Two-Week Clinical Safety and Saliva Flow Quantification

Johnson & Johnson Consumer Inc. (J&JCI)1 site in 1 country270 target enrollmentNovember 28, 2022

ConditionsHealthy

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Healthy
Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
Enrollment: 270
Locations: 1
Primary Endpoint: Change from Baseline in Oral Tolerance Based on Oral Hard and Soft Tissue Exams
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 28, 2022

End Date

December 16, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

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 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)

Outcomes

Primary Outcomes

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

Time Frame: Baseline up to Day 14

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.

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(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)