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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Listerine Clinical Solutions Teeth Strength; Drug: Colgate Cavity Protection Toothpaste; Drug: Listerine Total Care Zero Alcohol Mouthwash; Other: Listerine Cool Mint Zero Alcohol Mouthwash

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Clinical Solutions Teeth Strength mouthwash.; Drug: Colgate Cavity Protection Toothpaste; Participants will brush for 1 timed minute with 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: Colgate Cavity Protection Toothpaste; Participants will brush for 1 timed minute with Colgate Cavity Protection toothpaste.; Drug: Listerine 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.
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.	Drug: Colgate Cavity Protection Toothpaste; Participants will brush for 1 timed minute with Colgate Cavity Protection toothpaste.; Other: Listerine 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.
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; Participants will brush for 1 timed minute with Colgate Cavity Protection toothpaste.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Taken at Baseline and at 2.5, 5, 10, 15, and 30 minute timepoints

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
• Investigators: Principal Investigator: Jeffery Milleman, DDS, Salus Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Actual): November 16, 2023
• Study Completion (Actual): November 16, 2023

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Protective Agents; Cariostatic Agents; Ethanol; Listerine; Sodium Fluoride
• Other Study ID Numbers: CCSORC005482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No