Unique Anti-microbial Rinse to Reduce Oral Inflammation

独特的抗菌冲洗剂可减少口腔炎症

基本信息

批准号：
8123164
负责人：
Charles J Gauntt
金额：
$ 29.99万
依托单位：
BIOMEDICAL DEVELOPMENT CORPORATION
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：
2010-09-01 至 2014-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8123164
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 quality assurance response success tool

项目摘要

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.

描述（由申请人提供）：牙周疾病最近被确定为胰腺癌，心血管疾病（动脉粥样硬化，心肌梗死和中风）和糖尿病等全身性疾病的发病率和死亡率增加的危险因素，以及诸如自早产之类的妊娠并发症。众所周知，牙周疾病是由牙菌斑生物膜中的微生物引起的。口服细菌及其成分引发的炎症反应与牙周组织破坏的发病机理有关，并可能有助于全身性疾病的发展。尽管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学标志物。该项目的目的是开发处方抗菌口腔冲洗，以减少口腔和战斗口腔疾病和炎症的细菌生物负担。当前的口头冲洗产品要么充满副作用，例如染色和味觉改变，这些副作用将其用法限制在急性环境中，要么无效。基于初步研究，本文开发的口腔冲洗预计将比当前可用的处方产品更有效，而没有副作用。高效的口头冲洗的发展可能会对公共卫生产生深远的影响并取得巨大的商业成功。这项研究是一项快速曲目的建议，将I期和II期研究结合在一个应用中。第一阶段的部分具有两个具体的目的：目标1。复合口服冲洗配方，用于临床试验AIM 2。在人类的牙龈炎症临床试验中，评估口服冲洗的剂量反应，并研究对表现出全身性疾病的生物学标志物的影响。 II期部分具有三个特定的目的：目标1。复合口服冲洗配方，用于临床试验AIM 2。评估牙龈炎的人类临床试验中的口服冲洗，以满足FDA的需求并研究对表现出全身性疾病的生物学标志物的影响。