Quick-Set Material-Phase II

描述（由申请人提供）：快速凝固材料-第二阶段快速凝固材料拟用于活髓治疗和非活髓牙髓治疗，以使临床程序更短、更一致，对患者和临床医生都有好处，并提高积极结果的可能性。新材料应促进牙周韧带和牙骨质组织的再生，这些组织因根管感染而受损或在根管治疗过程中被移除。组织的这种再生增强了根管系统的生物密封，以减少再感染的可能性，并增强牙齿保持力，而不会进一步破坏根管系统。 治疗、手术或拔牙。该材料旨在对现有标准护理MTA材料进行改进，该材料存在凝固时间长（小时）、难以放置和保留、低于预期的射线不透性以及在酸性条件下无法发挥作用的临床缺陷。在第1阶段，Quick-Set被证明在约10分钟（而不是数小时）内凝固，并被证明具有上级密封性（包括牙本质小管的渗透性）、更高的射线不透性和更好的抗感染酸能力。Quick-Set材料被证明具有碱性pH值，释放钙离子，在合成体液中形成羟基磷灰石，并符合ADA 57要求。本第2阶段项目旨在测试第1阶段的快速凝固材料的生物相容性和体内性能。本试验计划使用成牙本质细胞样细胞培养物检查生物相容性，然后将试验扩展至犬和大鼠体内性能。犬研究将比较Quick-Set与白色MTA材料在活髓和非活髓适应症中的效果。钙化和脱钙组织学将通过测量由CT确定的骨再生来增强。大鼠研究将使用口面疼痛测量（进餐时间测量）和炎症标志物的ELIZA组织学比较两种材料之间牙髓感染的愈合性能。临床处理和填充根和活髓治疗将被检查 由临床医生进行动物研究，以确保材料符合临床预期。与此同时，将在实验室中开发一种快速凝固密封剂配方（在本文中称为快速凝固密封剂）。根管封闭剂应具有与Quick-Set相同的良好质量，但应包含更细的颗粒，符合ISO 6876和ADA 57的所有要求，并具有更长的固化时间，处理类似于传统的根管封闭剂。Quick-Set骨水泥将用于第二项脱钙组织学犬研究。还将进行实验室测试，以增加Quick-Set的强度测量，并开发基于糊状物的配方。 公共卫生相关性：快速固化材料，第二阶段快速固化材料正在开发中，使牙科医生能够治疗受感染的牙髓或牙根，以更快地完成程序，并取得更好的效果。许多使用计划快速设置材料愈合感染的牙髓和根感染，目的是保留牙齿，减少对其他程序，如提取或植入的需要。快速固化材料的设计是更快的设置，即使在感染的存在，并密封和愈合牙齿比现有的材料。

DESCRIPTION (provided by applicant): Quick-Set Material- Phase II Quick-Set material is proposed for vital pulp therapy and for non-vital endodontic use to make the clinical procedures shorter and more consistent, of benefit to the patient and clinician, and enhance the probability for a positive outcome. The new material should promote regeneration of the periodontal ligament and cemental tissues that are injured by endodontic infections or removed during endodontic procedures. Such regeneration of tissues enhances the biological seal of the root canal system to reduce the possibility of re-infection, and enhance tooth retention without further treatment, surgery, or extraction. The material is intended to be an improvement on the present standard of care, MTA material which suffers from clinical deficiencies of long setting times (hours), difficulty in placement and retention, lower than desired radiopacity, and inability to se under acid conditions. In Phase 1, Quick-Set was shown to set in about 10 minutes (not hours) and was demonstrated to have superior sealing (including penetration of dentinal tubules), higher radiopacity, and better resistance to acids present in infections. The Quick-Set material was shown to have an alkaline pH, release calcium ions, form hydroxyapatite in synthetic body fluids, and meet ADA 57 requirements as they apply. This Phase 2 project is to test the Quick-Set Material from Phase 1 for its biocompatibility and in vivo performance. This testing planned is to examine the biocompatibility using odontoblast-like cell cultures, and then expand the testing to performance in vivo with canines and rats. The canine study will compare Quick-Set to White MTA material in both vital and non-vital pulp indications. Calcified & decalcified histology will be augmented by measurement of bone regeneration determined by ¿CT. The rat study will compare the healing performance of pulp infections between the two materials, using orofacial pain measurements (meal duration measurement) and ELIZA histology for markers of inflammation. The clinical handling and filling of roots and vital pulp treatments will be examined by the clinicians performing the animal studies, to ensure the material can meet clinical expectations. In parallel, a sealer formula (denoted herein as Quick-Set Sealer) will be developed in the laboratory. The sealer should have the same good qualities of Quick-Set, but should contain finer particles, meet all the requirements of ISO 6876 and ADA 57, and have a longer setting time, with handling similar to conventional root canal sealers. The Quick-Set sealer will be used in a second canine study with decalcified histology. Laboratory testing will also be performed to increase the strength measurements of Quick-Set and develop paste-based formulas. PUBLIC HEALTH RELEVANCE: Quick-Set Material, Phase II Quick-Set material is being developed to enable dentists treating the infected pulp of teeth or their roots to complete the procedures more quickly and with better results. Many uses are planned for Quick-Set material to heal infected pulps and root infections, with the goal of retaining teeth and reducing the need for other procedures such as extraction or implants. The Quick-Set material is designed to be quicker-setting, even when an infection is present, and to seal and heal teeth better than existing materials.