Oral & Respiratory Status of Retarded/Disabled Persons

描述（由申请人提供）：呼吸道感染是被收容的智力迟钝和发育障碍者（MRDD）死亡的主要原因。吸入受污染的口腔分泌物是呼吸道感染的主要原因，而由于口腔卫生不充分而导致的致病菌在口腔定植已被证明在其他高危人群中是常规的。MRDD患者口腔呼吸道病原体定植的危险因素与危重患者和养老院患者相似，包括口干和口腔卫生差。在MRDD住院患者中，口腔状况不佳可能是常见的，这是一个显著的健康差异，并且不知道他们的口腔是否被致病性呼吸道生物定植。因此，我们建议开展探索性研究，以填补这方面的知识空白，评估措施和方法，并为适当的临床试验提供试点数据。本发展性/探索性研究旨在回答制度化MRDD患者的以下问题：MRDD住院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. 在这个人群中口腔中有哪些种类和数量的呼吸道病原体？4. 口腔状况不佳与口腔呼吸道病原体定植有关吗？5. 口腔状况不佳和呼吸道病原体定植与呼吸道感染有关吗？我们将对四家机构的220名MRDD住院患者进行探索性研究。口腔检查和样本采集将在基线时进行，然后每月进行一次，直到第六个月底。将对这200名受试者收集的所有牙齿和舌头样本进行PCR分析。我们还将监测6个月期间呼吸道感染的发病率。主要结果将是呼吸道病原体定植的流行程度，以及微生物样品PCR分析确定的病原体类型和数量。解释变量包括牙菌斑、牙龈炎和口腔卫生指数、合并症以及专业和常规口腔护理。次要结果将是在6个月的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）的关系。拟议的研究将测试措施和方法，并将为全面临床试验的样本量估计提供试点数据。

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.