Novel Intraoral Chlorhexidine Releasing (CHXR) System

The overall objective of this program is to commercially develop a novel Intraoral Chlorhexidine (CSystem for physically handicapped patients which is superior to the currently marketed oral care prorely on patient compliance for effectiveness in preventing the development of plaque and gingivitis.this Phase I proposal are to demonstrate the technical feasibility of preparing 3-5,000 controlled r(CHX) devices per batch with 0.4 mg/day and 2.0 mg/day of CHX-release rates that provides continuousplaque accumulation and gingivitis, for one to four months, easily replaceable by a trained health gdepend on patients compliance for effectiveness. Specific objectives are to characterize the CHXR- dcontent, uniformity of dosage, kinetics of CHX release in the presence of saliva, determine the bioaCHX to inhibit the proliferation of bacteria associated with plaque accumulation and gingivitis by esystem, and determine the LD(50) of the controlled release CHXR-devices in rats.If the results are promising, continue the CHXR-product development, determine the long-term usage (appropriate animal models, assemble the generated information into an Investigational New Drug (IND)with the Food and Drug Administration (FDA) for the initiation of safety and efficacy (Phase I and Ipart of the Phase II program.