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Listerine Cool Mint Antiseptic Mouthwash for Healthy Subjects

Phase 4
Waitlist Available
Led By Jeffery Milleman, DDS
Research Sponsored by Johnson & Johnson Consumer Inc. (J&JCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1, 4 and 12
Awards & highlights

Study Summary

This trial is testing if using an essential oil mouthwash can help reduce gingivitis and plaque.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 4 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 4 and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Whole-mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use
Whole-mouth Mean Plaque Index (TPI) Score After 12 Weeks of Product use
Secondary outcome measures
Categorical Species Microbial Load
Human Microbiome
Number of Distinct Bacterial Species
+8 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Zero Alcohol Gum PrototypeExperimental Treatment2 Interventions
Participants assigned to this group will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily and rinse with 20 milliliters (mL) of the Zero Alcohol Gum Prototype Mouth Rinse for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home.
Group II: Listerine Cool Mint Antiseptic MouthwashExperimental Treatment2 Interventions
Participants assigned to this group will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily and rinse with 20 mL of the Listerine Cool Mint Mouth rinse for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home.
Group III: Alcohol Gum PrototypeExperimental Treatment2 Interventions
Participants assigned to this group will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily and rinse with 20 mL of the Alcohol Gum Prototype Mouth Rinse for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home.
Group IV: Negative Control: 5 percent (%) HydroalcoholActive Control2 Interventions
Participants assigned to this group will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily and rinse with 20 mL of the 5% Hydroalcohol Mouth Rinse for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home.

Find a Location

Who is running the clinical trial?

Johnson & Johnson Consumer Inc. (J&JCI)Lead Sponsor
52 Previous Clinical Trials
5,302 Total Patients Enrolled
Jeffery Milleman, DDSPrincipal InvestigatorSalus Research, Inc.
8 Previous Clinical Trials
1,688 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims is this investigation attempting to achieve?

"This clinical trial is designed to measure the Whole-mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use as its primary outcome, with associated secondary outcomes including the Whole-mouth Mean MGI Score After 1 and 4 Weeks of Product Use, Percentage of Bleeding Sites Based on the EBI Score at 1, 4, and 12 Weeks of Product use, and Categorical Species Microbial Load. The latter involves evaluating supragingival plaque levels according to a specific scale."

Answered by AI

How many participants are admitted to this trial?

"Affirmative. According to the clinicaltrials.gov listing, this medical study is presently open for enrollment and was first introduced on August 31st 2022. The most recent update took place on November 28th of that same year and 192 patients are required at a single site."

Answered by AI

Are there currently any opportunities to join this clinical experiment?

"Indeed, the information provided on clinicaltrials.gov confirms that this study is actively recruiting participants since it was first posted in August of 2022 and reevaluated at the end of November. This medical trial seeks a total 192 patients from one centre."

Answered by AI

Could you expound on the safety risks associated with Listerine Cool Mint Antiseptic Mouthwash?

"We award Listerine Cool Mint Antiseptic Mouthwash a safety score of 3, given the successful completion and approval of Phase 4 clinical trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Twelve Week Study of Prototypes Mouth Rinses
2022. "A Twelve Week Study of Prototypes Mouth Rinses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05526586.
~74 spots leftby Apr 2025
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