Determination of the Safety and Efficacy of a Novel Oral Rinse on Oral Health

Study Overview
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Brief Summary
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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
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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)

Official Title
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Determination of the Safety and Efficacy of a Novel Oral Rinse on Oral Health

Conditions
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Plaque, Gingivitis

Intervention / Treatment
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* Device: Experimental Oral Rinse
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Oral Rinse<br>In this arm the test article,oral rinse, a proprietary formulation of agents including xylitol, Caffeine, Essential oils, Monk fruit extract, which can reduce the plaque formation Subjects rinse twice a day with 10 mL of the oral rinse for 2 minutes for 30 days. They will note, in the daily oral hygiene diary, the date and time of brushing and rinsing. | Device: Experimental Oral Rinse<br>* Experimental Oral Rinse is a proprietary formulation of GRAS ingredients<br>|
| Placebo Comparator: Placebo Oral Rinse<br>This arm will use a placebo with out the active ingredients same way the experimental arm do. | Device: Placebo<br>* Placebo formulation without the active ingredients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the oral rinse in reducing plaque | Plaque accumulation will be measured by the Turesky modification of the Quigley-Hein method of quantifying plaque formulation (PI). | 4 weeks | 
| Effectiveness of the oral rinse in reducing gingivitis | Gingival health will be measured using the Modified Gingival Index (MGI) | 4 weeks | 
| Effectiveness of the oral rinse in improving a patient's breath | 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, | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation of the test Oral Rinse | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 4 weeks |