The purpose of this study is to explore the dose-response relationship of Iocide oral rinse
in a clinical trial of gingivitis.
Approximately sixty (60) otherwise healthy subjects having gingivitis will be randomized into
the 3-month study to provide 40 total evaluable subjects (10 per group). Each study
participant will have four visits: a screening visit up to 21 days before the beginning of
the trial, a baseline visit at day 1, and visits at weeks 8 and 12. The duration of the
dose/range study will be three months to facilitate compliance and ensure timely completion
of the Phase II study.
Three dose/regimens will be evaluated against a placebo control oral rinse. Indices for
gingivitis, plaque and bleeding will be scored and blood tests will be performed to determine
the effect of the antimicrobial oral rinse on relative levels of biological markers of
inflammation.
Phase:
Phase 2
Details
Lead Sponsor:
Biomedical Development Corporation
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI) University of Texas