Determination of the Oral Irritation Potential of Two Alc... | NCT07160166

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental: Prototype 1 Regimen	Experimental	All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Cavity Protection) and a soft flat trimmed bristled toothbrush and their assigned mouthwash at their Screening/Baseline visit to use throughout the study. Subjects will use their assigned study products and complete their oral care regimen for the first time at the site under supervision. At home, subjects will brush twice daily for at least 1 timed minute with the toothpaste and toothbrush provided. After brushing for at least 1 timed minute, subjects will rinse with their assigned mouthwash according to the product label. Subjects will be required to record their twice daily product usage on a subject diary starting with their first product use at the site.	Other: Prototype 1
Experimental: Prototype 2 Regimen	Experimental	All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Cavity Protection) and a soft flat trimmed bristled toothbrush and their assigned mouthwash at their Screening/Baseline visit to use throughout the study. Subjects will use their assigned study products and complete their oral care regimen for the first time at the site under supervision. At home, subjects will brush twice daily for at least 1 timed minute with the toothpaste and toothbrush provided. After brushing for at least 1 timed minute, subjects will rinse with their assigned mouthwash according to the product label. Subjects will be required to record their twice daily product usage on a subject diary starting with their first product use at the site.	Other: Prototype 2
Active Comparator: Marketed Comparator Regimen	Active Comparator	All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Cavity Protection) and a soft flat trimmed bristled toothbrush and their assigned mouthwash at their Screening/Baseline visit to use throughout the study. Subjects will use their assigned study products and complete their oral care regimen for the first time at the site under supervision. At home, subjects will brush twice daily for at least 1 timed minute with the toothpaste and toothbrush provided. After brushing for at least 1 timed minute, subjects will rinse with their assigned mouthwash according to the product label. Subjects will be required to record their twice daily product usage on a subject diary starting with their first product use at the site.

Name	Type	Description	Arm Group Labels	Other Names
Prototype 1	Other	Subjects will brush and rinse with their assigned mouthwash twice daily.	Experimental: Prototype 1 Regimen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in baseline in oral tolerance based on oral hard and soft tissue exams	Change in baseline in oral tolerance based on oral hard and soft tissue exams will be reported. Oral examinations will be conducted to monitor oral hard and soft tissues tolerance to the treatments. Buccal and sublingual mucosae, lips/labial mucosa, mucobuccal gold, 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.	Up to Day 14
Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical study participant temporarily 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

Measure	Description	Time Frame
Mouthwash Habits Baseline Questionnaire	For the Mouthwash Habits Baseline Questionnaire, the number and percentage of subjects for each response of each question will be presented by investigational product group. For these aggregated response categories, percentages of subjects will be compared between investigational product groups using a chi-square test, or Fisher's exact test if the expected cell size is sufficiently small. For ordinal response questions (9-point Liking scales and 5-point scales), the mean and standard deviation for each ordinal response variable will also be displayed. Each statistical test will be carried out at the 0.10 level of significance, two-sided. Note that testing at the 0.10 level of significance is reasonable for consumer perception testing, as decisions based on these types of data are typically based on this significance level.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults, 18 years of age and older, at the time of screening/baseline (approximately 15% Black and 5% Asian race; approximately 10% Hispanic ethnicity).
Generally, in good general and oral health (i.e. brush teeth daily and exhibit no signs of gross oral neglect) without any known allergy to commercial dental products or cosmetics.
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.
Individual has signed the Consent for Photograph Release and ICD (and/or Assent Document, as applicable)including Health Insurance Portability and Accountability Act (HIPAA) disclosure.
Able to read and understand the local language (subject is capable of reading the documents).
Generally, in good health based on medical history reported by the subject.
In good oral health with adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of gross oral neglect).
Negative pregnancy urine tests (females of child-bearing potential only):
- For females: Postmenopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first study IP administration) or premenopausal/perimenopausal state with an effective means of contraception.
- For males: No pregnant or lactating spouse or partner at screening and willingness to utilize an acceptable form of birth control with spouse or any potential partner during the study and for 30 days thereafter.
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. Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include:
- Double barrier method (condoms, diaphragm or cervical cap with spermicide),
- Hormonal prescription contraceptives (i.e., oral, injectable, implanted, patch or vaginal ring hormone therapy)
- Intrauterine device (IUD)
- Surgical sterilization (e.g., vasectomy that has been confirmed effective by sperm count check, tubal ligation, hysterectomy and/or bilateral oophorectomy)
- Abstinence
A minimum of 16 uncrowned teeth.
Absence of significant oral soft tissue pathology, periodontitis and active dental caries, based on a visual examination and at the discretion of the Investigator.
Absence of partial dentures, dentures, orthodontic bands, fixed retainers, removable orthodontic appliances.

Exclusion Criteria:

Diagnosed with Xerostomia.
Suspected alcohol or substance abuse at the discretion of the Investigator (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates).
Known sensitivity, allergy or contraindications to any investigational product ingredient, oral care products and auxiliary supplies provided for the study.
Self-reported smokeless tobacco user including snuff, chewing tobacco, vaping and e-cigarette usage.
Females who are self-reported to be pregnant, planning to become pregnant or breastfeeding during the study.
Participation in any clinical study investigation within 30 days of Screening visit (Visit 1).
Planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period.
Has a compromised immune system, in the judgement of the medically qualified investigator.
Has any acute or chronic, medical or psychiatric conditions) 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 judgement of the medically qualified investigator, would make the subject inappropriate for entry in this study;
Significant, unstable or uncontrolled medical condition which may interfere with subject's participation in the study, at the discretion of the Investigator.
Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication;
Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:
- Immunosuppressive or steroidal drugs within 2 months before Visit 1.*
- Non-steroidal anti-inflammatory drugs within 5 days before Visit 1.
- Antihistamines within 2 weeks before Visit 1.
Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., principal Investigator, sub-investigators, study coordinators, other site personnel, employees of Kenvue Brands LLC/Johnson & Johnson (J&J) subsidiaries, contractors of Kenvue/J&J, and the families of each).