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

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID: NCT06798441
Run by: Johnson & Johnson Consumer and Personal Products Worldwide
People needed: 161
Starts: 2025-01-20
Expected to finish: 2025-02-20
Last updated by the study team: 2025-03-12

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Salus Research, Inc. — Fort Wayne, Indiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.