A Twelve Week Study of Experimental Mouth Rinses
NCT05120141 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2023-06-29
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
- 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.
Sponsors & Collaborators
-
Johnson & Johnson Consumer Inc. (J&JCI)
lead INDUSTRY
Principal Investigators
-
Chhaju Ram Goyal, DDS · All Sum Research Center Ltd.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-03-29
- Primary Completion
- 2021-07-23
- Completion
- 2021-07-23
Countries
- Canada
Study Locations
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