CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 274 enrolled
Drug / intervention
Colgate (R) 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/NCT05121909
NCT05121909Phase 4Completed

Twelve Week Safety/Clinical/Microbiological Efficacy of Experimental Mouthwashes

Johnson & Johnson Consumer Inc. (J&JCI)·interventional·Posted Nov 16, 2021·Updated Nov 13, 2023

In Brief

A Phase 4 clinical trial evaluating Colgate (R) Cavity Protection Toothpaste, Colgate (R) Cello Toothbrush, and 5 other interventions for Gingivitis and Plaque. Completed, enrolled 274 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedNov 16, 2021
Enrollment StartNov 15, 2021
Primary CompletionApr 14, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.6 years ago

Interventions

Colgate (R) Cavity Protection Toothpasteother

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

Colgate (R) Cello Toothbrushdevice

Participants will use Colgate (R) Cello Toothbrush for brushing teeth twice daily.

Prototype 1 Mouthwashother

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

Prototype 2 Mouthwashother

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

Prototype 3 Mouthwashother

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

Listerine (R) Cool Mint (R) Antiseptic Mouthwashother

Participants will use 20 mL of Listerine (R) Cool Mint (R) Antiseptic Mouthwash for 30 seconds after brushing twice daily.

5% Hydroalcohol Mouthwashother

Participants will use 20 mL of 5% Hydroalcohol Mouthwash for 30 seconds after brushing twice daily.