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

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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.