Gingivitis, Investigation of Biological Markers of Inflammation
Conditions
Keywords
Gingivitis, Biomarkers, Biological Markers of Inflammation
Brief summary
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.
Interventions
DRUGPlacebo
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Kentucky
Biomedical Development Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects shall meet all of the following inclusion criteria to be eligible for participation in this study: * Males or non-pregnant females of at least 18 years of age, and in good general health, as determined by Investigator; * Have at least 16 natural, gradable teeth and good dental health, as determined by Investigator; * Have \> 25% sites with Gingival Index (GI) scores of \> 2 at Visits 1 and 2; * Have Plaque Index (PI) scores of \> 1 on \> 50% of sites; * Use of effective method of contraception for the duration of the study or permanently sterilized; * Able and willing to comply with study requirements including following instructions on study treatment and returning for follow-up visits as required by the protocol; * Have full understanding of all elements of, and signature and dating of the written informed consent prior to the initiation of protocol specified procedures; * Females with childbearing potential must have a negative pregnancy test before and during the study period. Sexually active females must be using an effective form of birth control or abstinence. These methods include oral contraceptives (the pill), an intrauterine device (IUD), levonogestrol implants (Norplant®), medroxyprogesterone acetate injections (Depo-provera®) or contraceptive foam with a condom.
Exclusion criteria
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Mean Gingival Index (GI) | Study Days -21 to -7 through Study Day 168 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Biological Marker Data | Study Day 1, Day 28, Day 84 and Day 168 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Product Safety | Study Days 1 through Study Days 168 | 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. |
Countries
United States
Contacts
Primary ContactHailey Gallivan, CCRP
Backup ContactKarl McCloskey
Outcome results
None listed