Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing

Plaque, Dental Clinical Trial

Official title:

Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04794439
• Other study ID #: ST-20-U81
• Status: Completed
• Phase: Phase 2
• Start date: November 16, 2020
• Est. completion date: December 18, 2020

Study information

• Verified date: March 2021
• Source: Church & Dwight Company, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 18, 2020
• Est. primary completion date: December 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

1) 18 to 69 years

Exclusion Criteria:

1. Have any known allergies or sensitivities to marketed dentifrice or oral hygiene products.

2. Have fixed or removable orthodontic appliances, peri/oral piercings, or removable partial dentures.

3. Evidence of poor oral hygiene, rampant dental caries, presence of extrinsic stain or calculus deposits that may interfere with plaque assessments.

Related Conditions & MeSH terms

• Dental Plaque
• Plaque, Dental

Intervention

Drug:
• Dentifrices
Dentifrice on plaque

Locations

Country	Name	City	State
United States	Salus Research, Inc.	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Church & Dwight Company, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all surfaces of the whole mouth measured.	plaque evaluation	up to 4 weeks