NCT05120141

A Twelve Week Study of Experimental Mouth Rinses

Twelve Week Safety and Clinical Efficacy of Experimental Mouth Rinses

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of experimental mouth rinse formulations compared to a hydroalcohol control mouth rinse and a positive control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a twelve-week product usage period.

Conditions

• Gingivitis
• Plaque

Interventions

Type	Name	Description
OTHER	Colgate Cavity Protection Toothpaste	Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.
OTHER	American Dental Association (ADA) Ref Toothbrush	Participants will use soft bristled Toothbrush for brushing teeth twice daily.
OTHER	Prototype 1 Mouth Rinse	Participants will use 20 mL of Prototype 1 Mouth Rinse for 30 seconds after brushing twice daily.
OTHER	Prototype 2 Mouth Rinse	Participants will use 20 mL of Prototype 2 Mouth Rinse for 30 seconds after brushing twice daily.
OTHER	Prototype 3 Mouth Rinse	Participants will use 20 mL of Prototype 3 Mouth Rinse for 30 seconds after brushing twice daily.
OTHER	Listerine Cool Mint Mouth Rinse	Participants will use 20 mL of Listerine Cool Mint Mouth Rinse for 30 seconds after brushing twice daily.
OTHER	Hydroalcohol Mouth Rinse	Participants will use 20 mL of Hydroalcohol Mouth Rinse for 30 seconds after brushing twice daily.

Timeline

• Start date: 2021-03-29
• Primary completion: 2021-07-23
• Completion: 2021-07-23
• First posted: 2021-11-15
• Last updated: 2023-06-29

Locations

1 site across 1 country: Canada