| Eligibility |
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
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