Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04794439

Enrollment

Registered

2021-03-12

Start date

2020-11-16

Completion date

2020-12-18

Last updated

2021-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque, Dental

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.

Interventions

DRUGDentifrices

Dentifrice on plaque

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026