Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients

头颈癌患者牙科结果的临床登记

基本信息

批准号：
8920183
负责人：
MICHAEL T BRENNAN
金额：
$ 6.68万
依托单位：
CAROLINAS MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-26 至 2017-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8920183
关键词：
Address Adverse effects Affect Caring Clinical Clinical Research Clinical assessments Cohort Studies Complex Country Data Data Collection Decision Making Dental Dental Care Dental Practice Management Dental caries Development Documentation Dose External Beam Radiation Therapy Failure Fluorides Frequencies Future Goals Head and Neck Cancer Head and neck structure Healed Health Health Policy Health Status Individual Knowledge Lead Life Measures Medical Modality Morbidity - disease rate Mouth Diseases National Institute of Dental and Craniofacial Research Operative Surgical Procedures Oral Oral health Osteoradionecrosis Outcome Patient Care Patients Periodontal Index Periodontal Pocket Population Population Study Public Health Radiation Radiation therapy Registries Reporting Research Risk Risk Factors Salivary Glands Severities Site Time Tissues Tooth Diseases Tooth Loss Tooth structure Treatment Effectiveness Visit Xerostomia base bone cancer radiation therapy care delivery chemotherapy comparative effectiveness cost craniofacial design evidence base evidence based guidelines experience follow-up head and neck cancer patient healing high risk improved maxillofacial oral status patient population prevent prospective research study restoration restorative material standard of care

项目摘要

DESCRIPTION (provided by applicant): This application addresses the RFA: Effectiveness of Treatment for Oral Diseases in Medically Compromised Patients (R01). Radiation therapy (RT) for head and neck (H&N) cancer has significant long-term adverse effects, including irreversible hyposalivation and xerostomia, which result in increased rates of dental caries and tooth loss. RT also impairs the ability of bone to heal, leading to a life-long risk of osteoradionecrosis (ORN), often precipitated by dental extractions. Consequently, these patients are caught in a vicious circle, being at higher risk of needing dental extractions, but with extractions to be avoided post-RT due to risk for ORN. To reduce such complications, pre-RT dental assessment is now considered a best practice. However, pre- and post-RT dental management varies widely among centers, due to lack of reliable data on which evidence-based guidelines can be based. The objectives of this prospective observational cohort study are to collect data on dental outcomes after H&N RT, to identify risk factors associated with tooth loss and restoration failure, and to conduct selected comparative effectiveness analyses among dental restorative materials (some of which have been reported to have very high failure rates in this population). The specific aims are: 1.To measure the 2-year rate of tooth loss in patients who have received a standard of care dental assessment prior to H&N RT. A multi-center longitudinal cohort study will be conducted of H&N cancer patients who are to receive high-dose RT. All subjects will receive a standard-of-care pre-RT dental assessment with detailed documentation of dental/oral status and pre-RT dental management. Tooth loss will be documented at follow- up visits every 6 months. Secondary analyses will assess risk factors for tooth loss by examining associations between oral health status variables (for example: periodontal index) prior to RT and subsequent tooth loss. 2. To measure failure rates of the most commonly used dental restorative materials in patients who have received H&N RT. Additional clinical assessments, at the pre-RT and follow-up study visits, will include documentation of date and type of restorations placed and of restoration failure or replacement. Secondary analyses will compare failure rates for the most common restorative materials, and assess risk factors for restoration failure by examining associations between variables affecting oral health status (for example: fluoride use) and subsequent restoration failure. The proposed research will provide evidence to guide decision-making for optimal management of these complex patients. This contribution will be highly significant because it will directly improve patient care and outcomes by identifying evidence-based best practices for the pre- and post-RT dental management of patients receiving H&N RT. This research will enable the long-term outcome goal of developing evidence-based guidelines for management of dental disease in these patients.

描述（由申请人提供）：本申请介绍了RFA：对医学损害患者的口腔疾病治疗的有效性（R01）。头颈癌（H＆N）癌症的放射治疗（RT）具有显着的长期不良反应，包括不可逆转的衰减和静态症，这导致龋齿和牙齿脱落的发生率增加。 RT还会损害骨骼愈合的能力，从而导致终身骨质脱落的风险（ORN），通常是由于牙齿提取而沉淀的。因此，这些患者被恶性循环捕获，需要牙齿提取的风险较高，但由于ORN的风险，需要避免萃取后RT提取。为了减少这种并发症，现在被认为是最佳实践。但是，由于缺乏可靠的数据可以基于证据的指南，因此中心的前后牙齿管理在中心之间有很大差异。这项前瞻性观察队列研究的目标是收集有关H＆N RT后牙齿结局的数据，以确定与牙齿脱落和恢复衰竭相关的危险因素，并在牙科修复材料中进行了相对有效性分析（其中一些在该人群中的失败率很高）。具体目的是：1。衡量在H＆N RT之前接受过护理牙齿评估的患者的2年牙齿损失率。将对要接受高剂量RT的H＆N癌症患者进行多中心纵向队列研究。所有受试者都将获得护理标准的RT牙科评估，并详细介绍牙科/口服状态以及前RT牙科管理。每6个月的后续访问时，牙齿脱落将记录下来。次级分析将通过检查口腔健康状况变量之间的关联（例如：牙周指数）和随后的牙齿脱落来评估牙齿脱落的风险因素。 2。测量接受H＆N RT的患者中最常用的牙齿修复材料的失败率。在RT和随访研究访问中，其他临床评估将包括放置日期和修复的日期和恢复失败或更换的文档。次级分析将比较最常见的修复材料的失败率，并通过检查影响口腔健康状况的变量（例如：氟化物使用）和随后的恢复失败来评估恢复失败的风险因素。拟议的研究将提供证据，以指导决策，以最佳管理这些复杂的患者。这项贡献将非常重要，因为它将通过确定接受H＆N RT的患者前后牙科治疗的循证最佳实践来直接改善患者护理和结果。这项研究将使这些患者制定基于证据的牙齿疾病管理指南的长期结果。