HealthyNCT06798441
Determination of the Oral Irritation Potential of a Fluoride Rinse in Children
A study testing Brush Only, Brush / Rinse (Jolly Rancher Prototype) and Brush / Rinse (LISTERINE® Total Care Zero Alcohol) in people with Healthy, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in United States.
Trial summary
The primary objective of this clinical trial is to determine the oral hard and soft tissue tolerance of an investigational essential oil, non-alcohol, fluoride containing mouth rinse in children 6-11 years of age compared to brushing alone and a marketed comparator mouth rinse when used as directed over a four-week… Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Brush Only, Brush / Rinse (Jolly Rancher Prototype) and Brush / Rinse (LISTERINE® Total Care Zero Alcohol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2025to 20 Feb 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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children, 6-11 years of age (inclusive) at the time of screening/baseline (minimum 15% Black and 5% Asian race; minimum 10% Hispanic ethnicity)
- Minimum of 16 natural teeth
- Generally, in good health
- In good oral health with adequate oral hygiene
- Willingness to participate in the clinical trial after the nature of the clinical trial has been fully explained to the child and their assent obtained
- Willingness to use the assigned products according to instructions, availability for appointments, and likelihood of completing the clinical trial
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- Individual (and/or their legally acceptable representative, as applicable) has signed the Consent for Photograph Release and ICD (and/or Assent Document, as applicable) including Health Insurance Portability and Accountability Act (HIPAA) disclosure
- Absence of significant oral soft tissue pathology and active dental caries, based on the dentist's visual examination and at the discretion of the Investigator
- Able to read and understand the local language and provide written informed assent and parent/guardian to provide a signed and dated informed consent form prior to any study- related procedures
Who cannot join
- History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses, and red food dye
- Use of antibiotics, or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator
- Dental prophylaxis within four weeks prior to Screening/Baseline visit
- Subjects who were previously screened and ineligible or were randomized to receive investigational product
- Significant, unstable or uncontrolled medical condition which may interfere with a subject's participation in the study, at the discretion of the Investigator
- Subjects who are related to those persons involved directly or indirectly with the conduct of this study
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- Self-reported smokeless tobacco user including snuff, chewing tobacco, vaping and e- cigarette usage
- Subjects who wear orthodontic bands, fixed retainers, removable orthodontic appliances, clear aligners or night guards or subjects who have had significant cosmetic restorations
- Hasself-reported Type 1 or Type 2 diabetes oris 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
- Is self-reported to be pregnant or planning to become pregnant during the study
- Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
- Participation in any clinical trial within 30 days of the Screening/Baseline visit
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this clinical trial is to determine the oral hard and soft tissue tolerance of an investigational essential oil, non-alcohol, fluoride containing mouth rinse in children 6-11 years of age compared to brushing alone and a marketed comparator mouth rinse when used as directed over a four-week period.
- Conditions
- Healthy
- Being tested
- Brush Only, Brush / Rinse (Jolly Rancher Prototype), Brush / Rinse (LISTERINE® Total Care Zero Alcohol)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brush OnlyOther
Subjects will brush twice daily for one timed minute with the toothpaste and toothbrush provided. Subjects will record their twice daily product usage on a subject diary.
Brush / Rinse (Jolly Rancher Prototype)Other
Subjects will brush twice daily for one timed minute with the toothpaste and toothbrush provided. After brushing for 1 timed minute, subjects will vigorously swish with 10mL (2 teaspoons) of rinse between their teeth for 1 minute and then spit out. Subjects will record their twice daily product usage on a subject diary.
Brush / Rinse (LISTERINE® Total Care Zero Alcohol)Other
Subjects will brush twice daily for one timed minute with the toothpaste and toothbrush provided. After brushing for 1 timed minute, subjects will vigorously swish with 10mL (2 teaspoons) of rinse between their teeth for 1 minute and then spit out. Subjects will record their twice daily product usage on a subject diary.
| Study group | Role | What they receive |
|---|---|---|
| Brush Only | Active comparator | All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Kids Maximum Cavity Protection Pump Toothpaste) and a soft flat trimmed bristled toothbrush at their Screening/Baseline visit to use throughout the study. Receives: Other: Brush Only |
| Brush / Rinse (Jolly Rancher Prototype) | Experimental | All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Kids Maximum Cavity Protection Pump Toothpaste) and a soft flat trimmed bristled toothbrush at their Screening/Baseline visit to use throughout the study. The subjects in this arm will receive also the assigned mouthwash (Jolly Rancher Prototype). Receives: Other: Brush / Rinse (Jolly Rancher Prototype) |
| Brush / Rinse (LISTERINE® Total Care Zero Alcohol) | Experimental | All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Kids Maximum Cavity Protection Pump Toothpaste) and a soft flat trimmed bristled toothbrush at their Screening/Baseline visit to use throughout the study. The subjects in this arm will receive also the assigned mouthwash (LISTERINE® Total Care Zero Alcohol). Receives: Other: Brush / Rinse (LISTERINE® Total Care Zero Alcohol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Tolerance as Assessed by Clinical Examinations of Oral Hard and Soft Tissues
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 28 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 tissues tolerance to the treatments.
Measured: Up to Day 28
Secondary outcomes (2)
Parent perception questionnaire
Parent perception questionnaire will be summarized at Day 0 and Day 28 by investigational product, descriptively. No statistical comparisons will be performed.
Measured: Visit 1 (Day 0) and Visit 3 (Day 28)
Children self-perception questionnaire
Children self-perception questionnaire will be summarized at Day 0 and Day 28 by investigational product, descriptively. No statistical comparisons will be performed.
Measured: Visit 1 (Day 0) and Visit 3 (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start20 Jan 2025
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798441
- Sponsor's protocol ID
- CS2024OC100194
- Status last verified
- Mar 2025
- First submitted
- 14 Jan 2025
- Last updated
- 12 Mar 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Oral Irritation Potential of a Fluoride Rinse in Children
- ClinicalTrials.gov ID
- NCT06798441
- Acronym / sponsor ID
- CS2024OC100194
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 29 Jan 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 primary objective of this clinical trial is to determine the oral hard and soft tissue tolerance of an investigational essential oil, non-alcohol, fluoride containing mouth rinse in children 6-11 years of age compared to brushing alone and a marketed comparator mouth rinse when used as directed over a four-week period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brush Only | Active comparator | Other: Brush OnlyAll subjects will receive a marketed fluoride-containing dentifrice (Colgate® Kids Maximum Cavity Protection Pump Toothpaste) and a soft flat trimmed bristled toothbrush at their Screening/Baseline visit to use throughout the study. |
| Brush / Rinse (Jolly Rancher Prototype) | Experimental | Other: Brush / Rinse (Jolly Rancher Prototype)All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Kids Maximum Cavity Protection Pump Toothpaste) and a soft flat trimmed bristled toothbrush at their Screening/Baseline visit to use throughout the study. The subjects in this arm will receive also the assigned mouthwash (Jolly Rancher Prototype). |
| Brush / Rinse (LISTERINE® Total Care Zero Alcohol) | Experimental | Other: Brush / Rinse (LISTERINE® Total Care Zero Alcohol)All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Kids Maximum Cavity Protection Pump Toothpaste) and a soft flat trimmed bristled toothbrush at their Screening/Baseline visit to use throughout the study. The subjects in this arm will receive also the assigned mouthwash (LISTERINE® Total Care Zero Alcohol). |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children, 6-11 years of age (inclusive) at the time of screening/baseline (minimum 15% Black and 5% Asian race; minimum 10% Hispanic ethnicity)
- Minimum of 16 natural teeth
- Generally, in good health
- In good oral health with adequate oral hygiene
- Willingness to participate in the clinical trial after the nature of the clinical trial has been fully explained to the child and their assent obtained
Key exclusion criteria (16 listed)
- History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses, and red food dye
- Use of antibiotics, or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator
- Dental prophylaxis within four weeks prior to Screening/Baseline visit
- Subjects who were previously screened and ineligible or were randomized to receive investigational product
- Significant, unstable or uncontrolled medical condition which may interfere with a subject's participation in the study, at the discretion of the Investigator
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 |
|---|---|---|
| Brush OnlySubjects will brush twice daily for one timed minute with the toothpaste and toothbrush provided. Subjects will record their twice daily product usage on a subject diary. | Other | Brush Only |
| Brush / Rinse (Jolly Rancher Prototype)Subjects will brush twice daily for one timed minute with the toothpaste and toothbrush provided. After brushing for 1 timed minute, subjects will vigorously swish with 10mL (2 teaspoons) of rinse between their teeth for 1 minute and then spit out. Subjects will record their twice daily product usage on a subject diary. | Other | Brush / Rinse (Jolly Rancher Prototype) |
| Brush / Rinse (LISTERINE® Total Care Zero Alcohol)Subjects will brush twice daily for one timed minute with the toothpaste and toothbrush provided. After brushing for 1 timed minute, subjects will vigorously swish with 10mL (2 teaspoons) of rinse between their teeth for 1 minute and then spit out. Subjects will record their twice daily product usage on a subject diary. | Other | Brush / Rinse (LISTERINE® Total Care Zero Alcohol) |
Primary outcome
Oral Tolerance as Assessed by Clinical Examinations of Oral Hard and Soft Tissues
Time frame: Up to Day 28
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 28 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 tissues tolerance to the treatments.
2 secondary outcomes
Parent perception questionnaire
Time frame: Visit 1 (Day 0) and Visit 3 (Day 28)
Children self-perception questionnaire
Time frame: Visit 1 (Day 0) and Visit 3 (Day 28)
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 12 Mar 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 Brush Only, Brush / Rinse (Jolly Rancher Prototype) and Brush / Rinse (LISTERINE® Total Care Zero Alcohol) in people with Healthy, run by Johnson & Johnson Consumer and Personal Products Worldwide 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 9 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 12 Mar 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?
Oral Tolerance as Assessed by Clinical Examinations of Oral Hard and Soft Tissues (time frame: Up to Day 28). 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 12 Mar 2025.