CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 300 enrolled
Drug / intervention
Colgate Cavity Protection Toothpaste +6 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05120141
NCT05120141Phase 4Completed

Twelve Week Safety and Clinical Efficacy of Experimental Mouth Rinses

Johnson & Johnson Consumer Inc. (J&JCI)·interventional·Posted Nov 15, 2021·Updated Jun 29, 2023

In Brief

A Phase 4 clinical trial evaluating Colgate Cavity Protection Toothpaste, American Dental Association (ADA) Ref Toothbrush, and 5 other interventions for Gingivitis and Plaque. Completed, enrolled 300 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGingivitis, Plaque
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedNov 15, 2021
Enrollment StartMar 29, 2021
Primary CompletionJul 23, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.6 years ago

Interventions

Colgate Cavity Protection Toothpasteother

Participants will use Colgate Cavity Protection Toothpaste for brushing teeth twice daily.

American Dental Association (ADA) Ref Toothbrushother

Participants will use soft bristled Toothbrush for brushing teeth twice daily.

Prototype 1 Mouth Rinseother

Participants will use 20 mL of Prototype 1 Mouth Rinse for 30 seconds after brushing twice daily.

Prototype 2 Mouth Rinseother

Participants will use 20 mL of Prototype 2 Mouth Rinse for 30 seconds after brushing twice daily.

Prototype 3 Mouth Rinseother

Participants will use 20 mL of Prototype 3 Mouth Rinse for 30 seconds after brushing twice daily.

Listerine Cool Mint Mouth Rinseother

Participants will use 20 mL of Listerine Cool Mint Mouth Rinse for 30 seconds after brushing twice daily.

Hydroalcohol Mouth Rinseother

Participants will use 20 mL of Hydroalcohol Mouth Rinse for 30 seconds after brushing twice daily.