HealthyPhase 4NCT06136455

A Study to Investigate Salivary Flow and Potential of Hydrogen (pH) Following Use of Essential-Oil Containing Mouthwashes

A Phase 4 study testing Listerine Clinical Solutions Teeth Strength, Listerine Total Care Zero Alcohol Mouthwash and Listerine Cool Mint Zero Alcohol Mouthwash in people with Healthy, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Listerine Clinical Solutions Teeth Strength, Listerine Total Care Zero Alcohol Mouthwash and Listerine Cool Mint Zero Alcohol Mouthwash
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 164 participants
Where: 1 siteUnited States
Study dates: 13 Nov 2023to 16 Nov 2023
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Able to comprehend and follow the requirements and restrictions of the clinical trial (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical trial) based upon research site personnel's assessment
Evidence of a personally signed and dated informed consent document indicating the participant (or legally acceptable representative) has been informed of all pertinent aspects of the trial
Able to read and understand the local language (participant is capable of reading the documents)
Adequate oral hygiene [that is (i.e.), brush teeth daily and exhibit no signs of oral neglect]
Adults, 18 years of age and older, in good general and oral health without any known allergy to commercial dental products or cosmetics
Evidence of being fully vaccinated for COVID-19 (adults 60 years and older)

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Negative pregnancy urine tests (females of child-bearing potential only)
Females of childbearing potential must be 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 their participation in the clinical trial
Resting baseline unstimulated salivary sample must be equal to or greater than 0.3 mL/min to continue in the clinical trial
A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count
Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator
Absence of advanced periodontitis based on a clinical examination and discretion of the dental examiner
Absence of fixed or removable orthodontic appliance or removable partial dentures

Who cannot join

History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouthwashes and red food dye
Dental prophylaxis within four weeks prior to Visit 1
History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
Use of antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, cyclosporin A, immunostimulants/ immunomodulators during the clinical trial or within the one month prior to the Baseline exam at Visit 1. Intermittent use of certain antiinflammatory medication (ibuprofen, Aspirin); oral steroids and calcium channel blockers are acceptable at the discretion of the investigator
Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride (CPC), sodium fluoride with CPC, stannous fluoride, zinc or chlorhexidine digluconate containing mouthwashes and toothpastes within the four weeks prior to Visit 1
Known allergy or sensitivity or history of significant adverse effects to any of the investigational product and/or product ingredients (or other ingredients in the products) specifically Cinnamyl Alcohol, Benzyl Alcohol, Citral, Citronellol, Linalool and Limonene

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Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of clinical trial results)
Self-reported smokeless tobacco user including snuff, chewing tobacco, vaping and e-cigarette usage
Males with a pregnant partner or a partner who is currently trying to become pregnant
Suspected alcohol or substance abuse (for example, amphetamines, benzodiazepines, cocaine, marijuana, opiates)
Significant medical or oral condition which may interfere with a participant's participation in the clinical trial, including cancer, chronic kidney disease, COPD (chronic obstructive pulmonary disease), immunocompromised state (weakened immune system) from solid organ transplant, serious heart conditions, (such as heart failure, coronary artery disease, or cardiomyopathies) Sickle cell disease, Type 2 diabetes mellitus at the discretion of the Investigator
Participation in any clinical trial within 30 days of Visit 1
Diagnosed Temporo-mandibular joint dysfunction/disorder
Participants who wear bruxing devices, dental aligners, retainers
Participants who were previously screened and ineligible or were randomized to receive investigational product
Participants who are related to those persons involved directly or indirectly with the conduct of this clinical trial (i.e., principal investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson \& Johnson subsidiaries, contractors of Johnson \& Johnson, and the families of each)
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the participant inappropriate for entry into this clinical trial

Trial locations and contacts

1 site in 1 country.

United States1 site

Salus Research, Inc.
Fort Wayne, Indiana, 46825

Other trials in United States

About this study

Official title: A Randomized Clinical Trial to Investigate Salivary Flow and pH Following Use of Essential-Oil Containing Mouthwashes

Conditions: Healthy
Being tested: Listerine Clinical Solutions Teeth Strength, Listerine Total Care Zero Alcohol Mouthwash, Listerine Cool Mint Zero Alcohol Mouthwash, Colgate Cavity Protection Toothpaste

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Listerine Clinical Solutions Teeth StrengthDrug
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Clinical Solutions Teeth Strength mouthwash.
Listerine Total Care Zero Alcohol MouthwashDrug
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Total Care Zero mouthwash.
Listerine Cool Mint Zero Alcohol MouthwashOther
After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with Listerine Cool Mint Zero mouthwash.
Colgate Cavity Protection ToothpasteDrug
Participants will brush for 1 timed minute with Colgate Cavity Protection toothpaste.

Study groups in NCT06136455
Study group	Role	What they receive
Arm 1: Brush / Listerine Clinical Solutions Teeth Strength	Experimental	After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Clinical Solutions Teeth Strength mouthwash. Receives: Drug: Listerine Clinical Solutions Teeth Strength; Drug: Colgate Cavity Protection Toothpaste
Arm 2: Brush / Listerine Total Care Zero	Experimental	After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Total Care Zero mouthwash. Receives: Drug: Listerine Total Care Zero Alcohol Mouthwash; Drug: Colgate Cavity Protection Toothpaste
Arm 3: Brush / Listerine Cool Mint Zero	Experimental	After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with Listerine Cool Mint Zero mouthwash. Receives: Other: Listerine Cool Mint Zero Alcohol Mouthwash; Drug: Colgate Cavity Protection Toothpaste
Arm 4: Brush / Water (Negative Control)	Other	After brushing for 1 timed minute, participants will rinse with for 1 minute with tap water. Receives: Drug: Colgate Cavity Protection Toothpaste

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Taken at Baseline and at 2.5, 5, 10, 15, and 30 minute timepoints

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 202316 Nov 2023

First posted18 Nov 2023
Study start13 Nov 2023
Primary completion16 Nov 2023
Study completion16 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 164 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06136455
Sponsor's protocol ID: CCSORC005482
Status last verified: Jan 2024
First submitted: 13 Nov 2023
Last updated: 3 Jan 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Clinical Trial to Investigate Salivary Flow and pH Following Use of Essential-Oil Containing Mouthwashes
ClinicalTrials.gov ID: NCT06136455
Acronym / sponsor ID: CCSORC005482
Conditions: Healthy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 164 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
Study start: 13 Nov 2023 (actual)
Primary completion: 16 Nov 2023 (actual)
Study completion: 16 Nov 2023 (actual)
First posted: 18 Nov 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
Arm 1: Brush / Listerine Clinical Solutions Teeth Strength	Experimental	Drug: Listerine Clinical Solutions Teeth Strength, Drug: Colgate Cavity Protection ToothpasteAfter brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Clinical Solutions Teeth Strength mouthwash.
Arm 2: Brush / Listerine Total Care Zero	Experimental	Drug: Listerine Total Care Zero Alcohol Mouthwash, Drug: Colgate Cavity Protection ToothpasteAfter brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Total Care Zero mouthwash.
Arm 3: Brush / Listerine Cool Mint Zero	Experimental	Other: Listerine Cool Mint Zero Alcohol Mouthwash, Drug: Colgate Cavity Protection ToothpasteAfter brushing for 1 timed minute, participants will rinse full strength for 30 seconds with Listerine Cool Mint Zero mouthwash.
Arm 4: Brush / Water (Negative Control)	Other	Drug: Colgate Cavity Protection ToothpasteAfter brushing for 1 timed minute, participants will rinse with for 1 minute with tap water.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Able to comprehend and follow the requirements and restrictions of the clinical trial (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical trial) based upon research site personnel's assessment
Evidence of a personally signed and dated informed consent document indicating the participant (or legally acceptable representative) has been informed of all pertinent aspects of the trial
Able to read and understand the local language (participant is capable of reading the documents)
Adequate oral hygiene [that is (i.e.), brush teeth daily and exhibit no signs of oral neglect]
Adults, 18 years of age and older, in good general and oral health without any known allergy to commercial dental products or cosmetics

Key exclusion criteria (17 listed)

History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouthwashes and red food dye
Dental prophylaxis within four weeks prior to Visit 1
History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
Use of antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, cyclosporin A, immunostimulants/ immunomodulators during the clinical trial or within the one month prior to the Baseline exam at Visit 1. Intermittent use of certain antiinflammatory medication (ibuprofen, Aspirin); oral steroids and calcium channel blockers are acceptable at the discretion of the investigator
Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride (CPC), sodium fluoride with CPC, stannous fluoride, zinc or chlorhexidine digluconate containing mouthwashes and toothpastes within the four weeks prior to Visit 1

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Listerine Clinical Solutions Teeth StrengthAfter brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Clinical Solutions Teeth Strength mouthwash.	Drug	Arm 1: Brush / Listerine Clinical Solutions Teeth Strength
Listerine Total Care Zero Alcohol MouthwashAfter brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Total Care Zero mouthwash.	Drug	Arm 2: Brush / Listerine Total Care Zero
Listerine Cool Mint Zero Alcohol MouthwashAfter brushing for 1 timed minute, participants will rinse full strength for 30 seconds with Listerine Cool Mint Zero mouthwash.	Other	Arm 3: Brush / Listerine Cool Mint Zero
Colgate Cavity Protection ToothpasteParticipants will brush for 1 timed minute with Colgate Cavity Protection toothpaste.	Drug	Arm 1: Brush / Listerine Clinical Solutions Teeth Strength, Arm 2: Brush / Listerine Total Care Zero, Arm 3: Brush / Listerine Cool Mint Zero, Arm 4: Brush / Water (Negative Control)

Primary outcome

Salivary Flow Rate
Time frame: Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints
Saliva samples will be collected by participants at specified timepoints. The final amount of saliva will be weighed and flow rate will be determined.
Saliva Potential of Hydrogen (pH)
Time frame: Taken at Baseline and at 2.5, 5, 10, 15, and 30 minute timepoints
The pH value of saliva will be measured by placing the saliva sample onto the pH sensitive electrode.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
Individual participant dataSharing planned: 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.

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THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
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A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeffery Milleman, DDS principal investigator

Salus Research, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Salivary Flow Rate (time frame: Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06136455.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.