CLINICAL TRIAL: CLINICAL TRIALS OF 25% CHLORHEXIDINE DIACETATE INTRAORAL DELIVER

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 该申请包括由国家牙科和颅面研究所（NIDCR）资助的两项临床试验。 这些试验中的第一项（牙龈炎受试者中2.5%二醋酸氯己定口腔给药系统的药代动力学试验）将在本申请中被称为I期。 这些试验中的第二项（在NIH坏死性溃疡性牙周炎受试者中进行的2. 5%二醋酸氯己定口腔内给药系统II期试验）将被称为II期试验。 I期和II期的实验药物均为双乳酸氯己定，这是一种广谱抗菌剂，对革兰氏阴性和革兰氏阳性细菌、酵母菌、真菌和病毒均有活性。 二醋酸氯己定（2.5%重量）已被纳入一种新型口内给药系统（乙烯醋酸乙烯酯或伊娃护齿套），用于HIV患者坏死性溃疡性牙周炎（NUP）的靶向适应症。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This application includes two clinical trials funded by the National Institute of Dental and Craniofacial Research (NIDCR). The first of these trials (Pharmacokinetic Trial of 2.5% Chlorhexidine Diacetate Intraoral Delivery System in Subjects with Gingivitis) will be referred as Phase I within this applicaiton. The second of these trials (Phase 2 Trial of 2.5% Chorhexidine Diacetate Intraoral Delivery System in NIH Subjects with Necrotizing Ulcerative Periodontis) will be referred as Phase II. The experimental drug for both the Phase I and Phase II will be chlorhexidine diactate, which is a broad spectrum antimicrobial with activity against both Gram-negative and Gram-positive bacteria, yeast, fungi, and viruses. Chlorhexidine diacetate (2.5% by weight) has been incorporated into a novel intraoral delivery system (ethylene vinyl acetate or EVA mouthguard) for the targeted indication of necrotizing ulcerative periodonttis (NUP) in HIV patients.