Effect of Curved Design Soft-Picks on Plaque Accumulation on Patients With Signs of Gingivitis
Phase: NA
Conditions: Gingivitis
Sponsor: Sunstar Americas

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Title: Effect of Curved Design Soft-Picks® on Plaque Accumulation on Patients 
with Signs of Gingivitis 
 
Project Code: Curved Pick Study (CPS) 
 
 
Version#:6 
 
Date: October 20, 2016 
 
 
 
Study Site: 
Center for Oral and Systemic Diseases 
 
 
 
 
 
General and Oral Health Center 
2040 Old Dental, CB #7450 
 
 
 
 
 
University of North Carolina at Chapel Hill 
 
 
 
 
 
School of Dentistry 
 
 
 
 
 
Chapel Hill, NC 27599-7450 
 
 
 
 
 
Tel:  919.537-3424 
 
 
Principal Investigator: 
Antonio J. Moretti, DDS, MS 
 
Clinical Associate Professor and Graduate Program Director 
 
UNC School of Dentistry, Department of Periodontology  
 
111 Brauer Hall 
 
Chapel Hill, NC 27599-7450 
 
Tel. 919-537-3734  Fax 919-537-3732 
 
antonio_moretti@unc.edu  
 
 
Study Coordinator: 
 
 
S.T. Phillips, RDH-BS 
 
 
 
 
 
2020 First Dental Building, CB #7450 
 
 
 
 
 
385 S. Columbia St.  
 
 
 
 
 
Chapel Hill, NC  27599-7450 
 
 
 
 
 
Tel: 919-537-3422 
 
 
 
 
 
stphillips@unc.edu 
 
 
Study Sponsor: 
Sunstar Americas, Inc. 
 
301 E. Central Rd. 
 
Schaumburg, IL 60195 
 
 
 
 
 

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Sponsor Clinical Project Manager: 
Akane Takemura, PhD 
 
Senior Manager 
 
Technology and Product Development 
  
Sunstar Americas, Inc. 
 
301 E. Central Road 
 
Schaumburg, IL 60195 
 
Tel:  847-794-4276 
 
akane.takemura@us.sunstar.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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STUDY OVERVIEW 
 
Study Title (ID) 
Effect of Curved Design Soft-Picks® on Plaque Accumulation on Patients 
with Signs of Gingivitis 
Project 
 
The aim of this study is to evaluate the efficacy of a new interdental cleaning 
device called Soft-Picks® Advanced, as compared to a leading brand floss; 
and, how ease of use can promote the establishment of a hygienic routine of 
cleaning interproximal spaces. The Soft-Picks® Advanced has a new design 
allowing a user to easily access to difficult interdental sites, such as spaces 
between premolars and molars. As compared to conventional Soft-Picks®, it 
has a unique handle design with an increase in thickness.  This study is a single 
center with parallel design, single blinded, which will randomize eligible 
subjects into two treatment groups. 
 
Subjects 
 
 
It is planned that 53 subjects will be enrolled and randomized with 15% 
dropout, in order to complete with a minimum of 44 subjects (22 subjects per 
treatment group) which is eligible for statistical analysis.   
Subjects must: 
• be age 18 -70 years 
• be routine manual toothbrush users 
• have no or little[1] experience with interproximal cleaning devices, such as 
floss or interdental brush 
• have signs and symptoms of gingivitis, defined by: all PD ≤4mm and BOP 
≥10% but ≤50% of sites. 
 
Subjects must not: 
• have participated in an oral care study in the previous 90 days 
 
Subjects may not: 
• have any tooth site with  >5mm PD or  >3mm attachment loss 
 
[1] Definition of little: no habitual use of any interproximal cleaning devices; subjects cannot recall the last time 
he/she used it, and/or he/she can recall such experience only at a dental office visit 
 
Study Design 
 
• Single Center 
• Parallel design 
• Randomized: 2 treatment groups (1 Device-A Group and 1 Device-B 
Group) with 53 randomized to complete with minimum of  44  subjects (22 
subjects per Treatment Group) balanced for gender 
• Home use period of total 28 days (4 weeks) 
• Single Blinded (efficacy examiner(s)) 
Treatment Groups   
• Device-A: Oral-B Glide Pro-Health Floss Original   
• Device-B: Sunstar GUM Soft-Picks® Advanced  

 
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Clinical 
Evaluations 
 
• Oral Examination 
• Lobene - Turesky Modification of the Quigley-Hein Plaque Index (2) 
• UNC Modified Gingival Index (UNC-GI)  
• BOP - bleeding on probing 
• PPD - probing pocket depth 
• CEJ - cementoenamel junction  
• Safety 
(2) Turesky S, Gilmore N, Glickman I.  Reduced plaque formation by the chloromethyl analogue of Vitamin C.  
J Periodontol 1970; 41: 41-43. 
 
Subject Visit 
Summary 
 
Visit 1 – Screening and enrollment: 
Informed Consent; Screening Medical/Dental History and Demographics; 
Screening Oral Exam;  Screening Clinical Indices: MQH-PI (designated teeth 
only), UNC-GI (full mouth); PPD, CEJ and BOP (full mouth); Teeth Site 
Selection(s); Enrollment, Prophylaxis; Regime Product  Dispense: Assigned 
Manual Toothbrush and Dentifrice; Supervise Use; Follow-up Visits 
Scheduled 
 
Visit 2 – Baseline: 
12-18 hours of Plaque Accumulation,  and 3-6 hours of  Diet Restriction 
Observed;  Randomization; AE Monitoring: Interview and Oral Exam; Taking 
Clinical Indices: MQH-PI, UNC-GI (designated interproximal sites); PPD, 
CEJ and BOP (designated interproximal sites) Dispense: Assigned Products; 
Usage Instruction, Supervise Use; Distribute Subject Diary; Follow-up Visits 
Scheduled 
 
Visit 3 – Two (2) weeks observation:   
12-18 hours of  Plaque Accumulation and 3-6 hours of  Diet Restriction 
Observed;  Compliance Monitoring; AE Monitoring: Interview and Oral 
Exam; Taking Clinical Indices: MQH-PI, UNC-GI (designated interproximal 
sites); Follow-up Visits Scheduled 
 
Visit 4 – Four (4) weeks observation:   
12-18 hours of  Plaque Accumulation and 3-6 hours of  Diet Restriction 
Observed;  Compliance Monitoring; AE Monitoring: Interview and Oral 
Exam; Taking Clinical Indices: MQH-PI, UNC-GI (designated interproximal 
sites); PPD, CEJ and BOP (full mouth); Prophylaxis and Referral for Further 
Care, if indicated; Product & Diary Return; Subject Compensation, 
Questionnaire and Study Dismissal  
 

 
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Home Use: 
 
• Daily afternoon/evening use of assigned treatment products until return for 
final visit 
• Record product performance and experience on a diary 
• All studied treatment products are to be used with: 1) Crest Cool Mint Gel 
toothpaste and 2) Oral-B Indicator manual toothbrush 
• No other oral hygiene aids allowed during the study 
 
 
 
 

 
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List of Abbreviations 
Abbreviation 
Definition 
ADA 
American Dental Association  
AE 
Adverse Event 
ANOVA 
Analysis of Variance 
B 
Buccal 
BOP 
Bleeding on Probing 
CAL 
Clinical Attachment Level 
CFR 
Code of Federal Regulation 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
DDE 
Direct Data Entry 
DF 
Distofacial 
DL 
Distolingual 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
GBI 
Gingival Bleeding Index 
GCP 
Good Clinical Practice 
GM 
Gingival Margin 
ICH 
International Conference on Harmonization 
IP 
Interproximal 
IRB 
Institutional Review Board 
ITT 
Intent to Treat 
IU 
Interproximal Unit 
L 
Lingual 
LL 
Lower Left 
LR 
Lower Right 
MF 
Mesiofacial 
UNC-GI 
UNC (modified) Gingival Index 
ML 
Mesiolingual 
MTB 
Manual Toothbrush 
MQH-PI 
Lobene - Turesky Modification of the Quigley-Hein Plaque Index 
PPD 
Probing Pocket Depth 
QTS 
Quadrant Tooth Site 
SAE 
Serious Adverse Event 
SAS 
Statistical Analysis Software 
UADE 
Unanticipated Adverse Device Effect 
UL 
Upper Left 
UR 
Upper Right 
 
 
 
 
 
 
 

 
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Table of Contents 
1.0 
Background .................................................................................................................. 9 
1.1 
Introduction & Product Description ........................................................................... 9 
1.2 
Risks and Benefits ................................................................................................... 10 
1.3 
Justification of Treatment Periods and Regimens ..................................................... 10 
1.4 
Subject Population to be Studied .............................................................................. 10 
1.5 
Statement of Compliance ......................................................................................... 10 
2.0 
Study Objective(s) ...................................................................................................... 11 
2.1 
Primary Objective .................................................................................................... 11 
2.2 
Secondary Objective(s) ............................................................................................ 11 
2.2.1 to evaluate the user experience in terms of ease of product use and motivational level 
to use (level of difficulty in hygienic routine establishment); .............................................. 11 
2.2.2 to evaluate the level of correspondence between user experience and product 
performance (satisfaction level). ......................................................................................... 11 
3.0 
Study Design .............................................................................................................. 11 
3.1 
Primary Endpoint ..................................................................................................... 11 
3.2 
Secondary Endpoint(s) ............................................................................................. 11 
3.2.1 performance of an assigned product based on user experience; ................................ 11 
3.2.2 reductions from baseline in gingivitis as measured by interproximal UNC-GI, PPD 
and BOP post home use for 28 days; .................................................................................. 11 
3.2.3 safety of the study products; .................................................................................... 11 
3.3 
Trial Design ............................................................................................................. 12 
3.4 
Controls to Minimize Bias ....................................................................................... 12 
3.4.1 Randomization of Subjects ...................................................................................... 12 
3.4.2 Blinding .................................................................................................................. 12 
3.5 
Study Regimen and Product Labeling ...................................................................... 12 
3.5.1 Study Regimens ...................................................................................................... 12 
3.5.2 Product Labeling ..................................................................................................... 12 
3.6 
Products, Treatments and Medications not Permitted on Study ................................ 12 
3.7 
Study Sequence Diagram ......................................................................................... 14 
3.8 
Expected Duration of Study ..................................................................................... 15 
3.9 
Discontinuation Criteria/Stopping Rules .................................................................. 15 
3.10 
Maintenance of Randomization Information ............................................................ 15 
3.10.1 Sponsor ................................................................................................................... 15 
3.10.2 Site ......................................................................................................................... 15 
3.10.3 Procedures for Breaking Randomization Codes ....................................................... 15 
3.11 
Study Data:  Source Documentation, EDC Reporting and Data Quality Control ....... 15 
3.11.1 Source Documentation ............................................................................................ 15 
3.11.2 EDC Reporting ....................................................................................................... 16 
3.11.3 Data Quality Control ............................................................................................... 17 
4.0 
Study Design .............................................................................................................. 17 
4.1 
Inclusion Criteria ..................................................................................................... 17 
4.2 
Exclusion Criteria .................................................................................................... 18 
4.3 
Continuation Criteria ............................................................................................... 19 
4.4 
Withdrawal Criteria ................................................................................................. 19 
5.0 
Treatment of Subjects ................................................................................................. 19 
5.1 
Schedule of Examinations and Tests ........................................................................ 19 
5.1.1 Visit 1 – Screening and Enrollment ......................................................................... 19 

 
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5.1.2 Visit 2 – Baseline .................................................................................................... 21 
5.1.3 Visit 3– Day 14 ....................................................................................................... 23 
5.1.4 Visit 4– Day 28, Final ............................................................................................. 24 
5.1.5 Visit Overview Table .............................................................................................. 27 
5.2 
Procedures for Monitoring Compliance .................................................................... 29 
5.3 
Product Accountability ............................................................................................ 29 
6.0 
Efficacy Assessments ................................................................................................. 30 
6.1 
Parameters of Efficacy ............................................................................................. 30 
6.2 
Methods and Timing of Assessing and Analyzing Efficacy Variables ...................... 30 
7.0 
Safety Assessments..................................................................................................... 30 
7.1 
Concomitant Medications ........................................................................................ 31 
7.2 
Adverse Events ........................................................................................................ 31 
7.3 
Unanticipated Adverse Device Effects ..................................................................... 32 
7.4 
Parameters of Safety ................................................................................................ 32 
7.5 
Methods and Timing of Assessing and Analyzing Safety Variables ......................... 32 
7.6 
Procedures for Reporting Safety Events ................................................................... 33 
7.6.1 Expedited Reporting ............................................................................................... 33 
7.6.2 Other Reporting ...................................................................................................... 33 
7.7 
Disposition and Follow-up of Adverse Events.......................................................... 33 
8.0 
Statistical and Analytical Plan..................................................................................... 33 
8.1 
Determination of Sample Size .................................................................................. 33 
8.2 
General Considerations ............................................................................................ 34 
8.3 
Subject Disposition .................................................................................................. 35 
8.4 
Demographics and Baseline Characteristics ............................................................. 35 
8.5 
Treatment Compliance ............................................................................................. 35 
8.6 
Primary Efficacy Analysis ....................................................................................... 35 
8.7 
Secondary Efficacy Analysis.................................................................................... 36 
8.8 
Safety Analysis ........................................................................................................ 36 
8.9 
Interim Analysis ...................................................................................................... 36 
9.0 
Access to Source Documents ...................................................................................... 37 
10.0 
Ethical Considerations ................................................................................................ 37 
11.0 
Study Confidentiality .................................................................................................. 37 
11.1 
Confidentiality Standards ......................................................................................... 37 
11.2 
Participant Confidentiality ....................................................................................... 37 
12.0 
Financial Considerations ............................................................................................. 38 
13.0 
Publication Policy ....................................................................................................... 38 
14.0 
Investigator’s Statement.............................................................................................. 39 
15.0 
References .................................................................................................................. 40 
16.0 
Appendix I Product Instruction for tooth brushing (by ADA) ...................................... 41 
17.0 
Appendix II Product Instruction for GUM Soft-Picks® Advanced .............................. 42 
18.0 
Appendix III Product Instruction for Glide Pro-Health Floss ....................................... 43 
19.0 
Appendix IV Template of a User Diary (only Day 1) .................................................. 44 
20.0 
Appendix V   User Questionnaire ............................................................................... 49 
 
 
 
 

 
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Background 
Introduction & Product Description 
 
Product Description: 
 
In order to maintain good gingival and periodontal health, the most effective approach is 
to regularly remove bacterial biofilm, which poses threats to develop gingivitis and likely 
periodontitis, if unremoved. The biofilm is removed by toothbrushing, a most known 
method; however there is still a risk of developing periodontal diseases when they are left 
unremoved, especially in interproximal spaces. Interproximal spaces are naturally 
difficult to reach for plaque removal. The teeth contours are different among people; 
therefore there has been need of interproximal cleaning devices, such as floss and 
interdental brushes. Along with such product development, there have been many clinical 
studies which succeeded in showing that the combination of using a toothbrush and 
interproximal cleaning devices improve the reduction in biofilm accumulation. This 
practice  is recommended by the American Dental Association (ADA)[3]: 
 
The ADA recommends brushing twice a day and cleaning between teeth with 
floss (or another interdental cleaner) once a day.  
 
According to the American Academy of Periodontology (AAP) survey[4], 27% of US 
adults have admitted they have provided false information regarding their flossing routine 
to their dentists. In addition, the survey shows that 36% of Americans would rather do an 
unpleasant activity, such as cleaning the toilet, rather than flossing. This indicates that 
establishing a routine to floss regularly is difficult and challenging, yet it has been 
recommended that with regular brushing, interproximal cleaning is an important aspect to 
maintain good gingival and periodontal health.  
 
In order to overcome such patient compliance problem, different types of interproximal 
cleaning devices have been developed and released in the market. Since their release, 
interdental brushes have gained popularity because they are easy to use. Soft-Picks® by 
Sunstar G·U·M is one of the many types of interdental cleaning devices in the market; 
however, it has a unique design that is different from other devices. It has an 
advantageous design which uses gentle rubber bristles (small ridges), as compared to 
regular nylon bristles, which can potentially cause gingival irritation and trauma.  
 
The aim of this study is to evaluate the efficacy of a new interdental device called Soft-
Picks® Advanced, as compared to a leading brand floss, and how ease of use can 
promote the establishment of a hygienic routine of cleaning interproximal spaces. The 
Soft-Picks® Advanced has a new design allowing a user to easily access difficult 
interdental spaces, such as spaces between premolars and molars. As compared to 
conventional Soft-Picks®, it has a unique handle design with an increase in thickness and 
curvature. 
 
[3] http://www.ada.org/en/science-research/ada-seal-of-acceptance/product-category-information/floss-and-other-
interdental-cleaners  
[4] https://www.perio.org/consumer/quarter-of-adults-dishonest-with-dentists 
 

 
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Risks and Benefits 
Participants enrolled in this study may experience risks associated with standard dental 
examinations, dental prophylaxis, tooth brushing and use of manual interdental oral 
hygiene devices. Risks are not limited to but may include the following: 
• Gingival inflammation, irritation, bleeding or abrasion from tooth brushing and/or 
use of the investigational (interdental) devices.  
• Minor pain, discomfort and bleeding may be present during periodontal probing. 
• Gingival and/or tooth pain or sensitivity, loosened or damaged dental restorations 
may occur as a result dental prophylaxis 
• Jaw soreness may occur as a result of opening the mouth for examinations and 
procedures.  
 
 
Justification of Treatment Periods and Regimens 
 
Visit 1: Screening and enrollment    
Study participants are consented and selected based on a standard set of eligibility criteria 
in order to limit exposure to subjects who may experience undue risk by participating, 
and to select a panel exhibiting moderate levels of plaque accumulation and mild level of 
gingival inflammation, in whom a response may be evaluated over time. 
 
Visit 2: Baseline    
This is a baseline assessment following 21 days from the screening and enrollment visit. 
The randomization and assignment of home use treatment regimen are defined. 
 
Visit 3: Two (2) weeks follow-up   
This is the first efficacy assessment following 14 days of the assigned home use regimen, 
as well as the mid-point safety visit.  It was selected as a point in time deemed sufficient 
to elicit responses in both the clinical and sub-clinical manifestations of change in oral 
health status, should any changes occur. 
 
Visit 4: Four (4) weeks follow-up   
This is the secondary efficacy assessment following 28 days of the assigned home use 
regimen, as well as the final safety visit.  It was selected as a point in time deemed 
sufficient to elicit responses in both the clinical and sub-clinical manifestations of change 
in oral health status, should any changes occur. 
 
 
Subject Population to be Studied 
This study shall be conducted with male and female volunteers in good general health, 
aged 18 -70 years who have signs and symptoms of gingivitis. Complete 
inclusion/exclusion criteria are provided in Section 4.0. 
 
 
Statement of Compliance 
This study is being conducted according to the ICH Guideline for Good Clinical Practices 
(GCPs).  All study materials are to be reviewed by the UNC Institutional Review Board 
(IRB) prior to enrollment of any subject or dispense of any test article. The ethical 

 
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principles for the treatment of human subjects on this study have their origin in the 
Declaration of Helsinki.   
 
All study personnel will be required to have completed Human Subjects Protection 
Training and Good Clinical Practice Training. A copy of each person’s completion 
certificate is maintained in the GO Health Center and will be added to the Study Master 
File. All study staff will receive training on all aspects of the protocol. Study personnel 
will ensure that the research study is conducted, recorded and reported in accordance with 
the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and 
the applicable regulatory requirements. The study coordinator will monitor source 
documentation daily to ensure that data fields are complete and accurately reflect study 
activities. 
 
Study Objective(s) 
Primary Objective 
The primary objective of this study is to evaluate the possible difference in interproximal 
plaque accumulation between lead-brand floss users and Soft-Picks® Advanced (non-
wired interdental brush) users 
 
Secondary Objective(s) 
The secondary objectives focus on the relationship between a user and a product. This is 
important due to the fact that periodontal preventative care is mostly accomplished by a 
public health approach; therefore the secondary objectives of the study are:  
 
 
Also the secondary objective of the study contains evaluation of the possible difference in 
gingival inflammation between lead-brand floss users and Soft-Picks® Advanced (non-
wired interdental brush) users 
 
Study Design 
Primary Endpoint 
The primary endpoint is the reduction from baseline in interproximal plaque 
accumulation as measured by MQH-PI following a period of home use for 14 and 28 
days. 
 
Secondary Endpoint(s) 
The Secondary Endpoints of the study are: 
 
reductions from baseline in gingivitis as measured by interproximal UNC-GI, 
PPD and BOP post home use for 28 days; 
 
to evaluate the user experience in terms of ease of product use and motivational level to 
use (level of difficulty in hygienic routine establishment); 
to evaluate the level of correspondence between user experience and product 
performance (satisfaction level).  
performance of an assigned product based on user experience; 
safety of the study products; 

 
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Trial Design 
This is randomized, parallel, single-blinded study design.  This is a standard study design 
used to compare treatments following a period of home use of the assigned study 
products. 
 
A summary of activities and evaluations at each study visit is outlined in Section 5.0.   
 
Controls to Minimize Bias 
In order to minimize bias, all study participants will be randomly allocated to a treatment 
assignment.  Additionally, applicable staff member(s) who are performing efficacy 
assessments will be blinded to the treatment assignment of the study subjects.    
 
Subjects shall be allocated to the treatment groups according to a pre-defined 
randomization schedule.  Randomization will be blocked by sex only. 
 
 
The blinded staff member(s), e.g., Examiners, shall be blinded to the treatment 
allocation of the study subjects at the time of randomization and efficacy 
evaluation period.  All other personnel involved with the conduct of this study 
will not be blinded.  If the Principal Investigator is also working in a capacity that 
requires that he/she directly assess an efficacy endpoint, he/she shall be blinded 
until all efficacy endpoint evaluations are completed. 
 
Product allocation shall be reported in a database so that compliance and 
randomization can be monitored for accuracy.  However, the blinded staff 
member(s) shall not have access to the database until all efficacy evaluations are 
completed. 
 
Study Regimen and Product Labeling 
 
The study regimens consist of the following: 
 
• Regimen 1/Interproximal Cleaning Aids 
Once daily use of GUM Soft-Picks® Advanced or Oral-B Glide Pro-
Health Original each afternoon or evening at approximately the same time 
every day 
 
• Regimen 2/Manual Toothbrush 
Twice daily use of: Oral-B Indicator manual toothbrush & Crest Cool 
Mint Gel dentifrice.  
 
 
Products, Treatments and Medications not Permitted on Study 
Once a subject is enrolled on-study, the use of any additional oral hygiene treatments and 
aids other than those prescribed is prohibited. A list of prohibited devices and aids 
Randomization of Subjects  
Blinding 
Study Regimens 
Product Labeling 

 
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includes but is not limited to: power toothbrushes, other types of interproximal cleaning 
aids, mouthwash, chewing gum, oral irrigators or whitening products. The use of any 
dentifrice other than Crest Cool Mint Gel is also prohibited.   
 
The use of antibiotics or antibacterial agents is prohibited.  Chronic use (i.e., two weeks 
or more) of any medication known to affect periodontal status (e.g., phenytoin, calcium 
antagonists, cyclosporine, non-steroidal anti-inflammatories and anticoagulants) is also 
prohibited. (Daily use of 81mg Aspirin is allowed).   
 
All deviations shall be documented.  Participants who have used prohibited products, 
devices and/or medications may be discontinued.  Upon discovery of such usage, the 
Principle Investigator shall be notified for discussion and reassessment of eligibility and 
study continuation.  
 
In the event that an enrolled subject requires dental care outside the scope of the study, 
he/she may be discontinued from the trial and no further procedures performed, other 
than safety assessments (e.g., oral exam and adverse event interview).  
 
 
 

 
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Study Sequence Diagram 
Schema 1 below illustrates the sequence of examinations and treatment periods for study 
subjects. 
 
 
 
Visit 1, Screening and 
Enrollment
Visit 2, Baseline 
Consent 
Medical/Dental History & Demographics 
Oral Exam  
Teeth Selection 
Enroll 
Plaque Accumulation and Diet Restrictions Observed 
Med History Update 
AE Monitoring: Interview  
AE Monitoring: Oral Exam 
Med History Update 
Compliance Monitoring 
MQH-PI, UNC-GI, (designated teeth);  
12-18 hrs since last 
oral hygiene 
Visit 4, Final Visit 
(Day 28) 
12-18 hrs since last 
oral hygiene
21+/- 2 days 
Plaque Accumulation and Diet Restrictions Observed 
AE Monitoring: Interview  
AE Monitoring: Oral Exam 
Med History Update 
MQH-PI, UNC-GI, PPD, CEJ & BOP  
(designated teeth)
14+/-2 days 
Visit 3, Two weeks 
Visit 
12-18 hrs since last 
oral hygiene
Plaque Accumulation and Diet Restrictions Observed 
AE Monitoring: Interview  
AE Monitoring: Oral Exam 
Med History Update 
Compliance Monitoring
14+/-2 days 

 
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Expected Duration of Study 
Study participation period per individual is approximately 49 days. 
 
Discontinuation Criteria/Stopping Rules 
Individual participants may be removed from the study if significant non-compliance is 
noted.  Additionally, if in the opinion of the investigator, the health or safety of a subject 
is affected adversely by participation in the study, the subject shall be removed.  A 
subject may be replaced in the event of withdrawal or dropout. 
 
Maintenance of Randomization Information 
 
 
Once study procedures have been completed, a copy of the completed 
randomization list shall be collected from the site for the Sponsor files.  Once the 
study is completed and all data cleaned, the randomization schedules will be 
merged with the overall database for analysis.     
 
A randomization list will be created by UNC Dental Data Manager and provided 
only to the assigned personnel in the GO Health Center who are responsible for 
randomization and product dispensation.   The randomization ID and the 
corresponding treatment shall be transcribed into the study case report forms 
(CRFs).  It is the responsibility of the designated Site personnel to maintain the 
integrity and the blind of randomization.  The original completed list shall remain 
in the site master file and be available for review by study Monitor(s) to ensure 
compliance.   
 
Emergency unblinding for adverse events may be performed by requesting the 
participant’s specific treatment assignment from the Site personnel delegated 
randomization responsibilities. Such an event should be documented and include 
the number of the subjects unblinded, the date, and a list of all ‘blinded’ personnel 
that received the unblinded information. If a subject’s treatment assignment is 
unblinded, the sponsor and the IRB must be notified immediately by telephone or 
e-mail.   
 
 
Study Data:  Source Documentation, EDC Reporting and Data Quality Control  
 
Source data includes all information in original records and certified copies of 
original records of clinical findings, observations, or other activities in a clinical 
investigation used for reconstructing and evaluating the investigation.  This 
information may be collected prior to (e.g., medical history), during or after the 
trial.   
 
Sponsor 
Site 
Procedures for Breaking Randomization Codes 
Source Documentation 

 
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Good documentation practices shall be followed to ensure that study results are 
built on a foundation of credible and valid data.  Also, to ensure an independent 
evaluator may reconstruct the trial as it happens. 
 
Source data may be captured as follows: 
• on paper or in electronic site study records or other health facility records 
for later transcription into eCRFs, or  
• directly reported into the eCRFs at the time of study observation or 
procedure completion (direct data entry (DDE)) 
 
A combination of the above is typical and expected for this study.  Source data 
shall be captured as follows: 
 
Site or other Health Facility Records 
(paper)* 
Directly in the eCRFs 
Consent process & disposition 
Clinical Indices (e.g., plaque index) 
Pre-existing Medical/Dental History  
& Updates  
             Oral Examinations  
Subject Diary Metrics 
  Demographic Information 
Product dispense and return 
                Vitals 
Safety and Eligibility  
        Height & Weight 
Adverse Events & Deviations 
           Tooth Status 
 
*Note:  Site study documents (paper) shall also be used when DDE is not possible (e.g., 
lost internet connection).   
 
Source documents to capture original data for later transcription shall have 
adequate Site/facility and subject identifiers, dates, etc., as appropriate and must 
be legible.   
 
Key Reminders:   
• Any source data captured directly in the eCRFs shall occur at the time of 
observation or procedure completion 
• All transcribed data must have paper/electronic source documents for 
verification 
• If handwritten, a black pen should be used to capture the data.  A pencil 
should never be used.  
• Corrections to source data should only be made at the time of original data 
capture or when other corroborating source documentation supports the 
edit.   
• Corrections to source data should be lined-through, initialed, dated.  
White-out or other obliterating techniques should never be used. 
 
EDC Reporting 

 
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Electronic Source Data for all subjects will be entered into Dental Toolkit. This is 
a secure, web-based EDC system, validated and US CFR Part 11 compliant 
provided by the GO Health Center. 
 
Access to the EDC system shall be protected by login identification and 
password. All delegated Site personnel shall be trained on procedures for data 
entry into the web-based system prior to study start.  Following, delegated staff 
shall be provided ID codes and passwords unique to each team member’s 
delegated study role and blinding requirements. A staff member’s ID 
code/password shall never be shared or used by another staff member, in any 
circumstance.   
 
Data submitted to the EDC system must follow automated parameters 
programmed to ensure the collection of consistent and complete data. Clinical 
data for eligibility and safety will be calculated and verified via SAS programing. 
The project statistician and study coordinator may remotely review data listings 
generated at different time points during the study. Data queries may be generated 
to resolve any discrepancies or concerns. Submitted data as well as all data 
modifications to submitted data shall be documented in system audit trails. 
 
Upon conclusion of the study, after all eCRFs are marked as complete and all 
discrepancies resolved, the Principal Investigator will be notified to review the 
case books. Once the Investigator has had time to review the case books, user 
privileges will be removed for all research personnel. Subsequently, the database 
shall be locked from all personnel other than the system administrator. The final 
data set shall be transferred to SAS and delivered via disk or into a protected file 
on a cloud server for the sponsor.  A copy of the data shall be saved to a disk for 
archiving purposes, and be made available for any potential audits.  
 
 
Study Design 
It is planned that healthy volunteers will be consented and screened to enroll 53 subjects in order 
to complete with a minimum of 44 subjects (22 per treatment group).  The following criteria 
must be met for subjects to qualify for enrollment: 
 
Inclusion Criteria 
Subjects accepted into the study must: 
 
INCL1 
Be willing and physically able to carry out all study procedures and be 
available at all times required for participation 
INCL2 
Be able to fully understand and comply with the written and verbal 
instructions provided 
INCL3 Provide written Informed Consent 
INCL4 
Be age 18 – 70 years 
INCL5 
Agree to return study materials at the required visit(s) 
INCL6 
Have a minimum of 20 ‘scorable’ teeth (excluding 3rd molars) 
Data Quality Control 

 
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INCL7 Have more than or equal to 10% and less than or equal to 50% Bleeding on 
Probing (BOP) sites 
INCL8 Have all PD less than or equal to 4mm 
INCL10 Have at least 12 qualifying, interproximal units (3 per quadrant) with closed 
contacts, without crown or restorations. (See section 5.1.1 ‘Teeth Selection’) 
INCL11 Be a regular manual toothbrush user for at least 2 months. 
INCL12 Be a non-smoker for at least 2 years. 
INCL13 Be willing to abstain from use of chewing gum and consumption of apples, 
carrots or other hard crunchy foods or thick skinned fruits for 3-6 hours before 
each visit.   
INCL14 Be willing to comply with 12-18 hours of no oral hygiene practices  
 
 
Exclusion Criteria 
Subjects shall be excluded if any of the following are present:  
 
EXCL1 A Medical or Dental condition that would be unduly affected by participation 
in this study, per Investigator Discretion 
EXCL2 Pregnant or nursing, per urine based pregnancy test 
EXCL3 A medical condition requiring antibiotic pre-medication prior to dental 
appointments 
EXCL4 Diagnosis of Xerostomia 
EXCL5 Any oral or extra oral piercing that interferes with the ability to perform study 
procedures and/or clinical assessments in the mouth 
EXCL6 Currently undergoing or requiring dental/periodontal treatment, or having had 
periodontal treatment in the six months preceding the study, where the 
subject’s study participation could present an undue safety risk or obscure the 
evaluation of study endpoints, per Investigator /Examiner discretion 
EXCL7 Oral surgery within the last 2 months 
EXCL8 A known allergy or sensitivity to products planned for use in this study 
EXCL9 Unwillingness to abstain from all other oral hygiene products other than those 
prescribed for the duration of the study 
EXCL10 Participation in an oral care study within the previous 90 days 
EXCL11 Are a dental student or dental professional 
EXCL12 Diagnosed diabetes with a current (30 days) HbA1C greater than 7 
EXCL13 Current use of antibiotic medications or use within 4 weeks of enrollment 
EXCL14 Presence of heavy deposits of calculus, either supragingival and/or 
subgingival, per Investigator/Examiner discretion  
EXCL15 Extensive crown or bridge work, rampant decay or excessive gingival 
recession, per Investigator/Examiner discretion 
EXCL16 Presence of orthodontic bands interfering with efficacy outcome(s) per 
Investigator/Examiner discretion  
EXCL17 Current use of professionally dispensed bleaching products or use within one 
month of screening. 
EXCL18 Be an employee, spouse or a relative of an employee of the clinical  
research site, or a dental products manufacturing, research or marketing firm. 
EXCL19 Chronic treatment (i.e., two weeks or more) with any medication known to 
affect periodontal status (e.g., phenytoin, calcium antagonists, cyclosporine, 

 
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anticoagulants, non-steroidal anti-inflammatory drugs) within one month of 
the screening examination (daily use of 81 mg Aspirin is not exclusionary)  
EXCL20 Have any tooth sites with:  > 5mm PD or attachment loss > 3mm, excluding 
3rd molars 
 
 
Continuation Criteria 
Subjects who sign the informed consent form are screened for eligibility at Visit 1. 
Subjects meeting all enrollment criteria shall be enrolled into the study. 
 
Withdrawal Criteria 
Study participation is voluntary. The participant 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).  Compensation for participation will be prorated for prematurely withdrawn 
subjects, (See Section 3.6 Products, Treatments and Medications not Permitted on Study  
 
Treatment of Subjects 
Subjects enrolled on the study are planned to complete 4 study visits as described below: 
 
Schedule of Examinations and Tests 
 
Visit 1 shall be conducted in the following manner: 
 
• Informed Consent 
Potential subjects are given the most current IRB/EC-approved consent to 
read and are provided the opportunity to ask and have answered questions 
about the study.  If they agree to participate, they shall sign the consent form 
and be given a copy for their records. Study procedures may then begin. 
 
• Medical/Dental History & Demographics 
The subject’s medical and dental history and baseline health status (including 
baseline medications) shall be captured and screened by the investigator or 
designee against the eligibility criteria. Further, eligibility screening shall be 
assessed by participant interview, where appropriate.  For safety monitoring, 
the baseline status shall be referenced when assessing for Adverse Events.  A 
template of the medical/dental history form can be found in the Essential 
Documents File. Demographics (age, sex, race and ethnicity) shall also be 
collected. 
 
• Baseline Oral Examination  
A dental examiner shall perform an oral examination to note baseline 
anomalies for future safety assessments. The gingiva, buccal mucosa, lips, 
vestibule, palate, tongue, and floor of the mouth are examined.  The oral 
cavity is carefully inspected for pathological conditions and other 
Visit 1 – Screening and Enrollment  

 
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abnormalities; e.g., evidence of gingival abrasion, irritations, lacerations, or 
ulcerations.    
 
Additionally, teeth are examined to note the location and condition of all 
restorations, including, but not limited to:  crowns (porcelain or metal), 
veneers, alloy restorations, composite restorations, etc. 
 
 
• Teeth Selection 
Twelve interproximal units shall be selected and qualified (3 units per 
quadrant) in order to collect MQH-PI and UNC-GI.  All 12 interproximal 
units shall be sampled for MQH-PI and UNC GI to collect a total of 24 facial 
site scores.  
The following are the selection qualifiers, for study teeth/sites  
 
➢ 
Qualifying units must include 1 anterior interproximal unit and 2 
posterior interproximal units in each quadrant. (Two of the four 
posterior units must include a 1st molar and 2nd molar.)  
➢ 
Qualifying units must not include 3rd molars 
➢ 
Qualifying units must include teeth with closed contacts. 
➢ 
Qualifying units must include only natural dentition without dental 
restorations covering any portion of the mesiobuccal or distobuccal 
surfaces of the tooth. 
 
• Modified QH Plaque Index   
A plaque assessment shall be assessed on teeth that make up the qualifying 
interproximal test sites using the Lobene - Turesky Modification of the 
Quigley-Hein Plaque Index(2). Plaque scores shall be visually assessed at the 
four (2) tooth surfaces that make up each of the 12 (6 per side) qualifying 
interproximal test units: mesiobuccal and distobuccal (scale of 0-5, see Table 
1 footnotes for details).   
 
• UNC Gingival Index (UNC-GI) 
A gingival assessment shall be performed based on the UNC modification of 
the Löe and Silness Gingival Index.  The gingiva shall be assessed at 6 sites 
per tooth:  distobuccal, direct buccal, mesiobuccal, distolingual, direct lingual 
and mesiolingual surfaces. 
 
Periodontal clinical measurements, including Peridodontal Probing Depth (PPD) 
and cementoenamel junction measures relative to the gingival margin (CEJ) and 
Bleeding on Probing (BOP) shall be assessed and reported per octant (quadrant 1 
facial, quadrant 2 facial, quadrant 2 lingual, quadrant 1 lingual, quadrant 3 facial, 
quadrant 4 facial, quadrant 4 lingual, quadrant 3 lingual). The gingiva shall be 
gently dried and segmented into marginal and papillary units, 6 sites per tooth:  
distobuccal, direct buccal, mesiobuccal, distolingual, direct lingual and 
mesiolingual surfaces. PPD shall be measured and recorded in tandem, at a site, 
before moving on to the next site within an octant.  Once the PPD assessment is 
completed in an octant, BOP shall be assessed in the same site order in that 

 
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octant.  Once all 3 measures have been collected in an octant, the process shall be 
repeated in the next octant until all octants have been assessed.   
 
• Probing Pocket Depth (PPD)  
Full-mouth probing pockets depths shall be assessed at 6 sites per tooth using 
a UNC15 periodontal probe (type to be used for all participants, all visits).  
PPD shall be measured from the free gingival margin to the base of the pocket 
and shall be recorded in millimeters (mm), rounding down to the nearest 
millimeter.   
 
• Bleeding on Probing (BOP)  
A full mouth bleeding assessment shall be assessed at 6 sites per tooth.  A 
dichotomous index shall be used to record:  bleeding (1), or the absence of 
bleeding (0). 
 
• Enrollment 
Subjects who meet the eligibility criteria shall be enrolled. (Note: Eligibility 
criteria that require paper-based source documentation will be identified prior 
to study start (see section 3.11.1 for details)).  The individual who confirms 
eligibility status to all criteria shall provide their signature/initials and date 
upon confirmation. 
 
•   Prophylaxis and Referral for Care, if indicated 
All subjects will be provided with dental prophylaxis. Any subject for whom a 
referral for urgent dental care is appropriate, will be provided these services. 
 
• 
Regime Product Dispense 
All participants shall be dispensed the same oral hygiene products (Regimen 
2- Twice daily use of: Oral-B Indicator manual toothbrush with Crest Cool 
Mint Gel dentifrice) in order to keep consistent during the study.   
 
• Supervised Regime Product Use  
Participants shall demonstrate understanding of the brushing instructions in a 
supervised session.  Research staff shall observe participants using their 
products to ensure proper usage according to instructions recommended by 
ADA, see Appendix I.  
 
• Follow-up Visit(s) Scheduled 
The appointments for Visits 2 shall be scheduled.  Plaque accumulation and 
diet restriction instructions, prior to the appointments, shall be reviewed.  
Additionally, participants shall be given verbal instructions to refrain from 
using prohibited treatments, medications and dental supplements for the 
duration of the study (see Section 3.6). Participants will be asked to provide 
preferred contact information (e.g. e-mail, phone or text) so that weekly visit 
reminders may be established.   
 
     Visit 2 shall occur 21 days after Visit 1 (+/- 3 days), in the following manner: 
Visit 2 – Baseline 

 
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• Randomization 
Participants shall be assigned their treatment group, using a randomization list 
generated by UNC and provided to the GO Health Center unblinded study 
personnel prior to study activation.  The Examiner(s) is blinded to which 
group each participant is assigned until conclusion of efficacy evaluations. 
 
• Plaque Accumulation 
Participants shall be instructed to perform toothbrushing 12-18 hours prior to 
their scheduled appointment, and then refrain from all oral hygiene.  A 
reminder message will be sent within 24 hours prior to the next scheduled 
study visit. This will allow for 12-18 hours of plaque accumulation.  For 
example, if their appointment is on Monday, Jan 14th at 11:00am, the 
participant should brush on Sunday, January 13th between 7:00pm and 
11:00pm with no brushing after 11:00pm.  Actual accumulation shall be 
documented and any deviations reported. 
 
• Diet Restriction 
Participants shall be instructed to refrain from use of chewing gum and 
consumption of apples, carrots or other hard crunchy foods or thick skinned 
fruits during the plaque accumulation period (3-6 hours prior to their study 
visits).   
 
• Adverse Event Monitoring:  Oral Exam 
An oral examination is conducted as described in Section 5.1.1.  Any adverse 
change(s) in the mouth are to be documented as Adverse Event(s).  See 
Section 7.0 for details. 
 
• Modified QH Plaque Index 
A designated-site plaque index shall be performed as described in Section 
5.1.1.  
 
• UNC Gingival Index 
A designated-site gingival index shall be performed as described in Section 
5.1.1. 
 
• Probing Pocket Depth (PPD) & CEJ 
A designated-site probing pocket depth shall be performed as described in 
Section 5.1.1. 
 
• Bleeding on Probing (BOP) 
A designated-site bleeding assessment shall be performed as described in 
Section 5.1.1. 
 

 
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• 
Treatment Product Dispense 
Participants shall be dispensed the appropriate treatment products according to 
their randomization assignment.  Participants will receive either: GUM Soft-
Picks® Advanced or Oral-B Pro-Health Glide Original floss 
 
• Treatment Product Usage Instruction 
Participants shall be provided the appropriate written instructions with 
detailed review of product use by the research staff. See Appendices II and III. 
 
• Supervised Treatment Product Use  
Participants shall demonstrate understanding of the interdental cleaning 
instructions in a supervised session.  Research staff shall observe participants 
using their dispensed products to ensure proper usage according to 
instructions.  
 
• Issue Subject Diary 
Participants are provided an at-home user experience diary, as well as his/her 
compliance diary. Participants shall be instructed on proper completion by the 
designated research staff.  The diary should indicate the level of motivation to 
use the product and end satisfaction for each encounter.  A template of the 
diary can be found in Appendix IV.   
 
• Follow-up Visit(s) Scheduled 
The appointment for Visit 3 shall be scheduled.  Plaque accumulation and diet 
restriction instructions that apply to the next scheduled appointment shall be 
reviewed.  Additionally, participants shall be given verbal instructions to 
refrain from using prohibited treatments, medications and dental supplements 
for the duration of the study (see Section 3.6). Study visit appointment 
reminders will be sent within 24 hours prior to the next scheduled study visits.  
 
 
    Visit 3 shall occur 14 days after Visit 2 (+/- 2 days), in the following manner: 
 
• Plaque Accumulation   
Participants shall be instructed to perform their last brushing 12-18 hours prior 
to their scheduled appointment as described in Section 5.1.2.  The actual 
accumulation shall be documented and any deviations reported. 
 
• Diet Restriction 
Participants shall be instructed to refrain from use of chewing gum and 
consumption of apples, carrots or other hard crunchy foods or thick skinned 
fruits during the plaque accumulation period (3-6 hours prior to their 
appointment).   
 
• Compliance Monitoring  
The research staff performs a compliance check with a verbal interview and 
review of the diary to determine if the subject has followed study instructions.  
Visit 3– Day 14 

 
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Any non-compliance to requirements (see Section 5.2) is to be documented as 
a protocol deviation(s). 
 
• Adverse Events Monitoring:  Interview and Health History Update 
The research staff research staff and/or dental examiner shall review with the 
participants their medical/dental status, health history and medications and 
compare to baseline for any potential adverse changes.  See Section 7.0 for 
details on reportable Adverse Events.   
 
• Adverse Event Monitoring:  Oral Exam 
An oral examination is conducted as described in Section 5.1.1.  Any adverse 
change(s) in the mouth are to be documented as Adverse Event(s).  See 
Section 7.0 for details. 
 
•     Modified QH Plaque Index 
A designated-site plaque index shall be performed as described in Section 
5.1.1.  
 
• UNC Gingival Index 
A designated-site gingival index shall be performed as described in Section 
5.1.1. 
 
• Follow-up Visit(s) Scheduled 
The appointments for Visits 4 shall be scheduled.  Plaque accumulation and 
diet restriction instructions, prior to the appointments, shall be reviewed.  
Additionally, subjects shall be given verbal instructions to refrain from using 
prohibited treatments, medications and dental supplements for the duration of 
the study (see Section 3.6).  Lastly, participants shall be informed to return 
with their study diary. 
 
 
 
Visit 4 shall occur 28 days after Visit 2 (+/- 2 days), in the following manner: 
 
• Plaque Accumulation   
Participants shall be instructed to perform their last brushing 12-18 hours prior 
to their scheduled appointment as described in Section 5.1.2.  The actual 
accumulation shall be documented and any deviations reported. 
 
•    Diet Restriction 
Participants shall be instructed to refrain from use of chewing gum and 
consumption of apples, carrots or other hard crunchy foods or thick skinned 
fruits during the plaque accumulation period (3-6 hours prior to their 
appointment).   
 
Visit 4– Day 28, Final 

 
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• Compliance Monitoring  
Research staff will perform a compliance check with a verbal interview and 
review of the diary to determine if the subject has followed study instructions.  
Any non-compliance to requirements (see Section 5.2) is to be documented as 
a protocol deviation(s). 
 
• Adverse Events Monitoring:  Interview and Health History Update 
Research staff and/or the dental examiner shall review with the participants 
their medical/dental status, health history and medications and compare to 
baseline for any potential adverse changes.  See Section 7.0 for details on 
reportable Adverse Events.   
 
• Adverse Event Monitoring:  Oral Exam 
An oral examination is conducted as described in Section 5.1.1.  Any adverse 
change(s) in the mouth are to be documented as Adverse Event(s).  See 
Section 7.0 for details. 
 
•    Modified QH Plaque Index 
A designated-site plaque index shall be performed as described in Section 
5.1.1.  
 
•     UNC Gingival Index 
A designated-site gingival index shall be performed as described in Section 
5.1.1. 
 
•     Probing Pocket Depth (PPD) & CEJ 
A full mouth probing pocket depth and CEJ measures shall be performed as 
described in visit 1.  
 
•    Bleeding on Probing (BOP) 
A full mouth bleeding assessment shall be performed as described in visit 1. 
 
• Prophylaxis and Referral for Care, if indicated 
At the discretion of the Examiner, any subject for whom a referral to 
additional dental care, or for whom a prophylaxis is appropriate, is provided 
these services. 
 
• Product Return   
Participants shall return study diary and any unused study products. Report 
any forgotten product(s) as a protocol deviation.  If the diary is forgotten, 
remind the participant to return with the diary as soon as conveniently 
possible.  
 
• Subject Questionnaire 
All participants are provided a questionnaire and  shall be instructed on proper 
completion by the designated research staff .  The questionnaire should 
indicate the level of product familiarity, overall usage satisfaction, as well as 

 
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motivation to use the product in the future. A template of the questionnaire 
can be found in Appendix V.   
 
• Subject Compensation 
All participants that sign the informed consent, whether they complete the 
study or not, shall be reimbursed according to the schedule outlined in the 
IRB/EC-approved Informed Consent Form.  
 
• Subject Dismissed 
Subjects are dismissed from the study.  See Section 7.0 in the event of an 
ongoing Adverse Event at the time of dismissal.   
 

 
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Table 1 provides an overview of Visits and Study Procedures:  
 
 
*  Blinding not required during visit 1 clinical indices 
AModified QH Plaque Index (Lobene - Turesky Modification of the Quigley-Hein Plaque Index) reference # 2 - Dental Plaque 
and debris will be graded using the same scale as the Turesky Index, but only at the two (2) sites that make up each of the 12 (3 
per quadrant) qualifying interproximal units: mesiobuccal and distobuccal surfaces. The area to be graded on the mesial and 
distal will be determined by three reference points. These points are the line angle of the tooth to the contact point both 
Visit Overview Table 
Procedure 
Performed by: 
Visit 
1 
Screening 
2 
Day 0 
3 
Day 12 
4 
Day 28 
Plaque Accumulation  
Participant 
X 
X 
X 
X 
Diet Restriction 
Participant 
X 
X 
X 
X 
Informed Consent 
Study Coordinator/ 
Research Staff 
X 
 
 
 
Medical/Dental History & 
Demographics 
Examiner/ Designee 
X 
 
 
 
Compliance Monitoring 
Coordinator/Research 
Staff 
 
 
X 
X 
AE Monitoring:  Interview 
Coordinator/Research 
Staff 
X 
X 
X 
X 
Baseline Oral Exam 
Examiner 
 
X 
 
 
AE Monitoring: Oral Exam 
Blinded Examiner 
X* 
X 
X 
X 
Teeth Selection  
Examiner 
X 
 
 
 
Modified QH Plaque IndexA 
Blinded Examiner 
X* 
X 
X 
X 
UNC Gingival Index 
Blinded Examiner 
X* 
XB 
XB 
XB 
Pocket  Probing Depth & CEJC   
Blinded Examiner 
X* 
X 
 
X 
Bleeding on ProbingD 
Blinded Examiner 
X* 
X 
 
X 
Enrollment 
Study Coordinator/ 
Research Staff  
X 
 
 
 
Randomization 
Study Coordinator/ 
Unblinded Research 
Staff 
 
X 
 
 
Product Dispense with Usage 
Instruction 
Coordinator/Unblinded 
Research Staff 
X 
X 
 
 
Supervised Product Use 
Coordinator/Unblinded 
Research Staff 
X 
X 
 
 
Issue Subject Diary  
Coordinator/Unblinded 
Research Staff 
 
X 
 
 
Follow-up Visits Scheduled 
Research Staff 
X 
X 
X 
 
Follow Up Visit Reminders 
Research Staff 
X 
X 
X 
 
Prophylaxis and/or Referral for Care, 
if indicated 
Treatment Provider 
X 
 
 
X 
Questionnaire 
Participant 
 
 
 
X 
Compliance Review & Subject 
Compensation 
Study 
Coordinator/Research 
Assistant 
 
X 
X 
X 

 
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bordered by the gingival margin. This allows a small triangular area to be graded. In the event that there is no contact between 
teeth, the height of contour of the tooth should be used as the reference point. 
 
0 =No debris or stain present on the clinical crown. 
1=Presence of a discontinuous line of plaque at the gingival margin  
 
2=A continuous line of plaque at the gingival margin which does not extend greater than 1 mm from the margin 
3=Plaque coverage which is greater than 1 mm but does not extend more than one third of the tooth 
4=Plaque which covers more than one third but not more than two third of  the tooth surface 
5=Plaque coverage over more than two third of the tooth surface 
 
B UNC Gingival Index: - grading will include only the two (2) sites that make up each of the 12 (3 per quadrant) qualifying 
interproximal units: mesiobuccal and distobuccal surfaces.  
0 =Normal gingiva (pink, firm, stippled),  
1 =Mild inflammation: slight change in color, slight edema, no bleeding on probing,  
2 =Moderate inflammation: glazing, redness, edema, bleeding on probing,  
3 =Severe inflammation: marked redness and edema, ulceration, tendency to spontaneous bleeding 
 
C Pocket Probing Depth & CEJ: - Full mouth (excluding 3rd molars); 6 sites per tooth: distobuccal, distal, mesiobuccal, and 
distolingual, lingual and mesiolingual surfaces: (mm) 
 
 
DBleeding on Probing - Full mouth (excluding 3rd molars); 6 sites per tooth: distobuccal, distal, mesiobuccal, and distolingual, 
lingual and mesiolingual surfaces, except for last site in each arch:  
0 =No bleeding within 10 seconds after probing. 
1 =Bleeding within 10 seconds after probing. 
 
 
 

 
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Procedures for Monitoring Compliance 
Completion of all study procedures, both site-performed and subject-performed, shall be 
source documented, either on paper or directly in the EDC system (see Section 3.11). 
 
At Visit 1, participants’ medical/dental status shall be documented.   
 
At the follow-up visit(s), the medical/dental status shall be reviewed with the participant 
for any changes to health, medications, therapies or treatments. Additionally, the 
participant’s diary shall be reviewed for at home product use. 
 
All non-compliance to protocol procedures shall be reported as protocol deviation(s).  
Examples of non-compliance include, but are not limited to:  
 
Participant Non-Compliance 
General Non-Compliance 
• failure to follow brushing instruction 
• mis-randomization*  
• failure to complete study diary 
• wrong product dispensed 
• failure to follow plaque accumulation 
instruction 
• failure to supervise brushing or any other 
missed procedure 
• prohibited  medication usage 
• subject return visit outside of protocol 
window 
• prohibited oral care product usage  
• enrollment of ineligible subject* 
• failure to return product 
• Interval of non-compliance 
 
Significant non-compliance (marked above with an ‘*’, or other non-compliance that may 
affect study integrity (e.g., a participant did not perform ‘most all’ of the at-home product 
usage procedures, participant received prohibited dental treatment, etc.)), shall be 
reported immediately to the Sponsor as well as the Principal Investigator.  
 
Product Accountability 
Receipt and return/disposition of all study products (from and to the Sponsor) shall be 
tracked on Accountability records provided by the Sponsor.  Upon receipt, product 
shipments shall be inventoried and written, dated confirmation provided on the 
Accountability records.  A copy shall be provided to the Sponsor by fax or scanned into 
emails. 
 
Product dispense, return and disposition (to and from study subjects) shall be 
documented.  The procedure for documentation shall be determined prior to 
commencement of the study. 
 
At the conclusion of the study, all unused provided products by the Sponsor must be 
returned to the Sponsor.  The date of shipment return shall be reported on the 
accountability form. Once all returnable products are reconciled and accounted for they 
can be returned to Sunstar Americas, Inc. via FedEx using account 2290-76582 to at:   
 

 
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Attention:  Akane Takemura 
Sunstar Americas, Inc. 
301 E. Central Rd.  
Schaumburg, IL 60195 
 
 
Efficacy Assessments 
Parameters of Efficacy 
The primary efficacy measure for this study is reduction in interproximal plaque 
accumulation from baseline as evaluated by the MQH-PI following 14 (2 weeks) and 28 
days (4 weeks) of home-use. MQH-PI will be assessed by the mean change and percent 
reduction from baseline (Visit 2) to post 14 days (Visit 3) and 28 days (Visit 4) of home 
use in plaque index score. A designated site plaque assessment shall be performed using 
the Lobene - Turesky Modification of the Quigley-Hein Plaque Index. Plaque removal 
will be summarized overall and by region (i.e. anterior interproximal and posterior 
interproximal).  Overall and for each region, plaque score will be calculated as the total 
number of sites classified as having plaque present divided by total number of evaluable 
sites. 
 
Secondary efficacy parameter is reduction in gingival inflammation from baseline as 
evaluated by the UNC-GI, PPD and BOP following 28 days (4 weeks) of home-use.  
UNC-GI score will be calculated as the sum of scores of all evaluable sites divided by the 
number of evaluable sites. UNC-GI score will be expressed as the raw average score for a 
subject, as a reduction from baseline (baseline score minus post-baseline score), and as 
percent reduction calculated as the reduction in UNC-GI score divided by the baseline 
UNC-GI score times 100. Same score evaluation will be performed for PPD and BOP, 
which is baseline score minus post-baseline score, and as for calculating percent 
reduction, the reduction in PPD/BOP score will be divided by the baseline PPD/BOP 
score times 100. 
 
 
 Methods and Timing of Assessing and Analyzing Efficacy Variables 
MQH-PI, UNC-GI, PPD and BOP will be assessed at baseline (i.e., Study Visit 2), post 
14 and 28 days for MQH-PI, and only post 28 days for all other indices, of home use (i.e., 
Study Visits 3 and Visit 4).  Participants will be instructed to abstain from brushing 12-18 
hours prior to their scheduled appointment.  A trained and calibrated examiner shall 
perform all clinical evaluations. 
 
 
Safety Assessments 
Participant safety shall be monitored from the time each subject signs the Informed 
Consent Form until conclusion of the study.  Any event, however, that is a UADE (see 
Section 7.2) in the opinion of the investigator is to be followed until resolution (see 
Section 7.6).  Subject safety shall be monitored to detect any deviations in the 
medical/dental status present at baseline.   
 

 
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Concomitant Medications 
At Visit 1, baseline concomitant medications shall be source documented and reviewed 
by the Investigator/Examiner against eligibility criteria.  Only changes to baseline 
medications (i.e., changes to amount, frequency, etc.) or new medications require 
reporting in the CRFs.  Changes shall be reviewed with the Investigator/ and study 
coordinator for ‘reportable’ Adverse Events. 
 
Adverse Events   
At Visit 1, a medical/dental history form is provided to each participant and is reviewed 
with the participant by the Investigator/Examiner to establish baseline health status.  
Relevant historical and current health information is noted.  Additionally, an oral exam 
further identifies baseline dental status.  At all subsequent study visits, adverse changes 
from the baseline medical/dental status of each participant is assessed via participant 
interview, diary review, oral exams, etc.  The subject may report adverse events and 
changes to con meds by phone or other means of communications at any time until 
conclusion of the study.  
 
The following adverse changes from baseline require reporting as Adverse Events in the 
eCRFs: 
 
• Any adverse change that has either of the following relations to the test 
products or study procedures:  ‘possibly related’ or ‘related’ 
• Any adverse change which occurs in/around the oral cavity, regardless of 
relationship status 
• Any event that is an Unanticipated Adverse Device Effect (UADE, see section 
7.2) 
 
An adverse change that does not meet any of the above does not require reporting to the 
Sponsor (or the CRFs).   
 

 
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Examples of reportable AEs and non-reportable AEs include, but are not limited to: 
 
Reportable AEs 
Non-reportable AEs 
• abrasion in /around the oral cavity 
• broken bone 
• lost tooth  
• cold symptoms 
• tooth sensitivity 
• headache, if it isn’t at least possibly 
related to study participation  
• mucosal fibroma 
• noticeable increase in gingival inflammation 
• infection, if it isn’t at least possibly 
related to study participation 
• oral ulceration 
• palatal burn 
• cold sore  
• gum irritation / soreness 
• cheek bite 
• papilla laceration / trauma 
• linea alba 
• damaged restoration 
• loosened filling 
 
• dry or cracked lips 
 
 
 
  
 
Unanticipated Adverse Device Effects 
A UADE is defined in the United States 21 Code of Federal Regulations Part 812.3(s) as 
“any serious adverse effect on health or safety or any life-threatening problem or death 
caused by, or associated with, a device, if that effect, problem, or death was not 
previously identified in nature, severity, or degree of incidence in the investigational plan 
or application (including a supplementary plan or application), or any other unanticipated 
serious problem associated with a device that relates to the rights, safety, or welfare of 
subjects”. 
 
Other important medical events which may not result in any of the outcomes above, but 
which may require intervention to prevent one of the outcomes above, may in the opinion 
of the investigator, be considered a UADE. 
 
Any UADE requires immediate reporting to the Sponsor upon discovery:  
 
Contact:  Akane Takemura 
E-mail: akane.takemura@us.sunstar.com 
Tel:  847-794-4276 
 
 
Parameters of Safety 
Parameters of safety include reportable (see Section 7.1) adverse changes in the medical 
and/or dental status of the subject from the time of assignment of investigational products 
until completion of the study or resolution of the event, as appropriate.  Additional 
parameters of safety include review of concomitant medications and deviation or 
violations from the protocol for each participant. 
 
Methods and Timing of Assessing and Analyzing Safety Variables 
Safety variables are assessed in a verbal interview and examinations at each follow-up 
study visit in which the participant’s current medical and dental status is reviewed 
compared to baseline, and a determination is made about the relation of any events to the 
study participation.  In addition, the oral examination conducted at these visits is also 
used to screen for adverse events with relevant safety information recorded.  Lastly, any 

 
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adverse event reported by a subject in between visits is assessed upon reporting as 
described above. 
 
Procedures for Reporting Safety Events 
Reportable Adverse Events, as described in Section 7.1, shall be recorded in the eCRFs, 
and an assessment shall be made by the Principal Investigator/designee of the following 
metrics for each event:  severity, serious, anticipated (if serious), relation (to study 
participation and device), action taken and outcome.  Options for each of these metrics 
can be found in the Source Document Template Adverse Events Log form. 
 
All adverse events that are serious and occurring in the mouth; or serious and at 
least possibly related to the study, as well as all UADEs (see Section 7.2) are to be 
reported to the Sponsor within 24 hours of the investigator learning of the event.   
 
Contact:  Akane Takemura 
E-mail:  akane.takemura@us.sunstar.com 
Tel:  847-794-4276 
 
The Principal Investigator is responsible for reporting the event to the appropriate 
IRB/EC as dictated by the guidelines defined by the IRB/EC.   
 
All other safety events that do not meet the expedited reporting criteria as 
described above are collected at the time of reporting by the participant, or 
detection by the investigator.  They are recorded and maintained as part of the 
study record and reported to the Sponsor via the eCRF.    
 
The disposition of all safety events, assignment of relatedness, seriousness is the 
responsibility of the Principal Investigator.   
 
Disposition and Follow-up of Adverse Events 
An adverse event that is present at the time of study completion is to be designated as 
ongoing on the eCRF (i.e., ‘Recovering/Resolving’ or ‘Not Recovered/Not Resolved’).  
However, all ongoing events that require expedited reporting, as described in Section 7.5, 
or other important medical findings, per the opinion of the investigator, are to be 
followed until resolution. 
 
 
Statistical and Analytical Plan 
Determination of Sample Size 
The primary endpoint of this study is to distinguish the difference in measured 
interproximal plaque indices between two treatment groups after 14-day and 28-day of 
using a different kind of interproximal cleaning device. Therefore the determination of 
sample size is based on the following equation and parameters [1]: 
 
Expedited Reporting 
Other Reporting 

 
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𝑛= 2[(𝑎+ 𝑏)2𝜎2]
(𝜇1 −𝜇2)
 
 
Where: 
n = the sample size in each of the groups 
µ1 = population mean in treatment Group A 
µ2 = population mean in treatment Group B 
µ1 - µ2 = the difference the investigator wishes to detect 
σ2 = estimated standard deviation 
a = conventional multiplier for alpha (type I error) 
b = conventional multiplier for power (type II error) 
 
The value of the difference between two treatment groups (µ1 - µ2) was referenced from 
the similar clinical study focused on plaque accumulation reduction by using different 
types of interproximal cleaning devices[2]. It was determined when the value of the 
difference between two groups was 0.25 based on the fact that the measured difference 
between an interdental brush and floss was larger ( >0.30 at week 6) in the mentioned 
clinical study[2]. 
 
 
By substituting all parameters with follows, the value of sample size n becomes: n = 33: 
 
(µ1 - µ2) 
0.25 
σ2 
(0.25)2 = 0.0625 
a 
1.96 (for 95% confidence intervals (CI)) 
b 
1.28 (90% power) 
n 
22 
 
 
[1] Noordzij M, Tripepi G, Dekker FW, et al. Sample size calculations: basic principles and common pitfalls. Nephrol 
Dial Transplant 2010;25:1388-1393. 
[2] Jackson MA, Kellett M, Worthington HV, et al. Comparison of interdental cleaning methods: a randomized 
controlled trial. J Periodontol 2006;77:1421-1429. 
 
General Considerations 
The primary analysis will be performed including all randomized subjects with a baseline 
and post Day 14 and Day 28 (i.e., Visit 3 and Visit 4) efficacy evaluation (modified intent 
to treat, MITT).  Subjects with a compliance level of 75% will be grouped according to 
the randomized treatment assignment.  The analysis of safety will include all randomized 
subjects who were exposed to treatment. 
 
All variables will be summarized by descriptive statistics.  The statistics for continuous 
variables include: number of observations, mean, median, and standard deviation, 
minimum, maximum and 95% confidence intervals (CIs).  For categorical variables, 
number and percentage of subjects with the event will be presented. 
 
All analyses will be conducted using SAS® or equivalent software 

 
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Subject Disposition 
Participant disposition, including the total number of participants enrolled, randomized, 
completed, early terminations and withdrawals, will be presented by study visit, treatment 
group, and overall. In addition, a listing will be provided with the reasons for 
discontinuation by treatment group. 
 
Demographics and Baseline Characteristics  
Standard subject demographics (e.g., age, sex, race and ethnicity) and baseline 
characteristics (e.g., number of missing teeth, plaque score, etc.) will be summarized for 
all participants randomized and for MITT subjects.  For continuous participant 
characteristics, means will be compared using one way analysis of variance (ANOVA).  
The incidence of the categorical variables will be compared using the Chi-square test or 
Fisher’s exact test as appropriate.    
 
All summaries will be presented by treatment group and overall.  In addition, baseline 
characteristics will be summarized by treatment group and sex. 
 
Treatment Compliance 
Participant compliance will be listed by treatment group. If applicable, comparability 
between the treatment groups will be evaluated using a Chi-square or Fisher’s exact test 
as appropriate for categorical variables, and one way ANOVA for continuous variables. 
A listing of all deviations will be presented. 
 
 Primary Efficacy Analysis  
The primary efficacy measure for this study is reduction in plaque index as evaluated by 
MQH-PI following 14 days (2 weeks) and 28 days (4 weeks) of home use.  MQH-PI 
score will be considered as continuous variable and will be calculated as the sum of 
scores of all evaluable sites divided by the number of evaluable sites. MQH-PI score will 
be expressed as the raw average score for a participant, as a reduction from baseline 
(baseline score minus post-baseline score), and as percent reduction calculated as the 
reduction in MQH-PI score divided by the baseline MQH-PI score times 100. 
 
The following hypothesis will be tested: 
Ho: UMQHPI-SP – UMPI-floss = 0 
HA: UMQHPI-SP – UMPI-floss ≠ 0 
 
The primary analysis will be done on a modified ITT basis including all participants with 
baseline and post baseline efficacy evaluation as follows:   
Yij = µ + bi + λj + εij  
 
Where:  
Yijk denotes the overall change (or percent reduction) in MQH-PI for the participant i, 
treatment j, i = 1,2,…, N; j = 1,2,3,4. 
 
µ denotes the overall mean. 
bi denotes the baseline efficacy level corresponding to ith subject. 
λj denotes the fixed effect corresponding to the jth treatment. 

 
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εij denotes the unexplained or residual variation. 
 
In addition, the following assumptions will be made: 
εij ~ N(0,σ2) for all i=1, 2,…,N; for all j = 1,2,...M; where N denotes the total number of 
participants , M  denotes the total number of treatments. 
 
Analysis of the statistical model above will be performed using Mixed model.  If the 
required assumptions for the mixed model are violated, transformation of the data or non-
parametric procedures may be used.  Superiority will be declared based on the F-test.   In 
addition, least square means (LSM) and 95% confidence interval for the means will be 
presented. 
 
Supplementary analyses will be performed with sex as a covariate in the model.  Least 
squares means, SEs of the least square means, and two-sided 95% CIs will be presented 
by treatment group and sex. 
 
Secondary Efficacy Analysis 
The secondary efficacy measure for this study is the reduction from baseline for UNC-GI 
and BOP (after 28 days). UNC-GI will be calculated as described above.  BOP will be 
calculated as the number of sites classified as having bleeding present divided by the 
number of evaluable sites.  BOP score will be expressed as the raw average score for a 
participant, as a reduction from baseline to post 28 days of home use, and as percent 
reduction calculated as the reduction in BOP score divided by the baseline BOP score 
times 100. Additionally, the number and percent of bleeding sites will be evaluated. Any 
site with a BOP score =1 will be counted as a bleeding site. The percent of sites bleeding 
will be calculated as the number of sites with BOP score =1 divided by the number of 
evaluable sites times 100.  
 
The secondary analysis will include all randomized participants with a baseline and a 
post baseline evaluation for the parameter of interest. A statistical model similar to the 
primary analysis will be used to generate LS means, SEs for the least square means, and 
two-sided 95% CIs. In addition, PPD will be analyzed using 28 days as repeated measure 
over time.  
Supplementary analyses will be performed with sex as a covariate in the model.  Least 
squares means, SEs of the means, and two-sided 95% CIs will be presented by treatment 
group and gender. In addition all primary and secondary endpoints will be analyzed using 
a repeated measure approach. 
 
Safety Analysis 
Adverse events and oral examination abnormalities will be presented in data listings. 
 
Interim Analysis 
There is no interim analysis planned for this study. 
 

 
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Access to Source Documents 
This study will be monitored to ensure that documents used to originally record 
participant data (source documents) are maintained, and to verify that transcribed data are 
accurately reflected on the study electronic Case Report Forms.  Source documentation 
must be maintained in a secure area.  Study-specific source documentation shall have 
limited access to Investigator-delegated study staff.  Until all study procedures are 
performed, no blinded study staff shall have access to source documentation which may 
indicates product assignment or efficacy outcomes.  All source documentation must be 
made available for review by Sponsor or its designees as well as regulatory agencies.   
 
Ethical Considerations 
All participants enrolled on this study shall receive an oral hygiene regimen that is, at 
minimum, considered standard of care.  There is no placebo offered in this trial and no 
participant shall therefore forego general dental hygiene.  The ethical principles for the 
treatment of human participants on this study have their origin in the Declaration of 
Helsinki.  This protocol must be reviewed and approved by an authorized IRB/EC prior 
to its implementation.  Any amendments to the protocol must be reviewed and approved 
by the study Sponsor, and subsequently, by the designated IRB/EC, according to the 
approval committee’s requirements. 
 
Study Confidentiality 
Study records, including each participant’s signed informed consent, 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.   
 
Confidentiality Standards 
This protocol, test-methodology, study products, the study data and data management 
system contain confidential and proprietary information.  Release of such information 
outside the scope of planned study operation is prohibited.  
 
Participant Confidentiality 
Participants enrolled on study shall be assigned a study ID code.  All recorded data are 
then entered per the unique Subject ID.  Study data available to the Sponsor are thus a 
‘coded’ data set.  Participant information shall remain confidential.  However, consent 
forms and dental records that identify participants 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), other foreign regulatory bodies and the Institutional Review Board/Ethics 
Committee for this study.  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 beyond the above mentioned representatives and 
agencies is prohibited. 
 

 
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Financial Considerations 
Each participant shall receive compensation as designated in the IRB/EC approved 
Informed Consent Form.  In the event that a participant withdraws or is removed from the 
study, compensation shall be pro-rated appropriately, as defined in the Informed Consent 
Form. 
 
Publication Policy 
The rights for publication of results from this study are at the coordination discretion of 
Sponsor and UNC.  The Investigator must request permission from Sponsor prior to 
initiating any publication. Permission must be requested and received in writing.  Review 
and approval of any data, abstract or manuscript is required.  Sponsor reserves the right to 
review any presentation of study methodology, data collection, data analysis, 
interpretation of data, proprietary information or patented technology.  
 

 
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Investigator’s Statement 
I agree to conduct the trial as outlined in the protocol in accordance with the Sponsor’s guidelines and 
other applicable FDA regulations, and conditions of approval imposed by the reviewing IRB.  The 
Sponsor’s guidelines include, but are not limited to: 
 
• 
Provide Sunstar Americas Inc. selected representative with current curriculum vitae including a 
statement regarding relevant experience. 
• 
Provide supervision of all device testing involving human subjects.   
• 
Permission to allow Sunstar Amercias, Inc. and/or regulatory agencies to inspect study facilities 
and pertinent records at reasonable times and in a reasonable manner that ensures subject 
confidentiality.   
• 
Submission of the proposed clinical investigation including the protocol and the consent form to 
an IRB for approval and the acquisition of written approval for each subject ensuring that the 
requirements for obtaining informed consent are obtained prior to the use of any test articles. 
• 
Submission of any significant deviations from the protocol to the IRB and the sponsor.  Any 
proposed changes or deviations from the protocol require that the informed consent also reflects 
such changes or deviations and that the revised informed consent be approved by an IRB. 
• 
Documentation and explanation of individual protocol deviations and violations are captured with 
explanations as indicated. 
• 
Submission of reports of Adverse Events to the Sponsor and IRB as outlined in the protocol. 
• 
Submission of timely progress reports to the IRB and Sponsor at appropriate intervals on a 
schedule determined by the IRB or Sponsor, as indicated. 
• 
Record keeping:  the Investigator shall maintain adequate and accurate records designed to record 
completion of all study procedures, related observations and other key data (such as safety, 
compliance and product accountability) pertinent to the investigation on each subject enrolled.  
The investigator must maintain these records for a period of 10 years following completion of the 
study report and related publications. 
 
I agree that all information provided to me by the Sponsor including pre-clinical data, protocols, 
electronic databases, CRFs, and verbal and written information shall be kept strictly confidential and 
confined to the clinical personnel involved in conduct of the trial.  It is recognized that this information 
may be related in confidence to the IRB/EC.  I also understand that reports or information about the trial 
or its progress shall not be provided to anyone not involved in the trial other than the Sponsor or other 
legally constituted authority. 
 
 
_______________________________  
___________ 
Principal Investigator’s Signature 
 
Date 
 
_Antonio J. Moretti______________________________ 
Principal Investigator’s Printed Name 
 

 
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References 
 
 
Greene JC, Vermillion JR. The simplified oral hygiene index. J Amer Dent Assoc 1964; 68: 7-13.  
Greene JC, Vermillion JR. The oral hygiene index: a method for classifying oral hygiene status. 
J Amer Dent Assoc 1960; 61: 29-35. 
Löe H, Sillness J. Periodontal disease in pregnancy (i) Prevalence and severity.  Acta Odontol 
Scand 1963; 21: 532-551 
 
Van der Weijden, Timmerman M.F., Nijboer A., Reijerse E., Van der Velden U. Comparison of 
different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Perio 1994; 
21:589-594. 
 
U.S. Department of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (CDRH).  Guidance for Industry, E6 Good Clinical Practice:  
Consolidated Guidance.  April 1996 
 
U.S. Department of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (CDRH).  Guidance for Industry, Electronic Source Data in 
Clinical Investigations.  September 2013 
 
U.S. Department of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (CDRH).  Guidance for Industry, Oversight of Clinical 
Investigations – A -Risk Based Approach to Monitoring.  August 2013 
 
Quigley GA, Hein JW. Comparative cleansing efficiency of manual and power brushing. JADA 
1962;65:26-29 
 
Turesky S, Gilmore ND, Glickman L. Reduced formation by chloromethyl analogue of vitamin 
C. J Periodontol 1970;41:41-43 
 
Lobene RR, Soparker PM. & Newman B.S. Use of Dental Floss. Effect of plaque and Gingivitis. 
Clin Preven Dent 1982;4:5-8 
 
Paraskevas S, Rosema NA, Versteeg P, Timmerman MF, van der Velden U, van der Weijden 
GA. The additional effect of a dentifrice on the instant efficacy of toothbrushing: a crossover 
study. J Periodontol 2007;78:1011-1016 
 

 
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Appendix I 
Product Instruction for tooth brushing (by ADA) 
 

 
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Appendix II 
Product Instruction for GUM Soft-Picks® Advanced 
 
 
 

 
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Appendix III 
Product Instruction for Glide Pro-Health Floss 
 

 
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Appendix IV 
Template of a User Diary (only Day 1) 
 
 

 
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MEDICATION FORM 

 
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Name of the 
Medication 
Reason Taken 
Dosage 
Date Started 
(mm / dd/ yyyy) 
Date Stopped 
(mm / dd/ yyyy) 
e.g. Tylenol 
Headache 
1 tab / 3 times / day 
7/28/2016 
7/28/2016 
 
 
 
 
 
 
 
 
 
 
Comments: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Appendix V 
  User Questionnaire 
 
For each statement, please describe how important it is to you when choosing a product for 
between teeth cleaning, using the following scale: 
 
 
Not At All 
Important 
Not Very 
Important 
Somewhat 
Important 
Very 
Important 
Extremely 
Important 
 
1 
2 
3 
4 
5 
Removes food and debris from between 
teeth 
 
 
 
 
 
Provides a thorough clean between teeth 
 
 
 
 
 
Fits easily between my teeth 
 
 
 
 
 
Is easy to clean back teeth 
 
 
 
 
 
Makes between teeth cleaning quick 
 
 
 
 
 
Makes between teeth cleaning easy 
 
 
 
 
 
Makes between teeth cleaning convenient 
 
 
 
 
 
Is easy to hold during use 
 
 
 
 
 
Feels comfortable during use 
 
 
 
 
 
Makes my mouth feel fresh 
 
 
 
 
 
Is easy to understand how to use correctly 
 
 
 
 
 
Makes my mouth feel clean 
 
 
 
 
 
Are easy to use out of the home  
 
 
 
 
 
Is pleasant to use 
 
 
 
 
 
Cleans easily around crowns and bridges 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Please indicate how much you agree that each of the following characteristics accurately 
describes the product you used during this study: 
 
 
Disagree 
Strongly 
Disagree 
Somewhat 
Agree nor 
Disagree 
Agree 
Somewhat 
Agree 
Strongly 
 
1 
2 
3 
4 
5 
Removes food and debris from between teeth 
 
 
 
 
 
Provides a thorough clean between teeth 
 
 
 
 
 
Fits easily between my teeth 
 
 
 
 
 
Is easy to clean back teeth 
 
 
 
 
 
Makes between teeth cleaning quick 
 
 
 
 
 
Makes between teeth cleaning easy 
 
 
 
 
 
Makes between teeth cleaning convenient 
 
 
 
 
 
Is easy to hold during use 
 
 
 
 
 
Is difficult to use 
 
 
 
 
 
Feels comfortable during use 
 
 
 
 
 
Makes my mouth feel fresh 
 
 
 
 
 
Is easy to understand how to use correctly 
 
 
 
 
 
Makes my mouth feel clean 
 
 
 
 
 
Are easy to use out of the home  
 
 
 
 
 
Is pleasant to use 
 
 
 
 
 
Cleans easily around crowns and bridges