Fluoride Rinse for Oral Health

Overseen By Kenvue Global Clinical Operations

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Must not be taking: Antibiotics, Anticoagulants, Immunosuppressives, others

Disqualifiers: Diabetes, Pregnancy, Tobacco use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

161 Participants Needed

Trial Summary

What is the purpose of this trial?

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

This trial is for healthy children aged 6-11 with good oral hygiene, at least 16 natural teeth, and no significant dental issues. They must understand the study and agree to participate along with parental consent. The study aims for diversity including a minimum percentage of Black, Asian, and Hispanic participants.

Inclusion Criteria

I am a child aged 6-11, possibly Black, Asian, or Hispanic.

Generally, in good health

I have at least 16 natural teeth.

Exclusion Criteria

I have had a dental check-up in the last 4 weeks.

Subjects who were previously screened and ineligible or were randomized to receive investigational product

Subjects who are related to those persons involved directly or indirectly with the conduct of this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants use the assigned mouth rinse or brushing regimen for oral tissue tolerance assessment over a four-week period

4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fluoride Rinse

Trial Overview The trial tests the safety of an experimental fluoride mouth rinse compared to brushing alone and a commercial mouthwash (LISTERINE® Total Care Zero Alcohol). Over four weeks, kids will follow assigned oral care routines to assess tissue tolerance in their mouths.

Participant Groups

Group I: Brush / Rinse (LISTERINE® Total Care Zero Alcohol) Experimental Treatment 1 Intervention

All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Kids Maximum Cavity Protection Pump Toothpaste) and a soft flat trimmed bristled toothbrush at their Screening/Baseline visit to use throughout the study. The subjects in this arm will receive also the assigned mouthwash (LISTERINE® Total Care Zero Alcohol).

Group II: Brush / Rinse (Jolly Rancher Prototype) Experimental Treatment 1 Intervention

All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Kids Maximum Cavity Protection Pump Toothpaste) and a soft flat trimmed bristled toothbrush at their Screening/Baseline visit to use throughout the study. The subjects in this arm will receive also the assigned mouthwash (Jolly Rancher Prototype).

Group III: Brush Only Active Control 1 Intervention

All subjects will receive a marketed fluoride-containing dentifrice (Colgate® Kids Maximum Cavity Protection Pump Toothpaste) and a soft flat trimmed bristled toothbrush at their Screening/Baseline visit to use throughout the study.

Who Is Running the Clinical Trial?

Johnson & Johnson Consumer and Personal Products Worldwide

Lead Sponsor

Trials

64

Recruited

14,800+

Thibaut Mongon

Johnson & Johnson Consumer and Personal Products Worldwide

Chief Executive Officer since 2023

MBA from INSEAD, Bachelor's in Business Administration from KEDGE Bordeaux Business School

Dr. Mathai Mammen

Johnson & Johnson Consumer and Personal Products Worldwide

Chief Medical Officer since 2021

MD from Harvard Medical School