Gingivitis Clinical Trial
Official title:
Phase II Study: Evaluate Dose-Response of Iocide Oral Rinse in a Human Clinical Trial of Gingival Inflammation and Investigate Effects of Biological Markers Indicative of Systemic Disease
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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