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Mechanism of Action of GEM 21S® in an Osseous Wound.

Important Safety Information.

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1. Following thorough debridement of the osseous defect, it is completely filled with GEM 21S®. Initial release of PDGF occurs within minutes of grafting. PDGF is released from the β-TCP matrix into the surrounding environment. PDGF then binds to specific cell surface receptors on target cells initiating a cascade of intracellular signaling pathways.
2. PDGF - induced intracellular events lead to directed cell migration or chemotaxis and cell proliferation of osteoblasts, fibroblasts and cementoblasts. (Based on in vitro and in vivo data.)
3. Proliferation of osteoblasts, fibroblasts and cementoblasts leads to increased matrix synthesis, resulting in formation of new alveolar bone, periodontal ligament and cementum. (Based on in vitro and in vivo data.)
4. Clinical data suggests that over time (after approximately 6 months), maturation of supporting alveolar bone, cementum, and periodontal ligament occurs. The end result is enhanced bone and periodontal regeneration and retention of the natural tooth.
5. The goal of using GEM 21S® is to restore normal esthetics., anatomic form and function.