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

NCT06798441 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2025-03-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2025-02-20
Completion
2025-02-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06798441 on ClinicalTrials.gov