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CompletedNCT04794439Updated Mar 12, 2021

Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing

A Phase 2 interventional study of Dentifrices in Plaque, Dental, sponsored by Church & Dwight Company, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-12.

Sponsored by Church & Dwight Company, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2020, 5 years 9 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 69 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Plaque, Dental

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03

In context

Dental Plaque

314 studies on the registry are indexed under Dental Plaque; 54 are open to participants now.

This study's enrollment of 70 is above the median of 59 across 279 interventional studies indexed under Dental Plaque.

Browse Dental Plaque studies →

Lead sponsor

Church & Dwight Company, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 18 to 69 years

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    Toothpaste 1 with Stannous Fluoride

    Toothpaste with Stannous Fluoride

    Drug: Dentifrices

  • Active comparator
    Toothpaste 1 with Sodium Fluoride and sodium bicarbonate

    Toothpaste with Sodium Fluoride and sodium bicarbonate

    Drug: Dentifrices

  • Active comparator
    Toothpaste 2 with Stannous Fluoride

    Toothpaste with Stannous Fluoride

    Drug: Dentifrices

  • Active comparator
    Toothpaste 2 with sodium Fluoride and sodium bicarbonate

    Toothpaste with sodium Fluoride and sodium bicarbonate

    Drug: Dentifrices

Interventions

  • DrugDentifrices

    Dentifrice on plaque

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 4 weeks

07

Study locations

1 site
  • Salus Research, Inc.
    Fort Wayne, Indiana 46825, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04794439
Lead sponsor
Church & Dwight Company, Inc.
Responsible party
Sponsor
First posted
Mar 12, 2021
Start date
Nov 16, 2020
Primary completion
Dec 18, 2020
Completion
Dec 18, 2020
Last update
Mar 12, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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