Efficacy of Plaque Removal of a Novel Brushing Device Compared to a Manual Toothbrush
Phase: NA
Conditions: Dental Plaque
Sponsor: University of Washington

 
 
 
 
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Study title: Efficacy of a Novel Brushing Device 
NCT #: NCT05038293 
PI Name: Diane M Daubert 
Document Name: Protocol 
Approval Date: June 7, 2021 
 
Please find the attached protocol used for this study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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Study Protocol 
 
Efficacy of a Novel Brushing Device 
 
Protocol ID:  UW01 
 
Version: 1 
 
Date: 2021-2-11 
 
 
 
 
Principal Investigator:  
Diane M Daubert RDH, MS, PhD 
 
 
 
 
Department of Periodontics 
   
University of Washington School of Dentistry 
Box 357444 
Seattle, WA 98195 
Email: ddaubert@uw.edu 
 
 
Sub-Investigator:  
 
Marilynn Rothen RDH, MS 
 
 
 
 
Department of Oral Health Sciences 
   
 
 
 
1959 NE Pacific Street 
Seattle, WA 98195 
 
 
 
Research Site: 
 
University of Washington  
 
 
 
 
Center for Pediatric Dentistry 
 
 
 
 
Seattle, WA 98195 
 
 
 
 
 
 
 
  
 
   
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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Table of Contents 
 
Study Overview......................................................................................................................................... 4 
Background Information ........................................................................................................................ 5 
Description of the Device Studied ....................................................................................................... 6 
1 
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Study Objectives and Purpose:............................................................................................................ 8 
Study Design: ............................................................................................................................................ 8 
Number of Subjects: .......................................................................................................................... 8 
Duration of subject participation and duration of study: ............................................................... 8 
Schedule of Events: ........................................................................................................................... 8 
Selection and Withdrawal of Subjects: .............................................................................................. 9 
Inclusion Criteria: ...................................................................................................................................... 9 
Exclusion Criteria: ..................................................................................................................................... 9 
Withdrawal Criteria ................................................................................................................................. 10 
Subjects Study Visits ....................................................................................................................... 10 
Welcome Subject and Consent ...................................................................................................... 10 
Enrollment ......................................................................................................................................... 10 
Study Visits ........................................................................................................................................ 10 
Randomization .................................................................................................................................. 11 
Product Use ....................................................................................................................................... 11 
Assessment of Safety and Adverse Event Reporting .................................................................. 11 
Device Deficiencies ............................................................................................................................... 13 
Statistical Analysis Plan ....................................................................................................................... 13 
Access to Source Data ......................................................................................................................... 13 
Case Report Forms ................................................................................................................................ 13 
Study Confidentiality ............................................................................................................................. 14 
Subject Confidentiality ............................................................................................................................ 14 
Risk and Benefit Analysis .................................................................................................................... 14 
Anticipated Clinical Benefits ........................................................................................................... 14 
 
 

 
 
 
 
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Study Overview 
 
 Study Overview 
  
Subjects 
Recruit 60 subjects. Each subject will make 1-2 visits. The entire study is estimated to 
take approximately 6 months. 
Inclusion/Exclusion 
Criteria 
Potential subjects will be given a checklist of the inclusion and exclusion criteria to 
determine if they are eligible to participate.  A study staff will confirm the eligibility 
by the “yes” and “no” responses accordingly.  
  
Inclusion Criteria (All answers should be yes): 
  
• 
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 (To qualify, all answers must be no): 
  
• 
Have advanced periodontal disease or severe gum disease 
• 
Have mouth or teeth pain that prevents brushing in any areas  
• 
Have intraoral piercings (tongue or lip) that cannot be removed 
• 
Have non-controlled diabetes 
• 
Have any autoimmune or infectious disease or any medical condition that would 
delay wound healing  
• 
Have untreated visible cavities or untreated dental work 
• 
Had 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 
Study Objectives 
To compare plaque removal efficacy of an automated mouthpiece-based toothbrush 
to a manual toothbrush, and to assess effect on oral soft tissues. 
Study Design 
• 
Single Site 
• 
Parallel Design 
• 
60 Subjects stratified by dentition (primary, mixed, and permanent) are 
randomized evenly to 2 treatment groups 
• 
Randomized, blinded, 2 treatment groups 
Study 
Duration             
• 
2 visits  
• 
Each study visit will take approximately 90 minutes 
Study Devices 
List of Devices:  
Primary Investigation: (All 60 subjects) 
1. Automated brush: 30 subjects 
2. Manual toothbrush: 30 subjects   

 
 
 
 
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Study Summary 
Visit 1: Screening (may be by telephone) 
• 
Inclusion / Exclusion reviewed  
• 
Consent if in person visit  
• 
Subject will be asked to abstain from brushing, flossing, gum or mouthwash for 24 
hours prior to visit 2  
• 
Schedule next visit 
 
Visit 2: 
• 
Consent 
• 
Review Inclusion / Exclusion Questionnaire 
• 
Randomization to experimental or control group 
• 
Intraoral Evaluation by dental examiner  
• 
Plaque disclosing and plaque score 
• 
Intraoral photographs: (1 anterior, one posterior right and one posterior left)  
• 
Brushing instructions 
• 
Supervised and Timed Brushing with assigned product and measured toothpaste  
• 
Restain with plaque disclosing solution and 2nd plaque index as well as gingival 
abrasion 
• 
Intraoral photographs (1 anterior, one posterior right and one posterior left) 
• 
Subject questionnaire 
 
 
Background Information 
 
A healthy mouth is a crucial condition for a healthy body. 
Maintaining good oral health requires good oral hygiene meaning good plaque control.  Plaque 
is one of the main etiological factors in dental decay1 and the principal etiologic factor for 
periodontal diseases 2 which, beyond the discomfort they can inherently cause, are linked to 
more systemic conditions such as cardiovascular disease, pre-term low birthweight babies, 
Alzheimer’s disease, 3 and stroke. 4  
It is now well recognized that tooth brushing is the most efficient plaque control method,5 at least 
when used in an optimal way. 
Although toothbrushes have greatly evolved, from pig bristles to connected sonic devices, 
dexterity is still the key component to an efficient cleaning routine. Regardless of the type of 
toothbrush, if it cannot be used properly, plaque cannot be removed properly. And it has been 
shown in recent research that on a population with a general good health, the plaque score 
reduction is only an average 42% (range 30-53%) for manual toothbrushes 6 and 46% (range 
36-65%) for powered ones. 7 
Based on these observations, the sponsor has developed a powered teeth cleaning device to 
bypass the variability of each individual dexterity according to which cleaning is performed by a 
contraction and a relaxation, according to successive cycles in the presence of a liquid 
dentifrice, of a mouthpiece made of a resilient material receiving and enclosing all the teeth of 
an arch. 

 
 
 
 
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Description of the Device Studied  
 
Device Classification 
Device is in class 1, 501K exempt according to the 21 CRF 872 section 6865. 
 
 
Mechanism of Action 
The automated brush is a device aiming at improving and automating tooth brushing by bypassing 
the user’s dexterity variability. To this end, it is composed of a combination of an injection pump 
and a vacuum pump that allows for the injection and the evacuation of a cleaning liquid into a 
supple TPE bristled mouthpiece enclosing one arch at a time.  The border of the mouthpiece, the 
oral vestibule and the cheek create an airtight environment inside the mouthpiece, the suction of 
the liquid generates successive depressions allowing plaque disruption by the motion of the 
mouthpiece bristles onto the teeth surfaces. 

 
 
 
 
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Study Objectives and Purpose:  
 
Primary Objective:  To compare the effects of the test brushing device versus a manual brush 
on plaque removal 
 
Secondary Objective: To determine if soft tissue abrasion differs between test and control group 
Study Design: 
 
This is 2 visit, single-blinded, randomized controlled clinical trial.   
All subjects will sign an Institutional Review Board (IRB)-approved informed consent form before 
any study procedures may be performed.  This study will be completed according to applicable 
Good Clinical Practices and the Declaration of Helsinki.   
This study includes  
 
Number of Subjects: 
The target number of subjects to be randomized to this study are 60 subjects.  
Duration of subject participation and duration of study: 
All subjects will have two visits and should complete the study in approximately two weeks. The 
visits may be combined following a telephone screening. Each appointment will be approximately 
90 minutes.   
Schedule of Events:  
 
Procedures 
Performed by: 
Visit 1 
Visit 2 
Informed Consent 
Research Staff 
X 
 
Inclusion/Exclusion 
Criteria/Review 
Research Staff 
X 
X 
Enrollment 
Research Staff 
X 
 
Intra oral Examination  
Examiner 
X 
  
Randomization 
Research Staff 
 
X 
Intra oral Examination (Pre 
& Post) 
Examiner 
 
X 
Intra-oral photographs (Pre 
& Post) 
Research Staff 
 
X 
Plaque disclosing index (Pre 
& Post) 
Examiner 
 
X 
Brushing Dispense & 
Instruction 
Research Staff 
  
X 

 
 
 
 
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Study Product Usage 
Subject 
 
X 
Schedule Next Study Visit 
Research Staff 
X 
  
Subject Compensation 
Research Staff 
 X 
X 
  
Selection and Withdrawal of Subjects: 
 
Potential subjects will be recruited via flyers or direct contact at the Center for Pediatric 
Dentistry, with a phone number to call.  A study staff will go over a checklist of the inclusion and 
exclusion criteria to determine if they are eligible to participate.  At the initial visit a dental 
examiner will confirm the eligibility by the “yes” and “no” responses accordingly and ask 
additional questions as appropriate. Subjects who sign the informed consent form are screened 
for eligibility at the baseline visit. Subjects meeting all eligibility criteria shall begin the study 
procedures.  
Inclusion Criteria: 
 
5-17 years of age 
 
In good general health 
Fluent in English 
 
Willing and able to sign assent or informed consent as age appropriate 
Parent or guardian willing and able to provide written informed consent 
Be willing and able to carry out all study procedures (written and verbal) and be available 
 
at all times required for participation. 
 
16 scoreable teeth (non-crown/bridge/ or full amalgams) 
 
Has had a dental exam and cleaning within 24 months 
Exclusion Criteria:  
 
Advanced periodontal disease or severe gum disease 
 
Mouth or tooth pain that prevents brushing in any areas 
 
 
 
Have intraoral piercings (tongue or lip) that cannot be removed 
 
Have non-controlled diabetes 
 
Have any autoimmune or infectious disease or any medical condition that would delay  
 
 
wound healing 
 
Have untreated visible cavities or untreated dental work 
 
Had oral or gum surgery in the previous 2 months 
 
Take antibiotic premedication for dental procedures 
Undergoing or require extensive dental or orthodontic treatment, (space maintainers or 
 
removable appliances ok) 
Current smoker 
Generalized gingival recession over 1 mm  
 

 
 
 
 
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Withdrawal Criteria 
Study participation is voluntary. The subject may refuse to consent or may withdraw from this 
study at any time without penalty or loss of benefits to which he/she is otherwise entitled.  The 
Principal Investigator may terminate a study subject’s participation in this study without his/her 
consent (e.g., for safety or significant non-compliance) or other reasons that may warrant 
withdrawal. 
The study team will document whether or not each subject completed the study.  If, for any 
subject, study treatment or assessments were discontinued, the reason will be recorded. 
Subjects that withdraw from the study may be replaced but their study ID will not be re used and 
no further subject’s data will be collected after date of withdrawal.     
 
Subjects Study Visits 
 
Welcome Subject and Consent 
A research staff member who is currently trained in human subjects will greet the subject, and 
complete an eligibility inclusion/ exclusion form, and perform the consent process. Potential 
subjects are given the IRB-approved consent form to read and are provided the opportunity to 
ask questions about the study.  
If any subject does not meet the requirement, they will not be screened further and will be thanked 
for their time.  
If the potential subject does meet the requirement, study procedures may begin. 
Enrollment 
As part of study participation, each subject will be assigned a Subject ID number. This Subject 
ID number will be maintained throughout the study. The subject ID number which was assigned 
to them will not be re-used. 
Study Visits  
 
A dental examiner will review their eligibility questionnaires, ask any additional questions to 
clarify eligibility, and perform an intraoral evaluation which will determine eligibility and provide 
an initial baseline of the intraoral cavity prior to in-mouth use of the test product. 
 
Visit 1: May be combined with visit 2 if subject has abstained from brushing, flossing 
and mouthwash for 24 hours 
 
• 
Demographic information 
• 
Medical history taken 
• 
A dental examiner will perform an intraoral evaluation. The oral cavity will be evaluated and 
assessed for any abnormalities that may interfere with the brushing procedure, such as oral 
piercings.  
• 
  
 

 
 
 
 
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• 
Instructions given to abstain from brushing, flossing, gum or mouthwash for 24 hours prior to 
visit 2  
• 
Gift card dispensed 
• 
Schedule next visit 
 
Visit 2:  
 
• 
Review Inclusion / Exclusion Questionnaire 
• 
Randomization 
• 
Pre-brushing Intraoral Evaluation and plaque index   
• 
Intraoral photographs pre-brushing  
• 
Verbal review of brushing instructions 
• 
Supervised and Timed Brushing with assigned products    
• 
Dental examiner performs post- brushing intraoral evaluation and plaque index 
• 
Intraoral photographs post-brushing 
• 
Subject questionnaire 
• 
Gift card dispensed 
  
 Randomization 
Subjects will be randomized with a subject identification number throughout their study visits. A 
randomization table will be used by study staff to determine if the subject is a test or control brush.    
Product Use  
 
Subjects will be given verbal brushing instructions for the test or control brush.  
For the control group, the toothbrush bristles will be dampened with water and toothpaste, will be 
pre-dispensed (on a clean surface) by the study staff to assure that all subjects are given the 
same quantity of toothpaste and to assure that the proper amount of toothpaste will be given.  The 
same toothpaste will be provided to all the subjects. The subject will use the device directly over 
the sink.   
Subjects will be reminded of the brushing instructions and will be timed during their brushing.  
For the test group, the mouthpiece will be inserted by patient under the supervision of the study 
staff.  The subject will use the device directly over the sink. If the subject is having any difficulty 
or uncomfortable, the in-mouth testing will be stopped immediately and reported to the Principal 
Investigator.   
Assessment of Safety and Adverse Event Reporting 
Definitions 
Adverse Events (AEs) and Serious Adverse Events (SAEs) are defined by the ICH 
Guideline for Good Clinical Practice (ICH GCP) as follows: 
 
Adverse Event:  Any untoward medical occurrence in a patient or clinical 
investigations subject administered a pharmaceutical product and which does not 
necessarily have to have a causal relationship with this treatment.  An adverse event 

 
 
 
 
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(AE) can therefore be any unfavorable and unintended sign (including abnormal 
laboratory finding), symptom, or disease temporally associated with the use of a 
medicinal product, whether or not considered related to the medicinal product. 
 
AEs include any clinically significant deterioration of a subject’s medical status, after enrolled 
and signing an Informed Consent Form.  The AE may involve any organs or systems and can 
be represented by the new onset or the deterioration of a disease, a syndrome, a symptom, a 
physical sign, as well as by findings and results of instrumental examinations and laboratory 
tests.  Any medically relevant and untoward change from baseline, including frequency or 
pattern changes for a fluctuating condition (e.g., migraine), occurring after enrollment. All such 
occurrences must be recorded and reported accordingly, whether they appear causally related 
to the study product, or not. 
 
 
Serious Adverse Event: Any adverse event occurring at any dose that results in any 
of the following outcomes: 
• 
Death 
• 
Life threatening adverse event 
• 
Inpatient hospitalization, or prolongation of existing hospitalization 
• 
Persistent or significant disability/incapacity 
• 
Congenital anomaly/birth defect 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered a serious adverse experience when, based upon 
appropriate medical judgment, they may jeopardize the patient or subject and may 
require medical or surgical intervention to prevent one of the outcomes listed in this 
definition. 
 
   
 
Documenting and Reporting Adverse Events 
 
General Procedures for All Adverse Events 
All clinical complaints, symptoms, or signs that meet the adverse event definition will be 
recorded on the Adverse Reaction Form using a recognized medical term or diagnosis that 
accurately reflects the event.  Source documentation should be maintained that allows for clear 
identification of each adverse event and the following parameters required for the form: 
• 
AE description 
• 
Date of onset 
• 
Date of resolution 
• 
Outcome 
• 
Severity 
• 
Seriousness 
• 
Relationship to study product (causality) 
• 
Actions taken 
 
Adverse events will be assessed by the investigator or designee for severity, relationship to the 
study intervention, possible etiologies, and whether the event meets the criteria as a serious 
adverse event and therefore requires immediate notification of the sponsor. 

 
 
 
 
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For data collection purposes, the outcome of all adverse events recorded on the Adverse 
Reaction Form will be designated as of the completion of the final evaluation or examination.  
However, the investigator is responsible for following all adverse events until resolution or until 
no longer of clinical concern and providing these data to the sponsor. 
 
  
Baseline and Post-use Safety Evaluation 
Participant safety shall be monitored from the time each participant signs the Informed Consent 
Form until conclusion of the study.  Participant safety shall be monitored to detect any 
deviations in the medical health or dental status present at baseline.   
Device Deficiencies  
 
All device deficiencies use or user errors, and equipment failures will be documented.  Use or 
user errors will be captured as part of the source documentation  
Statistical Analysis Plan 
 
Multiple sites within each subject will be evaluated using a Turesky Modification of the Quigley-
Hein Plaque Index 8 at the treatment visit both before and after brushing.  
To assess the device effect after brushing, a paired t-test will be applied on the change 
outcome.  An unpaired t-test will be used to compare the efficacy of both devices.  A visual 
analog assessment will be done will be done on all subjects.  The number and percentage of 
reactions related to each brushing method will be collected and the final tolerance score 
estimated. 
 
The selection of 60 participants is expected to identify statistically significant differences in 
clinical parameters before and after brushing among the subjects of the study.  The power 
analysis was based upon a recent study by Klonowicz et al 9 in which a significant reduction of 
plaque was achieved after brushing of p<0.05. 
Access to Source Data 
This study will collect data on the performance of the study device. The data will be used 
without any personally identifiable information will be stored in the case report forms and 
entered into a spreadsheet for statistical analysis.   
Case Report Forms  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of 
the site investigator. The investigator is responsible for ensuring the accuracy, completeness, 
legibility, and timeliness of the data reported. Only staff that have been delegated by the 
Principal Investigator will be able to enter or make changes to data in the study documentation.    
 

 
 
 
 
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Study Confidentiality 
 
Study records, including each subject’s signed consent form and eligibility, and other study-
related documents pertaining to the conduct of the study shall be kept in a secure area.  
Confidentiality shall be maintained.  The results of this research project may be presented at 
meetings or in publications; however, subject identity will not be disclosed in such publications.   
  
Subject Confidentiality 
 
Subjects enrolled in the study shall be assigned a Subject ID number.  All recorded data are then 
entered per the unique Subject ID.  Subject information shall remain confidential.  However, 
consent forms that identify subjects may be inspected by the sponsor, its authorized designees 
and regulatory agencies including but not limited to, the Department of Health and Human 
Services (DHHS), the United States Food and Drug Administration (FDA) and other foreign 
regulatory bodies.  Because of the need to release information to these parties, absolute 
confidentiality cannot be guaranteed.  Only authorized personnel associated with the conduct 
and/or review of the study and the resultant data shall have access to information that links subject 
identifiers to the corresponding assigned study code.  Disclosure of subject information to 
personnel other than those permitted by study staff, its designees or representatives, or 
appropriate regulatory agencies is prohibited. 
  
Risk and Benefit Analysis  
 
The subject may be uncomfortable with another person watching them brush or experience some 
bleeding or sensitivity during this brushing procedure. All procedures conducted in the brushing 
procedure are like what is experienced during a routine tooth brushing. The examiner will perform 
a thorough pre intraoral evaluation to check for any type of abnormal abrasion or wound in the 
mouth. If there is any predisposing condition in the subject’s mouth, the dental examiner will inform 
the subject and may recommend the subject not participate in the study. The risk of permanent 
harm or injury, or disability as a result of participation in this research study is minimal. 
Participation is not expected to cause any oral conditions different from those normally 
experienced in routine brushing with a manual toothbrush. There is a chance that use of the 
research study products may involve risks that are currently unknown. The subject will be asked 
to report any discomfort or irritation that may be experienced while using research study products.   
 
Anticipated Clinical Benefits 
 
Participation in this trial may not result in direct benefit to the subject. The information collected 
from subjects will be used to improve future product design and function. 
Compensation 

 
 
 
 
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Participants in this study will receive up to $50 in gift cards for their participation. A $25 gift card 
will be given at the end of each visit. No therapeutic or other benefit will be received by 
participating in the study.  
 
References  
 
1. 
Fitzgerald RJ, Keyes PH. Demonstration of the etiologic role of streptococci in 
experimental caries in the hamster. J Am Dent Assoc 1960; 61: 9-19. 
2. 
Albandar JM. Global risk factors and risk indicators for periodontal diseases. Periodontol 
2000 2002; 29: 177-206. 
3. 
Chen CK, Wu YT, Chang YC. Association between chronic periodontitis and the risk of 
Alzheimer's disease: a retrospective, population-based, matched-cohort study. Alzheimers 
Research & Therapy 2017; 9. 
4. 
Lafon A, Pereira B, Dufour T, Rigouby V, Giroud M, Bejot Y, Tubert-Jeannin S. 
Periodontal disease and stroke: a meta-analysis of cohort studies. Eur J Neurol 2014; 21: 1155-
1161, e1166-1157. 
5. 
Grover D et al. Toothbrush ‘A key to mechanical plaque control’. Indian J Oral Sci 
2012;3:62-8. 
6. 
Slot DE, Wiggelinkhuizen L, Rosema NAM, Van der Weijden GA. The efficacy of manual 
toothbrushes following a brushing exercise: a systematic review. International Journal of Dental 
Hygiene 2012; 10: 187-197. 
7. 
Rosema NAM, Slot DE, Helderman WHV, Wiggelinkhuizen L, Van der Weijden GA. The 
efficacy of powered toothbrushes following a brushing exercise: a systematic review. 
International Journal of Dental Hygiene 2016; 14: 29-41. 
8. 
Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl 
analogue of victamine C. J Periodontol 1970; 41: 41-43. 
9. 
Klonowicz D, Czerwinska M, Sirvent A, Gatignol JP. A new tooth brushing approach 
supported by an innovative hybrid toothbrush-compared reduction of dental plaque after a single 
use versus an oscillating-rotating powered toothbrush. Bmc Oral Health 2018; 18.