Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2020-12-18

Brief Summary

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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.

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Detailed Description

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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

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Plaque, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Toothpaste 1 with Stannous Fluoride

Toothpaste with Stannous Fluoride

Group Type ACTIVE_COMPARATOR

Dentifrices

Intervention Type DRUG

Dentifrice on plaque

Toothpaste 1 with Sodium Fluoride and sodium bicarbonate

Toothpaste with Sodium Fluoride and sodium bicarbonate

Group Type ACTIVE_COMPARATOR

Dentifrices

Intervention Type DRUG

Dentifrice on plaque

Toothpaste 2 with Stannous Fluoride

Toothpaste with Stannous Fluoride

Group Type ACTIVE_COMPARATOR

Dentifrices

Intervention Type DRUG

Dentifrice on plaque

Toothpaste 2 with sodium Fluoride and sodium bicarbonate

Toothpaste with sodium Fluoride and sodium bicarbonate

Group Type ACTIVE_COMPARATOR

Dentifrices

Intervention Type DRUG

Dentifrice on plaque

Interventions

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Dentifrices

Dentifrice on plaque

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes