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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
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Oral Rinse | Experimental | 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. |
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| Placebo Oral Rinse | Placebo Comparator | This arm will use a placebo with out the active ingredients same way the experimental arm do. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Oral Rinse | Device | Experimental Oral Rinse is a proprietary formulation of GRAS ingredients |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Ciancio, D.D.S | Contact | 716-829-3848 | ciancio@buffalo.ed |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontics and Endodontics,School of Dental Medicine, University at Buffalo, SUNY | Buffalo | New York | 14214 | United States |
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| ID | Term |
|---|---|
| D058225 | Plaque, Amyloid |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D005882 | Gingival Diseases |
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| Placebo | Device | Placebo formulation without the active ingredients |
|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |