Evaluation of the Efficacy and Safety of a Loop Stretchable Dental Floss in Controlling Gingivitis and Supragingival Plaque Removal During Thirty Days
Phase: NA
Conditions: Gingivitis, Supragingival Plaque
Sponsor: Indiana University

IRB#: 22752 
Version Date: May 8, 2024 
Amendment 1: 23May2024 
Amendment 2: 27Sep2024 
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Evaluation of the efficacy and safety of a loop 
stretchable dental floss in controlling gingivitis and 
supragingival plaque removal during thirty days 
 
Principal Investigator 
Ana G. Gossweiler, DDS, MSD 
415 Lansing St., OH 106 
IU Indianapolis, IN 46202 
317-278-0772 
amgutier@iu.edu 
 
  
George Eckert, MAS 
Biostatistician Supervisor, Department of Biostatistics and Health Data Science 
Program Manager - Biostatistics, Epidemiology, and Research Design Program - Indiana CTSI 
Phone: (317) 274 – 2884 
geckert@iu.edu 
 
Clinical Trial Site 
Oral Health Research Institute 
Indiana University School of Dentistry 
415 Lansing St 
IU Indianapolis, IN 46202 
317-274-8822 
 
 
Amendment 2 
Support Provided by: 
Sponsor: Loops, LLC  
       Sponsor Representative: Steven Kayser, President 
PO Box 2936 
Ferndale, WA 98248 
360-366-3009/3011 
stevenkayser@flossloops.com 
 
  
 

IRB#: 22752 
Version Date: May 8, 2024 
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Table of Contents:  
Study Schema 
1.0 
Background & Rationale  
 
 
 
 
 
4 
2.0 
Objective(s)  
 
 
 
 
 
 
 
4 
2.1 
Primary Objective  
 
 
 
 
 
4 
3.0 
Outcome Measures  
 
 
 
 
 
 
4 
3.1 
Efficacy Outcome Measures 
 
 
 
 
4 
3.2 
Safety Outcome Measures 
 
 
 
 
6 
4.0 
Eligibility Criteria 
 
 
 
 
 
 
 
6 
4.1 
Inclusion Criteria 
 
 
 
 
 
 
6 
4.2 
Exclusion Criteria  
 
 
 
 
 
6 
5.0 
Study Design 
 
 
 
 
 
 
 
7 
6.0 
Enrollment/Randomization 
 
 
 
 
 
8 
7.0 
Study Procedures  
 
 
 
 
 
 
9 
7.1 
Visit 1: Screening/Baseline Visit  
 
 
 
9 
7.2 
15-day Compliance Call 
 
 
 
 
          10 
7.3 
Visits 2: 30-day visit 
 
 
 
 
          10 
7.4 
Oral Exam 
 
 
 
 
 
 
          10 
7.5 
Modified Gingival Index 
 
 
 
 
          10 
7.6 
Bleeding on Marginal Probing 
                                           11 
7.7 
Plaque Index 
 
 
 
 
 
          11 
7.8 
Home Use Diary 
 
 
 
 
 
          11 
7.9 
Loops Stretchable Floss TM 
 
 
 
          12 
8.0 
Reportable Events  
 
 
 
 
 
          12 
9.0 
Data Safety Monitoring 
 
 
 
 
 
          12 
10.0 Study Withdrawal/Discontinuation 
 
 
 
          12 
11.0 Statistical Considerations  
 
 
 
 
          13 
12.0 Privacy/Confidentiality Issues 
 
 
 
 
          13 
13.0 Follow-up and Record Retention  
 
 
 
          14 
14.0 References  
 
 
 
 
 
 
          14 
 
List of Tables/diagrams 
 
1.0 
Abbreviations 
 
 
 
 
 
 
 
3 
2.0 
Modified Gingival Index 
 
 
 
 
 
 
5 
3.0 
Plaque Index 
 
 
 
 
 
 
 
5 
4.0 
Study Flow Diagram 
 
 
 
 
 
 
8 
Appendix 
 
 
 
 
 
 
 
 
         15 
1.0 
Flossing Instructions 
 
 
 
 
 
         15 
2.0 
Subject’s Restrictions 
 
 
 
 
 
         16 
 

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Version Date: May 8, 2024 
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Amendment 2: 27Sep2024 
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Abbreviations (Table 1) 
 
AE 
Adverse Event 
BOMP 
Bleeding on Marginal Probing 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CRF 
Case Report Form 
DSMB 
Data Safety Monitoring Board 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDA 
Food and Drug Administration Amendments Act of 2007 
GCP 
Good Clinical Practice 
MGI 
Modified Gingival Index 
GMP 
Good Manufacturing Practices 
HIPAA 
Health Insurance Portability and Accountability Act  
IB 
Investigator’s Brochure 
IRB 
Institutional Review Board 
NCT 
National Clinical Trial 
NSAID 
Non-Steroidal Anti-Inflammatory Drug 
NIH  
National Institutes of Health 
OH 
Oral Hygiene 
PLI 
Plaque Index 
PTFE 
Polytetrafluoroethylene 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
TNF-AB 
Tumor Necrosis Factor Alpha Blocker 
UHMPE 
Ultra-high-molecular-weight polyethylene 
UP 
Unanticipated Problem 
US 
United States 
 
 
 
 
 
 

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1.0 
Background & Rationale 
Interproximal plaque control is the most efficient method to prevent inflammation at the 
papillary gingival unit. [1] This type of cleaning cannot be achieved with tooth brushing 
alone; flossing needs to be incorporated into the oral hygiene procedures to achieve and 
maintain the health of the interdental papilla. [2] Over the years, different types of 
materials have been used to produce dental floss, including nylon,[3] PTFE, silk, and 
UHMUPE, among others,[4]. Even though all these dental flosses are effective in 
removing dental plaque,[5] the users' subjective preference is based on the surface 
roughness and tensile strength. [4] The user's preferences regarding floss handling also 
have to be considered; loop floss provides a new design that appears to be easy to use 
and improves the user's manual dexterity. [6, 7] This study aims to evaluate the efficacy 
and safety of a stretchable floss controlling gingivitis and supragingival plaque removal 
between control and experimental groups in thirty days.  
 
2.0 
Objective(s) 
2.1 
Primary Objective 
This study aims to evaluate the efficacy and safety of Floss Loops stretchable 
floss for controlling gingivitis and supragingival plaque removal in a control and 
an experimental group over thirty days. 
 
3.0 
Outcome Measures/Endpoints 
3.1 
Efficacy Outcome Measures   
There will be two efficacy indexes used in this study; each index will be an 
overall total dentition score: 
A. For Gingivitis Assessment: The Lobene modified gingival index (MGI) will 
be used. This is a non-invasive index that assesses the health of the gums 
based on their visual clinical appearance. (Table 2) Each tooth will be evaluated 
visually on six surfaces (Mesio-buccal, buccal, disto-buccal, mesio-lingual, 
lingual, and disto-lingual). Each surface will be scored based on the 
inflammatory visual changes, severity, and extent. For the MGI calculation, all 
the values for each tooth will be added and divided by the number of surfaces 
examined. A score of 0 will represent healthy gingiva, a score of 1 and 2 will 
represent mild inflammation, a score of 3 will represent moderate inflammation 
and a score of 4 will represent severe inflammation. [8] Additionally, a similar 
calculation for the interproximal surfaces MGI score will be performed using 
only interproximal surfaces from each tooth. 
 
B. Bleeding on Marginal Probing (BOMP): Bleeding on probing will be 
assessed at six surfaces (Mesio-buccal, buccal,   disto-buccal, mesio-lingual, 
lingual, and disto-lingual). A periodontal probe with a rounded tip 0.5mm in 
diameter will be gently inserted into the gingival crevice to a depth of 
approximately 2 mm and run at an angle of approximately 60° about the 
longitudinal axis of the tooth, except for third molars if present. BOMP will be 
read up to 30 seconds after probing. The surfaces would be scored as negative 

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(0=no BOMP) or positive (1=BOMP). The percentage of bleeding sites will be 
determined by adding up the number of bleeding sites, dividing this number 
by the total number of probing sites, and multiplying by 100. [9, 10] 
Additionally, a similar calculation for the interproximal surfaces BOMP score will 
be performed using only interproximal surfaces from each tooth. 
 
 
Table 2: 
Lobene Modified Gingival Index (MGI) 
Score 
Inflammation 
Description 
0 
Normal 
Normal gingiva 
1 
Mild inflammation 
Slight changes in color and texture, but no in all portions of the 
gingival marginal or papillary 
2 
Mild Inflammation 
Slight changes in color and texture in all portions of the 
gingival marginal or papillary 
3 
Moderate 
Bright surface inflammation, erythema, edema and/or 
hypertrophy of gingival marginal or papillary 
4 
Severe 
Inflammation 
Erythema, edema, and/or marginal gingival hypertrophy of the 
unit or spontaneous bleeding, papillary, congestion, or 
ulceration.  
 
 
C. For the Dental Plaque Assessment: Dental plaque will be identified using 
a disclosing solution and scored using the Turesky modification of the Quigley 
and Hein Plaque Index (PLI). (Table 3) Each tooth, except the third molars, 
will be scored on six sites (Mesio-buccal, buccal, disto-buccal, mesio-lingual, 
lingual, and disto-lingual). The plaque score index for an individual is 
determined by adding all the individual scores and dividing the total score by 
the number of surfaces examined. [11] Additionally, a similar calculation for 
the interproximal surfaces PLI score will be performed using only 
interproximal surfaces from each tooth. 
 
Table 3: 
Quigley-Hein Plaque Index Scores with Turesky Modifications (PLI) 
Score 
Description 
0 
No plaque 
1 
Separate flecks of plaque at the cervical margin of the tooth 
2 
A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth 
3 
A band of plaque wider than one mm but covering less than one-third of the crown of the 
tooth 
4 
Plaque covering at least one-third but less than two-thirds of the crown of the tooth 
5 
Plaque covering two-thirds or more of the crown of the tooth 
 
 

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3.2 
Safety Outcome Measure 
A. Safety outcomes will be measured by assessing any study-related soft or 
hard tissue abnormalities. Oral soft tissue examinations will be assessed at 
the baseline and the end of study. Any abnormal oral findings will be 
recorded and evaluated to assess causality and possible relation to the study 
product. Abnormal findings during the study will be recorded as an AE or 
SAE.  
 
4.0 
Eligibility Criteria 
4.1 
Inclusion Criteria 
• 
Adult subjects between 18 to 65 years old 
• 
Willing to read and sign the IRB-approved informed consent 
• 
Healthy, as determined by pertinent medical history at the examiner dentist's 
discretion 
• 
A minimum of 20 natural teeth (excluding third molars) with at least two scorable 
surfaces per tooth (teeth with full crowns, large/extensive restorations on the 
interproximal areas, and orthodontic bands will not be included in the tooth count) 
• 
Mild to moderate plaque and gingivitis MGI of 1.75 or greater (Based on the 
Lobene-modified gingival index score)[9]. This calculation will be made based on a 
whole mouth score 
• 
PLI of 1.95 or greater (Based on the Turesky modification of the Quigley and Hein 
Plaque Index) calculation based on a whole mouth plaque score 
• 
Be willing to comply with study visits and requirements 
 
4.2 
Exclusion Criteria 
• 
Presence of any acute or chronic condition, organ system disease, or medication 
that, in the principal investigator's opinion, could compromise the subjects’ ability to 
participate in the study 
• 
Gross oral pathologies, including caries, calculus, or soft tissue conditions that show 
evidence of chronic neglect 
• 
Orthodontic appliances (except for fixed lingual retainers, teeth will be excluded 
from the teeth count) or any removable prosthesis 
• 
Evidence of acute periodontal conditions or periodontitis with pockets greater than 
5 mm on more than one site 
• 
Taking antibiotics two weeks before baseline procedures and throughout the study 
• 
Need for antibiotic prophylaxis prior to dental procedures 
• 
Use of daily anti-inflammatory drugs (NSAID, TNF- AB, others) within 30 days 
before baseline 
• 
Pregnant, wanting to get pregnant, or breast-feeding female 
• 
Acute Temporomandibular Disorders (TMD)  
• 
Subject who has participated in other studies (including non-medicinal studies) 
involving product(s) within 30 days before study entry  
• 
Subject who has previously been randomized in this study 
• 
Self-reported allergy to disclosing solution ingredients (red dye #28) 
• 
 An employee of the study site directly involved with the study 

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Amendment 2: 27Sep2024 
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5.0 
Study Design 
This will be a single-blind, single-center, parallel, randomized controlled clinical trial to evaluate 
the efficacy and safety of Floss Loops stretchable floss for the control of gingivitis and 
supragingival plaque removal between two groups, control (no-floss) and experimental (flossing 
with Floss Loops), during thirty (+/- 2 days). A flowchart of the study is shown in Fig 1 
 
Subjects will be asked to refrain from oral hygiene (OH) procedures the evening before and the 
morning of the screening visit, chewing gum for 12 hours and eating or drinking anything 2 
hours before oral assessments.  During the study, subjects will be asked to clean their teeth 
twice daily using only the toothbrush provided and an assigned ADA-accepted toothpaste. They 
will also be asked to abstain from professional dental cleaning during the study.  They will also 
need to refrain from elective dental procedures during  the study. 
 
At the screening/baseline visit, potential subjects will be given the IRB-approved informed 
consent form to read and ask questions, and adequate time to decide about their participation 
will be provided. A study representative trained and delegated by the Principal Investigator will 
review the IRB-approved consent and answer any questions the potential subject might have 
before the subject signs/dates the consent. After the subject signs and dates the consent, the 
study representative will sign and date the consent to confirm that the consent process was 
completed before initiating any study procedures. The subject will be given a copy of the signed 
consent.  
 
Information related to the subject’s demographic, medical, and concomitant medications will be 
collected and review. An oral examination and MGI, BOMP and PLI assessments will be 
performed by assessing the subject’s whole mouth gingival conditions and plaque accumulation. 
Each outcome measurement score will be given, and subjects must have a Modified Gingival 
Index (MGI) of 1.75 or greater and a Plaque Index (PLI) of 1.95 or greater to comply with the 
study inclusion criteria.  Other dental characteristics specified on the inclusion/ exclusion criteria 
will be assessed to determine subject eligibility. 
 
A total of 64 subjects who meet the study criteria will be enrolled and randomized into two 
groups. 32 subjects will be assigned to the control group (Brushing twice a day only and no 
flossing) and 32 to the experimental group (Brushing and Flossing with the stretchable loop 
floss at least twice daily).  Each subject will be instructed to clean their teeth daily using only 
the provided toothbrush with an assigned ADA-accepted fluoride dentifrice. Subjects assigned 
to the control group will brush their teeth at least twice a day only, and subjects in the 
experimental group will brush and floss with the provided stretchable loop floss at least twice a 
day. To assess compliance, each subject will be asked to fill out a diary every time they 
brush/floss. On day 15 (+/- 2 days) of product use, subjects will receive a phone call from the 
study coordinator or designee to assess brushing/flossing compliance. At day 30 (+/- 2 days), 
study hygiene and gum chewing restrictions as well as eating restrictions will apply, and the 
efficacy assessments will be repeated, subjects will be dismissed, and the study will finish.  
 
All clinical examinations will be performed by examiners who will be blind to the subject’s oral 
hygiene procedures.  

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The sponsor (Loops, LLC) will provide all the study materials, including the stretchable loop 
floss, toothbrushes, and toothpaste, before the beginning of the study. The stretchable loop 
floss is packaged with 30-33 floss in a clear bag along with the instructions for use. 
 
 
 
 
 Fig 1    Study Flow Diagram 
 
 
  
 
 
 
 
 
6.0 
Enrollment/Randomization 
Recruitment of potential subjects will be using the following methods: 
 
• 
Using fliers in the Indiana University School of Dentistry and other Indiana University 
Indianapolis campus locations, including IU Health facilities. Fliers may also be posted 
on Facebook. 
Screen subjects to obtain a N=64: Obtain informed consent. 
Screening based on Inclusion/exclusion criteria. Demographic, 
Med Hx, concomitant medications, oral exam, MGI, BOMP and 
PLI 
Regimen 1 
Visit 1 
Screening/Baseline  
Randomization/ Product 
Distribution/Instructions
/Diary 
Phone call from the study coordinator or designee to assess 
product compliance and confirm the next visit appointment 
15-day 
compliance Call 
OH without     
Flossing 
N=32 
OH with 
Flossing 
N=32 
Oral Exam, MGI, BOMP and PLI. End of Study. 
Visit 2 
30-day Visit  
(+/- 2 days) 

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• 
Sending outreach email messages to subject volunteers who are part of the All IN for 
Health Volunteer Registry using All IN For Health and iConnect. 
• 
Screening subjects from the Electronic Dental Records at IUSD. Potentially eligible 
subjects' names and addresses must be obtained from the patient's electronic dental 
record system at IUSD. The provider sending the letter will be the Associate Dean of 
Clinical Affairs, Office of Clinical Affairs, at IUSD, who provides administrative oversight 
of IUSD clinics. The recruitment letter will be submitted to the IRB as a recruitment tool. 
• 
Sending flyers and/or calling subjects who previously participated in other Oral Health 
Research Institute studies. (OHRI) 
 
Interested individuals can leave their contact information at the OHRI recruitment line or the 
OHRI recruiting email address. The potential subjects will be contacted, and a team member 
will conduct a screening phone interview. If the potential subjects appear to qualify, they will be 
scheduled for the screening/baseline visit.  
 
A sufficient number of subjects will be screened to participate, and 64 will be randomized. We 
intend to randomize a nearly equal number of female and male subjects. A unique screening 
number will identify all subjects screened for study participation. Screening numbers will be 
assigned according to appearance at the study site. Subjects who meet all inclusion and 
exclusion criteria will be randomized into the study. Block randomization will be used to assign 
subjects to one of the two sequences: control regiment or experimental regimen. 
Randomization will be stratified by gender at birth. Randomization numbers will be assigned 
using randomization schedules provided by the IU Department of Biostatistics and Health Data 
Science statistician.  
The clinical examiner will remain blind to the individual subjects’ treatment group during the 
entire study. If the treatment assignment must be unblinded for a subject, such as in the case 
of an emergency, the Investigator will provide written documentation of the unblinding request. 
Unblinding would involve withdrawing the subject from the study. Otherwise, blinding will not 
be broken, unless required in the circumstances detailed above, until all subjects have 
completed the final study visit and the database has been monitored, locked, and approved by 
the Investigator. 
7.0 
Study Procedures 
7.1 Visit 1: Screening/Baseline Visit  
Following the consenting procedure and demographic/medical history data collection, 
the following will be performed: 
a. An oral exam will be completed, and MGI, BOMP and PLI will be assessed and 
recorded. 
b. Inclusion/Exclusion criteria will be reviewed to determine eligibility. 
c. If qualified, the subject will be randomized to an experimental group. 
i. A qualified study team member will prepare and distribute the 
randomized study product, toothpaste, how-to-use instructions (Append 
1), lifestyle restrictions (Append 2), and compliance dairy to the subject. 
Subjects will be asked to brush their teeth twice daily with the toothpaste 
and toothbrush provided.  

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ii. Subjects in the experimental group must use the provided stretchable 
dental floss at least twice a day after brushing their teeth. 
iii. Subjects will be asked to refrain from their usual oral hygiene procedures 
and professional dental cleaning during the study. They will also need to 
refrain from elective dental procedures. 
d. Each subject will be scheduled for a telephone call on Day 15 (+/—2 days) and 
an appointment on Day 30 (+/—2 days). 
e. Subject payment will be given.   
7.2 
15-day Compliance Call  
a. On day 15 (+/—2 days), a staff member will call subjects to assess product 
compliance.  
b. During this call, subjects will be asked if they have any issues using the provided 
products and will be reminded to record the requested information in the provided 
diary.  
c. They will also be reminded of the appointment date and time for the 30-day visit 
at the study site. 
d. Subjects will be compensated for the phone call.   
7.3 
Visit 2: 30-day visit   
a. On day 30 (+/—2 days), subject continuance criteria will be assessed. 
b. Randomized products will be collected. 
c. An oral exam will be completed, and MGI, BOMP and PLI will be assessed. 
d. Subject payment will be given. 
7.4 
Oral Exam 
The study dentist will complete an oral soft and hard tissue (OSHT) examination at 
screening/baseline and each study visit. The exams will be conducted via a visual 
examination of the oral cavity and perioral area utilizing a light source, dental mirror, 
gauze, periodontal probe, and tongue blade, as needed. The soft tissue structures 
examined will involve the labial mucosa, including lips, buccal mucosa, mucogingival 
folds, gingival mucosa, hard and soft palate, tonsillar and pharyngeal areas, tongue, 
sublingual area/floor of the mouth, submandibular area, major salivary glands, head 
and neck, and TMJ. Observations will be listed as “Normal” and “Abnormal,” and 
abnormalities will be described.  
The hard tissue structures examined will include assessing for enamel irregularities, 
tooth fracture, pathologic tooth wear, cavitated lesions, residual roots, faulty 
restorations, and implants. Observations will be listed as “Absent” or “Present,” and 
conditions noted as present will be described. 
7.5  
Modified Gingival Index (MGI)  
The Lobene-modified gingival index (MGI) will be used. This is a non-invasive index 
that assesses the health of the gums based on their visual clinical appearance. 
(Table 2) Each tooth will be evaluated visually on six surfaces (Mesio-buccal, buccal, 
distobuccal, mesio-lingual, lingual, and disto-lingual). Each surface will be scored 
based on the inflammatory visual changes, severity, and extent. A score of 0 will 

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represent normal. A score of 1 and 2 will represent mild inflammation, a score of 3 
indicates moderate inflammation and a score of 4 indicates severe inflammation). (8) 
A single, trained examiner will complete all the examinations. For the whole-mouth 
MGI calculation, all the values for each tooth will be added and divided by the 
number of surfaces examined. A similar calculation for the interproximal surfaces 
MGI score will be performed using only interproximal surfaces from each tooth. 
7.6 
Bleeding on Marginal Probing (BOMP) 
Bleeding on probing will be assessed at six surfaces (Mesio-buccal, buccal, 
distobuccal, mesio-lingual, lingual, and disto-lingual). A periodontal probe with a 
rounded tip 0.5mm in diameter will be gently inserted into the gingival crevice to a 
depth of approximately 2 mm and run at an angle of roughly 60° about the 
longitudinal axis of the tooth, except for third molars if present. BOMP will be read 
up to 30 seconds after probing. The surfaces would be scored as negative (0=no 
BOMP) or positive (1=BOMP). The whole-mouth BOMP score will be calculated as 
the percentage of bleeding sites, determined by adding up the number of bleeding 
sites, dividing this number by the total number of probing sites, and multiplying by 
100. [9] A similar calculation for the interproximal surfaces BOMP score will be 
performed using only interproximal surfaces from each tooth. 
7.7 
Plaque Index (PLI) 
Supragingival plaque will be assessed following disclosure with dye solution on the 
facial (buccal) and lingual surfaces of all scorable teeth according to the criteria of 
the Turesky modification of the Quigley-Hein Plaque Index (Table 3). Each tooth 
will be visually assessed on six surfaces (Mesio-buccal, buccal, disto-buccal, mesio-
lingual, lingual, and disto-lingual). For PLI calculation, all the individual scores will 
be added and divided by the number of surfaces examined for calculation of the 
whole-mouth PLI score. A similar calculation for the interproximal surfaces PLI score 
will be performed using only interproximal surfaces from each tooth. The same 
trained examiner will also perform this assessment.  
7.8 
Home Use Diary 
At the start of the study period, subjects will be provided with a diary to record the 
date and the time of the morning (a.m.) and evening (p.m.) brushing/flossing 
procedures and any deviation from the brushing regimen. In addition, subjects will 
record any new or any changes in pre-existing medical conditions, medications, or 
treatments or any change in signs or symptoms.  
Subjects must bring the completed diary to the end of the treatment visit. Study 
staff will review the diary with the subject to confirm treatment compliance and 
clarify listed medical conditions, medications, and treatments. Subjects will be 
allowed to miss up to 10% of their flossing times (6 times). Those subjects who 
miss more than 6 flossing times will be considered non-compliant.  
 

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7.9 
Loops Stretchable Floss TM 
Floss Loops is a stretchable dental floss made of polyurethane. It has a half 
circumference of 55.0 mm, a thickness of 0.3 mm, and a cut width of 2.0 mm. It 
has a two-color presentation, and each color represents a different flavor. The blue 
color is mint, and the clear, semi-transparent is antiseptic. For this study, we will be 
using the mint loops blue color. It is packed in a transparent, easy-to-open, Ziplock 
plastic bag with 30 to 33 units (Package by weight count). This floss has been 
primarily designed for use by inmates and patients where safety is the principal 
concern, and it has been used by Federal, State, and County Correctional Facilities 
since 1996. 
8 Reportable Events 
Adverse events are not anticipated with Loops Stretchable Floss or its packaging. The product is 
designed to break easily if too much pressure is applied. No anticipated gum lacerations are 
expected. However, any tissue changes during the study will be documented and reported. The 
product is packaged in a small clear plastic bag that is easy to open and close. 
 
Subjects will be questioned regarding any general health or oral complaints and symptoms they 
have experienced during or following their treatment. Any findings will be documented on the 
AE CRF. Subjects reporting AEs outside the scheduled clinical visit will be assessed by the study 
dentist and/or principal investigator as soon as possible. 
All AEs, regardless of severity or relationship to the test product, will be recorded.  
 
Serious AEs include any events resulting in death, decreased life expectancy, life-threatening 
situations, persistent or permanent disability/incapacity, hospitalization, or congenital 
anomaly/congenital disability. Within 24 hours, the Investigator will submit a written report 
documenting the circumstances of the serious AE. The IRB will be notified within five days of 
the incident. 
 
9 Data Safety Monitoring 
The PI and the entire study team will monitor the data and safety.  They will monitor data 
quality, subject recruitment, accrual, retention, outcome, and adverse event data, or 
assessment of scientific reports, results of related studies that may impact subject safety, and 
procedures designed to protect subjects' privacy.  Safety data will be monitored regularly and 
immediately upon discovery of any SAE, major study event, or protocol deviation.    
10 Study Withdrawal/Discontinuation 
Subjects may withdraw from the study for any reason and at any time during the study without 
penalty.  Their decision to stop study-related procedures will not affect their dental treatment.  
The Principal Investigator may also withdraw the subject if they feel study participation is a 
safety concern or the subject is not compliant with study procedures. 
 
 

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11 Statistical Considerations 
 
MGI, BOMP, and PLI whole-mouth and interproximal surface scores will be summarized at 
baseline and 30 days for each group: sample size, mean, standard deviation, standard error, 
95% confidence interval for the mean, 25th percentile, 50th percentile, 75th percentile, 
minimum, maximum. Whole-mouth and interproximal surface MGI, BOMP and PLI change from 
baseline to 30 days will be calculated for each subject and will be summarized as above. 
Comparisons between the experimental and control groups for differences in baseline MGI, 
BOMP and PLI whole-mouth and interproximal surface scores will be performed using two-
sample t-tests. Comparisons between the experimental and control groups for differences in 30-
day MGI, BOMP and PLI whole-mouth and interproximal surface scores will be performed using 
two-sample t-tests. 95% confidence intervals for differences between groups will be calculated 
for all comparisons. For all analyses, the distribution of the MGI, BOMP and PLI whole-mouth 
and interproximal surface scores will be examined, and a transformation of the data (e.g. 
natural logarithm) prior to performing the two-sample t-tests or nonparametric Wilcoxon Rank 
Sum tests will be used if necessary. If data are normally distributed but variances for the two 
groups are different, the two-sample t-test will incorporate heterogenous variances. A two-sided 
5% significance level will be used for all tests. To demonstrate efficacy at 30 days, the 
experimental regimen must be statistically significantly lower than the control regimen with a 
mean difference of at least 10% for MGI and must be statistically significantly lower than the 
control regimen for PLI. 
Oral soft and hard tissue examination results for each structure/type will be summarized at 
baseline and 30 days for each group: total sample size, frequency and percent abnormal, 
frequency and percent normal. Comparisons between the two groups for differences in 30-day 
OST percent abnormal for each structure/type will be performed using chi-square tests, or 
Fisher’s Exact tests if the sample sizes in the contingency table are less than five. A two-sided 
5% significance level will be used for all tests. 
Sample size calculations are based on a prior study (Bosma 2024). The MGI mean in the control 
group at 4 weeks was 2.73, with standard deviation 0.35. The study will need to detect a 10% 
improvement in the experimental group compared to the control, so this study will be powered 
to detect a MGI difference of 0.27 between groups. With 80% power and two-sided 5% 
significance level in a two-sample t-test calculation, the study will need 28 subjects per group to 
complete the study. ADA guidelines require 30 subjects per group to complete the study. To 
account for dropout, 32 subjects will be enrolled per group.   
12 Privacy/Confidentiality Issues 
To maintain privacy, discussions about the study, the consenting process, and all other study 
procedures will be conducted in a dental office away from public places.   
 
Paper records will be kept confidential by being stored in a locked area that only study 
personnel can access. Subjects will be given a study number that will identify all documents. 
Documents containing the subject’s name (like the signed consent form) will be stored 
separately from other study documents.   
 
Electronic data will be stored in an encrypted, password-protected computer file that only study 
personnel can access. 
 

IRB#: 22752 
Version Date: May 8, 2024 
Amendment 1: 23May2024 
Amendment 2: 27Sep2024 
Page 14 of 16 
13 Follow-up and Record Retention 
As per Indiana law, study records will be maintained for at least seven years. 
 
14 References 
1. 
Kotsakis, G.A., et al., A network meta-analysis of interproximal oral hygiene methods in 
the reduction of clinical indices of inflammation. J Periodontol, 2018. 89(5): p. 558-570. 
2. 
Shamsoddin, E., Dental floss as an adjuvant of the toothbrush helps gingival health. Evid 
Based Dent, 2022. 23(3): p. 94-96. 
3. 
Alali, A.Y., et al., Frictional coefficient during flossing of teeth. Dent Mater, 2018. 
34(12): p. 1727-1734. 
4. 
Huang, Z., J.M. Broadbent, and J.J.E. Choi, Comparison of dental flosses - an 
investigation of subjective preference and mechanical properties. Biomater Investig 
Dent, 2023. 10(1): p. 2258919. 
5. 
Carr, M.P., G.L. Rice, and J.E. Horton, Evaluation of floss types for interproximal plaque 
removal. Am J Dent, 2000. 13(4): p. 212-4. 
6. 
Rich, S.K., J.A. Friedman, and L.A. Schultz, Effects of flossing on plaque and gingivitis in 
third grade schoolchildren. J Public Health Dent, 1989. 49(2): p. 73-7. 
7. 
Azcarate-Velázquez, F., et al., Effectiveness of flossing loops in the control of the 
gingival health. J Clin Exp Dent, 2017. 9(6): p. e756-e761. 
8. 
Lobene, R.R., et al., A modified gingival index for use in clinical trials. Clin Prev Dent, 
1986. 8(1): p. 3-6. 
9. 
Mancinelli-Lyle, D., et al., Effectiveness of a sonic-flosser toothbrush with different size 
brush heads and manual toothbrush plus dental floss on plaque, gingival bleeding and 
inflammation in adults with naturally occurring gingivitis: A 4-week randomized 
controlled trial. Int J Dent Hyg, 2023. 21(3): p. 624-633. 
10. 
Van der Weijden, G.A., et al., Comparison of different approaches to assess bleeding on 
probing as indicators of gingivitis. J Clin Periodontol, 1994. 21(9): p. 589-94. 
11. 
Turesky, S., N.D. Gilmore, and I. Glickman, Reduced plaque formation by the 
chloromethyl analogue of victamine C. J Periodontol, 1970. 41(1): p. 41-3. 
 
 
 
 
 
 
 
 
 
 

IRB#: 22752 
Version Date: May 8, 2024 
Amendment 1: 23May2024 
Amendment 2: 27Sep2024 
Page 15 of 16 
15  Appendix 
1.0 
Flossing Instructions 
 
 
 
Grasp the Floss Loops® in opposite hands 
and slightly stretch apart to create tension  
 
Wind the Floss Loop® once around the 
index finger of each hand  
 
 
Place thumbs on each forefinger over the 
Floss Loops® strand 
 
 
 
Insert Floss Loop® between teeth and slide 
along the side of each tooth to clean both 
above and below the gum line 
 
 
 
 
 
 
 
 
 
 
 

IRB#: 22752 
Version Date: May 8, 2024 
Amendment 1: 23May2024 
Amendment 2: 27Sep2024 
Page 16 of 16 
2.0 
Subject’s Restrictions  
 
 
During the study,  
 
• 
Do not have your teeth professionally cleaned  
• 
Refrain from elective dental procedures such as fillings  
• 
Do not use any other oral hygiene product or procedures other than provided during 
your study visit  
 
Prior to your next appointment:  
 
• 
Do not brush or floss the evening before or the morning of your appointment  
• 
Do not chew gum 12 hours before your appointment  
• 
Do not eat or drink anything 2 hours before your appointment