Unique Anti-microbial Rinse to Reduce Oral Inflammation

独特的抗菌冲洗剂可减少口腔炎症

• 批准号: 7928457
• 负责人: Charles J Gauntt
• 金额: $ 41.04万
• 依托单位: BIOMEDICAL DEVELOPMENT CORPORATION
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7928457
• 关键词: Acute; Adverse effects; Atherosclerosis; Bacteria; Biological Markers; Biological Markers; Blood Tests; Blood specimen; C-reactive protein; Calculi; Cardiovascular Diseases; Chairperson; Chlorhexidine; Chronic; Clinical; Clinical Research; Clinical Trials; Data; Dental; Dental Epidemiology; Dental Hygiene; Dental Plaque; Development; Diabetes Mellitus; Disease; Disease Marker; Distal; Doctor of Medicine; Doctor of Philosophy; Dose; Double-Blind Method; Drug Evaluation; Drug Formulations; E-Selectin; Endocrinology; Endotoxins; Engineering; Ensure; Etiology; Exposure to; Gingiva; Gingival Indexes; Gingivitis; Goals; Grant; Health; Health Sciences; Heart Diseases; Hemorrhage; Human; Incidence; Industry; Inflammation; Inflammatory; Interleukin-1; Interleukin-6; Intervention; Investigational New Drug Application; Iodine; LDL Cholesterol Lipoproteins; Laboratories; Lead; Link; Lipopolysaccharides; Listerine; Low-Density Lipoproteins; Malignant neoplasm of pancreas; Measurement; Measures; Methodology; Methods; Microbial Biofilms; Molecular; Morbidity - disease rate; Mouth Diseases; Myocardial Infarction; Oral; Oral Microbiology; Oral cavity; Oral health; Pathogenesis; Pathway interactions; Patients; Periodontal Diseases; Periodontal Infection; Periodontic specialty; Pharmaceutical Chemistry; Pharmacologic Substance; Phase; Placebo Control; Placebos; Play; Pregnancy Complications; Premature Birth; Prevention; Principal Investigator; Procedures; Process; Production; Prophylactic treatment; Public Health; Quality Control; Randomized; Reaction; Regulation; Reporting; Research Personnel; Risk Factors; Role; Safety; Science; Staining method; Stains; Stroke; Study Subject; System; Systemic disease; Taste Perception; Technology; Testing; Texas; Thyroid Function Tests; Thyroid Gland; Time; Tissues; Toxicology; Treatment Protocols; Universities; antimicrobial; base; chemical reaction; clinical efficacy; combat; commercialization; design; document outlines; dosage; double-blind placebo controlled trial; drug quality; early onset; efficacy trial; experience; improved; indexing; meetings; microbicide; microorganism; mortality; novel; oral bacteria; oral plaque; pathogen; phase 1 study; phase 2 study; prevent; primary outcome; professor; public health relevance; quality assurance; response; success; tool

DESCRIPTION (provided by applicant): Periodontal disease has been recently identified as a risk factor for increased morbidity and mortality for systemic diseases such as pancreatic cancer, cardiovascular disease (atherosclerosis, myocardial infarction, and stroke), and diabetes, as well as for pregnancy complications such as preterm birth. It is well established that periodontal disease results from microorganisms in dental plaque biofilm. Inflammatory reactions initiated by oral bacteria and their components are implicated locally in the pathogenesis of periodontal tissue destruction, and may contribute to the development of systemic disease. While causality has yet to be confirmed, some studies have shown that oral health interventions may impact biological markers of inflammation and disease. The goal of this project is to develop a prescription antimicrobial oral rinse to reduce bacterial bioburden in the oral cavity and combat oral disease and inflammation. Current oral rinse products are either fraught with side effects such as staining and taste alterations that limit their usage to acute settings, or are ineffective. Based on preliminary studies, the oral rinse developed herein is expected to be more effective than currently available prescription products without the side effects. The development of a highly effective oral rinse may have the potential to have a profound impact on public health and achieve significant commercial success. This study is a Fast-Track proposal that combines both Phase I and Phase II studies in one application. The Phase I portion has two Specific Aims: Aim 1. Compound Oral Rinse Formulations for Use in Clinical Trials Aim 2. Evaluate Dose-Response of the Oral Rinse in a Human Clinical Trial of Gingival Inflammation and Investigate Effects on Biological Markers Indicative of Systemic Disease. The Phase II portion has three Specific Aims: Aim 1. Compound Oral Rinse Formulations for Use in Clinical Trials Aim 2. Evaluate the Oral Rinse in a Human Clinical Trial of Gingivitis to Satisfy FDA Requirements and Investigate Effects on Biological Markers Indicative of Systemic Disease. PUBLIC HEALTH RELEVANCE: Recent studies have linked oral bacteria to systemic diseases such as pancreatic cancer, diabetes, stroke and heart disease. Although it has yet to be proven that oral bacteria cause these diseases directly, there is some evidence that dental treatment may improve markers of disease. The development of a safe and effective mouthrinse that could remove harmful oral bacteria and potentially reduce the incidence of disease would have a significant impact on public health.

描述（由申请人提供）：牙周病最近被确定为导致胰腺癌、心血管疾病（动脉粥样硬化、心肌梗塞和中风）和糖尿病等全身性疾病以及早产等妊娠并发症的发病率和死亡率增加的危险因素。众所周知，牙周病是由牙菌斑生物膜中的微生物引起的。由口腔细菌及其成分引发的炎症反应与牙周组织破坏的发病机制有关，并可能导致全身性疾病的发展。虽然因果关系尚未得到证实，但一些研究表明，口腔健康干预措施可能会影响炎症和疾病的生物标志物。该项目的目标是开发一种处方抗菌漱口水，以减少口腔中的细菌生物负荷并对抗口腔疾病和炎症。目前的口腔冲洗产品要么充满副作用，例如染色和味道改变，限制了它们在急性环境中的使用，要么是无效的。根据初步研究，本文开发的口腔冲洗剂预计比目前可用的处方产品更有效且无副作用。高效口腔冲洗剂的开发可能会对公众健康产生深远影响并取得重大商业成功。这项研究是一项快速通道提案，将第一阶段和第二阶段研究结合在一个申请中。 I 期部分有两个具体目标： 目标 1. 用于临床试验的复合口腔冲洗剂制剂 目标 2. 在牙龈炎症的人体临床试验中评估口腔冲洗剂的剂量反应，并研究对指示全身性疾病的生物标志物的影响。 II 期部分有三个具体目标： 目标 1. 用于临床试验的复合口腔冲洗剂配方 目标 2. 在牙龈炎人体临床试验中评估口腔冲洗剂以满足 FDA 要求并研究对指示全身性疾病的生物标志物的影响。 公共卫生相关性：最近的研究已将口腔细菌与胰腺癌、糖尿病、中风和心脏病等全身性疾病联系起来。尽管尚未证明口腔细菌直接导致这些疾病，但有一些证据表明牙科治疗可以改善疾病标志。开发一种安全有效的漱口水，可以去除有害的口腔细菌，并有可能降低疾病的发病率，将对公众健康产生重大影响。