Dental Plaque
Conditions
Keywords
Gingivitis, toothbrushing, oral hygiene, biofilm
Brief summary
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
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.
Interventions
DEVICEAutomated mouthpiece-based toothbrush
One-time use during study visit.
DEVICEManual toothbrush
One-time use during study visit.
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Single-blind, parallel group, randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Dental Plaque Removal Efficacy Using Turesky Modification of the Quigley-Hein Plaque Index | baseline,1 minute after brushing | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Presence of Soft Tissue Abrasion After Use of Automated Mouthpiece-based Brushing Versus Manual Toothbrush | baseline, 1 minute after brushing | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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. | 18 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | device was not operating properly for one subject. | 1 | 0 |
| Overall Study | one subject was dropped due to a behavioral issue | 1 | 0 |
Baseline characteristics
| Characteristic | Automated Mouthpiece-based Toothbrush | Manual Toothbrush | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 22 Participants | 18 Participants | 40 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 10.1 years | 10.8 years | 10.45 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 17 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Region of Enrollment United States | 22 participants | 18 participants | 40 participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 11 Participants | 7 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 18 |
| other Total, other adverse events | 2 / 22 | 1 / 18 |
| serious Total, serious adverse events | 0 / 22 | 0 / 18 |
Outcome results
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.
Time frame: baseline,1 minute after brushing
Population: participants aged 5-17 years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Automated Mouthpiece-based Toothbrush | Change From Baseline in Dental Plaque Removal Efficacy Using Turesky Modification of the Quigley-Hein Plaque Index | 0.29 units on a scale |
| Manual Toothbrush | Change From Baseline in Dental Plaque Removal Efficacy Using Turesky Modification of the Quigley-Hein Plaque Index | 0.6 units on a scale |
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.
Time frame: baseline, 1 minute after brushing
Population: 5-17 year old subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Automated Mouthpiece-based Toothbrush | Change From Baseline in Presence of Soft Tissue Abrasion After Use of Automated Mouthpiece-based Brushing Versus Manual Toothbrush | 2 Participants |
| Manual Toothbrush | Change From Baseline in Presence of Soft Tissue Abrasion After Use of Automated Mouthpiece-based Brushing Versus Manual Toothbrush | 1 Participants |