CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 179 enrolled
Drug / intervention
Triclosan/fluoride toothpaste +4 moredrug
Likely dose
fluoride only toothpaste 20 mlfrom 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/NCT02366689
NCT02366689Phase 4Completed

Clinical Efficacy in Reducing Established Dental Plaque and Gingivitis of a Toothpaste Containing 0.3% Triclosan, 2% Copolymer / Sodium Fluoride and a Manual Toothbrush as Compared to an Oral Hygiene Multi-component Regimen Encompassing the Use of a Manual Toothbrush, a Toothpaste Containing Stannous Fluoride / Sodium Hexametaphosphate and a Mouthwash Containing 0.07% Cetylpyridinium Chloride

Colgate Palmolive·interventional·Posted Feb 19, 2015·Updated Mar 30, 2016

In Brief

A Phase 4 clinical trial evaluating Triclosan/fluoride toothpaste, stannous fluoride toothpaste, and 3 other interventions for Dental Plaque and Gingivitis. Completed, enrolled 179 participants across 1 site.

Detailed Summary

The objective of this clinical research study is to assess the efficacy of a commercially available triclosan/copolymer toothpaste compared to a commercially available oral hygiene multi-component regimen encompassing the use of a manual toothbrush, a toothpaste containing stannous fluoride / sodium hexametaphosphate and a mouthwash containing cetylpyridinium chloride relative to a negative control regimen in reducing established dental plaque and gingivitis over three and six months of assigned product use.

Study Details

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

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 19, 2015
Enrollment StartJun 1, 2014
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.4 years ago

Interventions

Triclosan/fluoride toothpastedrug

Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).

stannous fluoride toothpastedrug

Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).

fluoride only toothpastedrug

Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.

Cetylpyridinium chloride mouthwashdrug

Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.

Fluoride only mouthwashdrug

Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.