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| ID | Type | Description | Link |
|---|---|---|---|
| R44HL101821 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University of Kentucky | OTHER |
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The purpose of this study is to explore the efficacy of Iocide oral rinse in a human clinical trial of gingivitis. Iocide oral rinse will be evaluated against a placebo 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iocide Oral Rinse | Active Comparator | Iocide Oral Rinse once daily 30 second rinse for 24 weeks |
|
| Placebo Control | Placebo Comparator | Once daily 30 second rinse for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iocide Oral Rinse | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Gingival Index (GI) | Study Days -21 to -7 through Study Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Biological Marker Data | Study Day 1, Day 28, Day 84 and Day 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Product Safety | The assessment of product safety will include the following: incidence of adverse events, measures of thyroid function, and iodine excretion. Additionally, investigators will assess any development of opportunistic infection with Candida albicans, changes in oral tissues, and concomitant medication interactions. | Study Days 1 through Study Days 168 |
Inclusion Criteria:
Subjects shall meet all of the following inclusion criteria to be eligible for participation in this study:
Exclusion Criteria:
Subjects meeting any of the following exclusion criteria will not be eligible for participation in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hailey Gallivan, CCRP | Contact | 859-323-4923 | hbwils00@uky.edu | |
| Karl McCloskey | Contact | (361) 442-7491 | mccloskey@biodevcorp.com |
| Name | Affiliation | Role |
|---|---|---|
| Dolphus R Dawson III, DMD, MS | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky, Center for Oral Health Research, College of Dentistry | Recruiting | Lexington | Kentucky | 40506 | United States |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| Placebo |
| Drug |
|
| D009057 |
| Stomatognathic Diseases |