Periodontal bone regeneration requires attention to (a) the need of a physical barrier to restrict the entry/formation of fibro-epithelial tissue, (b) he cause of bone loss that is due to host's inflammatory response to pathological cause and not due to the causative pathogen directly; so, along with bone regeneration strategies, the process also equally demands for inflammation control, and (c) avoid using a biomaterials that would require eventual removal and cause damage to newly regenerated tissue. This research proposes to design a device that will take care of the above issues. We have secured preliminary success in creating a biodegradable and bioabsorbable formulation that may provide sufficient structural and biomimetic support for proliferating and growing bone cells. However, this device would biodegrade and would not be able to support the regenerating cells before the needed time of support of 21 days. This proposal is an effort to enhance the biodegradation time of this biomimetic formulation up to 21-28 days by crosslinking its components with a non-toxic and tissue protective crosslinker and to design the resultant material into a xerogel film/sheet so that it can be used as a physical barrier film or sheet to be placed in periodontal pockets to restrict the entry/formation of fibro-epithelial tissue during the periodontal bone regeneration therapy. The biodegradation of the proposed formulation are well known anti-inflammatory agent that are supposed to negate the inflammatory host response to periodontal pathology. Therefore, this project will evaluate the proposed device for its biodegradation and anti-inflammatory profile inrelated simulated oral conditions and for its biomimetic osteogenic potential for up to 28 days. After completion of this phase-I research, it is expected to evolve a better and more complete periodontal bone regeneration device that would biodegrade without a need for an additional surgical procedure to remove the physical barrier after the periodontal regeneration is achieved. After further development of the proposed device under FDA supervision before the premarket notification (510K) in the phase-II and the following clinical evaluations, the outcome will be a marketable periodontal bone regeneration product that would bring patient morbidity and related medical expenses to a minimum.
Along with the help in bone regeneration, the periodontal regeneration therapy needs the elements to restrict the infiltration of epithelial cells and fibroblasts in the bone regeneration site and also to control the inflammation. The proposed research is expected to evolve a biodegradable device that, would act as physical barrier, would biodegrade slowly to anti-inflammatory ingredients, would be optimized to retain its structural entity tuned to the rate of biomimetic bone regeneration process, and would self - disintegrate so that there will be no need for eventual device removal surgery. Thus, an ideal periodontal bone regeneration device is expected to be evolved out this proposed research.
