A Biodégradable and Biomimetic Xerogel for Periodontal Bone Regeneration

用于牙周骨再生的可生物降解和仿生干凝胶

• 批准号: 8976129
• 负责人: Neera Satsangi
• 金额: $ 22.43万
• 依托单位: INNOVATIVE RESEARCH SOLUTIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-01 至 2017-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8976129
• 关键词: Alveolar Bone Loss; Anti-Inflammatory Agents; Anti-inflammatory; Attention; Biocompatible Materials; Biodegradation; Biomimetics; Bone Regeneration; Bone Tissue; Bone Transplantation; Calvaria; Caring; Cells; Chitosan; Chronic; Crosslinker; Debridement; Defect; Development; Device Removal; Devices; Disease; Drug Formulations; Elastin; Elements; Embryo; Environment; Epithelial; Epithelial Cells; Excision; Exhibits; Exposure to; Fibroblasts; Film; Gingival Indexes; Health; Human; Hydrogels; Hydroxyapatites; Immune response; Impaired wound healing; Infiltration; Inflammation; Inflammatory; Inflammatory Response; Lead; Left; Liquid substance; Manuals; Mechanics; Medical; Membrane; Mesenchyme; Morbidity - disease rate; Movement; Mus; Natural regeneration; Neonatal; Notification; Oligosaccharides; Operative Surgical Procedures; Oral; Outcome; Pathologic; Pathology; Patients; Periodontal Pocket; Periodontitis; Periodontium; Pharmaceutical Preparations; Phase; Polymers; Polytetrafluoroethylene; Procedures; Process; Proliferating; Property; Proteins; Relative (related person); Research; Risk; Secure; Site; Stem cells; Structure; Supervision; Surgical Flaps; Testing; Time; Tissues; Tooth Loss; Work; base; bone; bone cell; bone loss; calcification; crosslink; design; genipin; improved; oral condition; osteogenic; pathogen; prevent; regenerative; research clinical testing; scaffold; success; tissue regeneration; wound

DESCRIPTION (provided by applicant): 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.

描述（由申请人提供）：牙周骨再生需要注意(a)需要一个物理屏障来限制纤维上皮组织的进入/形成，(b)骨质流失的原因是由于宿主对病理原因的炎症反应，而不是直接由于致病病原体；因此，除了骨骼再生策略外，该过程还同样需要控制炎症，并且(c)避免使用最终需要移除并对新再生组织造成损害的生物材料。本研究提出设计一个装置，将照顾到上述问题。我们已经取得了初步的成功，创造了一种生物可降解和生物可吸收的配方，可以为骨细胞的增殖和生长提供足够的结构和仿生支持。然而，这种装置会生物降解，无法在所需的21天支持时间之前支持再生细胞。本提案旨在通过将其成分与无毒的组织保护性交联剂交联，将这种仿生制剂的生物降解时间延长至21-28天，并将合成材料设计成干凝胶膜/片，以便在牙周骨再生治疗期间用作放置在牙周袋中的物理屏障膜或片，以限制纤维上皮组织的进入/形成。提出的制剂的生物降解是众所周知的抗炎剂，应该否定炎症宿主对牙周病理的反应。因此，该项目将评估拟议的设备在模拟口腔条件下的生物降解和抗炎特征，以及其长达28天的仿生成骨潜力。在完成第一阶段的研究后，预计将发展成