Quick-Set Endodontic Material

描述(申请人提供)：快速定形牙髓材料添加以此新字体显示。该项目旨在开发一种在大约15分钟内固化的牙科材料，适用于外科或非外科牙髓治疗程序。该材料旨在改进目前的护理标准ProRoot MTA材料，该材料存在固化时间长(小时)、难以放置和保持、低于预期的放射不透明度以及无法在酸性条件下固化等临床缺陷。临床医生也一直不接受ProRoot MTA的高昂成本，每克约50美元，或每次治疗约10至20美元。除了快速固化和耐冲刷外，这种新材料还将是一种含有钙的材料，具有高pH值，并将含有羟基磷灰石。这种新材料的开发将超过ProRoot MTA的放射不透明度，即在一些口腔感染中发现的高pH环境中设定的能力。这种新材料必须具有与MTA一样的生物活性，具有高pH值，并含有羟基磷灰石。这种快速成型材料将使临床过程更短、更一致，这将有利于患者和临床医生，并提高阳性结果的概率。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。这项研究将采用实验设计，以确保新材料满足根管封闭剂和牙科粘固剂的放射不透明度、固化和工作时间、溶解度、尺寸稳定性和强度的ISO 6876和ISO 9917标准。洗涤试验应确定临床使用的稳定性。微渗漏测试将测试这种新材料是否适用于低微渗漏的牙髓治疗。体外生物活性测试将通过将准备好的牙齿浸泡在磷酸盐缓冲盐水溶液中来观察羟基磷灰石的原位沉淀。还将测试牙根和牙本质小管的临床处理和填充。用小鼠胚胎细胞进行细胞毒性测试将筛选出这种新材料的生物相容性测试。) 与公共卫生相关：本修订文件中快速设置的牙髓内科材料删除部分用删除线表示，新增部分以此新字体显示。将开发一种新的牙髓材料，使进行根管治疗的牙医能够更快地完成治疗过程，其材料优于目前的护理标准(ProRoot MTA材料)。新材料将：固化速度更快(几分钟而不是几小时)，更耐洗涤，在出现感染时固化，对X射线更不透明，抗微生物，并与护理材料的标准一样具有生物活性。所有这些都将提高临床医生和患者的操作程序，并改善根管治疗后的牙齿固位或牙髓愈合的结果。牙齿保留消除了其他程序的需要，如拔牙、植入物和假体装置。这种新材料将是治疗受感染牙齿时的一种新的特征组合和牙齿护理的优势，特别是在确信材料将固化并保持在原位的情况下。

DESCRIPTION (provided by applicant): Quick-Set Endodontic Material Additions are shown in this new font. This project is to develop a dental material that sets in about 15 minutes, and is suitable for use in surgical or non-surgical endodontic procedures. The material is intended to be an improvement on the present standard of care, ProRoot MTA material which suffers from clinical deficiencies of long setting times (hours), difficulty in placement and retention, lower than desired radiopacity, and inability to set under acid conditions. Clinicians have also been unaccepting of the high cost for ProRoot MTA, which is about $50 per gram, or about $10 to $20 per treatment. Besides being quick-setting and washout resistant, the new material will be a material that contains calcium, has a high pH, and will contain hydroxylapatite. The new material will be developed to exceed ProRoot MTA's radiopacity, ability to set in high pH environments found in some oral infections. The new material must be as bioactive as MTA, having a high pH and containing hydroxylapatite. Such a quick-setting material will make the clinical procedures shorter and more consistent, which will be 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. The research will use experimental designs to ensure the new material meets the ISO 6876 and ISO 9917 standards for root canal sealers and dental cements for radiopacity, setting & working times, solubility, dimensional stability, and strength. Washout testing should determine the stability for clinical use. Micro leakage testing will test the new material's suitability for endodontic use where low micro leakage is crucial. In vitro bioactivity will be tested by soaking prepared teeth in phosphate buffered saline solutions to observe the in situ precipitation of hydroxylapatite. The clinical handling and filling of roots and dentinal tubules will also be tested. Cytotoxicity tests with mouse embryonic cells will screen the biocompatibility test of the new material.) PUBLIC HEALTH RELEVANCE: Quick-Set Endodontic Material Deletions in this revised document are indicated by strikethrough and additions are shown in this new font. A new endodontic material is to be developed to enable dentists performing root canal therapy to complete the procedures more quickly, with a material is superior to the present standard of care (ProRoot MTA material). The new material will: be quicker-setting (minutes not hours), be much more resistant to washout, set when an infection is present, be more opaque to x-rays, be anti- microbial, and be as bioactive as the standard of care material. All these qualities would enhance the procedures for the clinician and the patient, and improve the outcome for tooth retention after root canal treatment, or dental pulp healing. Tooth retention eliminates the need for other procedures such as extraction, implants, and prosthetic devices. Such a new material would be a new combination of features and an advantage for dental care when treating infected teeth, especially to be confident that the material will set and remain in situ.