A Randomized Clinical Trial to Investigate Two-Week Clinical Safety, Changes in Salivary Flow and pH Following Use of an Anticavity Low pH Mouthwash
Overview
- Phase
- Phase 4
- Intervention
- Listerine Experimental Mouthwash
- Conditions
- Healthy
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Enrollment
- 163
- Locations
- 1
- Primary Endpoint
- Oral Tolerance as Assessed by Clinical Examinations of Oral Hard and Soft Tissues
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this clinical trial is to evaluate the oral tolerance of a new, experimental mouthwash compared to two mouth rinse formulations, which are already marketed, as well as compared to a tooth brushing only control group.
Investigators
Eligibility Criteria
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, 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 Coronavirus 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 clinical trial
- •Resting baseline unstimulated salivary sample must be equal to or greater than 0.3 milliliters per minute (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
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 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 clinical trial 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 cetylpyridinium chloride (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) 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, 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
Arms & Interventions
Arm 1: Brush / Listerine Experimental Mouthwash
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Experimental Mouthwash twice a day.
Intervention: Listerine Experimental Mouthwash
Arm 1: Brush / Listerine Experimental Mouthwash
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with Listerine Experimental Mouthwash twice a day.
Intervention: Colgate Cavity Protection Toothpaste
Arm 2: Brush / Listerine Cool Mint Zero
After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with experimental mouthwash twice a day.
Intervention: Colgate Cavity Protection Toothpaste
Arm 2: Brush / Listerine Cool Mint Zero
After brushing for 1 timed minute, participants will rinse full strength for 30 seconds with experimental mouthwash twice a day.
Intervention: Listerine Cool Mint Zero
Arm 3: Brush / Listerine Total Care Zero
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with experimental mouthwash twice a day.
Intervention: Colgate Cavity Protection Toothpaste
Arm 3: Brush / Listerine Total Care Zero
After brushing for 1 timed minute, participants will rinse full strength for 1 minute with experimental mouthwash twice a day.
Intervention: Listerine Total Care Zero
Arm 4: Brush only
Participants will brush their teeth using a soft bristled toothbrush and Colgate Cavity Protection Toothpaste twice daily for 1 timed minute and then rinse with water for 1 minute.
Intervention: Colgate Cavity Protection Toothpaste
Outcomes
Primary Outcomes
Oral Tolerance as Assessed by Clinical Examinations of Oral Hard and Soft Tissues
Time Frame: Up to Day 14
Oral tissue tolerance will include the assessment of the number of participants with treatment-emergent adverse events (TEAEs) and those experiencing investigational product-related AEs throughout the observational study period of 14 days. In particular, oral examinations will include clinical evaluation of soft and hard tissues, such as buccal and sublingual mucosa, tongue, hard and soft palate, gingiva, uvula, oropharynx, teeth, and dental restorations, with findings recorded in the electronic data capture (EDC) system.
Number of Participants with Adverse Events (AEs)
Time Frame: Up to Day 14
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.
Secondary Outcomes
- Salivary Flow Rate(Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints)
- Saliva Potential of Hydrogen (pH)(Taken at Baseline and immediately (0), and at 2.5, 5, 10, 15, and 30 minute timepoints)