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: 7173094
• 负责人: MARTIN A FREILICH
• 金额: $ 56.23万
• 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/7173094
• 关键词: bone; clinical research; health; implant; osteoporosis; success

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（由申请人提供）：骨质疏松症是我国老龄化人口中的一个主要公共卫生问题，影响着4400万美国人。文献证据表明，骨质疏松等骨骼疾病可能会影响骨增强手术的结果。因此，更好地了解这种疾病与骨增强/牙种植之间的关系是很重要的。这项描述性的“最佳临床实践”研究的目的是收集描述性数据，估计骨密度从正常到骨质疏松的绝经后妇女的牙槽骨增强/种植体置入术的成功率。这是理解这种潜在的重要关系的关键的第一步。这些数据需要支持骨骼生物学假设的未来发展，这些假设将研究骨骼健康的具体措施（包括骨质疏松症的历史）与骨增强手术中新骨的成功整合之间的潜在关联。我们的多学科团队拥有流行病学，行为科学，放射学，种植外科，修复学，内分泌学/骨生物学和骨质疏松症临床治疗方面的专业知识。我们计划通过追求两个具体目标来实现该应用的目标：1)对骨密度正常到骨质疏松的绝经后妇女进行骨增强后种植体放置的两年成功率进行描述性估计；2)探索骨健康参数（如骨密度、骨转换生化指标、骨折史和维生素D水平）与种植体失败之间的潜在关联。为了满足这两个目标，120名受试者将根据其具体的临床表现情况接受骨增强，植入物放置和假体治疗，并根据研究方案中的一套特定标准进行指导。种植体存活将是衡量成功的主要指标。然而，成功与否将由其他相关临床结果、临床效率、患者满意度、疼痛和生活质量来评估。描述性分析还将探索骨骼健康参数与骨增强/植入成功之间的潜在预测关联，无论是单独的还是相互结合的。这项研究的数据将为具有不同骨矿物质密度的女性提供不同植入成功率的信息。我们的长期目标是在骨骼健康受损和/或局部牙槽结构不利的患者中确定骨增强/种植体植入成功的最重要预测因素。然后，我们希望开发和测试提供这些治疗的最佳方法，包括在缺乏骨的部位引导新牙槽骨形成的技术的应用。这个应用程序代表了这项正在进行的研究计划的重要一步。