NCT01103102

Dose-Response Study of Iocide Oral Rinse

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Biomedical Development Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gingivitis

Interventions

Type	Name	Description
DRUG	Iocide Oral Rinse	Oral Rinse; dosages vary by treatment group; once to twice daily use (depending on treatment group); 12 weeks duration
DRUG	Placebo	Placebo

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-01-01
• Completion: 2012-04-01
• First posted: 2010-04-14
• Last updated: 2013-01-29

Locations

1 site across 1 country: United States