Unique Anti-microbial Rinse to Reduce Oral Inflammation

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。

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.