Evaluation of Toothbrush Bristles in Plaque Reduction
Phase: NA
Conditions: Plaque, Dental, Gingivitis
Sponsor: Sunstar Americas

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Protocol 
 
CLINICAL RESEARCH STUDY PROTOCOL 
 
 
Evaluation of Toothbrush Bristles in Plaque Reduction 
Study Number: CLP-2020-06-01-1 
 
 
 
Investigator: Dr. Franklin Garcia-Godoy 
 
 
Sponsor: Sunstar Americas, Inc. 
 
 
 
 
 
 
 
 
 
 
 
 
I. 
PROTOCOL APPROVAL SIGNATURES 
 
| 15:31:01 PDT 
 
 
Dr. Franklin Garcia-Godoy, UTHC 
DATE 
 
 
 
7/1/2020 | 13:28:06 PDT 
 
 
Steven R. 
Goodman, Ph. D. 
 
Vice Chancellor 
for Research 
DATE 
 
 
 
 
 
Page 1 of 16 
7/1/2020

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II. 
INTRODUCTION 
 
Toothbrushes with tapered bristles were designed to clean plaque accumulated interdental 
area effectively. In vitro studies showed that the effectiveness in artificial plaque reduction 
is greater than that of the conventional toothbrushes with end rounded bristles. However, 
clinical studies in dental plaque and gingivitis have not showed consistent  result  in  the  
superiority  comparing  to  conventional  toothbrushes1
)  -3)    _      The purpose of this cross-over 
clinical research is to evaluate the cleaning efficacy of toothbrushes tufted with two types of 
tapered bristles and end rounded bristles in removal of interdental plaque with clinical 
measurement (Plaque Index) and  objective measurement (digitally measured plaque area). 
This Proof of Concept study will 
demonstrate the influence by a type of processing bristles on removal of interdental plaque 
and determine an agreement between the different evaluation methods. 
 
 
Ill. 
STUDY OBJECTIVES 
 
The primary objective of this study is to evaluate and compare toothbrushes with three 
different bristle types in the reduction of plaque index (Pl) for interdental area and digitally 
measured interdental plaque area after one-time brushing. 
 
Secondary objectives are to evaluate toothbrushes with three different bristle types in the 
changes of Pl, digitally measured interdental plaque area and gingival abrasion one week 
after using the toothbrushes, and to assess an agreement between the different evaluation 
methods (Pl and a plaque area by image analysis) 
 
IV. 
STUDY GROUPS 
 
Three different bristles will be tufted into the same tuft pattern. All toothbrush head and 
handle are identical (Sonic TB without turning on the sonic vibration). The study samples 
will be provided by sponsor. The bristle dimensions (height, base diameter of filament) will 
be same. The difference of three toothbrushes is a type of processing bristles. 
 
A: Tapered bristles (double tapered J-hook) 
B: Tapered bristles (single tapered J-hook) 
C: End rounded bristles 
 
Table 1. Physical characteristics of the bristles in all test groups 
 
 
Product A
Product B
Product C
Name 
Double tapered J- 
hook (OTJ) 
Single tapered J-hook 
(STJ) 
End rounded 
(Control) 

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Individual filament 
heights in all tufts 
10and13mm 
10 and 13 mm 
13 and 13 mm 
Tall filament end
Chemically tapered
Chemically tapered
Rounded
Short filament end 
Chemically tapered 
Rounded 
Rounded 
Filament's base 
diameter, milli inch (mm)
7 (0.18) 
7 (0.18)
7 (0.18)
Filament material
PBT**
PBT**
Nylon
 
*Pending, to check with supplier, ** Polybutylene terephthalate 
 
 
Figure 1. Toothbrush head schematic showing tuft patterns (circles) used in all test groups 
 
 
V. 
SUBJECT INFORMATION AND CONSENT 
 
The clinical investigation, including the consent form, will be reviewed by an IRB in 
accordance with Title 21 of the Code of Federal Regulations, Parts 50 and 56. Subject 
consent will be obtained prior to participation in any study procedures as required by the 
Food and Drug Administration (FDA) GCP guidelines. Subjects will be given ample 
opportunity to read the consent form and to have all questions regarding study conduct 
answered prior to signing and dating the consent form. Each subject will be provided with 
an exact copy of the informed consent form to retain for his or her records. 
Informed consent means the knowing consent of an individual, so situated so as to 
exercise free power of choice without undue inducement or constraint or coercion. The 
elements of information necessary for such consent include: a statement that the study 
involves research; an explanation of the procedures to be followed and their purpose; 
identification of any procedures that are experimental; any expected discomforts, risks or 
benefits; approximate number of subjects involved in the study; any appropriate alternative 
procedures or treatments; description of the confidentiality of subject records; name and 
phone number of the individual to contact with inquiries concerning the research; 
explanation of compensation or free medical treatment available for research-related 
injury; statement that the subject is free to withdraw consent and to discontinue 
participation at any time; statement that participation is voluntary; indication of any 
additional costs to the subject; assurance that the subject will be notified of new findings 
relevant to the subject's participation; statement that it is within the Principal Investigator's 
discretion to drop the subject from participation at any time. 
In addition, the agreement entered into by the subject should include no exculpatory 

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language by which the subject is made to waive, or appear to waive, any of his/her legal 
rights or to release the institution from liability or negligence. 
 
VI. 
SUBJECT POPULATION 
 
Number of Subjects 
A total number of 10 subjects will be enrolled. Volunteers must read and sign the Informed 
Consent Form after the nature of the study has been fully explained. 
 
 
Inclusion Criteria 
Individuals may be included in the study provided they meet all of the following inclusion 
criteria: 
 
• 
Must have read, understood and signed an informed consent prior to being entered into 
the study. 
• 
Must be 18 to 70 years of age, male or female. 
• 
Have at least 20 natural or restored teeth. 
• 
Must have average Plaque Index of Ramfjord teeth at baseline greater than 2 
(Quigley and Hein)4l at screening. 
• 
Agree not to have a dental prophylaxis or any other elective, non-emergency dental 
procedures (other than those provided during the study) any time during the study. 
• 
Agree to refrain from regular oral hygiene regimen for 24 hours and eating for 4 hours 
before the appointment in the study. 
• 
Agree to abstain from the use of any dental products other than those provided in the 
study. 
• 
Agree to comply with the conditions and schedule of the study. 
 
Exclusion Criteria 
Individuals are not eligible for participation in this study if any of the following are noted: 
 
• 
Physical limitations or restrictions that might preclude normal tooth brushing. 
• 
Evidence of gross oral pathology 
• 
Presence of severe gingivitis with 30 or more sites showing bleeding on probing. 
• 
Evidence of major soft tissue lesions or trauma at the baseline visit as determined by 
the Investigator/Examiner. 
• 
Chronic disease with concomitant oral manifestations 
• 
Subjects who are currently undergoing, or require, extensive dental work, orthodontic 
treatment or periodontal surgery or orthodontic treatment in the preceding 3 months 
• 
Currently using bleaching trays 
• 
Eating disorders 
• 
Recent history of substance abuse 
• 
Smoking >10 cigarettes/day 

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• 
Participation in other clinical studies within 14 days of screening 
 
VII. 
STUDY DESIGN OVERVIEW 
 
This cross-over group, examiner blinded, randomized, single center study will enroll 
subjects to target 10 subjects completing the study. Subjects will visit the clinical site 7 
times including screening/enrollment visit. Subjects will be instructed to refrain from 
regular oral hygiene regimen for 24 hours and from eating for four hours before each 
appointment. The study examiner and staff will screen for subjects that meet the 
enrollment criteria. Subjects will be randomly assigned to one of three treatment groups. 
The study staff responsible for random assignments will be blinded to the product 
treatments. 
 
• 
Group 1:  A -> B -> C 
• 
Group 2:  B -> C -> A 
• 
Group 3:   C ->A-> B 
 
After distribution of an assigned test toothbrush, subjects will receive a basic brushing 
instruction for Bass method by a study staff but without actual brushing. Subjects will perform 
toothbrushing using the assigned product for 2 minutes under supervision. Plaque Index 
(Navy Pl), Gingival Abrasion Score and standardized digital dental photos will be taken 
before/after the one-time brushing. 
 
Subjects will use the assigned toothbrush for a week until the next visit for evaluation. At the 
visit, the used toothbrush shall be returned to the study staff to avoid mixing up with next test 
product. Pl and Gingival Abrasion Score will be recorded, and the standardized digital dental 
photos will be taken. After one week of wash-out period, subjects will return to the clinical 
site to start the next test product. The study schedule is showed in Table 2. Subjects will be 
instructed to keep a diary given by the study staff at Visit 1 throughout the study. Adverse 
experiences will be noted and recorded during the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table 2. Study Schedule 
 
 
 
 
Events 
 
 
Visit 1
 
Visit2 
 
Visit 3 
 
Visit 4 
 
Visit 5 
 
Visit 6 
 
Visit 7 
First product 
Second product
Third product 
Informed consent, demographics, 
Inclusion/Exclusion criteria, medical 
history, concurrent meds 
 
X 
 
 
 
 
 
 
Update of Inclusion/Exclusion 
criteria 
X* 
X 
X 
X 
X 
X 
X 
Clinical endpoints (Pl and Gingival 
Abrasion) 
 
X 
X 
X 
X 
X 
X 
Digital dental photos 
 
X 
X 
X 
X 
X 
X 
Test product distribution 
 
X 
 
X 
 
X 
 
Instruction of brushing 
 
X 
 
X 
 
X 
 
Clinical endpoints (Pl and Gingival 
Abrasion) immediate post-brushing 
 
X 
 
X 
 
X 
 
Digital dental photos immediate 
post-brushing 
 
X 
 
X 
 
X 
 
Wash-out period products 
distribution (TP and TB) 
X 
 
 
 
 
 
 
Used test product collection 
 
 
X 
 
X 
 
X 
Diary disbursement and collection 
 
X 
 
 
 
 
X 
Compliance check 
 
 
X 
 
X 
 
X 
Adverse events 
 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
Note: Visit 1, 3 and 5 will be followed by a 1 week "washout" period. 
*Evaluation of Pl (Quigley and Hein) is included. 

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VIII. 
CLINICAL SUPPLIES 
 
Test Materials 
The sponsor will provide the following items to the study site: 
• 
3 test toothbrushes with different types of bristles (A, B, C) 
• 
Toothbrush for wash-out period 
• 
Toothpaste throughout the study period 
 
Packaging and Labeling 
 
The toothbrushes will be identically labeled by the sponsor. 
 
Delivery and Inventory: 
 
Immediately upon receipt of study supplies at the clinical site, study personnel will 
account for all products. The study staffs are responsible to maintain the accountability 
log. 
 
Storage: 
 
Study supplies will be maintained under secure conditions, until assignment to subjects. 
 
Return of Study Supplies: 
 
At the conclusion of the study, all unused product will be returned to the Sponsor. 
Used products will also be returned to the Sponsor. 
 
 
IX. 
TREATMENT REGIMEN 
 
Qualified subjects meeting all inclusion and exclusion criteria will be provided their 
assigned toothbrush (A, B or C) at Visit 2, 4 and 6 for use for immediate post-brushing 
evaluation and during the one-week treatment phase of the study. Subjects will be 
instructed to brush their teeth as instructed with their assigned toothbrush 2 times daily 
(after breakfast, before going to bed) for 2 minutes, using only the provided toothpaste 
for one-week study period. 
 
Following their one week of use, they will then go through a one-week "washout" period 
and will follow their normal oral hygiene using study provided toothbrush and fluoride 
toothpaste. The same fluoride toothpaste will be used throughout the whole study period. 
Subjects will refrain from using other oral hygiene products throughout the study period. 

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X. 
PRODUCTUSECOMPLIANCE 
 
To demonstrate compliance with product use, each subject will complete a daily diary 
indicating the time of each brushing for the one-week duration of the study. The subjects 
will be requested to return their diary and assigned toothbrush at the end of the study 
period. 
 
XI. 
RESTRICTIONS 
 
Subjects will be advised of the following restrictions during the study period: 
• 
To avoid using other oral hygiene products throughout the study period. 
• 
To avoid starting or changing treatments, medications including OTC drugs and 
supplements that potentially modify plaque accumulation for the duration of the study. 
• 
To refrain from starting or changing habits (e.g. eating chewing gum) to potentially 
modify subject's plaque accumulation condition for the duration of the study. 
 
 
XII. 
STUDY PROCEDURE 
 
Screening and Enrollment Visit (Visit 1) 
Potential subjects will be instructed to refrain from regular oral hygiene regimen for 24 hours 
and eating for 4 hours before the appointment in the study. 
Male and female subjects will read and sign the informed consent prior to enrollment. 
Subjects will be asked about demographics, medical history, general health status and 
current medication usage, and the information will be recorded. 
Plaque Index (Quigley and Hein) of a whole mouth will be evaluated to verify that the subjects 
meet the inclusion and exclusion criteria (average Pl>2). 
If the participants meet the study criteria, they will be assigned to one of three treatment 
groups randomly based on computer generated randomized numbers. 
Subjects will be instructed to use a toothpaste and a toothbrush (for wash-out period) 
provided by the study staff until the next visit. The appointment of next visit will be scheduled 
within 7 days ± one day. 
 
 
Visit 2 
The following will happen at this visit: 
Potential subjects will be instructed to refrain from regular oral hygiene regimen for 24 
hours and eating for 4 hours before the appointment in the study. The study staff will 

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update of Inclusion/Exclusion Criteria, medical history, and concurrent medications. 
Whole-mouth Plaque Index (Navy Pl) and Gingival Abrasion Score will be evaluated by a 
qualified examiner following visualize dental plaque with a disclosing agent (Mira-2-Ton, 
Miradent) and record the scores on the Case Report Form for the baseline information. 
Successively, standardized dental digital photographs of three close-up views of the 
retracted views for plaque area measurement: front, left and right lateral sides. 
Assigned toothbrush and a fluoride toothpaste will be given to each subject. the study staff 
will instruct Bass method to each subject (without using a toothbrush) jTAJ1and provide the 
assigned toothbrush with a half inch length of the toothpaste. Subjects will brush their teeth 
for 2 minutes with Bass method under a supervision of the study staff. Whole-mouth Navy 
Pl and Gingival Abrasion Score will be recorded, and standardized dental digital photographs 
will be taken again for immediate post-brushing evaluation. 
Subjects will then be instructed to use assigned product to use 2 times daily, after breakfast 
and before bedtime, for one week for 2 minutes with instructed brushing method. They will 
maintain a daily diary of their product usage. Compliance will be assessed by subject diary. 
Next appointment will be scheduled within 7 days ± one day. Subjects will be instructed to 
refrain from regular oral hygiene regimen for 24 hours and eating for 4 hours before the 
appointment in the study. They will be advised to follow the instructions carefully and return 
to the study center with their assigned toothbrush and diary for their next examination. 
 
 
Visit 3 
After one week, subjects will return to the office to return the used toothbrush and their 
dairy. The following will happen at this visit: 
The study staff will update of inclusion/exclusion criteria, medical history and concurrent 
medications. Adverse experiences will be noted and recorded during the study. 
Whole-mouth Navy Plaque Index and Gingival Abrasion Score will be evaluated by a 
qualified examiner following visualize dental plaque and record. Then, standardized dental 
digital photographs of three close-up views of the retracted views: front, left and right lateral 
sides. 
Subjects will follow their normal oral hygiene using a toothbrush and a toothpaste for 
"wash-out" period given at Visit 1. 
Next appointment will be scheduled to return within 7 days ± one day, and subjects will be 
instructed to refrain from regular oral hygiene regimen for 24 hours and eating for 4 hours 
before the appointment in the study. 
 
 
Visit4 
After a 1-week washout, subjects will return to the office to begin the second period of the 

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study, using the same study procedures and be assigned the alternate toothbrush as in 
Visit 2. 
 
At the end of Visit 5 (examination for the second product) they will go through a 1 week 
wash out period and then return for Visit 6 (baseline for the third product). 
 
Rustogi Modified Navy Plaque Index (Rustogi et al.  J Clin Dent. 1992)5> 
 
After disclosing dental plaque on teeth, the Rustogi Modified Navy Plaque Index (Navy Pl) 
is evaluated as either present or absent (1 or 0) on each of the nine areas of the buccal and 
lingual tooth surfaces except for third molars. Whole tooth, marginal, and approximal areas 
are defined as shown below. Score of each area (from A to I) will be recorded for further 
assessments. In this study, the Pl should be evaluated by only trained and calibrated 
examiners. 
 
 
Gingival Abrasion Score (Van der Weijden et al.  J Clin Periodontol. 2004)6> 
 
After the gums were dried with compressed air, Mira-2-Ton® disclosing solution was applied 
for better visualization of areas where the surface of the oral epithelium had been abraded. 
The gingival tissues were divided into three areas: marginal (cervical free gingiva), interdental 
(papillary free gingiva) and mid-gingival (attached gingiva). 
 
The lesions were assessed as small (;5;2 mm), medium (3-5 mm) and large (>5 mm) using 
a periodontal probe. Those lesions measuring between 2 and 3 mm were assigned a score 
of small or medium according to nearest mm mark on the probe. 

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Standardized Digital Dental Photographs A4J 
Dental photographs will be taken by a digital SLR camera (model, maker) with a ring flash to 
distribute the light evenly with intraoral exposure. A macro lens (85 mm or more) will be used 
to take a close-up photo. 
To standardize the exposing views, the same magnification (1:1 or 1:2 views) and same 
views at the same distance from the subject shall be used for all subjects and all visits. 
Study staffs will expose the cheek retracted views. Retracted views from front, left and right 
lateral will be taken at the same setting. When an image of the front of the mouth is taken, 
the subject's bicuspids may be focused on to obtain the overall sharpness. Images from left 
and right lateral may be centered between the cuspid and the first premolar. 
A length of tooth height (mm) of one of maxillary central incisors will be recorded using a 
periodontal prove for future analyses. 
After image acquisition with same spatial resolution and contrast resolution for an existing 
image analysis software, the image of each non-molar tooth will be assessed. The entire 
visible tooth area and the area of plaque  of each tooth will be calculated  into either mm2  or 
number of pixels . 
 
 
lnterdental ,

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XIII. 
ADVERSE EXPERIENCES 
 
Adverse Event Definition and Handling 
An adverse event is any unexpected or serious medical occurrence in a clinical investigation 
subject during the study, whether or not related to the study product. All adverse events 
observed by the investigator and/or reported by the subject will be recorded throughout the 
entire study and documented. The Investigator will be asked to make a judgement on all 
adverse events as to their severity and possible relation to the study treatments. 
 
More specifically, adverse events would include: 
• 
Any unexpected event not seen before study initiation. 
• 
Any pre-existing event that recurs with increased intensity or increased frequency 
subsequent to initial product treatment. 
 
Adverse events will be reported to the investigator and the sponsor will be notified within 
24 hours of any serious adverse events. All adverse events should be recorded on the 
appropriate case report form, including date of onset, severity, duration, treatment and 
follow-up observation. 
The following definitions will be used for grading severity of adverse events: 
• 
Mild - Either asymptomatic, or subject is aware of the sign, symptom or event, but it 
is easily tolerated. 
• 
Moderate - Discomfort enough to cause interference with usual activity and may 
warrant intervention. 
• 
Severe - Incapacitating with inability to do usual activities. 
 
The investigator will make an assessment of the likelihood that there is a reasonable 
possibility of a causal relationship between a study product and the adverse event.  This will 
be captured using the following criteria: product related, non-product related, non- product 
related but protocol related. The causal relationship to the product will be assessed as: 
definitely related, probably related, possibly related, probably not related or definitely not 
related. 
 
 
Serious Adverse Event 
A serious adverse event is any adverse event that: 
• 
Results in death 
• 
Is life threatening (i.e., immediate risk of death as the event occurred). A life- 
threatening event does not include an event that, had it occurred in a more severe 
form, might have caused death, but as it occurred did not create an immediate risk 

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of death. For example, hepatitis that resolved without evidence of hepatic failure 
would not be considered life threatening even though hepatitis of a more severe 
nature can be fatal. Similarly, an allergic reaction resulting in angioedema of the face 
would not be life threatening, even though angioedema of the larynx, allergic 
bronchospasm, or anaphylaxis can be fatal. 
• 
Results in persistent or significant disability or incapacity (i.e., a substantial, persistent 
disruption in a subject's ability to conduct normal life functions). 
• 
Requires inpatient hospitalization or prolongation of an existing hospitalization. 
Hospitalization or prolongation of a hospitalization constitutes criteria for an 
adverse event to be serious; however, it is not in itself considered a serious adverse 
event. In the absence of an adverse event, a hospitalization or prolongation of a 
hospitalization should not be reported as a serious adverse event by the 
participating Investigator. This is the case in the following situations: 
• 
The hospitalization or prolongation of hospitalization is needed for a procedure 
required by the protocol. 
• 
The hospitalization or prolongation of hospitalization is part of a routine procedure 
followed by the center. This should be recorded in the study file. 
In addition, a hospitalization for a pre-existing condition that has not worsened 
does not constitute a serious adverse event. 
• 
Results in cancer 
• 
Results in a congenital anomaly or birth defect. 
Additionally, important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered a serious adverse event when, based upon 
appropriate medical judgment, the event(s) may jeopardize the subject and may require 
medical or surgical intervention to prevent one of the outcomes listed in this definition. 
Examples of such medical events include allergic bronchospasm requiring intensive 
treatment in an emergency room or at home, blood dyscrasias or convulsions that do not 
result in hospitalization, or the development of drug dependency or drug abuse. If there is 
any doubt whether the adverse event constitutes a serious adverse event, the information 
will be treated as a serious adverse event. 
 
 
XIV. SUBJECT COMPLETION AND WITHDRAWAL 
 
Subject Completion 
Only subjects who complete all procedures and comply with all areas  of the protocol will be 
deemed to have completed the study. Subjects will be compensated for their time and travel 
and for successfully completing all provisions and procedures of the study. If a subject 
voluntarily withdraws from the study, or if withdrawn by the Investigator for any reason, 
he/she will be compensated on a pro rata basis. Subject compensation will be 

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documented in the Informed Consent and will be approved by the IRB. 
 
Subject Withdrawal 
Subjects are free to withdraw at any time during the clinical trial. Subjects may also be 
withdrawn from the study at any time at the discretion of the Investigator. All subject 
withdrawals will be documented in the study file. Where possible, the reason for the 
withdrawal will be documented. Any withdrawals as the result of an adverse event will be 
followed-up at the discretion of the Study Investigator. Withdrawn subjects will not be 
replaced. 
 
Subject Discontinuation 
A subject will be considered discontinued from the study at any time under the following 
circumstances: 
• 
Any subject who violates any condition of the entrance criteria after having been 
entered into the study 
• 
Any subject who develops a confounding concomitant illness (as determined by the 
subject, Research Coordinator, or Investigator) or a serious adverse event 
• 
Any subject who becomes uncooperative, does not adhere to the requirements of the 
study protocol, or refuses to complete the study 
 
XV. 
EFFICACY 
 
Primary Outcome Variables 
The primary outcome variables to be assessed are: 
1) the reduction of plaque index (Navy Pl) for interdental area after one-time brushing in a 
whole mouth. 
2) the reduction of digitally measured interdental plaque area on non-molar teeth, 
facial/buccal aspect after one-time brushing by image analysis. 
 
Secondary Outcome Variables 
1) the change of plaque index for interdental area in a whole mouth one week after using 
the toothbrushes. 
2) the change of digitally measured interdental plaque area on non-molar teeth one week 
after using the toothbrushes. 
3) correlation between plaque index and plaque area by image analysis in non-molar 
teeth, facial/buccal aspect. 
4) The change of gingival abrasion score in whole mouth at one week after using the 
toothbrushes. 

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As necessary, additional exploratory statistical data analysis may be performed to further 
advance evaluation of the results. 
 
 
XVI. STATISTICAL ANALYSIS AND DATA MANAGEMENT 
 
Since this study is a Proof of Concept study, the sample size calculation was not performed. 
 
Descriptive statistics for all subjects will be performed for background and demographic 
variables. Continuous variables are expressed as frequencies (n), mean +/- SD and 
categorical variables are expressed as frequencies (n) and percentages (%). 
 
Student t test or Wilcoxon rank sum test where appropriate, will be used to compare among 
different bristles. For intragroup changes of endpoints before/after one-time brushing or use 
for one-week, paired t test or Wilcoxon signed rank test will be used where appropriate. 
Spearman Rank Order Correlation was used to analyze correlations between the variables. 
 
Safety parameters will include oral soft and hard tissues and subjective reports as well as 
any AEs. The analysis will include all observed effects which initially occurred or worsened 
following treatment. Any adverse effects will be summarized classified according to their 
intensity (mild, moderate, or severe) and relationship (definitely related, probably related, 
possibly related, probably not related or definitely not related) to study product. 
 
All statistical tests will be conducted using Minitab 18. 
 
 
XVII. RERFERENCES 
 
1) Hoogteijling F, Hennequin-Hoenderdos NL, Van der Weijden GA, Slot DE. The effect of 
tapered toothbrush filaments compared to end-rounded filaments on dental plaque, 
gingivitis and gingival abrasion: a systematic review and meta-analysis. Int J Dent Hyg. 
2018;16(1):3- 12. doi:10.1111/idh.12272 
2) Ni L, Tang R, He T, et al. Clinical effect of a manual toothbrush with tapered filaments on 
dental plaque and gingivitis reduction . Am J Dent. 2017;30(5):272 - 278. 
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