Advertisement

Topics

Dose-Response Study of Iocide Oral Rinse

2014-08-27 03:14:38 | BioPortfolio

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)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:38-0400

Clinical Trials [1005 Associated Clinical Trials listed on BioPortfolio]

Next Science Antimicrobial Mouth Rinse Study

To assess the effect of a test antimicrobial oral rinse from Next Science on the prevention of oral biofilm formation and thereby preventing gingivitis by monitoring the oral microbial flo...

Novel Rinse to Treat in Oral Candidiasis in Cancer Patients

The purpose of the study is to evaluate the efficacy of Iocide oral rinse as a treatment for Oral Candidiasis in any patient including but not limited to patients receiving radiation thera...

Exploratory Study of Iocide Oral Rinse in a Diabetic Population

The goals of this exploratory study are to 1)examine an investigational oral rinse as an adjunctive agent to scaling and root planing in treating chronic periodontitis in a periodontitis-s...

Pilot Efficacy Study to Treat Gingivitis

The primary purpose is to demonstrate the efficacy of a prescription mouthrinse in human subjects for treatment of Gingivitis.

Controlling Oral Malodor by ClōSYS® Oral Rinse

The purpose of this Study is to assess the efficacy of two ClōSYS Oral Rinse products in human subjects in controlling oral malodor in partial fulfillment of the requirements for American...

PubMed Articles [4822 Associated PubMed Articles listed on BioPortfolio]

Efficacy of a glycopolymer-based oral rinse upon pain associated with ulcerative and erosive lesions of the oral mucosa: A within-subject pilot study.

The purpose of this pilot study was to assess the magnitude of effect for a new topical rinse that may impact oral soreness and function in ulcerative oral mucosal lesions.

Effects of Compounded Stanford Modified Oral Rinse (MucoLox) on the Survival and Migration of Oral Keratinocytes and Fibroblasts: Implications for Wound Healing.

Several oral rinses are commercially available to alleviate the symptoms of oral mucositis. Prolonged retention of active pharmaceutical ingredients in the oral cavity is a major problem. In this stud...

Molecular basis for immunohistochemical and inflammatory changes during progression of gingivitis to periodontitis.

Two common diseases - gingivitis and periodontitis - affect the periodontium. Symptoms of disease entities are used for distinguishing various forms of gingivitis and periodontitis. Gingivitis follows...

Effects of chlorhexidine preprocedural rinse on bacteremia in periodontal patients: a randomized clinical trial.

Single dose of systemic antibiotics and short-term use of mouthwashes reduce bacteremia. However, the effects of a single dose of preprocedural rinse are still controversial. This study evaluated, in ...

The effect of dietary corn oil and fish oil supplementation in dogs with naturally occurring gingivitis.

The aim of this randomized, double-blinded, placebo-controlled study was to evaluate if downregulation of the inflammatory response due to ingestion of high levels of eicosapentaenoic acid (EPA) and d...

Medical and Biotech [MESH] Definitions

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.

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)

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)

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

The practice of personal hygiene of the mouth. It includes the maintenance of oral cleanliness, tissue tone, and general preservation of oral health.

More From BioPortfolio on "Dose-Response Study of Iocide Oral Rinse"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...


Searches Linking to this Trial