Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing

Phase 2

Completed

• Conditions: Plaque, Dental
• Interventions: Drug: Dentifrices

• Registration Number: NCT04794439
• Lead Sponsor: Church & Dwight Company, Inc.

Brief 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.

Study Timeline

• Study Start: 2020-11-16
• Primary Completion: 2020-12-18
• Study Completion: 2020-12-18
• Study First Submitted: 2021-02-14
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-10
• Last Update Submitted: 2021-03-10
• Study First Posted: 2021-03-12
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Toothpaste 1 with Sodium Fluoride and sodium bicarbonate	Dentifrices	Toothpaste with Sodium Fluoride and sodium bicarbonate
Toothpaste 1 with Stannous Fluoride	Dentifrices	Toothpaste with Stannous Fluoride
Toothpaste 2 with Stannous Fluoride	Dentifrices	Toothpaste with Stannous Fluoride
Toothpaste 2 with sodium Fluoride and sodium bicarbonate	Dentifrices	Toothpaste with sodium Fluoride and sodium bicarbonate

Primary Outcome Measures

Name	Time	Method
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.	up to 4 weeks	plaque evaluation

Trial Locations

Locations (1)

Salus Research, Inc.; 🇺🇸 Fort Wayne, Indiana, United States