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| ID | Type | Description | Link |
|---|---|---|---|
| CCSORC005342 | Other Identifier | Johnson & Johnson Consumer Inc. |
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The purpose of this clinical trial is to evaluate the oral tolerance of a new, experimental mouthwash compared to two mouth rinse formulations, which are already marketed, as well as compared to a tooth brushing only control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Brush / Listerine Experimental Mouthwash | Experimental | After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Experimental Mouthwash twice a day. |
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| Arm 2: Brush / Listerine Cool Mint Zero | Experimental | After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with experimental mouthwash twice a day. |
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| Arm 3: Brush / Listerine Total Care Zero | Experimental | After brushing for 1 timed minute, participants will rinse full strength for 1 minute with experimental mouthwash twice a day. |
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| Arm 4: Brush only | Other | Participants will brush their teeth using a soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily for 1 timed minute and then rinse with water for 1 minute. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Listerine Experimental Mouthwash | Drug | After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Experimental Mouthwash twice a day, morning and night. |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Tolerance as Assessed by Clinical Examinations of Oral Hard and Soft Tissues | Oral tissue tolerance will include the assessment of the number of participants with treatment-emergent adverse events (TEAEs) and those experiencing investigational product-related AEs throughout the observational study period of 14 days. In particular, oral examinations will include clinical evaluation of soft and hard tissues, such as buccal and sublingual mucosa, tongue, hard and soft palate, gingiva, uvula, oropharynx, teeth, and dental restorations, with findings recorded in the electronic data capture (EDC) system. | Up to Day 14 |
| Number of Participants with Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant temporally associated with the clinical investigation, whether or not the event has a causal relationship to the participant's participation in the trial. | Up to Day 14 |
| 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) |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29321067 | Background | Lynch MC, Cortelli SC, McGuire JA, Zhang J, Ricci-Nittel D, Mordas CJ, Aquino DR, Cortelli JR. The effects of essential oil mouthrinses with or without alcohol on plaque and gingivitis: a randomized controlled clinical study. BMC Oral Health. 2018 Jan 10;18(1):6. doi: 10.1186/s12903-017-0454-6. | |
| 23986962 | Background |
| Label | URL |
|---|---|
| A Randomized Clinical Trial to Investigate Two-Week Clinical Safety, Changes in Salivary Flow and pH Following Use of an Anticavity Low pH Mouthwash | View source |
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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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| Colgate Cavity Protection Toothpaste | Drug | Participants will brush twice daily for 1 timed minute with Colgate Cavity Protection toothpaste. |
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| Listerine Total Care Zero | Drug | After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Total Care Zero mouthwash twice a day, morning and night. |
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| Listerine Cool Mint Zero | Other | After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with Listerine Cool Mint Zero mouthwash twice a day, morning and night. |
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The pH value of saliva will be measured by placing the saliva sample onto the pH-sensitive electrode. |
| Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints |
| Cortelli SC, Cortelli JR, Shang H, McGuire JA, Charles CA. Long-term management of plaque and gingivitis using an alcohol-free essential oil containing mouthrinse: a 6-month randomized clinical trial. Am J Dent. 2013 Jun;26(3):149-55. |