Efficacy of Plaque Removal of a Novel Brushing Device

Study Overview
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Brief Summary
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The purpose of this research study is to compare how a novel, automated mouthpiece-based toothbrushing device removes dental plaque compared to a manual toothbrush.

Detailed Description
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Plaque is one of the main etiological factors in dental decay and the principal etiological factor for periodontal diseases. Although toothbrushes have greatly evolved, dexterity is still the key component to an efficient cleaning routine. The primary goal is to examine 60 participants to determine the efficacy of a new powered teeth cleaning device designed to bypass the variability of individual dexterity compared with manual toothbrushing. This is a single-blind, randomized controlled trial. Sixty pediatric patients will be recruited for the study and randomized into treatment and control groups, subdivided into primary (20), mixed (20), and permanent dentition (20). Participants will be asked to abstain from brushing, flossing, gum or mouthwash use for 24 hours prior to the study visit. Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index before and after a one-time brushing with the assigned study device. A soft tissue assessment will be conducted and intraoral photos taken pre- and post-brushing.

Official Title
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Efficacy of Plaque Removal of a Novel Brushing Device Compared to a Manual Toothbrush

Conditions
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Dental Plaque

Intervention / Treatment
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* Device: Automated mouthpiece-based toothbrush
* Device: Manual toothbrush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 5-17 In good general health Fluent in English Parent or guardian willing and able to provide written informed consent Have 16 scorable teeth (non-crown/bridge/or full amalgams) Have had a dental cleaning and exam in the past 24 months Exclusion Criteria: Advanced periodontal disease or severe gum disease Mouth or teeth pain that prevents brushing in any areas Intraoral piercings (tongue or lip) that cannot be removed Non-controlled diabetes Any autoimmune or infectious disease or any medical condition that would delay wound healing Untreated visible cavities or untreated dental work Oral or gum surgery in the previous 2 months Take antibiotic premedication for dental procedures Undergoing or require extensive dental or orthodontic treatment Current smoker Generalized recession over 1mm

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 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: Parallel Assignment
Interventional Model Description: Single-blind, parallel group, randomized controlled clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automated mouthpiece-based toothbrush<br>Under observation of study staff, participants assigned to the automated mouthpiece-based toothbrush will insert a properly fitted mouthpiece and use the automated device directly over the sink. | Device: Automated mouthpiece-based toothbrush<br>* One-time use during study visit.<br>* Other names: Novel toothbrushing device;|
| Active Comparator: Manual toothbrush<br>Under observation of study staff, participants assigned to the manual toothbrush will be timed brushing their teeth directly over the sink using a pre-dispensed quantity of toothpaste on bristles dampened with water. | Device: Manual toothbrush<br>* One-time use during study visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Dental Plaque Removal Efficacy Using Turesky Modification of the Quigley-Hein Plaque Index | Average Change from baseline plaque index after brushing with the automated mouthpiece-based brushing device versus a manual toothbrush. The Turesky Modification of the Quigley-Hein Plaque Index evaluates 6 areas per tooth and gives a score from 0-5 with 0 being no plaque and 5 being the highest amount of plaque and the average score for all sites was used for analysis. | baseline,1 minute after brushing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Presence of Soft Tissue Abrasion After Use of Automated Mouthpiece-based Brushing Versus Manual Toothbrush | Number of participants with soft tissue abrasion after brushing with the automated mouthpiece-based.brushing device versus a manual toothbrush. An intraoral soft tissue examination will be done before and after brushing and a binary scale will be used to note any areas of abrasion (yes or no). Outcome is the presence of any soft tissue abrasion that was not present prior to brushing. | baseline, 1 minute after brushing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingivitis, toothbrushing, oral hygiene, biofilm