Pilot Efficacy Study to Treat Gingivitis

NCT00391547 | Completed Phase 2

• 2 other identifiers: 0609059R44NR009015-02NIH Grant No. 9R44NR009015-02
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gingival Diseases

Keywords

Gingivitis Disease

Outcome Measures

Primary Outcomes (1)

• Reduction of the Gingival Index values over a 12 weeks period.

Secondary Outcomes (1)

• Reduction of the Plaque Index values over a 12 weeks period.

Interventions

Frio Oral Rinse DRUG

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 18 years of age, and in good general health, as determined by Investigator.
• Have 16 natural, gradable teeth and good dental health, as determined by Investigator.
• Have \> 25% sites with GI scores \> 2.
• Have average 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 (drug) 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. 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.

You may not qualify if:

• History, or current evidence, of any significant acute or chronic 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.
• Treatment with antibiotic within the one (1) month period prior to the screening examination.
• Presence of heart murmur, history of rheumatic fever, valvular disease or prosthetic implant requiring antibiotic premedication.
• History of thyroid disease.
• Known 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.
• 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.
• History of or current alcohol abuse that, in the opinion of the Investigator, could influence the outcome of the study.
• History of, 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).

Sponsors & Collaborators

• Biomedical Development Corporation: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Missouri at Kansas City, School of Dentistry

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

• Guidance for Industry Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention

  BACKGROUND

MeSH Terms

Conditions

Gingival Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Lynn Friesen, DDS

  University of Missouri at Kansas City, School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 20, 2006
• First Posted: October 24, 2006
• Study Start: October 1, 2006
• Study Completion: January 1, 2007
• Last Updated: October 22, 2007

Record last verified: 2007-10

Locations

US (1)