Oral & Respiratory Status of Retarded/Disabled Persons

口服

• 批准号: 6887549
• 负责人: CATHERINE J BINKLEY
• 金额: $ 22.05万
• 依托单位: UNIVERSITY OF LOUISVILLE
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-01 至 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6887549
• 关键词: clinical research; comorbidity; dental plaque; gingivitis; human subject; mental health facility; mental retardation; microorganism culture; microorganism growth; oral bacteria; oral health; patient oriented research; person with disability; polymerase chain reaction; respiratory infections; sample collection; tongue

DESCRIPTION (provided by applicant): Respiratory tract infections are the primary causes of death in institutionalized mentally retarded and developmental disabled (MRDD) persons. Aspiration of contaminated oral secretions is a major cause of respiratory infections and oral colonization by pathogenic bacteria resulting from inadequate oral hygiene has been shown to be routine in other high-risk populations. MRDD patients have similar risk factors for oral respiratory pathogen colonization as critically ill and nursing home patients, including dry mouth and poor oral hygiene. Poor oral status may be common in institutionalized MRDD patients, a significant health disparity, and it is not known if their oral cavities become colonized with pathogenic respiratory organisms. We thus propose to conduct exploratory research to fill this gap in knowledge, evaluate measures and methodology, and provide pilot data for a properly powered clinical trial. This developmental/exploratory research seeks to answer the following questions in institutionalized MRDD patients: 1. What is the oral status of institutionalized MRDD patients? 2. What is the prevalence of oral respiratory pathogen colonization? 3. What species and quantity of respiratory pathogens colonize the oral cavity in this population? 4. Is poor oral status associated with oral respiratory pathogen colonization? 5. Is poor oral status and respiratory pathogen colonization associated with respiratory infection? We will conduct an exploratory study of 220 institutionalized MRDD patients at four facilities. Oral examinations and sample collection will be performed at baseline and then monthly until the end of month six. PCR analysis will be performed on all teeth and tongue samples collected from these 200 subjects. We will also monitor the incidence of respiratory tract infections over the 6-month period. The primary outcomes will be prevalence of respiratory pathogen colonization, and the types and quantities of pathogens as determined by PCR analysis of microbiological samples. Explanatory variables will include Plaque, Gingivitis, and Oral Hygiene Indices, co-morbidities, and professional and routine oral care. Secondary outcomes will be the association of oral status and respiratory pathogen colonization with respiratory tract infections including pneumonia over the 6-month reporting period. The proposed study will test measures and methodology and will provide pilot data for sample size estimation for a full clinical trial.

描述（由申请人提供）：呼吸道感染是制度化弱智和发育障碍（MRDD）患者的主要死亡原因。吸入受污染的口腔分泌物是呼吸道感染的主要原因，而口腔卫生不良导致的病原菌在口腔定植已被证明是其他高危人群的常见现象。MRDD患者的口腔呼吸道病原体定植风险因素与重症患者和疗养院患者相似，包括口干和口腔卫生不良。在住院的MRDD患者中，口腔状况不佳可能很常见，这是一个显著的健康差异，并且尚不清楚他们的口腔是否被致病性呼吸道微生物定植。因此，我们建议进行探索性研究，以填补这一知识空白，评估措施和方法，并提供适当的动力临床试验的试点数据。这项发展性/探索性研究旨在回答以下问题，在制度化的MRDD患者：1。住院MRDD患者的口腔状况如何？2.口腔呼吸道病原体定植的患病率是多少？3.该人群口腔中定植的呼吸道病原体的种类和数量是多少？4.口腔状况不佳与口腔呼吸道病原体定植相关吗？5.口腔状况不佳和呼吸道病原体定植与呼吸道感染相关吗？我们将在四个机构对220名住院MRDD患者进行探索性研究。将在基线时进行口腔检查和样本采集，然后每月进行一次，直至第6个月结束。将对从这200名受试者中采集的所有牙齿和舌头样本进行PCR分析。我们亦会在6个月期间监察呼吸道感染的发病率。主要结局将是呼吸道病原体定植的患病率，以及通过微生物样本的PCR分析确定的病原体类型和数量。解释变量将包括牙菌斑、牙龈炎和口腔卫生指数、共病以及专业和常规口腔护理。次要结局将是6个月报告期内口腔状况和呼吸道病原体定植与呼吸道感染（包括肺炎）的相关性。拟议的研究将测试措施和方法，并将为完整临床试验的样本量估计提供试点数据。