Efficacy of Iocide Oral Rinse Against Gingival Inflammation

Phase II Study: Evaluate Efficacy of Iocide Oral Rinse in a Human Clinical Trial of Gingival Inflammation and Investigate Effects on Biological Markers Indicative of Systemic Disease

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.

Study Overview

• Status: Unknown
• Conditions: Gingivitis; Investigation of Biological Markers of Inflammation
• Intervention / Treatment: Drug: Placebo; Drug: Iocide Oral Rinse

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hailey Gallivan, CCRP; Phone Number: 859-323-4923; Email: hbwils00@uky.edu
• Study Contact Backup: Name: Karl McCloskey; Phone Number: (361) 442-7491; Email: mccloskey@biodevcorp.com

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • University of Kentucky, Center for Oral Health Research, College of Dentistry
      • Principal Investigator: Dolph Dawson, DMD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 exclusion criteria will not be eligible for participation in this study:

• 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;
• Thyroid peroxidase antibody (TPOab) positive >34;
• Screening serum level of thyroid stimulating hormone (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, prosthetic implant or any other condition 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;
• True periodontal pockets of > 5 mm and/or visible recession indicative of attachment loss;
• 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;
• Chronic treatment (2 weeks or more) with any medication known to affect periodontal status (including phenytoin, calcium antagonists, cyclosporine, coumarin, non-steroidal antiinflammatory drugs, and aspirin) within 1 month of the screening examination. All other medications for chronic medical conditions have been initiated at least 3 months before enrollment;
• Current use of a statin or the use of a statin within the past sixty (60) days of screening;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Iocide Oral Rinse; Iocide Oral Rinse once daily 30 second rinse for 24 weeks	Drug: Iocide Oral Rinse; Other Names: Iocide Oral Rinse - once daily 30 second rinse for 24 weeks
Placebo Comparator: Placebo Control; Once daily 30 second rinse for 24 weeks	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Mean Gingival Index (GI)	Study Days -21 to -7 through Study Day 168

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Biological Marker Data	Study Day 1, Day 28, Day 84 and Day 168

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Biomedical Development Corporation
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Kentucky
• Investigators: Principal Investigator: Dolphus R Dawson III, DMD, MS, University of Kentucky

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): January 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: January 29, 2013
• First Submitted That Met QC Criteria: January 30, 2013
• First Posted (Estimate): February 1, 2013

Study Record Updates

• Last Update Posted (Estimate): August 14, 2013
• Last Update Submitted That Met QC Criteria: August 13, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Biomarkers; Gingivitis; Biological Markers of Inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Inflammation; Gingivitis
• Other Study ID Numbers: UK12-0972-F2L; R44HL101821 (U.S. NIH Grant/Contract)