Determination of the Oral Irritation Potential of a Fluoride Rinse in Children

NCT ID: NCT06798441

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2025-02-20

Brief 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 period.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Brush Only

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.

Group Type: ACTIVE_COMPARATOR

Brush Only

Intervention Type: OTHER

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)

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).

Group Type: EXPERIMENTAL

Brush / Rinse (Jolly Rancher Prototype)

Intervention Type: 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)

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).

Group Type: EXPERIMENTAL

Brush / Rinse (LISTERINE® Total Care Zero Alcohol)

Intervention Type: 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.

Interventions

Brush Only

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Salus Research, Inc.

Fort Wayne, Indiana, United States

Countries

United States

Other Identifiers

CS2024OC100194

Identifier Type: -

Identifier Source: org_study_id