Dose-Response Study of Iocide Oral Rinse

NCT01103102 | Completed Phase 2 DMC

• 2 other identifiers: HSC20090462H1R44HL101821-01
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Keywords

Gingivitis; Biological Markers

Outcome Measures

Primary Outcomes (1)

• Gingival Index

  The primary outcome measure will be the mean gingival index (GI) score.

  Study Day -21 to -7 through Study Day 84

Study Arms (4)

Lowest Dose

ACTIVE COMPARATOR

Drug: Iocide Oral Rinse

Intermediate Dose

ACTIVE COMPARATOR

Drug: Iocide Oral Rinse

Highest Dose

ACTIVE COMPARATOR

Drug: Iocide Oral Rinse

Placebo Control

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Iocide Oral Rinse DRUG

Oral Rinse; dosages vary by treatment group; once to twice daily use (depending on treatment group); 12 weeks duration

Highest Dose; Intermediate Dose; Lowest Dose

Placebo DRUG

Placebo

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Biomedical Development Corporation: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Texas: collaborator

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• David L. Cochran, DDS, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 14, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2012
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

US (1)