooth root surface cementum and periodontal ligament. At present there is little that can be done to predictably enhance osteoneogenesis and regeneration of the periodontal structures. During Phase I we have shown that the combination of human recombinant platelet-derived growth factor II (PDGF-II) and human recombinant insulin-like growth factor I (IGF-I) formulated in cellulose- based gel has significant potential for predictably enhancing osteoneogenesis and periodontal regeneration. We now propose to further develop and characterize the gel/PDGF-II/IGF-I product. We will determine the rate of release of PDGF-II and IGF-I from cellulose gel formulations under in vitro and in vivo conditions and correlate this data with the PDGF-II/IGF-I/gel formulations' ability to enhance periodontal regeneration. We will determine the appropriate dose of the gel formulated factors and their efficacy in two types of periodontal bone defects. The proper storage conditions and shelf life of the growth factor formulated gel product will then be determined in preparation for Phase III preclinical toxicology and human clinical trials.
