Efficacy of Iocide Oral Rinse Against Gingival Inflammation

This study is currently recruiting participants.
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

January 29, 2013
August 13, 2013
February 2013
January 2014   (final data collection date for primary outcome measure)
Change in Mean Gingival Index (GI) [ Time Frame: Study Days -21 to -7 through Study Day 168 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01782170 on ClinicalTrials.gov Archive Site
Change in Biological Marker Data [ Time Frame: Study Day 1, Day 28, Day 84 and Day 168 ] [ Designated as safety issue: No ]
Same as current
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.
Assessment of Product Safety [ Time Frame: Study Days 1 through Study Days 168 ] [ Designated as safety issue: Yes ]
The primary safety outcome measures will be the incidence of adverse events, measures of thyroid function, and iodine excretion. Secondary safety measures include development of opportunistic infection with Candida albicans, changes in oral tissues, and concomitant medication interactions.
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Gingivitis
  • Investigation of Biological Markers of Inflammation
  • Drug: Iocide Oral Rinse
    Other Name: Iocide Oral Rinse - once daily 30 second rinse for 24 weeks
  • Drug: Placebo
  • Active Comparator: Iocide Oral Rinse
    Iocide Oral Rinse once daily 30 second rinse for 24 weeks
    Intervention: Drug: Iocide Oral Rinse
  • Placebo Comparator: Placebo Control
    Once daily 30 second rinse for 24 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
May 2014
January 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Hailey Gallivan, CCRP 859-323-4923 hbwils00@uky.edu
Contact: Karl McCloskey (361) 442-7491 mccloskey@biodevcorp.com
United States
 
NCT01782170
UK12-0972-F2L, R44HL101821
No
Biomedical Development Corporation
Biomedical Development Corporation
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Kentucky
Principal Investigator: Dolphus R Dawson III, DMD, MS University of Kentucky
Biomedical Development Corporation
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP