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Interdental Brush/Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT) 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 after 4, 12 and 24 weeks
Awards & highlights
Study Summary
This trial looks at how well different oral hygiene routines work to prevent and treat plaque and gum disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 4, 12 and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 4, 12 and 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Interproximal Mean Modified Gingival Index (MGI) After 24 Weeks of Product Use
Interproximal Mean Turesky Plaque Index (TPI) After 24 Weeks of Product Use
Secondary outcome measures
Categorical Species Microbial Load
Expanded Interproximal Mean RMNPI (Sites D, F, A, and C)
Individual Species Microbial Load
+20 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Interdental Brush/Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT)Experimental Treatment3 Interventions
Participants will use their interdental brush according to their personalized "mouth map," rinse with water, brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protections Toothpaste for 2 timed minutes and then rinse for 30 seconds with LISTERINEZERO Alcohol Mouthwash COOL MINT under virtual supervision in the morning. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over weekends and holidays for the first 3 months of the study (up to visit 3). After visit 3, for the next three months until the end of the study, weekday virtual visits will drop to three times a week. Throughout the study, only tooth brushing will be performed a second time in the evening (no interdental brush use). First product use will occur at the site under supervision. Participants will be required to record their daily product use times on a participant diary.
Group II: Interdental Brush/Brush/Rinse (LISTERINE COOL MINT Antiseptic Mouthwash)Experimental Treatment3 Interventions
Participants will use their interdental brush according to their personalized "mouth map," rinse with water, brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protections Toothpaste for 2 timed minutes and then rinse for 30 seconds with LISTERINE COOL MINT Antiseptic Mouthwash under virtual supervision in the morning. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over weekends and holidays for the first 3 months of the study (up to visit 3). After visit 3, for the next three months until the end of the study, weekday virtual visits will drop to three times a week. Throughout the study, only tooth brushing will be performed a second time in the evening (no interdental brush use). First product use will occur at the site under supervision. Participants will be required to record their daily product use times on a participant diary.
Group III: Interdental Brush/BrushExperimental Treatment2 Interventions
Participants will use their interdental brush according to their personalized "mouth map", rinse with water then brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protections Toothpaste for 2 timed minutes under virtual supervision in the morning. At home, participants will brush a second time unsupervised daily in the evening and twice daily over weekends and holidays for the first 3 months of the study (up to visit 3). After visit 3, for the next three months until the end of the study, weekday virtual visits will drop to three times a week. Throughout the study, only tooth brushing will be performed a second time in the evening (no interdental brush use). First product use will occur at the site under supervision. Participants will be required to record their daily product use times on a participant diary.
Group IV: Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT)Experimental Treatment2 Interventions
Participants will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protections Toothpaste for 2 timed minutes and then rinse for 30 seconds with LISTERINE ZERO Alcohol Mouthwash COOL MINT under virtual supervision in the morning. At home, participants will brush and rinse a second time unsupervised daily in the evening and twice daily over weekends and holidays for the first 3 months of the study (up to visit 3). After visit 3, for the next three months until the end of the study, weekday virtual visits will drop to three times a week. First product use will occur at the site under supervision. Participants will be required to record their daily product use times on a participant diary.
Group V: Brush OnlyExperimental Treatment1 Intervention
Participants will brush their teeth using a marketed soft bristled toothbrush and Colgate Cavity Protections Toothpaste for 2 timed minutes under virtual supervision in the morning. At home, participants will brush a second time unsupervised daily in the evening and twice daily over weekends and holidays for the first 3 months of the study (up to visit 3). After visit 3, for the next three months until the end of the study, weekday virtual visits will drop to three times a week. First product use will occur at the site under supervision. Participants will be required to record their daily product use times on a participant diary.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LISTERINE ZERO Alcohol Mouthwash COOL MINT
2023
Completed Phase 4
~300
LISTERINE COOL MINT Antiseptic Mouthwash
2022
Completed Phase 4
~580
TePe Original Interdental Brush
2023
Completed Phase 4
~300
Colgate Cavity Protection Toothpaste
2020
Completed Phase 4
~2180
Find a Location
Who is running the clinical trial?
Johnson & Johnson Consumer Inc. (J&JCI)Lead Sponsor
52 Previous Clinical Trials
5,202 Total Patients Enrolled
Jeffery Milleman, DDSPrincipal InvestigatorSalus Research, Inc.
8 Previous Clinical Trials
1,588 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been regularly drinking or taking probiotic supplements within one week before the screening/baseline.You use smokeless tobacco products like snuff, chewing tobacco, vaping, or e-cigarettes.You have used certain types of mouthwashes and toothpastes that treat plaque or gingivitis within the past four weeks.You have had bad reactions in the past to oral hygiene products like toothpaste, mouthwash, or red food dye. You are also known to have allergies or sensitivities to any of the ingredients in the study products or other ingredients in general.You need to have enough space between your teeth to use an interdental brush.You have a serious medical or mental health condition or abnormal lab results that could make it risky for you to participate in the study or make it difficult to understand the study results.
Research Study Groups:
This trial has the following groups:- Group 1: Interdental Brush/Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT)
- Group 2: Interdental Brush/Brush
- Group 3: Brush Only
- Group 4: Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT)
- Group 5: Interdental Brush/Brush/Rinse (LISTERINE COOL MINT Antiseptic Mouthwash)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is this clinical trial being accessed by patients?
"Affirmative. The information on clinicaltrials.gov confirms that this research endeavor, which was first published on February 9th 2023, is actively recruiting patients. 300 individuals are sought at 1 medical centre."
Answered by AI
What potential health risks arise from using Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT)?
"This product has been authorised, so it is given a score of 3 on our safety scale. Brush/Rinse (LISTERINE ZERO Alcohol Mouthwash COOL MINT) is currently in its fourth phase clinical trial."
Answered by AI
Is this medical experiment enrolling participants at the present time?
"According to information found on clinicaltrials.gov, this research study is currently open for recruitment of participants. The project was initially posted online in February 9th, 2023 and its details were last updated March 2nd of the same year."
Answered by AI
What aims is this experiment attempting to fulfill?
"This clinical trial will be monitored over a 24 week period, with the primary outcome being an evaluation of Interproximal Mean Modified Gingival Index (MGI) after this term. Furthermore, secondary results such as Interproximal Mean MGI and Expanded Bleeding Index (EBI) After 4, 12 and 24 Weeks along with Percent Bleeding Sites based on EBI After 4, 12 and 24 Weeks will also be reported. To assess gingivitis or bleeding at any given site, a 0 to 4 scale is used where 0 denotes no inflammation or absence of bleeding respectively; 1 indicates slight change in colour/texture"
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What site did they apply to?
Salus Research, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
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