Quick-Set Material-Phase II

快凝材料-第二相

• 批准号: 8396407
• 负责人: Carolyn Margaret Primus
• 金额: $ 59.43万
• 依托单位: PRIMUS CONSULTING
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-01 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8396407
• 关键词: Acids; Animal Model; Animal Testing; Animals; Biocompatible; Biological; Body Fluids; Bone Regeneration; Calcified; Calcium ion; Canis familiaris; Cell Culture Techniques; Cells; Clinical; Compressive Strength; Dental Care; Dental Pulp; Dentists; Development; Endodontics; Ensure; Gel; Goals; Healed; Histology; Hour; Hydroxyapatites; Implant; Infection; Inflammation; Laboratories; Measurement; Methods; Modeling; Natural regeneration; Notification; Odontoblasts; Operative Surgical Procedures; Orofacial Pain; Outcome; Pain Measurement; Paste substance; Patients; Penetration; Performance; Periodontal Ligament; Phase; Plant Roots; Probability; Procedures; Property; Pulp Canals; Quickset; Rattus; Resistance; Rodent; Structure of periapical tissue; System; Testing; Time; Tissues; Tooth structure; base; biomaterial compatibility; canals sealer; commercialization; design; expectation; healing; in vivo; inflammatory marker; injured; meetings; particle; seal; standard of care; tissue regeneration

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.

描述（由申请人提供）：快速凝固材料 - II 期快速凝固材料建议用于活体牙髓治疗和非活体牙髓治疗，以使临床程序更短、更一致，对患者和临床医生有利，并提高取得积极结果的可能性。新材料应能促进因牙髓感染而损伤或在牙髓治疗过程中被去除的牙周膜和牙骨质组织的再生。这种组织再生增强了根管系统的生物密封，减少了再次感染的可能性，并增强了牙齿的保留，而无需进一步治疗。 治疗、手术或拔牙。该材料旨在改进目前的护理标准，MTA 材料存在凝固时间（小时）长、放置和保留困难、射线不透性低于预期以及无法在酸性条件下凝固等临床缺陷。在第一阶段，Quick-Set 被证明在大约 10 分钟（而不是几小时）内凝固，并被证明具有优异的密封性（包括牙本质小管的穿透性）、更高的射线不透性以及对感染中存在的酸的更好的抵抗力。 Quick-Set 材料具有碱性 pH 值，可释放钙离子，在合成体液中形成羟基磷灰石，并符合 ADA 57 的适用要求。该第二阶段项目旨在测试第一阶段的快速凝固材料的生物相容性和体内性能。计划进行的测试是使用成牙本质细胞样细胞培养物检查生物相容性，然后将测试扩展到犬和大鼠的体内性能。犬类研究将在活体和非活体牙髓适应症中比较 Quick-Set 与白色 MTA 材料。通过 ¿CT 确定的骨再生测量将增强钙化和脱钙组织学。大鼠研究将使用口面部疼痛测量（进餐时间测量）和 ELIZA 组织学炎症标记物来比较两种材料之间牙髓感染的愈合性能。将检查牙根和活髓治疗的临床处理和填充 由临床医生进行动物研究，以确保材料能够满足临床期望。与此同时，实验室将开发一种密封剂配方（本文称为“快速凝固密封剂”）。该封闭剂应具有与 Quick-Set 相同的优良品质，但应包含更细的颗粒，满足 ISO 6876 和 ADA 57 的所有要求，并具有更长的固化时间，其操作与传统根管封闭剂类似。 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，以提高 Quick-Set 的强度测量值并开发基于糊剂的配方。 公共健康相关性：快速凝固材料，第二阶段 正在开发快速凝固材料，使牙医能够更快地完成治疗受感染的牙髓或牙根的手术，并取得更好的效果。 Quick-Set 材料计划用于治愈受感染的牙髓和牙根感染，目的是保留牙齿并减少拔牙或种植牙等其他手术的需要。即使存在感染，快速凝固材料的设计也能更快凝固，并且比现有材料更好地密封和愈合牙齿。