An interventional study of Automated mouthpiece-based toothbrush and Manual toothbrush in Dental Plaque, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 5 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-31.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
314 studies on the registry are indexed under Dental Plaque; 55 are open to participants now.
This study's enrollment of 42 is below the median of 59 across 279 interventional studies indexed under Dental Plaque.
Browse Dental Plaque studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
One-time use during study visit.
Also known as: Novel toothbrushing device
One-time use during study visit.
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.
Time frame: baseline,1 minute after brushing
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.
Time frame: baseline, 1 minute after brushing
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.
| Milestone | Automated Mouthpiece-based Toothbrush | Manual Toothbrush |
|---|---|---|
| Started | 24 | 18 |
| Completed | 22 | 18 |
| Not completed | 2 | 0 |
| Withdrew: Device was not operating properly for one subject. | 1 | 0 |
| Withdrew: One subject was dropped due to a behavioral issue | 1 | 0 |
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.
| units on a scale | Automated Mouthpiece-based Toothbrush | Manual Toothbrush |
|---|---|---|
| Change From Baseline in Dental Plaque Removal Efficacy Using Turesky Modification of the Quigley-Hein Plaque Index | 0.29 (.287 to .293) | 0.6 (.578 to .628) |
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.
| Participants | Automated Mouthpiece-based Toothbrush | Manual Toothbrush |
|---|---|---|
| Change From Baseline in Presence of Soft Tissue Abrasion After Use of Automated Mouthpiece-based Brushing Versus Manual Toothbrush | 2 | 1 |
Collected over baseline visit up to 1.5 hours. (study was one visit only). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Automated Mouthpiece-based Toothbrush | 0/22 (0%) | 0/22 (0%) | 2/22 (9.1%) |
| Manual Toothbrush | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) |
| Event | Automated Mouthpiece-based Toothbrush | Manual Toothbrush |
|---|---|---|
| minor abrasionSkin and subcutaneous tissue disorders | 2/22 | 1/18 |
24 were enrolled but 2 dropped
| Age, Categorical(Participants) | Automated Mouthpiece-based Toothbrush | Manual Toothbrush | Total |
|---|---|---|---|
| <=18 years | 22 | 18 | 40 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Automated Mouthpiece-based Toothbrush | Manual Toothbrush | Total |
|---|---|---|---|
| Mean | 10.1 (5 to 17) | 10.8 (6 to 17) | 10.45 (5 to 17) |
| Sex: Female, Male(Participants) | Automated Mouthpiece-based Toothbrush | Manual Toothbrush | Total |
|---|---|---|---|
| Female | 11 | 11 | 22 |
| Male | 11 | 7 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Automated Mouthpiece-based Toothbrush | Manual Toothbrush | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 18 | 17 | 35 |
| Unknown or Not Reported | 3 | 1 | 4 |
| Region of Enrollment(participants) | Automated Mouthpiece-based Toothbrush | Manual Toothbrush | Total |
|---|---|---|---|
| United States | 22 | 18 | 40 |
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University of Washington