Osteoporosis and Bone Augmentation/Implant Outcomes: An Observational Study

骨质疏松症和骨增量/植入结果：一项观察性研究

• 批准号: 7276753
• 负责人: MARTIN A FREILICH
• 金额: $ 53.72万
• 依托单位: UNIVERSITY OF CONNECTICUT SCH OF MED/DNT
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-15 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7276753
• 关键词: Osteoporosis; Bone; Augmentation; Implant; Outcomes

DESCRIPTION (provided by applicant): Osteoporosis is a major public health issue in our aging population, affecting 44 million Americans. Evidence in the literature suggests that bone disorders such as osteoporosis, may compromise bone augmentation procedure outcomes. It is important, therefore, to better understand the relationship between this disorder and bone augmentation/dental implantation. The objective of this descriptive "best clinical practice" based study is to collect descriptive data estimating alveolar bone augmentation/implant placement success in postmenopausal women with bone mineral density (BMD) ranging from normal to osteoporotic. This is a critical first step in understanding this potentially important relationship. These data are needed to support the future development of bone biology founded hypotheses that will investigate potential associations of specific measures of bone health, including history of osteoporosis, with the successful integration of new bone from bone augmentation procedures. Our multidisciplinary group possesses expertise in epidemiology, behavioral science, radiography, implant surgery, prosthodontics, endocrinology/bone biology and clinical treatment of osteoporosis. We plan to accomplish the objectives of this application by pursuing two specific aims: 1) To generate a descriptive estimate of the two-year success rate of bone augmentation followed by dental implant placement in postmenopausal women with normal to osteoporotic bone density; and 2) To explore potential associations between bone health parameters (e.g., BMD, biochemical markers of bone turnover, fracture history and vitamin D levels) and implant failure. To satisfy both aims, 120 subjects will receive bone augmentation, implant placement and prosthetic treatment based upon their specific presenting clinical situation, as guided by a specific set of criteria that will be part of the study protocol. Implant survival will be the primary outcome measure of success. However, success will be secondarily assessed by other relevant clinical outcomes, clinical efficiency, as well as patient satisfaction, pain and quality of life. Descriptive analyses will also explore potential predictive associations between bone health parameters and bone augmentation/implant success, both individually and in conjunction with one another. Data from this study will provide information about differential implant success rates for women possessing a spectrum of bone mineral density. Our long-range goal is to identify the most important predictors of bone augmentation/implant placement success among patients with compromised bone health and/or unfavorable local alveolar architecture. We then wish to develop and test the best methods by which to provide these therapies, including the application of techniques with which to guide new alveolar bone formation at deficient osseous sites. This application represents an important step in this ongoing research initiative.

描述(申请人提供)：骨质疏松症是我们老龄化人口中的一个主要公共卫生问题，影响到4400万美国人。文献中的证据表明，骨质疏松症等骨病可能会影响骨增强手术的结果。因此，重要的是要更好地了解这种疾病与骨增强/牙种植体之间的关系。这项以“最佳临床实践”为基础的描述性研究的目的是收集描述性数据，以评估骨密度(BMD)从正常到骨质疏松的绝经后妇女的牙槽骨增强/种植体植入的成功率。这是理解这一潜在重要关系的关键第一步。需要这些数据来支持骨生物学建立的假说的未来发展，这些假说将调查包括骨质疏松症病史在内的特定骨健康指标与成功整合来自骨增强手术的新骨之间的潜在关联。我们的多学科小组在流行病学、行为科学、放射学、种植外科、口腔修复、内分泌学/骨生物学和骨质疏松症的临床治疗方面拥有专业知识。我们计划通过追求两个具体目标来实现这项应用的目标：1)对骨密度正常到骨质疏松的绝经后妇女进行骨增强和牙种植体植入的两年成功率的描述性估计；2)探索骨健康参数(例如骨密度、骨转换生化标记物、骨折病史和维生素D水平)与种植失败之间的潜在联系。为了实现这两个目标，120名受试者将根据他们的具体临床情况接受骨增强、植入物放置和假体治疗，并遵循一套特定的标准，这将是研究方案的一部分。植入物的存活率将是衡量成功的主要结果。然而，成功将根据其他相关的临床结果、临床效率以及患者满意度、疼痛和生活质量进行次要评估。描述性分析还将探索骨健康参数和骨增强/植入成功之间的潜在预测关联，既有单独的，也有相互关联的。这项研究的数据将提供具有不同骨矿密度谱的女性的不同植入成功率的信息。我们的长期目标是在骨健康受损和/或局部牙槽结构不良的患者中确定最重要的预测骨强化/种植体放置成功的因素。然后，我们希望开发和测试提供这些疗法的最佳方法，包括应用技术来引导缺损骨部位的新牙槽骨形成。这项申请代表着这项正在进行的研究计划中的重要一步。