Osteoporosis and Bone Augmentation/Implant Outcomes: An Observational Study

描述（由申请人提供）：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，影响着4400万美国人。文献中的证据表明，骨质疏松症等骨疾病可能会影响骨增强手术的结局。因此，更好地了解这种疾病与骨增量/牙科植入之间的关系非常重要。这项基于描述性“最佳临床实践”的研究旨在收集描述性数据，以估计骨密度（BMD）范围从正常到骨质疏松的绝经后女性的牙槽骨增量/种植体植入成功率。这是理解这一潜在重要关系的关键的第一步。需要这些数据来支持骨生物学建立的假设的未来发展，这些假设将调查骨健康的特定指标（包括骨质疏松症病史）与骨增强手术中新骨的成功整合的潜在关联。我们的多学科团队拥有流行病学、行为科学、放射学、种植手术、口腔修复学、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本申请的目标：1）对骨密度正常至骨质疏松的绝经后女性进行骨增量然后植入牙种植体的两年成功率进行描述性估计;和2）探索骨健康参数（例如，骨密度、骨转换生化标志物、骨折史和维生素D水平）和种植体失败。为了满足这两个目标，120名受试者将根据其具体的临床情况接受骨增量、种植体植入和假体治疗，并遵循研究方案中的一组特定标准。植入物存活率将是成功的主要结局指标。然而，成功将通过其他相关临床结局、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与骨增量/植入物成功之间的潜在预测关联，包括单独和相互结合。本研究的数据将提供关于不同骨密度女性的不同种植体成功率的信息。我们的长期目标是确定骨健康受损和/或局部牙槽骨结构不良患者中骨增强/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，包括应用技术来引导新的牙槽骨形成在骨缺损部位。该应用程序是这一正在进行的研究计划的重要一步。

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.