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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Automated mouthpiece-based toothbrush | Experimental | 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. |
|
| Manual toothbrush | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Automated mouthpiece-based toothbrush | Device | One-time use during study visit. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diane M Daubert, RDH, MS, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington, School of Dentistry, Regional Clinical Dental Research Center (RCDRC) | Seattle | Washington | 98195 | United States |
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62 parents called for a phone screening. Of those,48 subjects presented for the first appointment but 6 were not enrolled due to not meeting inclusion and exclusion criteria. 42 subjects were consented and enrolled.
subjects were recruited via flyers posted at the Center for Pediatric Dentistry at the University of Washington. If parents were interested they contacted the study coordinator for a phone screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Automated Mouthpiece-based Toothbrush | 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. Automated mouthpiece-based toothbrush: One-time use during study visit. |
| FG001 | Manual Toothbrush | 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. Manual toothbrush: One-time use during study visit. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
24 were enrolled but 2 dropped
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| ID | Title | Description |
|---|---|---|
| BG000 | Automated Mouthpiece-based Toothbrush | 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. Automated mouthpiece-based toothbrush: One-time use during study visit. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | participants aged 5-17 years | Posted | Mean | 95% Confidence Interval | units on a scale | baseline,1 minute after brushing |
|
baseline visit up to 1.5 hours. (study was one visit only)
definition does not differ
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Automated Mouthpiece-based Toothbrush | 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. Automated mouthpiece-based toothbrush: One-time use during study visit. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| minor abrasion | Skin and subcutaneous tissue disorders | Non-systematic Assessment | minor soft tissue abrasion from brushing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Diane Daubert | University of Washington Department of Periodontics | 206-685-3766 | ddaubert@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2021 | Jan 25, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 14, 2021 | Jan 25, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
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Single-blind, parallel group, randomized controlled clinical trial
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Outcomes assessors and the principal investigator will be blind to toothbrush device assignment. In order to maintain blinding and eliminate assessor bias, study team members instructing and observing participants in the use of the assigned toothbrushing device will not be outcomes assessors.
| Manual toothbrush | Device | One-time use during study visit. |
|
| baseline, 1 minute after brushing |
| Manual Toothbrush |
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. Manual toothbrush: One-time use during study visit. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | age, continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Manual Toothbrush | 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. Manual toothbrush: One-time use during study visit. |
|
|
| Secondary | 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. | 5-17 year old subjects | Posted | Count of Participants | Participants | baseline, 1 minute after brushing |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 2 |
| 22 |
| EG001 | Manual Toothbrush | 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. Manual toothbrush: One-time use during study visit. | 0 | 18 | 0 | 18 | 1 | 18 |
|
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| D005882 |
| Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |