Clinical trial NCT06798441: Determination of the Oral Irritation Potential of a Fluoride Rinse in Children
Official title: Determination of the Oral Irritation Potential of a Fluoride Rinse in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 161
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Oral Tolerance as Assessed by Clinical Examinations of Oral Hard and Soft Tissues
timeFrame: Up to Day 28
Secondary outcomes:
measure: Parent perception questionnaire
timeFrame: Visit 1 (Day 0) and Visit 3 (Day 28)
measure: Children self-perception questionnaire
timeFrame: Visit 1 (Day 0) and Visit 3 (Day 28)
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research, Inc.
state: Indiana
Study officials:
References: