Gingivitis, Plaque
Conditions
Brief summary
Since over 50% of the US population have gingivitis, mouthrinses serve as a valuable adjunct to brushing and flossing. The primary objective is to determine the effectiveness of the oral rinse in reducing plaque and gingivitis and improve a patient's breath
Detailed description
This clinical study design is a randomized, double-blind, single-treatment, parallel design with a placebo as the control. Following a screening exam, the duration of the trial will be 1 month. Oral examinations will occur at Visit 1 (baseline), and Visit 2 (4 weeks post screening). Also, at these visits, subjects will be asked keep a diary for the one month and their thoughts about the effect of the mouthrinse on their breath and their mouth feeling of freshness. They will also be asked about the taste and consistency of the mouth rinse. Plaque accumulation will be measured by the Turesky modification of the Quigley-Hein method of quantifying plaque formulation (PI). Gingival health will be measured using the Modified Gingival Index (MGI)
Interventions
DEVICEExperimental Oral Rinse
Experimental Oral Rinse is a proprietary formulation of GRAS ingredients
DEVICEPlacebo
Placebo formulation without the active ingredients
Sponsors
You First Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation. * Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations. * Subject is between the ages of 18 and 75 years inclusive. * Subject will not have professional cleaning during the study. * Subject has no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test drug, as determined by the Principal Investigator. * Subject has a minimum of 12 natural teeth. * Subject agrees to refrain from the use of any oral rinse, toothpaste or dentifrice other than the Aim® Fluoride toothpaste and study rinse provided on Visit 1 for the duration of the study. * Subject agrees to refrain from the use of other oral care products not supplied by the study center * Subject agrees to be compliant with study procedures. * Females of childbearing potential agree to use an adequate method of birth control and agree to pregnancy
Exclusion criteria
* Subject has read, signed and received a copy of the Informed Consent and HIPAA authorization prior to study initiation. * Subject is able to follow verbal and/or written instructions, perform oral hygiene procedures and return to the test facility for specified study examinations. * Subject is between the ages of 18 and 75 years inclusive. * Subject will not have professional cleaning during the study. * Subject has no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test drug, as determined by the Principal Investigator. * Subject has a minimum of 12 natural teeth. * Subject agrees to refrain from the use of any oral rinse, toothpaste or dentifrice other than the Aim® Fluoride toothpaste and study rinse provided on Visit 1 for the duration of the study. * Subject agrees to refrain from the use of other oral care products not supplied by the study center * Subject agrees to be compliant with study procedures. * Females of childbearing potential agree to use an adequate method of birth control and agree to pregnancy testing at the first and second visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of the oral rinse in reducing plaque | 4 weeks | Plaque accumulation will be measured by the Turesky modification of the Quigley-Hein method of quantifying plaque formulation (PI). |
| Effectiveness of the oral rinse in reducing gingivitis | 4 weeks | Gingival health will be measured using the Modified Gingival Index (MGI) |
| Effectiveness of the oral rinse in improving a patient's breath | 4 weeks | Subjects will be asked keep a diary for one month and their thoughts about the effect of the mouthrinse on their breath and their mouth feeling of freshness, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation of the test Oral Rinse | 4 weeks | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Countries
United States
Contacts
Primary ContactSebastian Ciancio, D.D.S
Outcome results
None listed