NCT04794439

Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Church & Dwight Company, Inc. · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate and compare plaque removal efficacy of four dentifrices following a single timed tooth brushing. Prior to each evaluation visit of the four-way cross-over study, subjects will abstain from all oral hygiene for 24 hours. At each evaluation visit, subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.

Detailed description

This study is a randomized, single-brushing, examiner-blinded, 4-cell cross-over design that enrolled approximately 70 subjects to ensure that at least 60 subjects to complete the study. This 4-week cross-over study will evaluate plaque removal following a single brushing with the assigned dentifrices. Qualified subjects will have sufficient plaque (Lobene-Soparkar Modification of Turesky Plaque Index). Subjects will be given a pre-brushing plaque evaluation, followed by a 1-minute supervised brushing and a post-brushing plaque evaluation.

Conditions

• Plaque, Dental

Interventions

Type	Name	Description
DRUG	Dentifrices	Dentifrice on plaque

Timeline

• Start date: 2020-11-16
• Primary completion: 2020-12-18
• Completion: 2020-12-18
• First posted: 2021-03-12
• Last updated: 2021-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study