Listerine Cool Mint Antiseptic Mouthwash for Healthy Subjects (HS)

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Salus Research, Inc., Fort Wayne, IN
Healthy Subjects (HS)
Listerine Cool Mint Antiseptic Mouthwash - Other
Eligibility
18+
All Sexes
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Study Summary

The purpose of this study is to evaluate the safety and efficacy of two essential oil containing experimental mouth rinse formulations and an essential oil containing mouth rinse compared to a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a twelve-week product usage period.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: Weeks 1, 4 and 12

Week 4
Whole-mouth Mean MGI Score After 1 and 4 Weeks of Product Use
Week 12
Percentage of Bleeding Sites, Based on the EBI Score at 1, 4, and 12 Weeks of Product use
After 12 weeks
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
Week 1
Whole-mouth Mean TPI Score After 1 and 4 Weeks of Product use
Week 12
Categorical Species Microbial Load
Changes in Microbiome Composition by Sample Clustering Analysis
Number of Distinct Bacterial Species
Shannon-weaver Diversity Index
Total Species Microbial Load
Week 12
Number of Live Bacterial Counts Expressed in Log10
At Week 12
Whole Mouth Bleeding on Probing Depth at 12 Week
Week 1
Whole-Mouth Mean Expanded Gingival Bleeding Index (EBI) Score at 1, 4 and 12 Weeks of Product use

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

Negative Control: 5 percent (%) Hydroalcohol
1 of 4
Listerine Cool Mint Antiseptic Mouthwash
1 of 4
Alcohol Gum Prototype
1 of 4
Zero Alcohol Gum Prototype
1 of 4
Active Control
Experimental Treatment

192 Total Participants · 4 Treatment Groups

Primary Treatment: Listerine Cool Mint Antiseptic Mouthwash · No Placebo Group · Phase 4

Listerine Cool Mint Antiseptic MouthwashExperimental Group · 2 Interventions: Listerine Cool Mint Antiseptic Mouthwash, Colgate Cavity Protection Toothpaste · Intervention Types: Other, Other
Alcohol Gum PrototypeExperimental Group · 2 Interventions: Colgate Cavity Protection Toothpaste, Alcohol Gum Prototype · Intervention Types: Other, Other
Zero Alcohol Gum PrototypeExperimental Group · 2 Interventions: Colgate Cavity Protection Toothpaste, Zero Alcohol Gum Prototype · Intervention Types: Other, Other
Negative Control: 5 percent (%) HydroalcoholActiveComparator Group · 2 Interventions: 5% Hydroalcohol, Colgate Cavity Protection Toothpaste · Intervention Types: Other, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 1, 4 and 12
Closest Location: Salus Research, Inc. · Fort Wayne, IN
Photo of indiana 1Photo of indiana 2Photo of indiana 3
2012First Recorded Clinical Trial
3 TrialsResearching Healthy Subjects (HS)
10 CompletedClinical Trials

Who is running the clinical trial?

Johnson & Johnson Consumer Inc. (J&JCI)Lead Sponsor
36 Previous Clinical Trials
3,112 Total Patients Enrolled
6 Trials studying Healthy Subjects (HS)
730 Patients Enrolled for Healthy Subjects (HS)
Jeffery Milleman, DDSPrincipal InvestigatorSalus Research, Inc.
3 Previous Clinical Trials
515 Total Patients Enrolled
2 Trials studying Healthy Subjects (HS)
358 Patients Enrolled for Healthy Subjects (HS)

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to comprehend and follow the requirements and restrictions of the study based upon research site personnel's assessment.
You have adequate oral hygiene.
Vaccination is required for adults 60 years and older.
You are of childbearing potential and you are using a medically acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during your participation in the study.
Teeth with carious lesions, abraded enamel, restored, orthodontically banded, or with third molars excluded.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.