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CompletedNCT06136455Updated Jan 3, 2024

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

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

Phase
Phase 4
Study type
Interventional
Enrollment
164
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. Three EO mouthwash formulations will be investigated in this regard, with the negative control being tap water.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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)
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
164 participants (actual)

Study arms

  • Experimental
    Arm 1: Brush / Listerine Clinical Solutions Teeth Strength

    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

  • Experimental
    Arm 2: Brush / Listerine Total Care Zero

    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

  • Experimental
    Arm 3: Brush / Listerine Cool Mint Zero

    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

  • Other
    Arm 4: Brush / Water (Negative Control)

    After brushing for 1 timed minute, participants will rinse with for 1 minute with tap water.

    Drug: Colgate Cavity Protection Toothpaste

Interventions

  • DrugListerine Clinical Solutions Teeth Strength

    After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Clinical Solutions Teeth Strength mouthwash.

  • DrugListerine Total Care Zero Alcohol Mouthwash

    After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Total Care Zero mouthwash.

  • OtherListerine Cool Mint Zero Alcohol Mouthwash

    After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with Listerine Cool Mint Zero mouthwash.

  • DrugColgate Cavity Protection Toothpaste

    Participants will brush for 1 timed minute with Colgate Cavity Protection toothpaste.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Study locations

1 site
  • Salus Research, Inc.
    Fort Wayne, Indiana 46825, United States
08

References and documents

Individual participant data

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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06136455
Lead sponsor
Johnson & Johnson Consumer Inc. (J&JCI)
Responsible party
Sponsor
First posted
Nov 18, 2023
Start date
Nov 13, 2023
Primary completion
Nov 16, 2023
Completion
Nov 16, 2023
Last update
Jan 3, 2024

Study contacts

Jeffery Milleman, DDS
principal investigator · Salus Research, Inc.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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