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The purpose of this trial is to evaluate the amount of saliva generated and changes in the oral Potential of Hydrogen (pH) after a single use of essential oil (EO)-containing mouth rinses compared to a negative control. Three EO mouthwash formulations will be investigated in this regard, with the negative control being tap water.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Brush / Listerine Clinical Solutions Teeth Strength | Experimental | After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Clinical Solutions Teeth Strength mouthwash. |
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| Arm 2: Brush / Listerine Total Care Zero | Experimental | After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Total Care Zero mouthwash. |
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| Arm 3: Brush / Listerine Cool Mint Zero | Experimental | After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with Listerine Cool Mint Zero mouthwash. |
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| Arm 4: Brush / Water (Negative Control) | Other | After brushing for 1 timed minute, participants will rinse with for 1 minute with tap water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Listerine Clinical Solutions Teeth Strength | Drug | After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Clinical Solutions Teeth Strength mouthwash. |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Flow Rate | Saliva samples will be collected by participants at specified timepoints. The final amount of saliva will be weighed and flow rate will be determined. | Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints |
| Saliva Potential of Hydrogen (pH) | The pH value of saliva will be measured by placing the saliva sample onto the pH sensitive electrode. | Taken at Baseline and at 2.5, 5, 10, 15, and 30 minute timepoints |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery Milleman, DDS | Salus Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research, Inc. | Fort Wayne | Indiana | 46825 | United States |
Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.
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| Listerine Total Care Zero Alcohol Mouthwash | Drug | After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Total Care Zero mouthwash. |
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| Listerine Cool Mint Zero Alcohol Mouthwash | Other | After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with Listerine Cool Mint Zero mouthwash. |
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| Colgate Cavity Protection Toothpaste | Drug | Participants will brush for 1 timed minute with Colgate Cavity Protection toothpaste. |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D009067 | Mouthwashes |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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