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

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT06798441
• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-14
• Study Start: 2025-01-20
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-29
• Primary Completion: 2025-02-20
• Study Completion: 2025-02-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oral Tolerance as Assessed by Clinical Examinations of Oral Hard and Soft Tissues	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.

Secondary Outcome Measures

Name	Time	Method
Parent perception questionnaire	Visit 1 (Day 0) and Visit 3 (Day 28)	Parent perception questionnaire will be summarized at Day 0 and Day 28 by investigational product, descriptively. No statistical comparisons will be performed.
Children self-perception questionnaire	Visit 1 (Day 0) and Visit 3 (Day 28)	Children self-perception questionnaire will be summarized at Day 0 and Day 28 by investigational product, descriptively. No statistical comparisons will be performed.

Trial Locations

Locations (1)

Salus Research, Inc.; 🇺🇸 Fort Wayne, Indiana, United States