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REGENERATION OF PULP-DENTIN DEVELOPMENT IN IMMATURE PERMANENT TEETH WITH NECROSIS

坏死的未成熟恒牙牙髓牙本质发育的再生

基本信息

批准号：
7876114
负责人：
Kenneth M Hargreaves
金额：
$ 24.69万
依托单位：
UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-07-06 至 2012-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7876114
关键词：
Address Antibiotics Apical Applications Grants Blood Clot Blood coagulation Budgets Calcified Chemicals Child Clinical Clinical Investigator Clinical Protocols Clinical Trials Clinical trial protocol document Consent Forms Controlled Clinical Trials Data Data Collection Dental Pulp Dental Pulp Necrosis Dental caries Dentin Development Diagnosis Disinfection Family Fracture Grant Healthcare Hemorrhage Infection Left Manuals Mesenchymal Stem Cells Methods Minerals National Institute of Dental and Craniofacial Research Natural regeneration Necrosis Outcome Measure Pamphlets Paste substance Phase Plant Roots Prevalence Procedures Protocols documentation Public Health Pulp Canals Randomized Reporting Research Research Ethics Committees Research Personnel Risk Safety Site Specific qualifier value Standardization System Testing Thick Tissue Engineering Tooth Extraction Tooth structure Training Trauma alternative treatment base data management novel strategies outcome forecast permanent tooth prospective public health relevance regenerative seal standard care stem cell population tongue papilla tool

项目摘要

DESCRIPTION (provided by applicant): The current method for treating a child's permanent tooth with an incompletely developed root and a necrotic root canal system is fraught with difficulty. Not only is the root canal system often difficult to fully disinfect, but the thin dentinal walls increase the risk of a subsequent root fracture, which often necessitates extraction of the tooth. Although this may occur in all children (eg., trauma), children from families with health care disparities are at particular risk due to a greater prevalence of caries. The current standard method of treating these cases is apexification (formation/induction of a calcified barrier across the root apex), which leaves a greatly weakened tooth with a poor long term prognosis. A recently reported regenerative procedure is a plausible treatment alternative. It involves the chemical disinfection of the root canal system followed by evoked bleeding into the root canal system, formation of a blood clot and immediate coronal seal. Built upon the concepts of tissue engineering, this new approach takes advantage of a rich supply of mesenchymal stem cells, possibly including the population of stem cells of the apical papilla (SCAP) that is adjacent to the open apex of the incompletely developed tooth. The objective of this R34 grant application is to plan and develop a subsequent U01 clinical trial protocol application that will test the central hypothesis that a regenerative clinical protocol, that involves the use of a triple antibiotic paste and evoked bleeding into the root canal system, will produce significantly greater continued development of dentinal wall thickness as compared to standard treatment (MTA apexification). This will be a prospective, Phase III, randomized, multi-center (3 sites: UTHSCSA, UCSF, UNC) controlled clinical trial. In the present R34 planning period, we will accomplish the following aims: Specific Aim 1: Develop a comprehensive clinical trial protocol that includes specified recruitment strategies and associated documents such as a Manual of Procedures, IRB protocol, consent form, clinical investigator's brochure, training manual, and proposed budget (for the U01 application). Specific Aim 2: Train and calibrate the research team for standardization of protocol procedures and data collection. Specific Aim 3: Develop tools and protocols required for data management, and appropriate and effective safety and operational oversight of the research. PUBLIC HEALTH RELEVANCE: This project is relevant to public health since children from families with health care disparities often have a greater risk of losing their permanent teeth due to caries or other factors. By studying a new and biologically-based method for treating infection and allowing the tooth to continue its development, this project directly addresses a key issue of high relevance to public health.

描述（申请人提供）：目前治疗牙根未完全发育、根管系统坏死的儿童恒牙的方法充满困难。不仅根管系统通常难以完全消毒，而且薄薄的牙本质壁增加了随后牙根折断的风险，这通常需要拔牙。尽管这种情况可能发生在所有儿童中（例如外伤），但由于龋齿患病率较高，来自医疗保健不平等家庭的儿童面临特别高的风险。目前治疗这些病例的标准方法是根尖化术（在根尖形成/诱导钙化屏障），这会使牙齿严重削弱，长期预后不佳。最近报道的再生手术是一种可行的治疗替代方案。它涉及对根管系统进行化学消毒，然后诱发根管系统出血，形成血凝块并立即进行冠状密封。这种新方法以组织工程的概念为基础，利用了丰富的间充质干细胞供应，其中可能包括邻近未完全发育的牙齿开放顶端的根尖乳头 (SCAP) 干细胞群。该 R34 拨款申请的目的是规划和开发后续的 U01 临床试验方案申请，该方案将测试以下中心假设：与标准治疗（MTA 根尖切除术）相比，再生临床方案（涉及使用三重抗生素糊剂并诱发根管系统出血）将产生显着更大的牙本质壁厚度持续发展。这将是一项前瞻性、III 期、随机、多中心（3 个地点：UTHSCSA、UCSF、UNC）对照临床试验。在当前的 R34 规划期内，我们将实现以下目标：具体目标 1：制定全面的临床试验方案，其中包括具体的招募策略和相关文件，例如程序手册、IRB 方案、同意书、临床研究者手册、培训手册和拟议预算（针对 U01 申请）。具体目标 2：培训和校准研究团队，以实现方案程序和数据收集的标准化。具体目标 3：开发数据管理所需的工具和协议，以及对研究进行适当且有效的安全和操作监督。公共健康相关性：该项目与公共健康相关，因为来自医疗保健不平等家庭的儿童往往因龋齿或其他因素而面临更大的失去恒牙的风险。通过研究一种基于生物学的新方法来治疗感染并让牙齿继续发育，该项目直接解决了与公共卫生高度相关的关键问题。