Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing

Study Overview
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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.

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.

Official Title
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Plaque Removal Efficacy of Four Dentifrices Following a Single Brushing

Conditions
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Plaque, Dental

Intervention / Treatment
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* Drug: Dentifrices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) 18 to 69 years Exclusion Criteria: Have any known allergies or sensitivities to marketed dentifrice or oral hygiene products. Have fixed or removable orthodontic appliances, peri/oral piercings, or removable partial dentures. Evidence of poor oral hygiene, rampant dental caries, presence of extrinsic stain or calculus deposits that may interfere with plaque assessments.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Toothpaste 1 with Stannous Fluoride<br>Toothpaste with Stannous Fluoride | Drug: Dentifrices<br>* Dentifrice on plaque<br>|
| Active Comparator: Toothpaste 1 with Sodium Fluoride and sodium bicarbonate<br>Toothpaste with Sodium Fluoride and sodium bicarbonate | Drug: Dentifrices<br>* Dentifrice on plaque<br>|
| Active Comparator: Toothpaste 2 with Stannous Fluoride<br>Toothpaste with Stannous Fluoride | Drug: Dentifrices<br>* Dentifrice on plaque<br>|
| Active Comparator: Toothpaste 2 with sodium Fluoride and sodium bicarbonate<br>Toothpaste with sodium Fluoride and sodium bicarbonate | Drug: Dentifrices<br>* Dentifrice on plaque<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |