NCT05121909

A Study of Experimental Mouthwashes

Twelve Week Safety/Clinical/Microbiological Efficacy of Experimental Mouthwashes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of experimental mouthwash formulations compared to a hydroalcohol control mouthwash and a positive control mouthwash 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 (R) Cavity Protection Toothpaste	Participants will use Colgate (R) Cavity Protection Toothpaste for brushing teeth twice daily.
DEVICE	Colgate (R) Cello Toothbrush	Participants will use Colgate (R) Cello Toothbrush for brushing teeth twice daily.
OTHER	Prototype 1 Mouthwash	Participants will use 20 mL of Prototype 1 Mouthwash for 30 seconds after brushing twice daily.
OTHER	Prototype 2 Mouthwash	Participants will use 20 mL of Prototype 2 Mouthwash for 30 seconds after brushing twice daily.
OTHER	Prototype 3 Mouthwash	Participants will use 20 mL of Prototype 3 Mouthwash for 30 seconds after brushing twice daily.
OTHER	Listerine (R) Cool Mint (R) Antiseptic Mouthwash	Participants will use 20 mL of Listerine (R) Cool Mint (R) Antiseptic Mouthwash for 30 seconds after brushing twice daily.
OTHER	5% Hydroalcohol Mouthwash	Participants will use 20 mL of 5% Hydroalcohol Mouthwash for 30 seconds after brushing twice daily.

Timeline

• Start date: 2021-11-15
• Primary completion: 2022-04-14
• Completion: 2022-04-14
• First posted: 2021-11-16
• Last updated: 2023-11-13

Locations

1 site across 1 country: Canada