NCT06798441

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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.
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.
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.

Timeline

• Start date: 2025-01-20
• Primary completion: 2025-02-20
• Completion: 2025-02-20
• First posted: 2025-01-29
• Last updated: 2025-03-12

Locations

1 site across 1 country: United States