Oral HealthNCT07160166
Determination of the Oral Irritation Potential of Two Alcohol-Free Rinses
A study testing Prototype 1, Prototype 2 and Marketed Comparator in people with Oral Health, run by Kenvue Brands LLC at 1 site in United States.
Trial summary
The objective of this study is to evaluate the oral soft and hard tissue tolerance after 14 days of a twice daily regimen of brushing and rinsing with essential oil containing alcohol free mouthwashes versus a control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- Prototype 1, Prototype 2 and Marketed Comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2025to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate the oral soft and hard tissue tolerance after 14 days of a twice daily regimen of brushing and rinsing with essential oil containing alcohol free mouthwashes versus a control.
- Conditions
- Oral Health
- Being tested
- Prototype 1, Prototype 2, Marketed Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype 1Other
Subjects will brush and rinse with their assigned mouthwash twice daily.
Prototype 2Other
Subjects will brush and rinse with their assigned mouthwash twice daily.
Marketed ComparatorOther
Subjects will brush and rinse with their assigned mouthwash twice daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Marketed Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to Day 14
Secondary outcomes (3)
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.
Measured: Visit 1 (Day 0)
Product Perception Claims Questionnaire
For the Product Perception Claims 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.
Measured: Visit 3 (Day 14 ± 1 day)
Comparison of the salivary microbial counts
Measured: Visit 1 (Day 0); Visit 3 (Day 14 ± 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start11 Jul 2025
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single center, examiner-blind, randomized, parallel-group, controlled clinical trial.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenvue Brands LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160166
- Sponsor's protocol ID
- CS2025OC100242
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Oral Irritation Potential of Two Alcohol-Free Rinses
- ClinicalTrials.gov ID
- NCT07160166
- Acronym / sponsor ID
- CS2025OC100242
- Conditions
- Oral Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Kenvue Brands LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the oral soft and hard tissue tolerance after 14 days of a twice daily regimen of brushing and rinsing with essential oil containing alcohol free mouthwashes versus a control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- This is a single center, examiner-blind, randomized, parallel-group, controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Prototype 1 Regimen | Experimental | Other: Prototype 1All 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. |
| Experimental: Prototype 2 Regimen | Experimental | Other: Prototype 2All 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. |
| Active Comparator: Marketed Comparator Regimen | Active comparator | Other: Marketed ComparatorAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prototype 1Subjects will brush and rinse with their assigned mouthwash twice daily. | Other | Experimental: Prototype 1 Regimen |
| Prototype 2Subjects will brush and rinse with their assigned mouthwash twice daily. | Other | Experimental: Prototype 2 Regimen |
| Marketed ComparatorSubjects will brush and rinse with their assigned mouthwash twice daily. | Other | Active Comparator: Marketed Comparator Regimen |
Primary outcome
Change in baseline in oral tolerance based on oral hard and soft tissue exams
Time frame: Up to Day 14
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.
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 temporarily associated with the clinical investigation, whether or not the event has a causal relationship to the participant's participation in the trial.
3 secondary outcomes
Mouthwash Habits Baseline Questionnaire
Time frame: Visit 1 (Day 0)
Product Perception Claims Questionnaire
Time frame: Visit 3 (Day 14 ± 1 day)
Comparison of the salivary microbial counts
Time frame: Visit 1 (Day 0); Visit 3 (Day 14 ± 1 day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prototype 1, Prototype 2 and Marketed Comparator in people with Oral Health, run by Kenvue Brands LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline in oral tolerance based on oral hard and soft tissue exams (time frame: Up to Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.