Quick-Set Material-Phase II

描述(申请人提供)：Quick-Set材料-II期Quick-Set材料建议用于重要的牙髓治疗和非重要的牙髓治疗，以使临床过程更短和更一致，对患者和临床医生有利，并增加阳性结果的可能性。这种新材料将促进牙周膜和牙骨质组织的再生，这些组织因牙髓感染而受伤，或在牙髓治疗过程中被移除。这种组织的再生增强了根管系统的生物封闭性，减少了再次感染的可能性，并增强了牙齿的固位力，而不会进一步 治疗、手术或摘除。该材料旨在改进目前的护理标准，MTA材料存在以下临床缺陷：凝结时间长(小时)、难以放置和保持、低于预期的放射不透明度以及在酸性条件下不能硒。在第一阶段，Quick-Set被证明在大约10分钟(而不是几个小时)内固化，并且被证明具有更好的密封性(包括对牙本质小管的穿透)，更高的放射不透明度，以及对感染中存在的酸的更好的抵抗力。这种快速固化材料被证明具有碱性pH，释放钙离子，在合成体液中形成羟基磷灰石，并且在应用时符合ADA 57的要求。这个第二阶段的项目是测试第一阶段的Quick-Set材料的生物兼容性和体内性能。这项测试计划使用成牙本质细胞样细胞培养来检查其生物相容性，然后将测试扩展到在犬和大鼠体内的表现。犬类研究将比较Quick-Set和White MTA材料在生命和非生命牙髓适应症上的差异。钙化和脱钙的组织学将通过CT确定的骨再生测量来增强。这项大鼠研究将使用口腔面部疼痛测量(用餐时间测量)和Eliza组织学炎症标志物来比较两种材料之间牙髓感染的愈合性能。将检查牙根和活性牙髓治疗的临床处理和充填。 由临床医生进行动物实验，以确保材料能够满足临床预期。同时，将在实验室开发一种密封剂配方(在此称为Quick-Set密封剂)。封闭剂应具有Quick-Set相同的优良性能，但应含有更细的颗粒，满足ISO 6876和ADA 57的所有要求，并具有更长的固化时间，操作方法与传统的根管封闭剂相似。Quick-Set封闭剂将用于第二项犬类脱钙组织学研究。还将进行实验室测试，以增加Quick-Set的强度测量并开发基于膏体的配方。 与公众健康相关：正在开发快速固化材料，即第二阶段快速固化材料，以使牙医能够更快地完成治疗牙齿或牙根感染的牙髓，并获得更好的结果。Quick-Set材料计划用于治疗感染的牙髓和牙根感染，目的是保留牙齿并减少对其他程序的需求，如拔牙或植入物。Quick-Set材料被设计为即使在存在感染的情况下也能更快地固化，并比现有材料更好地封闭和愈合牙齿。

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.