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Dose-Response Study of Iocide Oral Rinse

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ClinicalTrials.gov Identifier: NCT01103102
Recruitment Status : Completed
First Posted : April 14, 2010
Last Update Posted : January 29, 2013
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of Texas
Information provided by (Responsible Party):
Biomedical Development Corporation

Tracking Information
First Submitted Date  ICMJE April 12, 2010
First Posted Date  ICMJE April 14, 2010
Last Update Posted Date January 29, 2013
Study Start Date  ICMJE April 2010
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2010)
Gingival Index [ Time Frame: Study Day -21 to -7 through Study Day 84 ]
The primary outcome measure will be the mean gingival index (GI) score.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01103102 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-Response Study of Iocide Oral Rinse
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Gingivitis
Intervention  ICMJE
  • Drug: Iocide Oral Rinse
    Oral Rinse; dosages vary by treatment group; once to twice daily use (depending on treatment group); 12 weeks duration
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: Lowest Dose
    Intervention: Drug: Iocide Oral Rinse
  • Active Comparator: Intermediate Dose
    Intervention: Drug: Iocide Oral Rinse
  • Active Comparator: Highest Dose
    Intervention: Drug: Iocide Oral Rinse
  • Placebo Comparator: Placebo Control
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2013)
97
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2010)
60
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01103102
Other Study ID Numbers  ICMJE HSC20090462H
1R44HL101821-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biomedical Development Corporation
Study Sponsor  ICMJE Biomedical Development Corporation
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Texas
Investigators  ICMJE
Principal Investigator: David L. Cochran, DDS, PhD The University of Texas Health Science Center at San Antonio
PRS Account Biomedical Development Corporation
Verification Date January 2013

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