A Two-Week Study of Clinical Safety and Saliva Flow Quantification

NCT05645705 | Completed Phase 4

• 1 other identifier: CCSORC005121
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the oral tissue tolerance (tissues within the mouth) for irritation caused by added ingredients in mouthwashes. This will be assessed based on oral tissue exams and adverse reactions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Oral Tolerance Based on Oral Hard and Soft Tissue Exams

  Change from baseline in oral tolerance based on oral had and soft tissue exams will be reported. Oral examination will be conducted to monitor oral soft and hard tissues tolerance to the treatments. Buccal and sublingual mucosae, lips/labial mucosa, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations will be examined and findings will be recorded in the electronic data capture (EDC) system.

  Baseline up to Day 14

• Number of Participants with Adverse Events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant temporally associated with the clinical investigation, whether or not the event has a causal relationship to the participant's participation in the trial.

  Up to Day 14

Secondary Outcomes (2)

• Salivary Flow Rate

  Baseline and immediately (0), 2, 5, 10, 15 and 30 minutes after intervention use

• Saliva Potential of Hydrogen (pH)

  Baseline and 2, 5, 10, 15 and 30 minutes after intervention use

Study Arms (5)

Arm 1: Brush/ LISTERINE Cool Mint Antiseptic Mouthwash

EXPERIMENTAL

At Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days.

Other: Colgate Cavity Protection Toothpaste; Other: LISTERINE Cool Mint Antiseptic Mouthwash

Arm 2: Brush / Listerine Advanced Gum Alcohol

EXPERIMENTAL

At Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days.

Other: Colgate Cavity Protection Toothpaste; Other: Listerine Advanced Gum Alcohol

Arm 3: Brush / Listerine Advanced Gum Zero

EXPERIMENTAL

At Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days.

Other: Colgate Cavity Protection Toothpaste; Other: Listerine Advanced Gum Zero

Arm 4: Brush / LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint

EXPERIMENTAL

At Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days.

Other: Colgate Cavity Protection Toothpaste; Other: LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint

Arm 5: Brush Only

OTHER

At Day 0, participants will use their products at the site and saliva samples will be taken at pre-determined timepoints. At home, participants will use their products twice a day for approximately 14 days.

Other: Colgate Cavity Protection Toothpaste

Interventions

Colgate Cavity Protection Toothpaste OTHER

Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.

Arm 1: Brush/ LISTERINE Cool Mint Antiseptic Mouthwash; Arm 2: Brush / Listerine Advanced Gum Alcohol; Arm 3: Brush / Listerine Advanced Gum Zero; Arm 4: Brush / LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint; Arm 5: Brush Only

LISTERINE Cool Mint Antiseptic Mouthwash OTHER

Participants will use 20 mL of LISTERINE Cool Mint Antiseptic Mouthwash for 30 seconds after brushing twice daily.

Arm 1: Brush/ LISTERINE Cool Mint Antiseptic Mouthwash

Listerine Advanced Gum Alcohol OTHER

Participants will use 20 mL of Listerine Advanced Gum Alcohol Rinse for 30 seconds after brushing twice daily.

Arm 2: Brush / Listerine Advanced Gum Alcohol

Listerine Advanced Gum Zero OTHER

Participants will use 20 mL of Listerine Advanced Gum Zero Rinse for 30 seconds after brushing twice daily.

Arm 3: Brush / Listerine Advanced Gum Zero

LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint OTHER

Participants will use 20 mL of LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint Rinse for 30 seconds after brushing twice daily.

Arm 4: Brush / LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical study) 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, 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 corona virus disease-2019 (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 study
• Resting baseline unstimulated salivary sample must be equal to or greater than 0.3 milliliter per minute (mL/min) to continue in the study
• 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

You may not qualify if:

• 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 Baseline visit
• 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 study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory 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, sodium fluoride with CPC, stannous fluoride, zinc or chlorhexidine digluconate containing mouthwashes and toothpastes within the four weeks prior to the Baseline exam
• 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)
• Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study 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 (examples, amphetamines, benzodiazepines, cocaine, marijuana, opiates)
• Significant medical or oral condition which may interfere with a participant's participation in the study, including cancer, chronic kidney disease, chronic obstructive pulmonary disease (COPD), 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 Screening visit
• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Location

Related Publications (1)

• Milleman K, Bosma ML, Saito A, Gorecki P, Ding Y, DelSasso A, Wills K, Milleman JL. Comparison of safety, salivary flow rate, and pH with different mouthrinse formulations in addition to toothbrushing vs toothbrushing only: Results from a 2-week phase 4 randomized controlled clinical trial. J Am Dent Assoc. 2025 Dec;156(12):991-1000.e3. doi: 10.1016/j.adaj.2025.08.022.

  PMID: 41338687 DERIVED

Related Links

• Two-Week Clinical Safety and Saliva Flow Quantification

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Jeffery Milleman, DDS

  Salus Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: November 28, 2022
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)