CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 149 enrolled
Drug / intervention
Colgate Cavity Protection Toothpaste +4 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/NCT04696536
NCT04696536Phase 4Completed

Pilot Study: Twelve Week Clinical Efficacy of Supervised Mouth Rinse and Flossing: Effect on Plaque and Gingivitis

Johnson & Johnson Consumer Inc. (J&JCI)·interventional·Posted Jan 6, 2021·Updated Sep 28, 2021

In Brief

A Phase 4 clinical trial evaluating Colgate Cavity Protection Toothpaste, American Dental Association (ADA) Referenced Toothbrush, and 3 other interventions for Healthy. Completed, enrolled 149 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the efficacy of twice daily alcohol containing essential oil mouth rinse and brushing versus dental flossing and brushing under once daily supervision for the prevention and reduction of plaque and gingivitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJan 6, 2021
Enrollment StartSep 26, 2018
Primary CompletionDec 21, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.5 years ago

Interventions

Colgate Cavity Protection Toothpasteother

Participants will use Colgate cavity protection toothpaste for brushing teeth twice daily.

American Dental Association (ADA) Referenced Toothbrushother

Participants will brush teeth at least one minute with provided toothbrush twice daily.

5% Hydroalcohol Mouth Rinseother

Participants use 20 mL of 5% Hydroalcohol mouth rinse as negative control for 30 sec twice a day after brushing.

REACH Dental Flossother

Participants after brushing, rinse mouth with water and floss using Reach dental floss once a day.

Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed)other

Participants after brushing, rinse with 20mL of the AEO mouth rinse for 30 seconds twice a day.