Gingival Diseases
Conditions
Keywords
Gingivitis Disease
Brief summary
The primary purpose is to demonstrate the efficacy of a prescription mouthrinse in human subjects for treatment of Gingivitis.
Detailed description
Gingivitis is an endemic disease that is a precursor to periodontal disease. Two mouthrinse agents, Peridex and Listerine, have received the Seal of Acceptance from the Council on Dental Therapeutics of the American Dental Association for the control of supragingival plaque and gingivitis. Peridex (0.12% chlorhexidine, bisbiguanide cationic detergent) is a prescription mouthrinse that demonstrates potent anti-plaque and anti-gingivitis action. Chlorhexidine rinses are also prescribed to prevent post surgical infections. Chlorhexidine has broad spectrum antibacterial activity and substantivity. With prolonged use, chlorhexidine maintains its effectiveness but causes staining of natural teeth and composite materials used in restorative dentistry. Other side effects associated with chlorhexidine are calculus formation and possible alterations in taste. Although chlorhexidine rinses and supragingival irrigations have demonstrated significant efficacy in reducing plaque and gingivitis, chlorhexidine has had a minimal impact in treating periodontal disease. Listerine, comprised of essential oils, is an over-the-counter mouthrinse that is less effective than chlorhexidine in controlling plaque and gingivitis, but has minimal side effects. Other agents such as quaternary ammonium compounds and metal salts are rarely used alone but can be used in combination with other antimicrobial rinses to enhance their effectiveness.
Interventions
DRUGFrio Oral Rinse
Sponsors
National Institute of Nursing Research (NINR)
Biomedical Development Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects shall meet all of the following inclusion criteria to be eligible for participation in this study: * 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.
Exclusion criteria
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of the Gingival Index values over a 12 weeks period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of the Plaque Index values over a 12 weeks period. | — |
Countries
United States
Outcome results
None listed