Powertoothbrushing for Treating Gingivitis
Phase: NA
Conditions: Gingivitis
Sponsor: Marquette University

 
 
 
CLINICAL STUDY PROTOCOL 
 
POWER TOOTHBRUSHING FOR TREATING GINGIVITIS 
 
Protocol number: CLP-2017-06-01-1       NCT #03381339 
Date: 12/21/2017 
Amendment number: 5 
Amendment date: 8/14/2018 
 

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1. GENERAL INFORMATION 
Sponsor:  
 
 
 
Sunstar Americas, Inc. 
 
 
 
 
 
301 E Central Rd, Schaumburg, IL 60195 
Sponsor Clinical Program Manager: 
Supinda Watcharotone, PhD 
 
 
 
 
 
Research and Development Engineer 
 
 
 
 
 
(847) 794-4278 
Sponsor Clinical Advisor: 
 
Akane Takemura, PhD 
 
 
 
 
 
Senior Manager 
 
 
 
 
 
Technology and New Product Development 
 
 
 
 
 
(847) 794-4276 
Principal Investigator:   
 
Andrew Dentino, DDS, PhD 
Professor and Program Director of Periodontics 
Department of Surgical Sciences 
Marquette University School of Dentistry 
Adjunct Professor of the Clinical Translational Science Institute 
Medical College of Wisconsin 
1801 W Wisconsin Ave Marquette University School of Dentistry 
 
Milwaukee WI 53233 / 414-288-5944 
Study coordinators 
 
 
 Dr. Hala Afifa 
Examiners / Research Assistant  
 
                 Dr. Keerthi Kamreddy 
 
 
 
 
 
Ms. Gina Alfano Orendorf 
 
 
 
 
 
Dr. Laxmi Sukhtankar 
Ms Deb Pschied RDH  
Ms Colleen Wirth RDH 
Ms. Nadine Crivello RDH 
Jessica Karnowski RDH 
Research Assistant                                       Ms. Erica Renner  M.Ed, RDH 
Marquette University School of Dentistry 
 
 

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Study Timeline: 
Estimated date of first subject enrolled  
      December 2017 
Estimated date of last subject enrolled        October 
 
 2018  
Estimated date of last subject completes home use      December 2018  
 
2. BACKGROUND INFORMATION 
2.1. Investigational product 
ADA recommends brushing teeth twice daily with either a manual or power soft bristle toothbrush. 
Although the manual toothbrush is accepted and used widely, the efficient brushing movement that a 
power toothbrush generates helps remove plaque with little effort. This directly benefits adult users 
(including those with limited dexterity) and helps them to achieve and maintain good oral health.  
The present investigational product is a rechargeable power toothbrush. The toothbrush has two speed 
settings. The brush head portion is removable for routine replacement. The circular brush head moves in 
a rotation-oscillation fashion. In the bristle configuration of the investigational device, the eight inner 
tufts include end-rounded nylon filaments, and the surrounding tufts include longer tapered filaments. 
This configuration was designed to fit tooth contours, in which the center bristles forming a flat 
rectangular area that covers the tooth surface, while the longer tapered bristles are designed to 
increase subgingival and interproximal access.  
Two independent in-vitro efficacy studies have been conducted. The Subgingival Access Efficacy (SAE) 
and Interproximal Access Efficacy (IAE) are evaluated in-vitro using artificial plaque covered substrate 
placed around simulated anterior and posterior teeth.[1] The toothbrush is loaded with a 250 gram 
weight and controlled to brush in horizontal and vertical motions. The IAE was averaged over the results 
of horizontal and vertical brushing while the SAE over results of horizontal brushing. The IAE and SAE of 
the power toothbrush were found to be superior to an ADA reference flat trim manual toothbrush with 
statistical significance (p<0.001). Table 1 summarizes the in-vitro results conducted for the power and 
manual toothbrushes used in the study. The finding indicates that the tapered filament feature and 
unique bristle design enhance subgingival and interproximal access efficacies compared to a flat 
trimmed manual toothbrush.  
Table 1. The Interproximal Access Efficacy (IAE) and Subgingival Access Efficacy (SAE) of the 
investigational power toothbrush product and an ADA reference manual toothbrush. The IAE and SAE 
are the result of the in-vitro efficacy study.[1] 
Toothbrush 
IAE (mm) 
SAE (mm) 
Power 
11.3 
1.40 
Manual 
9.8 
0.02 
% difference* 
14% 
194% 
*% difference is the difference in percentage with respect to the average of the two numbers. 

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Moreover, the unique bristle design differentiates this device from other commercially available power 
toothbrushes with a similar rotation-oscillation movement. The in-vitro study results have shown the 
unique bristle design has superior access efficacy when compared to a commercially available rotation-
oscillation power toothbrush. (Data on file)  
The in-vitro access efficacy studies evaluate the effectiveness of the unique bristle design only in plaque 
removal in hard-to-reach areas. In-vitro studies are not able to test the effectiveness of the brushing 
movement the power brush generates, which helps the user to brush more easily. Moreover, in-vitro 
brushing on artificial plaque papers is not able to evaluate the effectiveness in treating and reducing 
gingivitis. Therefore, a clinical study is crucial to determine the clinical significance of the product in 
effectively treating and reducing gingivitis. 
 
2.2. Known potential risks and benefits 
The investigational device has no known potential risks. The literature published over the last 30 years 
has reported the rotation-oscillation power toothbrush to be safe compared to manual toothbrushes.[2] 
Moreover, a recent systematic review by Cochrane showed there was no apparent relationship between 
the use of a power toothbrush and soft tissue trauma.[2] 
The benefits of the investigational device are as follows: 
1. The unique bristle configuration is effective in removing plaque in the difficult-to-reach 
interproximal and subgingival areas, which should improve overall oral health if used regularly. 
2. The Cochrane Collaboration, an independent healthcare research group, reported that clinical 
research shows that rotating-oscillating toothbrushes reduce plaque and gingivitis more than 
manual toothbrushes.[2] 
3. The rotation-oscillation brushing movement helps facilitate more thorough brushing and makes 
brushing easier. This could benefits users with limited dexterity, such as elderly, people with 
disabilities. 
This study will be conducted in compliance with the protocol, Standard Operating Procedures (SOPs), 
Good Clinical Practices (GCPs) Guidelines and applicable regulatory requirements. All study materials are 
to be reviewed by the Marquette University Institutional Review Board (IRB) prior to the study.  
3. STUDY OBJECTIVES 
The objective of this 12-week, parallel-arm, single-blinded, clinical study is to investigate efficacy and 
safety of a new power toothbrush in comparison with a standard ADA accepted manual brush.  
3.1. Primary objective  
Primary objective is to evaluate effectiveness of the product on gingivitis reduction compared to a flat 
trim manual toothbrush.  
3.2. Secondary objectives 
Secondary objectives are to evaluate the following: 
- 
Effectiveness on plaque removal 

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- 
Hard and soft tissue damage 
4. STUDY DESIGN 
4.1. Clinical Parameters 
4.1.1 Oral Cavity Exam/Oral Safety Exam 
4.1.2 Modified Gingival Index[3] 
4.1.3 Lobene Modified Turesky Plaque Index[4,5] 
4.1.4 Full mouth periodontal charting of pocket depths and Bleeding Index 
4.2. Description of Clinical Parameters 
4.2.1. Oral cavity examination 
Oral cavity examination for safety assessments will include evaluation of the lips, tongue, hard and soft 
palate, gingiva, all mucobuccal fold areas, inner surface of the cheeks and sublingual areas, tooth 
surfaces and restoration surfaces. All areas will be assessed and reported as normal or abnormal with an 
explanation of any abnormality. In particular, the cervical root area will be carefully examined. 
4.2.2.  Lobene modification of the Loe and Silness Gingival Index 
The Modified Gingival Index3 (MGI) will be measured on six sites – mesio-buccal, buccal, disto-buccal, 
mesio-lingual, lingual and disto-lingual - of all teeth using a 0-4 scale. 
0 = Absence of inflammation. Normal gingiva. 
1 = Mild inflammation: slight change in color, little change in texture of any portion of, but not the entire 
marginal or papillary gingival unit. 
2 = Mild inflammation: criteria as above but involving the entire marginal or papillary unit. 
3 = Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the marginal or papillary 
gingival unit. 
4 = Severe inflammation: marked redness, edema, and/or hypertrophy of the marginal or papillary 
gingival unit, spontaneous bleeding, congestion, or ulceration. 
9 = Missing tooth or non-gradable tooth surface: a tooth surface will be considered non-gradable due to 
the presence of a crown, an extensive cervical restoration or a hypoplastic surface which could interfere 
with cleaning or cause plaque accumulation.  Any surface graded as a 9 will not be included in the data 
analysis. 
4.2.3.  Lobene Modification of the Turesky Plaque Index 
Dental plaque will be evaluated using the Lobene modification4 of the Turesky modification of the 
Quigley-Hein Plaque Index (PI)5.  Disclosing solution will be used to identify the plaque (2 tone disclosing 
solution to be paineted on the teeth with a microbrush then 10 ml's tap water used to, swish, then rinse 
again with water). Plaque will be scored on six surfaces of all natural teeth (3 buccal, 3 lingual) or 
nearest uncrowned tooth using a 0 scale. Subjects will abstain from brushing for at least 7 hours but no 
more than 12 hours prior to their evaluation appointment. 

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0 = No plaque/debris 
1 = Separate flecks of plaque at gingival margin 
2 = A thin continuous band of plaque (up to 1 mm) at the gingival margin 
3 = A band of continuous plaque up to 1/3 of the crown of the tooth 
4 = Plaque covering at least 1/3 but less than 2/3 of crown of tooth 
5 = Plaque covering 2/3 or more of the crown of the tooth 
9 = Missing tooth or non-gradable tooth surface: a tooth surface is considered non-gradable due to the 
presence of a crown, an extensive cervical restoration or a hypoplastic surface which could interfere 
with cleaning or cause plaque accumulation. Any surface graded as a 9 will not be included in the data 
analysis. 
4.2.4. Probing Pocket Depth 
Full-mouth Probing Pocket Depth (PPD) will be measured on the six locations of each tooth (mesial-
buccal, buccal, distal-buccal, mesial-lingual, lingual, distal-lingual) using a periodontal probe.  
4.2.5. Bleeding On Probing Index 
The Bleeding on Probing index (BOP) will be recorded from the gingival sulci of all teeth after 
periodontal probing at all six locations per tooth - mesial-buccal, buccal, distal-buccal, mesial-lingual, 
lingual, distal-lingual. The presence of any bleeding within 30 seconds of gentle probing will be 
considered a positive response and given a score of 1. Sites which do not bleed on probing will be scored 
as 0. 
0 = No bleeding 
1 = Bleeding 
4.3. Primary endpoint 
The primary endpoint of this study is reduction of gingivitis (change from baseline) as measured by BOP 
and MGI at baseline, and again at 12-week visits. 
4.4. Secondary endpoints 
The following indices and parameters are secondary endpoints. 
- 
Reduction of BOP and MGI at two-week, four-week visits from the baseline 
- 
Reduction of PPD at 2-week, 4-week and 12-week visits from the baseline  
- 
Reduction in plaque by measuring PI at 2-week, 4-week and 12-week visits as well as after a 
single use 
- 
Safety of the product: clinical examiners inspect for any hard or soft tissue damage 
- 
Patient reported outcomes from an exit survey and user diary 
 

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4.5. Study procedure 
 
The study to be conducted will be single-blinded, randomized controlled, parallel design. The study 
population will consist of Seventy-two (72) male and female subjects conforming to the following 
admission criteria. The subjects meeting the admission criteria with an anticipation of 40% dropout rate 
will be stratified into two groups balanced for MGI, BOP, PI, and gender using screening data. In this 
single-blind design, product assignment will be randomized after screening, and only the PI and the 
Study coordinator will have access to the randomization key.  
One group will be assigned to a new power toothbrush while the control group will be assigned an ADA 
approved manual toothbrush. The study involves a 12-week home use of the respective toothbrushes. 
Both groups will refrain from the regular use of mouthwash and any interdental device, such as floss, 
floss picks, toothpicks, water flossing device or interdental brush, during the length of the study. Written 
instructions on brushing and professional brushing demonstration will be provided at the outset of the 
study and each participant from both test and control groups will also receive a 2-minute timer to help 
them monitor their brushing time. Before each visit, subjects are expected to have at least 7 hours, but 
no more than 12 hours of accumulated, non-brushed, undisturbed plaque/debris. 
The study includes four or five visits – screening, baseline, 2-week follow-up, 4-week follow-up and 12-
week follow-up. Schematic 1 summarizes the study procedure and visits and Table 2 details procedures 
in this study.  The Screening and the baseline visit may happen on the same day. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Schematic 1. Study and visit procedures 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screening process 
Medical/dental history 
Visit 1: Screening 
and enrollment 
Oral examination for tissue abrasion and MGI 
Calibrated Examiner   
Enrollment 
Periodontal probing for BOP and PPD 
Calibrated Examiner 
Oral examination for PI 
Calibrated Examiner   
Informed consent form 
Yes  
No 
Same day 
7 – 12 hours of plaque 
accumulation 
Pre visit 
7 – 12 hours of plaque 
accumulation 
Re-appointment 
Visit 2: Baseline 
Randomization of eligible subjects 
Brush assignment and instruction 
Group A 
Power toothbrush 
and toothpaste 
Group B 
Manual toothbrush 
and toothpaste 
A 

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Pre visit 
7 – 12 hours of plaque 
accumulation 
Visit 3: Follow-up visit 
at 2 weeks 
Oral examination for tissue abrasion and MGI 
by calibrated examiners  
Periodontal probing for BOP and PPD 
by calibrated examiners  
Oral examination for PI 
By calibrated examiners 
Schedule next visit 
Schedule next visit 
A 
PI examination after 
brushing 
Single use 
result 
Use brush per instruction 
Visit 2: Baseline 
(continued) 
Visit 4: Follow-up visit 
at 4 weeks 
Oral examination for tissue abrasion and MGI 
by calibrated examiners 
Periodontal probing for BOP and PPD 
by calibrated examiners  
Oral examination for PI 
by calibrated examiner 
Schedule next visit 
A 
Pre visit 
7 – 12 hours of plaque 
accumulation 

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A 
Pre visit 
7 – 12 hours of plaque 
accumulation 
Visit 5: Follow-up visit 
at 12 weeks 
Oral examination for tissue abrasion and MGI 
by calibrated examiners  
Periodontal probing for BOP and PPD 
by calibrated examiners  
Oral examination for PI 
by calibrated examiners 
Exit survey 
Collect toothbrush/brush head 
+/- Prophylaxis 

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Table 2. Procedure overview during visits 
Procedure 
Performed by 
Visit 
Screening 
Baseline 
2-week 
4-week 
12-week 
Plaque accumulation 
Subject 
X 
X 
X 
X 
X 
Patient information 
 
 
 
 
 
 
Informed consent 
form 
Study coordinator/staff 
X 
 
 
 
 
Patient demographics 
Study coordinator/staff 
X 
 
 
 
 
Medical/dental history 
Study coordinator/staff 
X 
 
 
 
 
Oral examination 
Blinded examiners 
 
 
 
 
 
Oral cavity abrasion 
exam 
Examiners 1 and 2 
X 
X 
X 
X 
X 
Gingival Index (MGI) 
Examiners 1 and 2 
X 
X 
X 
X 
X 
Probing Pocket Depth  
Examiners 1 and 2 
X 
X 
X 
X 
X 
Bleeding Index  
Examiners 1 and 2 
X 
X 
X 
X 
X 
Plaque Index  
Examiners 3 and 4 
X 
 X* 
X 
X 
X 
Examiner calibration 
All examiners 
X 
 
 
 
X 
Others 
 
 
 
 
 
 
Inclusion/exclusion 
criteria 
Study coordinator/staff 
X 
X 
 
 
 
Prophylaxis 
Dental hygienist 
 
 
 
 
X 
Randomization 
Unblinded staff/study 
coordinator 
 
X 
 
 
 
Product introduction 
and instruction 
Unblinded staff/study 
coordinator 
 
X 
 
 
 
Brushing at clinic 
Subject 
 
X 
 
 
 
Scheduling future visit 
Study coordinator/staff 
X 
X 
X 
X 
 
Collect used brushes 
Unblinded staff/study 
coordinator 
 
 
 
 
X 
Exit survey 
Subject 
 
 
 
 
X 
*Twice 
 
 

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Visit 1: Screening and enrollment 
Subjects will be asked to report to the clinic with at least 7 but no more than 12 hours of accumulated, 
non-brushed, undisturbed plaque/debris. Prior to screening, subjects will sign a consent form after 
having gone over the consent with a member of the study staff and having all questions answered. In 
this visit, subjects will be asked about dental and medical history related to the admission and exclusion 
criteria.  
At the screening exam, subjects will receive an oral soft tissue exam with periodontal probing, modified 
Gingival Index on the Ramjford teeth, and the amount of stain and calculus will be noted. Following 
these examinations, the subject’s plaque will be disclosed with Trace 28 solution (4 drops under tongue) 
and they will swish for 10 seconds. Next, subjects will rinse with 10 ml. of tap water twice for 10 seconds 
each. Disclosed plaque will then be recorded on buccal and lingual surfaces of the Ramjford teeth using 
the Lobene modification of the Turesky Plaque Index.  If baseline happens on the same day then full 
mouth GI and BOP will be carried out prior to disclosing for full mouth plaque measurements. Subjects 
who meet the admission criteria will be allowed to enroll. If a subject fails the screening exam due to 
oral disease such as, but not limited to dental caries and periodontitis, the subject will be appropriately 
referred to the main Marquette University School of Dentistry (MUSoD) screening clinic to insure that 
they will be given an opportunity for full diagnosis and treatment at the school of dentistry or some 
other appropriate clinic. 
Each clinical index will be scored by one of two or three calibrated examiners. The oral cavity/oral safety 
exam and all measures of inflammation, the MGI, PPD and BOP will be carried out by examiners #1 and 
2 while disclosing and scoring of the PI will be scored by examiners #3 and 4.  A fifth examiner who is 
dual calibrated will be used if needed. Each examiner will be calibrated to the indices used, and will 
demonstrate repeatability of measures initially at the screening/calibration phase as well as during the 
study.   
Visit 2: Baseline 
Subjects who have signed consent form and met all the inclusion criteria and none of the exclusion 
criteria will be entered into the baseline procedure (day 0). This visit may occur the same day as 
screening. 
In this visit, subjects will first be evaluated for signs of soft or hard tissue trauma, and then full mouth 
Modified Gingival Index followed by full mouth probing of pocket depth and assessment of BOP.  Teeth 
with calculus will be recorded. After these data are recorded each subject will be disclosed and full 
mouth Plaque scores assessed and recorded by a calibrated examiner. Any scorable teeth that have 
plaque buildup on any six tooth sites will be recorded. The subjects will then leave the examining area to 
the randomization and toothbrush distribution area where they will be provided their assigned brush 
out of site of the examiners. Group A will be given a power toothbrush, while Group B will be given a 
manual toothbrush. Both groups will also be given a two minute timer and the same fluoride toothpaste 
(Colgate Cavity Protection toothpaste) as well as the appropriate set of written instructions on tooth 
brushing. The subjects in the test group will follow the instructions provided by the manufacturer, while 
subjects in the control group will be given a standard written and both groups provided visual 
instructions on proper brushing. A study staff member will be available to answer any questions 
pertaining to the instructions and coach patients toward optimal brushing technique. Then the subjects 
will be required to use the brush assigned for two minutes before being sent back to the examiner to 

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have a post-brushing plaque index recorded.  These pre- and post 2-minute brushing data will be 
collected to assess single use effect differences between the toothbrush types. Subjects will be 
reappointed and instructed to bring their assigned brush to the subsequent exam sessions in a brown 
bag to avoid unmasking any of the examiners. 
Visit 3: Two-week follow-up  
The first follow-up will take place two weeks after the baseline visit. Subjects can schedule the visit for 
any time between two days before and after the two-week use period (12-16 day range). Clinical 
examinations will be given to the subjects in the same order as the baseline visit with the exception that 
no second plaque index will be recorded.  All subjects must present with 7 to 12 hours of undisturbed 
plaque.  The oral safety exam will include a thorough examination of the gingiva to look for any signs of 
gingival trauma, irritation or abrasion. Any subjects who show signs of gingival trauma that appears to 
be toothbrush related will be exited from the study. The recorded findings will be reported as Adverse 
Events. In addition, any site in the mouth that shows an increase in probing pocket depth of 2 mm or 
greater from the baseline measurement will have that particular site treated with subgingival scaling 
and root planing or whatever the PI deems appropriate therapy. If subjects meet any of the 
discontinuation criteria, they will be withdrawn from the study. 
Visit 4: Four-week follow-up 
This visit should take place four weeks after the baseline visit within three days before and after the four 
week mark (25-31 day range). Subjects will receive full mouth examinations in the same order as the 
previous visit. Additionally, inspection for signs of gingival trauma and increase in PPD greater than 2 
mm from the baseline will be conducted and evaluated. The PI will determine if any subject meets the 
discontinuation criteria as well as appropriate therapy to treat.  
Visit 5: 12-week follow-up  
In this visit, subjects will return the products, including manual toothbrush, or brush head, brush handle, 
and charger. The procedure is similar to the four-week follow-up visit, in which full mouth clinical 
examination will be carried out as before on each of the subjects. The subjects’ disclosed plaque will be 
evaluated as usual. The examined results will be recorded. Prophylaxis will be carried out as needed. 
The used brushes/brush heads will be returned to sponsor at the end of the trial and examined for wear 
as an additional measure of compliance. 
1. SELECTION AND WITHDRAWAL OF SUBJECTS 
5.1. Admission Criteria 
 A subject who meets all the following criteria will be eligible to enroll in this study. 
1. Age range 18 – 65 years 
2. Routine manual toothbrush user 
3. A Subject who agrees to use the assigned toothbrush as the only cleaning device for the study 
duration, refraining from daily interdental cleaning and/ or antiseptic mouthrinsing. 
4. Mild to moderate gingivitis as measured by 
 
 
A. Modified Gingival Index (MGI) average score of at least 1.2, and / or 
 
 
B. Bleeding on Probing (BOP) of at least 20% of all sites but not more than 50% of sites. 

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5. Probing Pocket Depth (PPD) of 4 mm or lower 
6. At least 20 natural teeth – scoreable (crowns or bridgework are non-scoreable). 
5.2. Exclusion Criteria 
Any subject meeting one of the following criteria will not be included in the study. 
1. Daily user of interdental cleaning devices, such as floss, floss picks, toothpicks, interdental 
brush, water flossing device 
2. Regular user of antimicrobial mouthrinses within one week of entry into study 
3. Professional prophylaxis within one month of entry into the study 
4. Use of antibiotics within one month prior to the baseline exam 
5. Signs of moderate to severe periodontitis or caries, categorized as PPD of 5 mm of higher and 
attachment loss of 3 mm or higher 
6. Subjects with orthodontic bands and/or dental appliances. 
7. Participated in an oral care related study in the last 90 days prior to this study 
8. Pregnant or lactating women 
9. Patients with a history of significant cardiovascular disease, diabetes, cancer, AIDS, or other 
organ impairment that would preclude their participation in the study 
10. Acute/concurrent illness such as hepatitis, herpes simplex infections, influenza, etc. 
11. History of rheumatic fever, cardiovascular valvular disease, artificial joint replacement or kidney 
or liver disorders 
12. Chronic use of NSAID’s (> 325 mg/day) 
13. Current Smoker (within the last 3 months) 
14. Other medical or dental conditions that would affect the study 
15. Inability to commit to all necessary study visits from baseline to 12 weeks 
5.3. Discontinuation criteria 
  
The oral safety exam at the follow-up visits will include a thorough examination of the gingiva to look for 
any signs of gingival trauma, irritation or abrasion, as well as a periodontal probing. Any subjects who 
show signs of gingival trauma that appears to be toothbrush related will be exited from the study and 
the findings reported as Adverse Events. In addition, subjects may be discontinued due to the following 
reasons. 
1. Voluntary discontinuation: subjects are free to discontinue their participation in the study at any 
time. 
2. Safety concerns: the principal investigator may terminate a subject’s participation if gingival 
trauma occurs and appears to be toothbrush related  
3. Significant non-compliance to protocol: the principal investigator may terminate a subject’s 
participation if subjects are shown to be non-compliant to the protocol 
4. Incorrect enrollment: subjects who did not meet admission/exclusion criteria 
5. Subject received any type of dental treatment/care other than those required in the study, for 
example use of interdental devices, mouthrinses, chewing gum or prophylaxis treatment, 
without consent of the investigator 
Subjects who discontinue should be asked to a follow-up visit to observe any Adverse Events. 

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5.4 Rescue treatment 
Subjects may receive prophylaxis if needed. Other rescue treatments may be performed on subjects 
based upon the PI’s decision.  
If a subject fails the screening exam due to oral disease such as, but not limited to dental caries and 
periodontitis, the subject will be appropriately referred to the main MUSoD screening clinic to insure 
that they will be given an opportunity for full diagnosis and treatment at the school of dentistry or some 
other appropriate clinic. 
 6. SAFETY ASSESSMENT 
All staff involved in this study will have reviewed the following description of Adverse Events and 
Adverse Device Effect 
6.1. Adverse Event (AE) 
An AE is any untoward and unintended medical occurrence in a subject.  This definition does not imply 
that there is a relationship between the AE and the medical device under investigation.  An AE which is 
possibly related, is one that may have been caused by the medical device, or treatment, however there 
is insufficient information to determine the likelihood of this possibility.   
- 
Possibly related: temporal relationship of the onset of the event, relative to the 
use/administration of the medical device, is reasonable but the event could have been due to 
another, equally likely cause.  
- 
Non-related (unlikely): temporal relationship of the onset of the event, relative to the 
use/administration of the medical device, is not reasonable or another cause can itself explain 
the occurrence of the event. 
Ambiguous cases should be considered as possibly related. 
6.2. Adverse Device Effect (ADE) 
An ADE is any untoward and unintended response to a medical device.  This definition includes any 
event resulting from insufficiencies or inadequacies in the instructions for use of the medical device or 
any event that is a result of a user error.  This definition also includes treatment- or procedure-related 
events. ADEs can only occur from the time of medical device use/administration.  Here the event is 
related to the use of the medical device where there is a probable/definite relationship that the event 
may have been caused by the medical device, or treatment.  
- 
Probably related: temporal relationship of the onset of the event, relative to the 
use/administration of the medical device, is reasonable and the event is more likely explained 
by the medical device/treatment than by any other cause.  
- 
Definitely related: temporal relationship of the onset of the event, relative to the 
use/administration of the medical device, is reasonable and there is no other cause to explain 
the event. 
 

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6.3. Serious Adverse Event (SAE)  
An SAE is an AE/ADE occurring during any study phase of the medical device that fulfills one or more of 
the following criteria that the device: 
- 
Results in death 
- 
Is immediately life-threatening  
- 
Requires in-subject hospitalization or prolongation of existing hospitalization 
- 
Results in persistent or significant disability or incapacity 
- 
Is a congenital abnormality or birth defect 
- 
Is an important medical event that may jeopardize the subject or may require medical 
intervention to prevent one of the outcomes listed above 
If a non-related AE becomes an SAE, i.e. fulfilling one or more of the above criteria, action should be 
taken. 
6.4. Recording of Adverse Events and Adverse Device Effects 
At all follow-up visits, adverse changes will be assessed by asking subjects and carrying out the oral 
safety exam. Subjects may report adverse events at any time of the study. All adverse changes the 
investigator believes “possibly”, “probably” or “definitely” were caused by the device must be recorded 
on the case report form as AEs. Time of onset, action taken, outcome and the investigator’s opinion on 
the relationship of the device to each adverse reaction/change in the oral cavity will also be recorded.  
6.5. Reporting of Serious Adverse Events 
If any SAE occurs, the PI or other personnel is responsible to inform the sponsor within 24 hours after 
they become aware of the event. The PI also will also inform the IRB committee of SAEs. The PI and 
sponsor will investigate the event and determined if it is related to the device. If it is a device-related, a 
report will be issued to the regulatory authority. 
7. STATISTICAL ANALYSIS 
Each of the two research groups' patients will be assessed clinically at four time points (Baseline, 2 
weeks, 4 weeks and 12 weeks). These measures will be compared against one another and over time 
using a between-within factors repeated measures ANOVA.  
Further evaluation of interproximal and marginal scores will also be evaluated with a post hoc analysis.  
7.1. Sample size 
Assuming an alpha/p-value of 0.05, and a power of 0.95, the minimum number of subjects needed (after 
all drop-outs have been removed) is 44. Due to the length of the study and multiple visits required 
within the length of the study, the potential for moderately high drop-out rates is set at 40%. 72 
subjects will be initially enrolled; 36 will be assigned to the power toothbrush group, and 36 will be 
assigned to the manual toothbrush group.  
 

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7.2. Demographics and other baseline characteristics 
Subject demographics (e.g. age and sex), oral care habits (e.g. flossing and smoking) and baseline 
characteristics (e.g. MGI, BOP and PI) will be presented by treatment group and in total. Measurements 
of recorded teeth with calculus will not be included in statistical analysis.   
7.3. Significance level 
Unless stated otherwise, significance level is 0.05. A p-value may be complemented by confidence 
interval.   
7.4. Method 
Reductions in gingivitis – BOP, MGI and PPD – and plaque – PI from baseline scores after 2 weeks, 4 
weeks and 12 weeks of use will be evaluated. For each subject, mean score of each index will be 
calculated as well as reductions from baseline at three time points. Additionally, numbers of abrasion 
sites found will be compared. 
Assuming evaluated scores for the test and control groups are denoted UTest and UControl, respectively, 
the null hypothesis will be tested.  
H0: UTest - UControl = 0 
H1: UTest - UControl ≠ 0 
8. ACCESS TO SOURCE DOCUMENTS 
Access to source documents should be limited during the study. Blinded examiners will have access until 
the end of the study. All source documents will be made available to Sponsor, any third party with 
written permission from Sponsor and regulatory agencies. 
9. ETHICAL CONSIDERATION 
All subjects in this study will receive a standard of oral care. No placebo is involved. This study protocol 
must be reviewed and approved by the Marquette University IRB prior the study.  
10. DATA HANDLING AND RECORD KEEPING 
All patient data will be kept in individual booklets with all clinical research forms included.  After each 
visit the patient data booklets will be reviewed by the study coordinator to ensure complete data 
collection and then kept in a locked file cabinet in the office of the Principle Investigator. 
For any subjects screened but found ineligible their screening documents (health history/ charting) will 
be kept in a screen fail notebook with an explanation as to what the reason was for the screen fail. 
11. FINANCING 
Each subject will receive reimbursement for expense from the trip to the clinic at the end of baseline 
and follow-up visits. Reimbursement of $25 will be given at the baseline and 2-, 4- and 12-week visits in 
the form of Gift/Gas cards.  

CONFIDENTIAL 
Page 19 of 27 
 
 
12. PROTOCOL AMENDMENT  
If it is necessary for the study protocol to be amended, the amendment and/or a new version of the 
study protocol (Amended Protocol) must be notified to or approved by the MU IRB, and if applicable, 
also the local regulatory authority, before implementation. Local requirements must be followed. 
Sponsor will distribute administrative changes, amendments and new versions of the protocol to the 
principal investigator. 
13. MONITORING 
Sponsor will meet with staff members who are involved to review the protocol and ensure that the 
study will be conducted in accordance with the following: 
- 
Good Clinical Practices (GCPs) Guideline  
- 
The study contract 
- 
Conditions imposed by the IRB 
- 
Any applicable local or federal regulatory requirements 
14. STAFF TRAINING 
The principal investigator will maintain a record of all individuals involved in the study – dental assistant, 
oral examiners, and other staff – and ensure appropriate training is given and any new information 
relevant to the performance of the study is forwarded to involved staff members.  
15. REFERENCES 
[1] Yankell SL, Shi X, Spirgel CM. data on file with Sunstar 
[2] Yaacob M, Worthington HV, Deacon SA, Deery C, Walmsley AD, Robinson PG, Glenny AM. 
Powered versus manual toothbrushing for oral health. Cochrane Database of Systematic Reviews 
2014, Issue 6 
[3] Lobene RR, Weatherford T, Toss NM, Lamm RA, and Meanaker L. A Modified Gingival Index for 
Use in Clinical Trials. Clin, Prev. Dent., Vol. 8, No. 1, Jan-Feb, pp:3-6, 1986 
[4] Lobene RR, Soparkar PM, Newman MB. Use of dental floss.  Effect on plaque and gingivitis. Clin 
Prev Dent. 4: 5-8, 1982 
[5] Turesky S, Gilmore ND, Glickman I. Reduced Plaque Formation by the Chloromethyl Analog of 
Vitamin C, J. Periodont. 41:41-43, 1970 
 
 
 
 

CONFIDENTIAL 
Page 20 of 27 
 
PATIENT SCHEDULE 
 
SCREENING WILL BE CARRIED OUT IN ALL CLINICS AT MUSOD USING PERIO FACULTY 
 
BASELINE – APPROXIMATELY 1.25 HOURS 
 
RESEARCH ASSISTANT / STUDY COORDINATOR 
 
CHECKS PATIENT IN AND CONFIRMS  7-12 HOURS PLAQUE ACCUMULATION 
 
GIVES COPY OF CONSENT FORM 
 
PATIENT GIVEN RECORD TO CARRY THROUGH THE APPOINTMENT TO EACH STATION 
 
DIRECTS TO 1ST EXAMINERS 
1ST EXAMINERS – ORAL CAVITY EXAM, GINGIVAL INDEX, PROBING POCKET DEPTH, BLEEDING INDEX  
2ND EXAMINERS – PLAQUE INDEX PRE-BRUSHING 
PI / STUDY COORDINATOR 
 
ASSIGNS TOOTHBRUSH 
 
OHI DEMO & WRITTEN INSTRUCTIONS (TOOTHBRUSH USAGE AND STUDY PARTICIPATION) 
 
GIVES TUBE OF TOOTHPASTE & TIMER 
 
PT BRUSHES TO DEMONSTRATE COMPREHENSION OF INSTRUCTIONS THEN GIVES BRUSH BACK 
 
TO PI/STUDY COORDINATOR 
RESEARCH ASSISTANT 
 
TAKES PATIENT TO 2ND EXAMINERS FOR POST-BRUSHING PLAQUE INDEX 
2ND EXAMINERS – PLAQUE INDEX POST-BRUSHING 
 
  
RESEARCH ASSISTANT 
 
BRINGS THEM BACK TO GET THEIR BRUSH / PASTE 
 
CONFIRMS NEXT VISIT (DATE & TIME) 
 
BASELINE INFORMATION SHEET 
 
RECOVERS PATIENT RECORD FROM PATIENT / GIVES PATIENT THEIR HONORARIUM 
 
 
2  WEEKS VISIT – APPROXIMATELY 60 MINUTES 
RESEARCH ASSISTANT / STUDY COORDINATOR 
 
CHECKS PATIENT IN 
 
2 WEEK VISIT INFORMATION SHEET 
 
CONFIRMS 7-12 HOUR PLAQUE ACCUMULATION 
 
PATIENT GIVEN RECORD TO CARRY THROUGH THE APPOINTMENT TO EACH STATION 
 
DIRECTS TO 1ST EXAMINERS 
1ST EXAMINERS – ORAL CAVITY EXAM, GINGIVAL INDEX, PROBING POCKET DEPTH AND BLEEDING INDEX 
2ND EXAMINERS – PLAQUE INDEX  
RESEARCH ASSISTANT  
 
CONFIRMS NEXT VISIT (DATE & TIME) 
 
COMPLETES 2 WEEK VISIT EXIT INFORMATION SHEET 
 
RECOVERS PATIENT RECORD FROM PATIENT/ GIVES PATIENT THEIR HONORARIUM 
 
 
 

CONFIDENTIAL 
Page 21 of 27 
 
4  WEEKS VISIT – APPROXIMATELY 60 MINUTES 
RESEARCH ASSISTANT / STUDY COORDINATOR 
 
CHECKS PATIENT IN 
 
4 WEEK VISIT INFORMATION SHEET 
 
CONFIRMS 7-12 HOUR PLAQUE ACCUMULATION 
 
PATIENT GIVEN RECORD TO CARRY THROUGH THE APPOINTMENT TO EACH STATION 
 
DIRECTS TO 1ST EXAMINERS 
1ST EXAMINERS – ORAL CAVITY EXAM, GINGIVAL INDEX, PROBING POCKET DEPTH AND BLEEDING INDEX 
2ND EXAMINERS – PLAQUE INDEX  
RESEARCH ASSISTANT  
 
CONFIRMS NEXT VISIT (DATE & TIME) 
 
COMPLETES 4 WEEK VISIT EXIT INFORMATION SHEET 
 
GIVES NEW TOOTHBRUSH/TOOTHBRUSH HEAD AND/OR TUBE OF TOOTHPASTE PRN 
 
RECOVERS PATIENT RECORD FROM PATIENT/ GIVES PATIENT THEIR HONORARIUM 
 
12  WEEKS VISIT – APPROXIMATELY 60 MINUTES 
RESEARCH ASSISTANT / STUDY COORDINATOR 
 
CHECKS PATIENT IN 
 
12 WEEK VISIT INFORMATION SHEET 
 
COLLECTS TOOTHBRUSHES/ CONFIRMS 7-12 HOUR PLAQUE ACCUMULATION 
 
PATIENT GIVEN RECORD TO CARRY THROUGH THE APPOINTMENT TO EACH STATION 
 
DIRECTS TO 1ST EXAMINERS 
1ST EXAMINERS – ORAL CAVITY EXAM, GINGIVAL INDEX, PROBING POCKET DEPTH AND BLEEDING INDEX 
2ND EXAMINERS – PLAQUE INDEX  
RESEARCH ASSISTANT  
 
COMPLETES 12 WEEK VISIT EXIT INFORMATION SHEET 
 
PATIENT EXIT QUESTIONAIRE 
 
TAKES SUBJECT TO RDH FOR PROPHYLAXIS PRN 
 
RECOVERS PATIENT RECORD FROM PATIENT/ GIVES PATIENT THEIR HONORARIUM 
 
 
 

CONFIDENTIAL 
Page 22 of 27 
 
PATIENT RECORD 
 
ITEMS INCLUDED IN THE RECORD ARE AS FOLLOWS: 
 
PATIENT APPOINTMENT SCHEDULE 
 
BASELINE VISIT INFORMATION SHEET 
BASELINE VISIT – ORAL CAVITY EXAM, GINGIVAL & BLEEDING INDEX/ PD CHARTING 
BASELINE VISIT – PLAQUE INDEX PRE- AND POST-BRUSHING 
 
2 WEEK VISIT INFORMATION SHEET 
2 WEEK VISIT – ORAL CAVITY EXAM, GINGIVAL & BLEEDING INDEX/ PD CHARTING 
2 WEEK VISIT – PLAQUE INDEX  
 
4 WEEK VISIT INFORMATION SHEET 
4 WEEK VISIT – ORAL CAVITY EXAM, GINGIVAL & BLEEDING INDEX/ PD CHARTING 
4 WEEK VISIT – PLAQUE INDEX  
 
12 WEEK VISIT INFORMATION SHEET 
12 WEEK VISIT – ORAL CAVITY EXAM, GINGIVAL & BLEEDING INDEX/ PD CHARTING 
12 WEEK VISIT – PLAQUE INDEX  
 
SCREENING RECORD 
INCLUSION/EXCLUSION CRITERIA 
MUSOD MEDICAL/DENTAL HEALTH HISTORY 
CONSENT FORM 
PATIENT EXIT QUESTIONAIRE FORM 
THE FOLDER WILL ALSO CONTAIN:  
LABELS (2 EACH VISIT) FOR THE 12 WEEK TOOTHBRUSH/TOOTHBRUSH HEAD COLLECTION 
 
 
 
 
EXAMPLE:  
 
 
 
 
 
 
 
#101 D.O.E 
12 WEEK 

CONFIDENTIAL 
Page 23 of 27 
 
 
 
IMPORTANT NOTES 
 
Throughout the study you must refrain from daily flossing or interdental cleaning and daily use of 
mouthwash, or any other toothbrush or paste other than that which has been provided. 
 
Chewing gum is discouraged. 
 
For each clinic visit you must have at least 7 but no more than 12 hrs. of accumulated, non-brushed, 
undisturbed plaque/debris before each appointment. 
 
Do not have your teeth cleaned professionally during the study. 
 
If you should have any dental problems during the study, do not refrain from seeking proper treatment. 
Please inform us of any dental treatment as this might preclude you from further participation in the 
study. 
 
If you should have any other questions or concerns, please call Dr. Cathy Winters  (920) 517-5263. 
 
APPOINTMENTS: 
 
BASELINE 
DATE 
TIME 
 
 
2 WEEKS 
DATE 
TIME 
 
 
4 WEEKS 
DATE 
TIME 
 
 
12 WEEKS 
DATE 
TIME 
 
 
 
PLEASE NOTE:  If you are unable to keep your appointment, please contact Dr.Winters. This 
action may exit you from further participation in the study. We will try to reschedule, but there are 
limitations to the availability of the examiners and clinic hours. 
 
NOTE:  This appointment schedule will be sent to the patient prior to the start of the study. A 2nd 
copy will be given at the baseline visit. The 3rd copy will remain in the patient record. 
 
 
SUNSTAR POWERED TOOTHBRUSH STUDY 
MARQUETTE UNIVERSITY SCHOOL OF DENTISTRY 

CONFIDENTIAL 
Page 24 of 27 
 
DENTAL HISTORY 
 
How did you hear about the study?   
 
 
 
What are your feelings about the condition of your teeth?   
 
 
 
 
 
 
 
 
What are your feelings about your past dental experiences?   
 
 
 
 
 
 
 
 
Dental Experience:  Do you now or have you had 
 
 Toothaches 
 
 clenching/grinding day or night 
 
 orthodontics 
 
 Bad breath 
 
 pain in or near ear 
 
 root canal work 
 
 Pain in chewing   
 other sore or painful 
 
bridgework, or partial  
 
Canker sores 
 
areas in the mouth 
 
dentures 
 
Bleeding gums  
missing teeth 
 
Gum surgery – if Yes, where?   
 
 
Wisdom tooth removal – if Yes, when & where?  
 
 
 
 
List surgical procedures in sequence by date:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Have you had regular dental check-ups?   Yes   No      Date of last check-up: 
 
 
 
Dietary Profile: 
Do you eat or drink between meals?     Yes     No 
 
Does your diet include any of the following: 
 
Chewing gum Yes     No 
cookies/cakes/pastries 
Yes     No 
 
Candy bars 
Yes     No 
sugar in coffee or tea 
Yes     No 
 
Candy 
Yes     No 
breath mints/cough drops 
Yes     No 
Oral Hygiene Status – How often do you brush?   
 
 Type of toothpaste? 
 
Type of brush?    Power/manual    Hard /soft bristle?  How often do you change the brush: 
 
Do you use dental floss?    Yes     No        If Yes, how often?  Frequent (daily) 
 
 
 
 
Sporadic (weekly) 
 
 
 
 
Infrequent (monthly or less) 
What is your major dental concern?   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
To the best of my knowledge, I have answered every question completely and accurately, I will inform 
study group of any change in my health and/or of medication. 
 
Patient’s signature:    
 
 
 
 
 
 
Reviewed by:   
 
 
 
 
 
 
 
Date:    
 
 
 
 
 

CONFIDENTIAL 
Page 25 of 27 
 
 
INFORMED CONSENT: POWERED TOOTHBRUSH STUDY 
 
 
INTRODUCTION.  I,  
, hereby agree to participate in the 
research study entitled, powered tooth brushing on tooth / dental plaque and gingivitis. I understand 
that while the program will be under the supervision of Dr.’s Andrew Dentino and Dr. Cathy Winters 
other professional persons may be designated to assist or act for them. 
 
 
PURPOSE.  The purpose of the study is to examine over a three month period of time how the use of a 
new powered toothbrush compares to an ADA accepted manual brush in removing dental plaque and 
reducing gingivitis. 
 
 
PROCEDURES.  I will have a dentist examine my teeth and gums for the presence of dental plaque, 
tartar, and gingivitis four to five times over an approximately three month period. I will also be given an 
oral cancer screening examination at my first (screening) visit.   
 
 
The experimental aspect of this study is the short-term (3 month/12 week) comparison of the use of a 
new powered toothbrush compared to an ADA accepted manual brush with regard to their ability to 
remove plaque and reduce gingivitis. I agree to avoid daily use of mouthrinse and/or floss for the 
duration of the study. 
 
 
My participation in the project will be to come to the dental clinic four/five times over a three month 
time period. I will be asked to brush my teeth only with the assigned toothbrush and toothpaste for two 
minutes twice a day. My first visit will be a screening appointment which will take approximately 45 
minutes at which time I will be asked to fill out a medical and dental history, and then be given an oral 
examination by a dentist to see if I meet the entrance requirements of the study. If I meet the entrance 
criteria, I will be invited to participate in the study. For those subjects who qualify for the study there 
will be three to four additional appointments. The second visit is called the “baseline” appointment and 
will take approximately an hour and 15 minutes. At this visit I will have a dental professional re-examine 
my teeth and gums for plaque and gingivitis. After this I will be randomly assigned to either a manual or 
power brush and given toothpaste to use at home as directed. I understand that I must use only my 
assigned brush during the study. I understand that any questions I have regarding the use of the brush 
or the need for replacement must be directed to the study coordinator, Dr. Cathy Winters. At the 
following visits, 2, 4 and 12 weeks after the baseline visit, my teeth and gums will be examined again as 
before and I will return the assigned brush to the study coordinator at the last visit.  
 
 
I understand that approximately 72 subjects will be involved in this study. 
 
 

CONFIDENTIAL 
Page 26 of 27 
 
RISKS.  I have been informed of the discomforts and risks which I may reasonably expect as part of the 
study. These include minor discomfort involved with an examination of the gums which will involve 
periodontal probing as a part of the screening visit, and possibly a dental cleaning (prophylaxis) at the  
 
end. In addition, I may experience more gingivitis by not using interdental cleaners and mouthrinses 
during the length of the study.  The toothbrush I will be assigned is likely to be different from the one I 
currently use, and it may have a different feel to it. 
 
 
BENEFITS.  I understand that the information obtained may be useful scientifically and helpful to others. 
 
 
MONETARY BENEFITS.  I understand that I will receive $100.00 which will be paid to me in $25 dollar gift 
cards, one at each appointment, starting from the baseline visit. I further understand that I will not be 
paid for any visits that I do not complete. 
 
 
ALTERNATIVE PROCEDURES.  I understand that the appropriate alternative procedure which might be 
advantageous for me is to not participate in the study and seek standard dental care and use 
commercially available toothbrushes and toothpaste. 
 
 
CONFIDENTIALITY.  I have been promised that any information obtained from this investigation that can 
be identified with me will remain confidential or will be disclosed only with my permission. However, I 
am in agreement that scientific data or medical information not identifiable with me resulting from the 
study may be presented at meetings and published so that the information can be useful to others. This 
includes the possibility that your medical and dental records gathered in this study may be reviewed by  
the sponsor (Sunstar) as part of reviewing information pertinent to the study, and could include the 
FDA, the ADA and the IRB at Marquette University inspecting records from this study. 
 
 
RESEARCH SUBJECTS’ RIGHTS.  I have read or have had read to me all of the above. Dr. Dentino/Dr. 
Winters has explained the study to me and answered all of my questions. I have been told of the risks or 
discomforts and possible benefits of the study. 
 
 
If at any time I have any medical problems or questions, I may contact the Principle investigator, Dr. 
Dentino at (414) 288 5944 during the day, or Dr. Winters at (920) 517-5263 or Dr. Keerthi Kamreddy at 
(254) 979-2544, after hours. I also understand that if I have questions or concerns about my rights as a 
research participant I may contact the Office of Research Compliance at Marquette University at 414-
288-7570 for further information related to the research and my rights as a subject. 
 
 
I realize I have not released Marquette University from liability for negligence. In the event of physical 
injury resulting from biomedical and behavioral research procedures, medical treatment in the amount 
not to exceed $500 is available for such physical injury, but no monetary compensation is available for 
wages lost because of such physical injury. 
 
 

CONFIDENTIAL 
Page 27 of 27 
 
A description of this clinical trial will be available on http://www.ClinicalTrails.gov, as required by U.S. 
law.  This website will not include information that can identify you.  At most, the website will include a 
summary of the results.  You can search this web site at any time. 
 
 
WITHDRAWAL.  I understand that I do not have to take part in this study, and my refusal to participate 
will not prejudice my present of future relationship with Marquette University School of Dentistry. The 
results of this study may be published, but my records will not be revealed unless required by law. 
 
I understand my rights as a research subject, and I voluntarily consent to participate in this study. I 
understand what the study is about and how and why it is being done. I will receive a signed copy of this 
consent form. 
 
 
 
 
 
 
 
Subject Signature 
 
Date 
 
 
 
 
 
 
Signature of Subjects’ Representative* 
 
Date 
* Only required if subject not competent 
 
 
 
 
 
 
Signature Witness 
 
Date 
 
 
 
 
 
 
Signature of Investigator 
 
 
Date