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(申请人提供)：牙周病最近被确定为系统性疾病如胰腺癌、心血管疾病(动脉粥样硬化、心肌梗死和中风)和糖尿病以及早产等妊娠并发症发病率和死亡率增加的风险因素。众所周知，牙周病是由牙菌斑生物膜中的微生物引起的。口腔细菌及其成分引起的炎症反应局部参与了牙周组织破坏的发病机制，并可能导致全身性疾病的发生。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口腔漱口水，以减少口腔中的细菌生物堵塞，并与口腔疾病和炎症作斗争。目前的口腔漱口产品要么充满副作用，如染色和味道变化，将其使用限制在急性环境中，要么效果不佳。根据初步研究，本文开发的口腔漱口液有望比目前可用的无副作用的处方药更有效。高效口腔漱口水的开发可能会对公众健康产生深远的影响，并取得重大的商业成功。这项研究是一项快速通道建议，将第一阶段和第二阶段研究结合在一个应用程序中。第一阶段有两个具体目的：目的1.用于临床试验的复方口服液制剂目的2.在牙龈炎症的人类临床试验中评价口服液的剂量-反应，并调查对指示全身疾病的生物标志物的影响。第二阶段有三个具体目标：目标1.临床试验中使用的复方口服液制剂目的2.在牙周炎的人类临床试验中评价口腔冲洗液，以满足FDA的要求，并调查对指示全身疾病的生物标志物的影响。 公共卫生相关性：最近的研究将口腔细菌与胰腺癌、糖尿病、中风和心脏病等系统性疾病联系起来。虽然尚未证实口腔细菌直接导致这些疾病，但有一些证据表明，牙科治疗可能会改善疾病的标志。开发一种安全有效、可清除口腔有害细菌并有可能降低疾病发病率的含漱剂，将对公众健康产生重大影响。