NCT04921371

Six Week Study of Experimental Mouth Rinses: Effect on Gingivitis and Plaque

Six Week Safety and Clinical Efficacy of Experimental Mouth Rinses: Effect on Gingivitis and Plaque

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 157 (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 experimental mouth rinse formulations compared to a positive control mouth rinse and a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a six-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	Listerine® Cool Mint®	Participants will use 20 mL of Listerine® Cool Mint® mouth rinse for 30 seconds after brushing twice daily.
OTHER	Concept Curve Winter Series Toothbrush	Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.
OTHER	5% Hydroalcohol Mouthrinse	Participants will use 20 mL of 5% Hydroalcohol Mouthrinse for 30 seconds after brushing twice daily.
OTHER	Mouthrinse Prototype 1	Participants will use 20 mL of Mouthrinse Prototype 1 for 30 seconds after brushing twice daily.
OTHER	Mouthrinse Prototype 2	Participants will use 20 mL of Mouthrinse Prototype 2 for 30 seconds after brushing twice daily.

Timeline

• Start date: 2019-10-08
• Primary completion: 2019-12-19
• Completion: 2019-12-19
• First posted: 2021-06-10
• Last updated: 2023-09-28

Locations

1 site across 1 country: United States