Dose-Response Study of Iocide Oral Rinse
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Gingivitis
Intervention
Iocide Oral Rinse, Placebo
Location
University of Texas Health Science Center at San Antonio
San Antonio
Texas
United States
78229
Status
Recruiting
Source
Biomedical Development Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01103102
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Gingivitis, Necrotizing Ulcerative
An acute or chronic GINGIVITIS characterized by redness and swelling, NECROSIS extending from the interdental papillae along the gingival margins, PAIN; HEMORRHAGE, necrotic odor, and often a pseudomembrane. The condition may extend to the ORAL MUCOSA; TONGUE; PALATE; or PHARYNX. The etiology is somewhat unclear, but may involve a complex of FUSOBACTERIUM NUCLEATUM along with spirochetes BORRELIA or TREPONEMA.
Oral Ulcer
A loss of mucous substance of the mouth showing local excavation of the surface, resulting from the sloughing of inflammatory necrotic tissue. It is the result of a variety of causes, e.g., denture irritation, aphthous stomatitis (STOMATITIS, APHTHOUS); NOMA; necrotizing gingivitis (GINGIVITIS, NECROTIZING ULCERATIVE); TOOTHBRUSHING; and various irritants. (From Jablonski, Dictionary of Dentistry, 1992, p842)
Oral Medicine
A branch of dentistry dealing with diseases of the oral and paraoral structures and the oral management of systemic diseases. (Hall, What is Oral Medicine, Anyway? Clinical Update: National Naval Dental Center, March 1991, p7-8)
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Oral Hygiene
The practice of personal hygiene of the mouth. It includes the maintenance of oral cleanliness, tissue tone, and general preservation of oral health.
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