Examining multilevel associations in dental research

检查牙科研究中的多级关联

基本信息

批准号：
8096690
负责人：
Julie A Stoner
金额：
$ 14.82万
依托单位：
UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR
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：
2010-07-01 至 2013-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8096690
关键词：
Accounting Acute Address Age Alveolar Bone Loss Biological Markers Bone Density Bone Resorption C-reactive protein Characteristics Chronic Clinical Clinical Trials Code Collagen Complex Computer Assisted Controlled Clinical Trials Cross-Sectional Studies Data Data Analyses Data Set Data Sources Dental Research Development Disease Disease Marker Disease Progression Dose Double-Blind Method Doxycycline Enrollment Ensure Equation Funding Gelatinase A Gelatinase B Gingiva Goals Guidelines Height Hip region structure Image Analysis Inflammation Inflammation Mediators Inflammatory Lead Linear Regressions Manuals Matrix Metalloproteinases Measurement Measures Methodology Methods Modeling Mouth Diseases National Institute of Dental and Craniofacial Research Neck Oral Oral cavity Oral health Osteopenia Osteoporosis Patients Periodontal Attachment Loss Periodontal Diseases Periodontitis Placebo Control Population Postmenopause Procedures Process Protocols documentation Publishing Randomized Regression Analysis Relative (related person)Research Research Design Research Methodology Research Personnel Research Project Grants Risk Safety Sample Size Serum Site Staging Statistical Models Systemic disease Techniques Testing Therapeutic Time Tooth Loss Tooth structure United States Variant Vertebral column Woman Work aged alveolar bone antimicrobial base bone loss bone mass clinical care design effective therapy expectation follow-up improved innovation public health relevance research study simulation therapeutic target tool

项目摘要

DESCRIPTION (provided by applicant): In the United States in 2002, approximately 7.8 million women aged 50 and over had osteoporosis of the hip and an additional 21.8 million had low bone mass or osteopenia of the hip and were at risk for developing osteoporosis. Data, largely from cross-sectional studies, suggest that osteoporosis is associated with increased tooth loss, alveolar bone loss, and periodontal attachment loss. Oral health research studies investigating progression of periodontal disease and alveolar bone loss often involve multilevel, nested measures at the tooth-site level within subjects followed longitudinally over time. Disease processes may vary within a subject's mouth or over time within a subject and disease processes may differ between subjects. Typically, regression modeling approaches do not distinguish among effects of chronic or patient-level associations and associations with acute changes over time or spatial variation within a mouth. A better understanding of the multilevel disease processes could lead to more effective clinical follow-up procedures and more effective therapies. Our long-term goal is to slow the progression of alveolar bone loss and clinical attachment loss in post-menopausal osteopenic women with periodontitis. The specific aims of this proposal are to: 1) Develop computing macros, based on generalized estimating equation methodology, that can be implemented in SAS and R for fitting and statistically comparing separate within-mouth, across-time, and between-subject effects in correlated data regression models; 2) Through simulation, develop guidelines for study design, including sample size, to ensure adequate power to detect different within-mouth, across-time, and between-subject effects; and 3) Apply the developed regression analysis methodology to existing data from our recently-completed National Institute of Dental and Craniofacial Research (NIDCR)-funded (R01DE012872) randomized double-blind, placebo-controlled clinical trial of sub-antimicrobial dose doxycycline (SDD) in postmenopausal osteopenic women with moderate to advanced periodontitis. The proposed analyses will utilize existing oral radiographic and clinical periodontal measures, as well as serum inflammatory biomarker and systemic bone mineral density measurements, from the 128 women who were enrolled in the 2-year clinical trial. The objectives of the secondary data analyses are to identify oral and systemic factors associated with alveolar bone loss and periodontitis progression over a 2-year period, distinguishing among effects of chronic or patient-level associations and associations with acute changes over time or spatial variation within a mouth. A better understanding of the complex, multilevel associations among oral and systemic factors associated with alveolar bone loss and periodontitis progression could lead to new clinical follow-up protocols and therapeutic approaches that will improve the oral health of this population. PUBLIC HEALTH RELEVANCE: Through the planned research project, statistical analysis and research design tools will be developed to investigate factors associated with oral disease processes that may vary within a given subject's mouth from tooth to tooth, over time as a subject ages or undergoes therapy, or between subjects with different characteristics. The methods will be used to identify oral and systemic factors associated with oral bone loss and periodontitis progression over a 2-year period among post-menopausal osteopenic women with moderate to advanced periodontitis. A better understanding of the oral disease processes could lead to more effective clinical follow-up procedures and more effective therapies in this type of population.

描述（由申请人提供）：2002年，美国大约有780万50岁及以上的女性患有髋部骨质疏松症，另有2180万人骨量低或髋部骨质减少，有患骨质疏松症的风险。主要来自横断面研究的数据表明，骨质疏松症与牙齿脱落、牙槽骨丢失和牙周附着丧失增加有关。口腔健康研究调查牙周病和牙槽骨丢失的进展，通常涉及受试者牙齿部位水平的多层次、嵌套测量，并随着时间的推移进行纵向跟踪。疾病过程可以在受试者的口腔内或随着时间的推移在受试者内变化，并且疾病过程在受试者之间可以不同。通常，回归建模方法不区分慢性或患者水平关联的影响以及与口腔内随时间或空间变化的急性变化的关联。更好地了解多层次疾病过程可能会导致更有效的临床随访程序和更有效的治疗。我们的长期目标是减缓患有牙周炎的绝经后骨质疏松女性的牙槽骨丢失和临床附着丧失的进展。该提案的具体目标是： 1) 基于广义估计方程方法开发计算宏，可以在 SAS 和 R 中实现，用于拟合和统计比较单独的口腔内、跨时间和受试者间效应相关数据回归模型； 2) 通过模拟，制定研究设计指南，包括样本量，以确保有足够的功效来检测不同的口内、跨时间和受试者间效应； 3) 将开发的回归分析方法应用于我们最近完成的国家牙科和颅面研究所 (NIDCR) 资助的 (R01DE012872) 亚抗菌剂量多西环素 (SDD) 随机双盲、安慰剂对照临床试验的现有数据）患有中度至晚期牙周炎的绝经后骨质疏松女性。拟议的分析将利用现有的口腔放射学和临床牙周测量，以及血清炎症生物标志物和全身骨矿物质密度测量，这些测量来自参加为期 2 年临床试验的 128 名女性。二次数据分析的目的是确定两年内与牙槽骨丢失和牙周炎进展相关的口腔和全身因素，区分慢性或患者水平关联的影响以及随时间或空间变化而发生的急性变化的影响。一张嘴。更好地了解与牙槽骨丢失和牙周炎进展相关的口腔和全身因素之间复杂的多层次关联可能会导致新的临床随访方案和治疗方法，从而改善该人群的口腔健康。公共健康相关性：通过计划中的研究项目，将开发统计分析和研究设计工具，以调查与口腔疾病过程相关的因素，这些因素可能会随着受试者年龄的增长或接受治疗而在特定受试者的口腔内从一颗牙齿到另一颗牙齿发生变化，或具有不同特征的主题之间。这些方法将用于确定患有中度至晚期牙周炎的绝经后骨质疏松女性中与口腔骨质流失和牙周炎进展相关的口腔和全身因素，并在两年内进行。更好地了解口腔疾病过程可以为此类人群提供更有效的临床随访程序和更有效的治疗。