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| ID | Type | Description | Link |
|---|---|---|---|
| CCSORC005121 | Other Identifier | Johnson & Johnson Consumer Inc. (J&JCI) |
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The purpose of this study is to assess the oral tissue tolerance (tissues within the mouth) for irritation caused by added ingredients in mouthwashes. This will be assessed based on oral tissue exams and adverse reactions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Brush/ LISTERINE Cool Mint Antiseptic Mouthwash | Experimental | At Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days. |
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| Arm 2: Brush / Listerine Advanced Gum Alcohol | Experimental | At Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days. |
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| Arm 3: Brush / Listerine Advanced Gum Zero | Experimental | At Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days. |
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| Arm 4: Brush / LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint | Experimental | At Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colgate Cavity Protection Toothpaste | Other | Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Oral Tolerance Based on Oral Hard and Soft Tissue Exams | Change from baseline in oral tolerance based on oral had and soft tissue exams will be reported. Oral examination will be conducted to monitor oral soft and hard tissues tolerance to the treatments. Buccal and sublingual mucosae, lips/labial mucosa, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations will be examined and findings will be recorded in the electronic data capture (EDC) system. | Baseline 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 baseline and then immediately (0), 2, 5, 10, 15 and 30 minute timepoints after intervention. The final amount of saliva will be weighed to calculate the milliliter per minute (mL/min). The saliva flow rate will be expressed as mL/min. | Baseline and immediately (0), 2, 5, 10, 15 and 30 minutes after intervention use |
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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 |
|---|---|---|---|
| 41338687 | Derived | Milleman K, Bosma ML, Saito A, Gorecki P, Ding Y, DelSasso A, Wills K, Milleman JL. Comparison of safety, salivary flow rate, and pH with different mouthrinse formulations in addition to toothbrushing vs toothbrushing only: Results from a 2-week phase 4 randomized controlled clinical trial. J Am Dent Assoc. 2025 Dec;156(12):991-1000.e3. doi: 10.1016/j.adaj.2025.08.022. |
| Label | URL |
|---|---|
| Two-Week Clinical Safety and Saliva Flow Quantification | 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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| Arm 5: Brush Only | Other | At Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days. |
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| LISTERINE Cool Mint Antiseptic Mouthwash | Other | Participants will use 20 mL of LISTERINE Cool Mint Antiseptic Mouthwash for 30 seconds after brushing twice daily. |
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| Listerine Advanced Gum Alcohol | Other | Participants will use 20 mL of Listerine Advanced Gum Alcohol Rinse for 30 seconds after brushing twice daily. |
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| Listerine Advanced Gum Zero | Other | Participants will use 20 mL of Listerine Advanced Gum Zero Rinse for 30 seconds after brushing twice daily. |
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| LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint | Other | Participants will use 20 mL of LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint Rinse for 30 seconds after brushing twice daily. |
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| Saliva Potential of Hydrogen (pH) | The pH value of saliva will be measured by placing the saliva sample onto the pH-sensitive electrode. | Baseline and 2, 5, 10, 15 and 30 minutes after intervention use |
| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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