Efficacy of Iocide Oral Rinse Against Gingival Inflammation

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Biomedical Development Corporation
Sponsor:
Collaborators:
University of Kentucky
Information provided by (Responsible Party):
Biomedical Development Corporation
ClinicalTrials.gov Identifier:
NCT01782170
First received: January 29, 2013
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Gingivitis
Investigation of Biological Markers of Inflammation
Drug: Iocide Oral Rinse
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Biomedical Development Corporation:

Primary Outcome Measures:
  • Change in Mean Gingival Index (GI) [ Time Frame: Study Days -21 to -7 through Study Day 168 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Biological Marker Data [ Time Frame: Study Day 1, Day 28, Day 84 and Day 168 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Assessment of Product Safety [ Time Frame: Study Days 1 through Study Days 168 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 76
Study Start Date: February 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Iocide Oral Rinse
Iocide Oral Rinse once daily 30 second rinse for 24 weeks
Drug: Iocide Oral Rinse
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782170

Contacts
Contact: Hailey Gallivan, CCRP 859-323-4923 hbwils00@uky.edu
Contact: Karl McCloskey (361) 442-7491 mccloskey@biodevcorp.com

Locations
United States, Kentucky
University of Kentucky, Center for Oral Health Research, College of Dentistry Recruiting
Lexington, Kentucky, United States, 40506
Principal Investigator: Dolph Dawson, DMD, MS         
Sponsors and Collaborators
Biomedical Development Corporation
University of Kentucky
Investigators
Principal Investigator: Dolphus R Dawson III, DMD, MS University of Kentucky
  More Information

No publications provided

Responsible Party: Biomedical Development Corporation
ClinicalTrials.gov Identifier: NCT01782170     History of Changes
Other Study ID Numbers: UK12-0972-F2L, R44HL101821
Study First Received: January 29, 2013
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biomedical Development Corporation:
Gingivitis
Biomarkers
Biological Markers of Inflammation

Additional relevant MeSH terms:
Gingivitis
Inflammation
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014