A Phase 4 interventional study of Listerine Clinical Solutions Teeth Strength and Listerine Total Care Zero Alcohol Mouthwash in Healthy, sponsored by Johnson & Johnson Consumer Inc. (J&JCI). Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-03.
Sponsored by Johnson & Johnson Consumer Inc. (J&JCI) · Phase 4, Interventional, and Other
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.
Johnson & Johnson Consumer Inc. (J&JCI) is the lead sponsor of 52 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Clinical Solutions Teeth Strength mouthwash.
Drug: Listerine Clinical Solutions Teeth Strength · Drug: Colgate Cavity Protection Toothpaste
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Total Care Zero mouthwash.
Drug: Listerine Total Care Zero Alcohol Mouthwash · Drug: Colgate Cavity Protection Toothpaste
After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with Listerine Cool Mint Zero mouthwash.
Other: Listerine Cool Mint Zero Alcohol Mouthwash · Drug: Colgate Cavity Protection Toothpaste
After brushing for 1 timed minute, participants will rinse with for 1 minute with tap water.
Drug: Colgate Cavity Protection Toothpaste
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Clinical Solutions Teeth Strength mouthwash.
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Total Care Zero mouthwash.
After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with Listerine Cool Mint Zero mouthwash.
Participants will brush for 1 timed minute with Colgate Cavity Protection toothpaste.
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.
Time frame: 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.
Time frame: Taken at Baseline and at 2.5, 5, 10, 15, and 30 minute timepoints
Plan to share: Yes — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Consumer Inc. (J&JCI)