Dose-Response Study of Iocide Oral Rinse



Status:Recruiting
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:April 2010
Contact:Jenna Hollis
Email:hollisj@livemail.uthscsa.edu
Phone:785-375-5763

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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.


Inclusion Criteria:

- 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 > 2;

- Have average Plaque Index (PI) score > 2;

- 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), levonogestrel implants (Norplant®), medroxyprogesterone
acetate injections (Depo-provera®) or contraceptive foam with a condom.

Exclusion Criteria:

- History, or current evidence, of any significant acute or chronic subject-reported
medical or psychiatric condition that, in the opinion of the Investigator, would
render examination difficult or invalid or prevent the subject from active study
participation;

- ≤24% of sites with GI score >2;

- TPOab positive >34;

- Screening serum level of TSH <0.45 or >4.5;

- Treatment with antibiotic within the one (1) month period prior to the screening
examination;

- History of heart murmur, history of rheumatic fever, valvular disease or prosthetic
implant requiring antibiotic premedication;

- History of thyroid disease;

- Purported sensitivity or allergy to iodine;

- Known sensitivity or allergy to shellfish;

- History of diabetes;

- History of autoimmune disease;

- Gross oral pathology (periodontal disease, rampant caries, tissue damage created by
poor oral care or treatment, soft or hard tissue tumors) that, in the opinion of the
Investigator, could influence the outcome of the study;

- Periodontal disease screening will be performed by assessing periodontal pocket
depths >5mm on six (6) sites per tooth (distofacial, facial, mesiofacial,
mesiolingual, lingual and distolingual). A UNC-15 periodontal probe (Hu-Friedy) will
be used for all measurements. Any subject with true periodontal pockets > 5 mm will
be excluded from participation in this study;

- Current signs or symptoms of mucosal tissue ulcerations or inflammation, or canker
sores;

- Presence of orthodontic appliances or any removable appliance that impinges on the
oral tissues being assessed;

- History of early onset periodontal disease or acute necrotizing ulcerative
gingivitis;

- Subject reported history in past 6 months or current alcohol abuse that, in the
opinion of the Investigator, could influence the outcome of the study;

- Subject reported history of last past 6 months or current drug abuse;

- Use of concomitant medication that, in the opinion of the Investigator, might
interfere with the outcome of the study (e.g. antibiotics, immuno-suppressants,
steroids, or therapeutic doses of non-steroidal anti-inflammatory agents, phenytoin,
calcium antagonists, cyclosporine or coumadin);

- Concomitant therapy with another investigational drug or device without prior
approval from the Sponsor within four weeks prior to Visit 2 (Study Day 1);

- Concomitant endodontic or periodontal therapy other than prophylaxis in the past six
(6) months;

- Females with childbearing potential with a positive pregnancy test, pregnant or
nursing mothers, suspected pregnancy, or intention to become pregnant during the
study;

- Residence in the same household as a subject already enrolled in the study (inclusion
may create blinding and/or compliance issues);

- Unable and unwilling to comply with the informed consent process, to meet study
requirements including following instructions on study intervention, and to return
for follow-up visits as required by the protocol;
We found this trial at
1
site
4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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from
San Antonio, TX
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