NCT05526586

A Twelve Week Study of Prototypes Mouth Rinses

Twelve Week Safety, Clinical, and Microbiological Efficacy of Experimental Zinc Containing Mouth Rinses

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of two essential oil containing experimental mouth rinse formulations and an essential oil containing mouth rinse compared to a hydroalcohol 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

• Healthy

Interventions

Type	Name	Description
OTHER	Colgate Cavity Protection Toothpaste	Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.
OTHER	Zero Alcohol Gum Prototype	Participants will use 20 mL of Zero Alcohol Gum Prototype Mouth Rinse for 30 seconds after brushing twice daily.
OTHER	Alcohol Gum Prototype	Participants will use 20 mL of Alcohol Gum Prototype Mouth Rinse for 30 seconds after brushing twice daily.
OTHER	Listerine Cool Mint Antiseptic Mouthwash	Participants will use 20 mL of Listerine Cool Mint Mouth Rinse for 30 seconds after brushing twice daily.
OTHER	5% Hydroalcohol	Participants will use 20 mL of 5% Hydroalcohol Mouth Rinse for 30 seconds after brushing twice daily.

Timeline

• Start date: 2022-08-31
• Primary completion: 2022-12-08
• Completion: 2022-12-08
• First posted: 2022-09-02
• Last updated: 2023-09-05

Locations

1 site across 1 country: United States