Clinical trial NCT04830969
Conditions: Diabetes Mellitus, Type II Periodontitis
Sponsor: State University of New York at Buffalo
Start date: 2016-11-08; Completion date: 2021-01-28
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
With poorly controlled diabetes, periodontal status often worsens, and with severe periodontal conditions there is often poorer glycemic control. There are few published reports investigating the efficacy of periodontal therapy in diabetics and fewer that include evaluation of the oral microbial profiles (the microbiome). The investigators will examine systemic changes in diabetes status and microbiome influences on clinical response to periodontal therapy in a randomized clinical trial of participants with and without diabetes and with periodontal disease. Two different treatments will be used:

1. Scaling and root planning (SRP) alone, or
2. SRP and supportive periodontal therapy (SPT), the use of chlorhexidine gluconate rinse (Paroex®) and a rubber interdental bristle cleaner (Soft-Picks) The main goal of this clinical trial is to evaluate the effects of SRP alone versus SRP+SPT on clinical, microbiological and immunological status in participants. A clearer understanding of how periodontal therapy affects diabetes status could lead to the development of new therapies for periodontal disease and diabetes.

Detailed description:
With poorly controlled diabetes, periodontal disease worsens, and with severe periodontal conditions, there is often poorer glycemic control. Published papers conclude that periodontal treatment leads to a reduction in hemoglobin A1c; however, other studies show limited or no improvement. Some patients do not respond well to professional periodontal therapy, even without diabetes, which could be related to poor oral hygiene and/or host factors including microbial profiles. There are few published papers investigating the efficacy of periodontal therapy in diabetics and fewer that include assessment of the oral microbiome. The investigators will examine systemic changes in diabetes status and microbiome influences on clinical response to periodontal therapy in a randomized clinical trial. It has been shown that chlorhexidine gluconate rinse leads to significant clinical improvement over standard periodontal therapy alone, and interdental tooth cleaners remove more dental plaque (leading to reduced gingival inflammation) effectively than brushing alone. Therefore, in this study, standard periodontal therapy, scaling and root planning (SRP) will be provided alone, or SRP plus supportive periodontal therapy (SPT), the use of chlorhexidine gluconate rinse (Paroex®) and a rubber interdental bristle cleaner (Soft-Picks), to diabetics and non-diabetics with periodontal disease to determine the differences in response between the groups.

The main aim of this study is to evaluate the effects of SRP alone versus SRP+SPT on clinical, microbiological and immunological status of subjects with and without type 2 diabetes and with periodontal disease. A clearer understanding of how periodontal therapy affects diabetes status could lead to the development of novel new targeted therapies of both periodontal disease and diabetes.

Arms: arm 1: The first group, A, includes diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks. arm 2: The second group, B, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks. arm 3: The third group, C, includes diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP). arm 4: The second group, D, includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Interventions: intervention 1: Chlorhexidine gluconate oral rinse intervention 2: Scaling & Root Planing intervention 3: Soft Picks
Intervention descriptions: intervention 1: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops. intervention 2: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums. intervention 3: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.

Protocol documents:
Prot_SAP_000.pdf: 
 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federalwide Assurance ID#: FWA00008824 
Page 1 of 50 
 
 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions .......................................................................................................... 2 
1.0 
Objectives ................................................................................................................ 4 
2.0 
Scientific Endpoints ................................................................................................. 4 
3.0 
Background .............................................................................................................. 5 
4.0 
Study Design ............................................................................................................ 9 
5.0 
Local Number of Subjects ....................................................................................... 9 
6.0 
Inclusion and Exclusion Criteria ............................................................................ 10 
7.0 
Vulnerable Populations .......................................................................................... 12 
8.0 
Eligibility Screening .............................................................................................. 13 
9.0 
Recruitment Methods ............................................................................................. 14 
10.0 Procedures Involved ............................................................................................... 15 
11.0 Study Timelines ..................................................................................................... 22 
12.0 Setting .................................................................................................................... 22 
13.0 Community-Based Participatory Research ............................................................ 23 
14.0 Resources and Qualifications ................................................................................. 24 
15.0 Other Approvals ..................................................................................................... 27 
16.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 28 
17.0 Data Management and Analysis ............................................................................ 28 
18.0 Confidentiality ....................................................................................................... 31 
A. 
Confidentiality of Study Data ............................................................................ 31 
B. 
Confidentiality of Study Specimens ................................................................... 32 
19.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 33 
20.0 Withdrawal of Subjects .......................................................................................... 34 
21.0 Risks to Subjects .................................................................................................... 35 
22.0 Potential Benefits to Subjects ................................................................................ 38 
23.0 Compensation for Research-Related Injury ........................................................... 38 
24.0 Economic Burden to Subjects ................................................................................ 39 
25.0 Compensation for Participation ............................................................................. 39 
26.0 Consent Process ..................................................................................................... 39 
27.0 Waiver or Alteration of Consent Process ............................................................... 44 
28.0 Process to Document Consent ............................................................................... 45 
29.0 Multi-Site Research (Multisite/Multicenter Only) ................................................. 46 
30.0 Banking Data or Specimens for Future Use .......................................................... 47 
31.0 Drugs or Devices .................................................................................................... 48 
32.0 Humanitarian Use Devices .................................................................................... 50 
 
 
 


 
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IRB Version: JAN2016 
Template Instructions 
Sections that do not apply: 
• In several sections, the addition of checkboxes for Not Applicable have been 
added to the template as responses.   
o If an N/A checkbox is present, select the appropriate justification 
from the list.   
o If an N/A checkbox is not present, or if none of the existing 
checkboxes apply to your study, you must write in your own 
justification. 
• In addition: 
o For research where the only study procedures are records/chart 
review:  Sections 19, 20, 22, 23, 24, 25, 31, and 32 do not apply. 
o For exempt research:  Sections 31 and 32 do not apply. 
 
Studies with multiple participant groups: 
 
• If this study involves multiple participant groups (e.g. parents and children), 
provide information in applicable sections for each participant group. Clearly 
label responses when they differ.  For example: 
Response:  
Intervention Group:  
 
Control Group: 
 
Formatting: 
• Do not remove template instructions or section headings when they do not apply 
to your study. 
If you are pasting information from other documents using the “Merge Formatting” 
Paste option will maintain the formatting of the response boxes. 
Amendments: 
• When making modifications or revisions to this and other documents, use the 
Track Changes function in Microsoft Word. 
• Update the version date or number on Page 3. 
 
 


 
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IRB Version: JAN2016 
PROTOCOL TITLE: 
Include the full protocol title. 
Response:  
Impact of Periodontal Therapy on Patients with Diabetes: A Pilot Study 
 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response:  
Robert E. Schifferle, DDS, PhD 
Oral Biology/Periodontics and Endodontics 
716-829-2013 
res@buffalo.edu 
 
VERSION: 
Include the version date or number. 
Response: 3.1 
March 02, 2022 
 
GRANT APPLICABILITY: 
Indicate whether this protocol is funded by a grant (e.g. NIH, foundation grant).  
For a grant with multiple aims, indicate which aims are covered by this research 
proposal. 
NOTE: This question does not apply to studies funded by a sponsor contract. 
Include a copy of the grant proposal with your submission. 
Response: Funding by Sunstar has ended; this is now an unfunded study. 
 
 


 
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IRB Version: JAN2016 
RESEARCH REPOSITORY: 
Indicate where the research files will be kept, including when the study has been 
closed.  The repository should include, at minimum, copies of IRB 
correspondence (approval, determination letters) as well as signed consent 
documents.  This documentation should be maintained for 3 years after the study 
has been closed.   
Response: Study documents will be kept in the Periodontal Disease Research 
Center (PDRC), Foster Hall, UB South Campus and include clinical records 
and Informed Consents. 
Location: UB South Campus, PDRC, Foster Hall 
Address: 120 Foster Hall 
Department: Oral Biology 
1.0 Objectives 
1.1 Describe the purpose, specific aims, or objectives of this research. 
Response: Our main goal is to evaluate the efficacy of Supportive Periodontal 
Therapy (SPT), 0.12 % Chlorhexidine gluconate rinse (Paroex®) and Soft-
Picks, after professional Scaling and Root Planing (SRP) on clinical, 
microbiological and immunological status in subjects with type 2 diabetes.  
Our second goal is to compare the response to periodontal therapy (SRP only 
versus SRP + SPT) in participants with and without diabetes.  A clear 
understanding of how periodontal therapy affects clinical status and the 
microbiome could help to develop an effective treatment regimen for each 
subject. 
 
1.2 
State the hypotheses to be tested, if applicable. 
NOTE:  A hypothesis is a specific, testable prediction about what you expect to 
happen in your study that corresponds with your above listed objectives. 
Response:  
1. 
Supportive Periodontal Therapy (SPT) using Paroex® 
mouthrinse (0.12% chlorhexidine) and Soft-Picks leads to improved 
clinical status and change in oral microbiome greater than when 
Scaling and Root Planing (SRP) only is used. 
2. 
There will be about 35% who will be “Poor Responders” (PRs) (those 
needing Rescue Therapy).  The number of PRs in diabetics will be higher 
than in non-diabetics.  Poor Responders will have different clinical and 
microbiome in characteristics than responders. 
2.0 Scientific Endpoints 
 
2.1    Describe the scientific endpoint(s), the main result or occurrence under 
study.   
 


 
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NOTE:  Scientific endpoints are outcomes defined before the study begins to determine 
whether the objectives of the study have been met and to draw conclusions from the data.  
Include primary and secondary endpoints.  Some example endpoints are:  reduction of 
symptoms, improvement in quality of life, or survival.  Your response should not be a 
date.   
1. Response: Primary endpoints;  
Primary Endpoints: 
1. Change in Probing pocket depth (PPD) at the 6-month post-SRP completed 
at Baseline. 
Secondary Endpoints: 
1. Oral clinical variables: Changes in Bleeding on Probing (BOP), 
Clinical attachment level (CAL), and Gingival Index and Plaque Index 
(PI) at 3, 6, 9, and 12 months after treatment (Baseline); Change in PPD 
at 3, 9, and 12 months after treatment. 
2. Systemic variables: Changes in Hemoglobin A1c (HbA1c); Fasting blood 
glucose (FBG); Immunoreactive insulin (IRI); High sensitivity C-reactive 
protein (hs-CRP); at 3, 6, and 12 months after treatment.  Blood for C-peptide; 
proinsulin; total GLP-1, PYY, dipeptidyl peptidase-IV (DPP-IV); glucagon; 
plasma endotoxin (LPS); soluble TNF-α RI and RII; the dicarbonyl 
methylglyoxal (MGO), and Trimethylamine-N-Oxide (TMAO) will be collected 
at 3, 6, and 12 months study visits, but tested later. 
3. Microbiology endpoints: Changes in Subgingival salivary and gut 
microbiome after periodontal treatment (SRP or SRP + SPT).  Changes in the 
skin and vaginal microbiome after treatment will be assessed as resources 
permit. 
 
3.0 Background 
3.1 Provide the scientific or scholarly background, rationale, and significance 
of the research based on the existing literature and how it will contribute to 
existing knowledge.  Describe any gaps in current knowledge.  Include 
relevant preliminary findings or prior research by the investigator.  
Response:  
Type 2 diabetes mellitus is a metabolic disease with high blood glucose levels 
due to either low or lacking insulin production or failure to properly respond 
to insulin. Diabetes affects more than 400 million people world-wide and the 
number is increasing each year. Continuously high blood glucose levels lead 
to many complications, for example, retinopathy, nephropathy, neuropathy, 
and cardiovascular disease. Complications of diabetes lead to significant 
morbidity and mortality as well as to a decrease in quality of life (QOL). 
Diabetes and periodontal disease are also related and in a 
bidirectional manner. With poorly controlled blood glycemic levels, 


 
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periodontal status is often aggravated,1,2 and severe periodontal 
conditions are associated with poorer glycemic control.3 Systematic 
reviews and meta analyses conclude that periodontal disease leads to 
0.36% to 0.65% reductions in hemoglobin A1c (HbA1c).4,5 However, a 
multi-centered clinical trial showed non-surgical periodontal therapy 
did not improve glycemic control.6  Borgnakke et al7 reviewed the 
paper and found baseline HbA1c levels were already close to desired 
levels so there was little room for improvement. In addition, obesity 
could have influenced the results as it increases inflammation. A small 
percentage of patients even without diabetes do not respond well to 
SRP which could be related to poor home care, incomplete root 
planning and/or impaired or different host immune responses, or 
anatomic structures that preclude healing after therapy such as 
furcation clefts, enamel projections or other root abnormalities. 
Columbo et al8,9 found distinctly different microbial profiles in those 
who did not respond well to periodontal therapy by using the Human 
Oral Microbe Identification Microarray in comparison to those who 
did. 
In the past decade, the development of new next generation 
sequencing (NGS) techniques have shown a greater number of 
organisms that are related to periodontal disease than previously 
found when older assessment techniques were used. These older 
measures (for example, culturing) limited the number of bacteria that 
could be identified at one time and likely led to an incomplete 
understanding of the association between periodontal disease and 
diabetes. NGS allows for the characterization of hundreds of oral 
bacteria rather than a few leading to a more comprehensive 
assessment of the oral microbiome than was previously possible. The 
more complete assessment increases our ability to more fully examine 
the association between subjects with and without periodontal disease, 
those with and without diabetes and those with periodontal disease 
and diabetes versus those without either.10,11 Genco et al12 found 
correlations between periodontal status and the subgingival 
microbiome in diabetics; however, periodontal status has stronger 
correlations with subgingival microbiome composition than diabetes. 
In a pilot study, Anaeroglobus and Parvimonas are more abundant in 
subjects with diabetes and periodontits compared to those without 
diabetes but with periodontitis and those bacteria may be newly 
discovered periodontal pathogens.12,13 
There are few published reports investigating the efficacy of periodontal 
therapy on the microbiome in diabetics. We hypothesize that the microbiome 
influences clinical response to periodontal therapy and systemic changes 
showing improvement in diabetes status, i.e., improvement in HbA1c. As an 
adjunct to the professional mechanical periodontal therapy, chlorhexidine 
gluconate rinse previously demonstrated significant clinical improvements 
especially the reduction of bleeding, gingival inflammation, and dental 


 
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plaque accumulation.14-16 Moreover, interdental tooth cleaners removed 
more dental plaque effectively than only brushing and was followed by a 
reduction in gingival inflammation.17 Therefore we developed the plan to add 
SRP or SRP + SPT to the non-diabetic groups to determine the differences in 
response between diabetics and non-diabetics. The main aim of this study is 
to evaluate the effects of Supportive Periodontal Therapy, 0.12 % 
Chlorhexidine gluconate rinse (Paroex®) and a rubber interdental bristle 
cleaner (Soft-Picks) after professional Scaling and Root Planning (SRP), on 
clinical, microbiological and immunological status of subjects with type 2 
diabetes and periodontal disease. The second aim is to compare the response 
to Supportive Periodontal Therapy, SRP alone or SRP+SRP, between 
patients with and without type 2 diabetes. A clearer understanding of how 
periodontal therapy affects diabetes status could lead to the development of 
novel new targeted approaches to therapy of both periodontal disease and 
diabetes. 
 
3.2 Include complete citations or references. 
Response:  
1. 
Nelson RG, Shlossman M, Budding LM, Pettitt DJ, Saad MF, 
Genco RJ, Knowler WC. Periodontal disease and NIDDM in Pima 
Indians. Diabetes Care. 1990 13(8):836-840. 
2. 
Taylor GW, Burt BA, Becker MP, Genco RJ, Shlossman M, 
Knowler WC, Pettitt DJ. Non-insulin dependent diabetes mellitus and 
alveolar bone loss progression over 2 years. J Periodontol. 1998 
69(1):76-83. 
3. 
Arora N, Papapanou PN, Rosenbaum M, Jacobs DR Jr, 
Desvarieux M, Demmer RT. Periodontal infection, impaired fasting 
glucose and impaired glucose tolerance: results from the Continuous 
National Health and Nutrition Examination Survey 2009-2010. J Clin 
Periodontol. 2014 41(7):643-652. 
4. 
Engebretson S, Kocher T. Evidence that periodontal treatment 
improves diabetes outcomes: a systematic review and meta-analysis. J 
Periodontol. 2013 84(4 Suppl):S153-69. 
5. 
Sgolastra F, Severino M, Pietropaoli D, Gatto R, Monaco A. 
Effectiveness of periodontal treatment to improve metabolic control in 
patients with chronic periodontitis and type 2 diabetes: a meta-
analysis of randomized clinical trials. J Periodontol. 2013 84(7):958-
73. 
6. 
Engebretson SP, Hyman LG, Michalowicz BS, Schoenfeld ER, Gelato 
MC, Hou W et al. The effect of nonsurgical periodontal therapy on 
hemoglobin A1c levels in persons with type 2 diabetes and chronic 
periodontitis: a randomized clinical trial. J Am Med Assoc. 2013 310:2523-
2532. 


 
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7. 
Borgnakke WS, Chapple IL, Genco RJ, Armitage G, Bartold 
PM, D'Aiuto F, Eke PI, Giannobile WV, Kocher T, Kornman KS, 
Lang NP, Madianos PN, Murakami S, Nishimura F, Offenbacher S, 
Preshaw PM, Rahman AU, Sanz M, Slots J, Tonetti MS, Van Dyke 
TE. The multi-center randomized controlled trial (RCT) published by 
the journal of the American Medical Association (JAMA) on the effect 
of periodontal therapy on glycated hemoglobin (HbA1c) has 
fundamental problems. J Evid Based Dent Pract. 2014 14(3):127-132.  
8. 
Colombo AP, Boches SK, Cotton SL, Goodson JM, Kent R, 
Haffajee AD, Socransky SS, Hasturk H, Van Dyke TE, Dewhirst F, 
Paster BJ. Comparisons of subgingival microbial profiles of 
refractory periodontitis, severe periodontitis, and periodontal health 
using the human oral microbe identification microarray. J 
Periodontol. 2009 80(9):1421-32. 
9. 
Colombo AP, Bennet S, Cotton SL, Goodson JM, Kent R, 
Haffajee AD, Socransky SS, Hasturk H, Van Dyke TE, Dewhirst FE, 
Paster BJ. Impact of periodontal therapy on the subgingival 
microbiota of severe periodontitis: comparison between good 
responders and individuals with refractory periodontitis using the 
human oral microbe identification microarray. J Periodontol. 2012 
83(10):1279-87. 
10. 
Kirst ME, Li EC, Alfant B, Chi YY, Walker C, Magnusson I, 
Wang GP. Dysbiosis and alterations in predicted functions of the 
subgingival microbiome in chronic periodontitis. Appl Environ 
Microbiol. 2015 81(2):783-93. 
11. 
Wang J, Qi J, Zhao H, He S, Zhang Y, Wei S, Zhao F. 
Metagenomic sequencing reveals microbiota and its functional 
potential associated with periodontal disease. Sci Rep. 2013 3:1843. 
12. 
Genco RJ et al. The Subgingival `eriodontal Microbiome in 
Diabetes. The 3rd Microbiome R&D and Business Collaboration 
Forum 2015 
13. 
Pérez-Chaparro PJ, Gonçalves C, Figueiredo LC, Faveri1 M, 
Lobão E, Tamashiro N, Duarte P, Feres M. Newly Identified 
Pathogens Associated with Periodontitis: A Systematic Review. J Dent 
Res. 2014 93(9):846-858. 
14. 
Beiswanger BB, Mallat ME, Jackson RD, Mau MS, Farah CF, 
Bosma ML, Bollmer BW, Hancock EB. Clinical effects of a 0.12% 
chlorhexidine rinse as an adjunct to scaling and root planing. J Clin 
Dent. 1992 3(2):33-38. 
15. 
Faveri M, Gursky LC, Feres M, Shibli JA, Salvador SL, de 
Figueiredo LC. Scaling and root planing and chlorhexidine 
mouthrinses in the treatment of chronic periodontitis: a randomized, 


 
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placebo-controlled clinical trial. J Clin Periodontol. 2006 33(11):819-
828. 
16. 
Abouassi T, Woelber JP, Holst K, Stampf S, Doerfer CE, 
Hellwig E, Ratka-Krüger P. Clinical efficacy and patients' acceptance 
of a rubber interdental bristle. A randomized controlled trial. Clin 
Oral Investig. 2014 18(7):1873-80. 
17. 
Santos VR, Lima JA, Miranda TS, Gonçalves TE, Figueiredo LC, 
Faveri M, Duarte PM. Full-mouth disinfection as a therapeutic protocol for 
type-2 diabetic subjects with chronic periodontitis: twelve-month clinical 
outcomes: a randomized controlled clinical trial. J Clin Periodontol. 2013 
40(2):155-62. 
4.0 Study Design 
4.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response: A single-center, single-blind, randomized controlled clinical 
trial: 
Group A: Diabetic, Scaling & Root Planing (SRP) + Paroex® + Soft-
Picks 
Group B: Non-Diabetic, SRP + Paroex® + Soft-Picks 
Group C: Diabetic, SRP 
Group D: Non-Diabetic, SRP 
5.0 Local Number of Subjects 
5.1 Indicate the total number of subjects that will be enrolled or records that 
will be reviewed locally. 
Response: 104 with complete data; 26 per group 
 
5.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response: 250 
 
5.3 Justify the feasibility of recruiting the proposed number of eligible subjects 
within the anticipated recruitment period. For example, how many potential 
subjects do you have access to? What percentage of those potential subjects 
do you need to recruit? 
Response: We have a list of participants in previous studies that have given us 
permission to re-contact them about new studies.  We also have a successful 
history of being able to make and surpass recruitment goals.  Tactics such as 
word of mouth, flyers and posters, and ads have worked well in the past. 


 
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6.0 Inclusion and Exclusion Criteria 
6.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE:  This may be done in bullet point fashion. 
Response: Inclusion Criteria: To be in this study subjects must meet 
all of the following criteria: 
1) 
Be able to understand the informed consent form and be 
willing and able to read and sign it. 
2) 
At least 25 years of age. 
3) 
Be able to understand and follow directions for study 
procedures. 
4) 
At least 14 natural teeth, not counting third molars (“wisdom 
teeth”). 
5) 
For moderate periodontal disease: At least four (4) teeth with 
at least one (1) site with > 5 mm pocket depth (PD) and at least two (2) 
of the affected teeth with > 2 mm alveolar bone loss as shown on 
radiographs.  For Severe periodontal disease: At least eight (8) teeth 
with at least one (1) site with > 5 mm pocket depth (PD) and at least 
two (2) of the affected teeth with > 2 mm alveolar bone loss as shown 
on radiographs. 
6.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
Response:  Exclusion Criteria: Presence of the following criteria 
results in ineligibility for this study; 
1) 
Presence of orthodontic appliances (“braces”). 
2) 
An abnormal condition of lips, lining of the mouth, tongue, or 
gums (except for periodontal disease). If subject has a cold sore, 
canker sore, or injury in their mouth, they may return after the sore 
or injury heals.  
3) 
Abscess of the gingiva caused by periodontal disease, or visible 
gross tooth decay 
4) 
A broken tooth root or an abscessed tooth, per clinician’s 
judgement. Subject may be allowed to participate in the study after 
the condition is successfully treated or the study dentist reviews the 
condition and does not feel it will jeopardize the results of the study. 
5) 
Periodontal treatment in the past 6 months. 
6. 
Antibiotic therapy in the past three (3) months. 


 
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7) 
Have used cigarettes or other tobacco products in the past 
year. 
8) 
Body mass index (BMI) is > 45. 
9) 
Have regularly used non-steroidal anti-inflammatory drugs 
(such as >= 325 mg aspirin or ibuprofen) over the past 3 weeks. 
10) 
Regularly using drugs that weaken the immune system (such 
as corticosteroids taken by mouth or injection, and cyclosporine). 
11) 
Have participated in another clinical research study in the past 
30 days. 
12) 
Pregnant or breastfeeding. 
13) 
Have a condition that we feel will make study participation 
unsafe or difficult for the patient. 
14) 
Require premedication for dental exams. 
6.3 Indicate specifically whether you will include any of the following special 
populations in your study using the checkboxes below.   
 
NOTE:  Members of special populations may not be targeted for enrollment in 
your study unless you indicate this in your inclusion criteria. 
Response:  None. 
☐ 
Adults unable to consent 
☐ 
Individuals who are not yet adults (infants, children, teenagers) 
☐ 
Pregnant women 
☐ 
Prisoners 
 
6.4 Indicate whether you will include non-English speaking individuals in your 
study.  Provide justification if you will exclude non-English speaking 
individuals.  
In order to meet one of the primary ethical principles of equitable selection 
of subjects, non-English speaking individuals may not be routinely excluded 
from research as a matter of convenience. 
In cases where the research is of therapeutic intent or is designed to 
investigate areas that would necessarily require certain populations who 
may not speak English, the researcher is required to make efforts to recruit 
and include non-English speaking individuals.  However, there are studies 
in which it would be reasonable to limit subjects to those who speak 
English.  Some examples include pilot studies, small unfunded studies with 
validated instruments not available in other languages, studies with 
numerous questionnaires, and some non-therapeutic studies which offer no 
direct benefit. 


 
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Response: We will not be actively recruiting non-English speaking subjects.  
This is a pilot study with the aim to obtain preliminary data that can be used 
for a larger proposal in the future.  The expected number of subjects needed 
for this pilot does not warrant having the consent and surveys all officially 
translated into another language. 
 
7.0 Vulnerable Populations 
If the research involves special populations that are considered vulnerable, 
describe the safeguards included to protect their rights and welfare.   
NOTE: You should refer to the appropriate checklists, referenced below, to ensure you 
have provided adequate detail regarding safeguards and protections. You do not, 
however, need to provide these checklists to the IRB. 
7.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: 
 
☒ 
N/A:  This research does not involve pregnant women. 
7.2 For research that involves neonates of uncertain viability or non-viable 
neonates, safeguards include: 
NOTE CHECKLISTS: Non-Viable Neonates (HRP-413), or Neonates of Uncertain 
Viability (HRP-414) 
Response:  
 
☒ 
N/A:  This research does not involve non-viable neonates or neonates of 
uncertain viability. 
7.3 
For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
 
☒ 
N/A:  This research does not involve prisoners. 
7.4 For research that involves persons who have not attained the legal age for 
consent to treatments or procedures involved in the research (“children”), 
safeguards include:   
NOTE CHECKLIST: Children (HRP-416) 
Response:  
 
☒ 
N/A:  This research does not involve persons who have not attained the 
legal age for consent to treatments or procedures (“children”). 
7.5 For research that involves cognitively impaired adults, safeguards include: 


 
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NOTE CHECKLIST: Cognitively Impaired Adults (HRP-417) 
Response:  
 
☒ 
N/A:  This research does not involve cognitively impaired adults. 
7.6  Consider if other specifically targeted populations such as students, 
employees of a specific firm, or educationally or economically 
disadvantaged persons are vulnerable.  Provide information regarding 
their safeguards and protections, including safeguards to eliminate 
coercion or undue influence. 
Response: Students and employees may be screened and enrolled in the study 
if they meet eligibility criteria.  However, their enrollment is not tied to 
student status or grades nor employee performance or evaluations. 
 
8.0 Eligibility Screening  
8.1 
Describe screening procedures for determining subjects’ eligibility.  
Screening refers to determining if prospective participants meet inclusion and 
exclusion criteria.  
Include all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaire) 
Response: Potential participants may respond to flyers, posters, 
advertisements or word-of-mouth by phone call.  First, they will be screened 
over the phone and if eligible, scheduled for a screening visit which may be 
the same day as the first study visit (Baseline Visit (if eligible)).  A script will 
be used for the screening phone call plus a screening checklist.  In the 
screening telephone conversation, women are asked if they are pregnant and 
are ineligible for the Screening Visit if they say yes.  At the Screening visit, 
women of childbearing age are given a pregnancy test and if positive are 
ineligible.  This testing is completed because of the possible need for Rescue 
Therapy if the study treatment is not successful.  If the study treatment is not 
successful, the dentist/periodontist determines the nature and extent of the 
Rescue Therapy and it may include surgery and/or topical or systemic 
antibiotics.  The risk to any fetus from the study treatment is very low.  
However, if topical or systemic antibiotics are required because of failure to 
respond to the study treatment, the risk to the fetus is higher.  Hence, 
pregnancy tests will also be given at visits where additional therapy may be 
needed, and Arestin will NOT be given if the pregnancy test is positive.In 
addition, AxiUm, the patient data system in the School of Dental Medicine, will 
be accessed to identify patients with diabetes who might be eligible, willing and 
interested in joining the study.  For these patients, we will obtain permission of 
Dr. Joseph Gambacorta to contact identified patients, if he approves of the 
selection.  Then an IRB-approved letter will be sent to the patients informing 
them of the study, telling then they may call us for more information or that we 
may call them to provide information about the study.  Patients will also be told 


 
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they under no obligation to join the study.  From there we will use the IRB-
approved Telephone Screen Script and Screening Checklist to provide 
information to and assess eligibility of patient.  All procedures thereafter will be 
the same as with other participants. 
☐ 
N/A:  There is no screening as part of this protocol. 
9.0 Recruitment Methods 
☐ 
N/A:  This is a records review only, and subjects will not be 
recruited.  NOTE:  If you select this option, please make sure that 
all records review procedures and inclusion/exclusion screening 
are adequately described in other sections. 
9.1 
Describe when, where, and how potential subjects will be recruited.  
NOTE:  Recruitment refers to how you are identifying potential participants and 
introducing them to the study.  Include specific methods you will use (e.g. 
searching charts for specific ICD code numbers, Research Participant Groups, 
posted advertisements, etc.). 
Response: Participants will be recruited from previous studies (if they have 
indicated they are interested participating in other/new studies), as well as 
from responses to posters, flyers, advertisements, and word-of-mouth.  All 
advertising materials that will be used will be submitted to the IRB for 
approval BEFORE they are used.  In addition, we plan to contact senior 
citizens’ centers asking them to hang study posters and inform their 
participants about the study. 
Radio and television ads will be used for recruitment when other methods 
have declining effect/no longer work and resources allow.  Final versions of 
ads (radio and/or TV) will be submitted to the IRB for approval before use. 
The AxiUm system, the patient data system in the School of Dental Medicine, 
will be accessed to identify patients with diabetes who might be eligible, 
willing and interested in joining the study.  After receiving a partial HIPAA 
waiver for this work, we will request permission from Dr. Joseph 
Gambacorta to contact identified patients.  If he approves, an IRB-approved 
letter will be sent to the patients informing them of the study, telling then 
they may call us for more information or that we may call them to provide 
information about the study.  Patients will be told they under no obligation to 
join the study.  We will use the IRB-approved Telephone Screen Script and 
Screening Checklist to provide information to and assess eligibility of 
patients.  All procedures thereafter will be the same as with other 
participants. 
 
9.2 Describe how you will protect the privacy interests of prospective subjects 
during the recruitment process.   
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Response: Potential and enrolled participants will interact with the 
study staff, the dentists, registered dental hygienists, dental assistants, 
laboratory technicians, research associates and data manager, in an 
operatory in the PDRC.  If participants chose NOT to interact with 
one of these people, we can accommodate the request to a limited 
degree by having another dentist, hygienist, dental assistant or 
laboratory technician “work” with them, but once seen/examined by a 
dentist or hygienist we need to keep the same examiner for 
consistency of clinical examination data.  Participants can ask to be 
seen in an operatory with a door that can be closed to better ensure 
privacy.  Participants may also choose not to answer questions, but if 
those questions provide critical information needed to answer the 
research questions, the person will not be allowed to remain in the 
study.  When participants have samples such as saliva collected, they 
are provided privacy from the view of others; blood is collected and 
height and weight measured out of the view of others as well. 
The PDRC is a suite of rooms and operatories some of which have 
doors for privacy and quiet.  However, even operatories without doors 
have limited access and view and so provide a good degree of privacy 
to everyone. 
Participants “self-select” to join the study by calling us in response to flyers, 
posters and ads.  They are told they may withdraw from the study at any 
time with no adverse effects on them.  They are told we need certain data and 
that data need is explained prior to enrollment (at the time of the screening 
call and during the screening visit/first study visit. 
 
9.3 Identify any materials that will be used to recruit subjects.  
NOTE:  Examples include scripts for telephone calls, in person announcements / 
presentations, email invitations.  
For advertisements, include the final copy of printed advertisements with your 
submission. When advertisements are taped for broadcast, attach the final 
audio/video tape.  NOTE:  You may submit the wording of the advertisement prior 
to taping to ensure there will be no IRB-required revisions, provided the IRB also 
reviews and approves the final version. 
Response: Posters, flyers, ads and word-of-mouth, and AxiUm; a script is 
used for responses to these methods.  All advertising materials that will be 
used will be submitted to the IRB for approval BEFORE they are used. 
 
10.0 
Procedures Involved 
10.1 Provide a description of all research procedures or activities being 
performed and when they are performed once a subject is screened and 
determined to be eligible. Provide as much detail as possible.   


 
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NOTE:  This should serve as a blueprint for your study and include enough detail 
so that another investigator could pick up your protocol and replicate the research.  
For studies that have multiple or complex visits or procedures, consider the 
addition of a schedule of events table in in your response. 
Response: SCREENING VISIT: 
Subject will be recruited by advertisements, word-of-mouth, and by 
flyer and posters hung around the University and local community. 
1. 
Consent: Visits will take place in the Periodontal Disease 
Research Center, 120 Foster Hall, UB South Campus. We will explain 
the study and study procedures to participants. If they agree to 
participate in the study, we will ask them to read and sign the consent 
form. 
2. 
Demographic: Medical and dental histories and subject 
demographic information include date of birth, gender, racial and 
ethnic background, medical and dental histories, medications, lifestyle 
habits, dental home care, smoking status will be obtained. Height, 
weight, and blood pressure will be measured. 
3. 
Oral health examination for eligibility: The oral health 
examination including measurements to assess teeth and gingival 
status will be completed. Dental radiographs will be taken unless 
suitable x-rays taken elsewhere within the past two years can be 
acquired.  (Women of childbearing age will be required to take a 
pregnancy test before any radiographs are taken.) 
4. 
Instruct in how to collect fecal samples at home, and give a 
fecal collection kit.  Instruct to refrain from showering or washing 
hair for 24 hours before study visit. 
5. 
Make an appointment for Baseline visit. 
BASELINE VISIT: 
1. 
Review medical and dental histories. 
2. 
Baseline Taste Test 
3. 
Oral Health Examination: 
a) 
Plaque lndex (PI) 
b) 
Probing Pocket Depth (PPD) 
c) 
Bleeding on Probing (BOP) 
d) 
Gingival Index (GI) 
e) 
Clinical Attachment Level (CAL) 
4. 
Collect samples: 
a) 
Blood (FBS, HbA1c, Insulin, hs-CRP and microbiome testing, 
and for future testing of C-peptide, proinsulin, total GLP-1, PYY, 


 
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DPP-IV, glucagon, LPS, soluble-TNFα RI and RII, MGO, TMAO, 
creatinine, and for future unknown testing. 
b) 
Subgingival plaque and saliva. 
c) 
Fecal, skin, and vaginal samples 
3. 
Treatment: All participants will receive full mouth SRP within 
one month of the baseline visit. 
4. 
Oral health instruction: All participants will receive oral 
hygiene instruction from the hygienist. 
5. 
Participants will be randomized into one of the four groups. 
6. 
Groups A and B will receive the product, Soft-Picks, and 
information on how to use them. 
7. 
Make an appointment for 3 months after Baseline Visit. 
3-MONTH VISIT: 
1. 
Collect the unused Soft-Picks and Paroex® bottle from the 
participants in the Groups A and B. 
2. 
Ask the subjects to answer the Adverse Event, Taste and 
Compliance questionnaire. 
3. 
Review medical and dental histories. 
4. 
Taste Test. 
5. 
Oral health examination 
6. 
Collect saliva, subgingival plaque and stool/fecal samples. 
6. 
Anterior teeth cleaning: All subjects will receive anterior teeth 
cleaning. 
7. 
Groups A and B will have the product, Soft-Picks, replenished 
and usage instructions reviewed as needed. 
8. 
Make or confirm the next appointment. 
9. 
If any sites where pocket depths stay the same and are > 5 mm 
or if the pockets deepen, periodontal treatment will be repeated.  
Exact treatment will be determined by the clinician (dentist or 
periodontist).  The treatment will be explained to the participant and 
questions will be answered beforehand.  Options for Rescue Therapy 
treatment are: 
• Option 1:  No additional treatment. 
• Option 2:  Pocket depths of ≥ 5 mm will receive scaling and root 
planing, 
• Option 3:  Pocket depths of ≥ 5 mm will receive scaling and root 
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• Option 4:  Pocket depths of ≥ 5 mm will receive modified Widman 
flap surgery, 
• Option 5:  Pocket depths of ≥ 5 mm will receive modified Widman 
flap surgery with the addition of the GUIDOR® easy-graft® 
CLASSIC Alloplastic Bone Grafting System to infrabony defects that 
are amenable to regeneration. 
 
6-MONTH VISIT: 
1. 
Collect the unused Soft-Picks from the subjects in the Test 
Group. 
2. 
Ask the subjects to answer the Adverse Event, Taste and 
Compliance questionnaire. 
3. 
Review medical and dental histories. 
4. 
Taste Test. 
5. 
Oral health examination 
6. 
Collect samples: blood (FBS, HbA1c, Insulin, hs-CRP and 
microbiome testing, and for future testing of C-peptide, proinsulin, 
total GLP-1, PYY, DPP-IV, glucagon, LPS, soluble-TNFα RI and RII, 
MGO, TMAO, creatinine, and for future unknown testing), 
subgingival plaque, saliva, fecal, skin, and vaginal samples. 
7. 
Retreat all PD >= 5 mm sites.  Subjects will receive additional 
treatment (Rescue Therapy), including surgery and/or topical or 
systemic antibiotics, if a clinician (dentist or periodontist) decides they 
need it.  Rescue Therapy is standard of care for non-responsive 
periodontal lesions, the type depending on the clinical status of the 
participant.  The need for Rescue Therapy (yes, no and type) will be 
noted in the study records and considered in the analysis of the study 
data.  If on examination, a participant presents with an area showing 
a clinically defined worsening of their periodontal condition, rescue 
therapy will be initiated.  This therapy will reduce the chance of the 
tooth being lost from periodontal disease.  Rescue therapy will be 
provided to sites that remain at ≥ 5 mm or those demonstrating an 
increase in pocket depths of ≥ 2 mm from the baseline visit bringing 
them to or above the 5 mm level.  Treatment will consist of scaling 
and root planing of the affected tooth and if the pocket depth is ≥ 5 
mm, the site may also be treated by local drug delivery with Arestin.  
In women of childbearing potential, a urine pregnancy test will be 
provided prior to the placement of Arestin.  If the pregnancy test is 
positive, Arestin will not be used in treatment.  Local anesthetic may 
be used during the procedure as needed.  Other treatments for saving 
the tooth may be given as deemed necessary by the 
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month Visit).  The clinician will discuss the additional treatment with 
the participant before it is provided.  The clinician providing the 
rescue therapy in a given subject should not be the clinician that will 
provide the periodontal measurements for that participant during the 
study. 
8. 
Groups A and B will have the product, Soft-Picks, replenished 
and usage instructions reviewed as needed. 
9. 
Confirm the next appointment. 
9-MONTH VISIT: 
1. 
Collect the unused Soft-Picks from the subjects in Groups A 
and B. 
2. 
Ask the subjects to answer the Adverse Event, Taste and 
Compliance questionnaire. 
3. 
Review medical and dental histories. 
4. 
Taste Test. 
5. 
Oral health examination 
6. 
Retreat all PD >= 5 mm sites.  Rescue therapy will be provided 
to sites that remain at ≥ 5 mm or to those demonstrating an increase 
in pocket depths of ≥ 2 mm from the baseline visit bringing them to or 
above the 5 mm level.  Subjects will receive additional treatment 
(Rescue Therapy), including surgery and/or topical or systemic 
antibiotics, if a clinician (dentist or periodontist) decides they need it 
(as described in Number 9 of the 3-month Visit).  Again, Rescue 
Therapy is standard of care for non-responsive periodontal lesions, 
the type depending on the clinical status of the participant.  The need 
for Rescue Therapy (yes, no and type) will be noted in the study 
records and considered in the analysis of the study data. 
7. 
Groups A and B will have the product, Soft-Picks, replenished 
and usage instructions reviewed as needed. 
8. 
Make or confirm the next appointment. 
12-MONTH VISIT: 
1. 
Collect the unused Soft-Picks from the subjects in Groups A 
and B. 
2. 
Review medical and dental histories. 
3. 
Ask the subjects to answer the Adverse Event, and Compliance 
questionnaire. 
4. 
Weight 
5. 
Taste Test. 
6. 
Oral health examination 


 
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7. 
Collect samples: blood (FBS, HbA1c, Insulin, hs-CRP and 
microbiome testing, and for future testing of C-peptide, proinsulin, 
total GLP-1, PYY, DPP-IV, glucagon, LPS, soluble-TNFα RI and RII, 
MGO, TMAO, creatinine, and for future unknown testing), 
subgingival plaque, saliva, fecal, skin, and vaginal samples. 
8. 
Finish Study: Participants will receive a dental cleaning 
(prophy) and be referred to a dentist for any necessary dental 
treatment needed. 
10.2 Describe what data will be collected. 
NOTE:  For studies with multiple data collection points or long-term follow up, 
consider the addition of a schedule or table in your response. 
Response:  
1. Demographic information: age, date of birth, gender, racial and ethnic 
background 
2. Medical History with Concomitant Medications 
3. Dental History with Questionnaire to Assess Likelihood of Periodontal 
Disease 
4. Height and Weight 
5. Results of oral health examination and periodontal disease 
measurements 
6. History of cigarette smoking and alcohol intake 
7. Results of blood testing 
8. Results of microbiome testing 
10.3 List any instruments or measurement tools used to collect data 
(e.g. questionnaire, interview guide, validated instrument, data collection 
form).   
 
Include copies of these documents with your submission. 
Response:  
1. 
Medical History with Concomitant Medications 
2. 
Dental History with Questionnaire to Assess Likelihood of 
Periodontal Disease 
3. 
Forms – uploaded to Click as file “DM RCT Manual of Procedures” 
a. Height and Weight Form 
b. Blood Collection Form 
c. Saliva Collection Form 


 
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d. Clinical Report Form for Charting Teeth Status and 
Periodontal Measurement Results 
e. Plaque Collection Form 
f. Fecal Collection Information Form 
g. Vaginal Swab Collection Form 
h. Taste Test Scoring Form 
4. 
Study Visit Checklists for each visit 
10.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
Response: AxiUm will be used to identify SDM patients with diabetes (see 
previous comments).  We will not use school records, medical records 
(electronic or otherwise), or other existing records; only those for the study.  
They are as follows: 
1. Telephone Screening Checklist 
2. Medical History with Concomitant Medications 
3. Dental History with Questionnaire to Assess Likelihood of Periodontal 
Disease 
4. AE, Taste and Compliance Assessment Questions Form 
5. Blood Collection Form 
6. Saliva Collection Form 
7. Plaque Collection Form 
8. Height and Weight Form 
9. Fecal Collection Information Form 
10. Skin Site Collection Form 
11. Vaginal Swab Collection Form 
12. Clinical Report Form for Charting Teeth Status and Periodontal 
Measurement Results 
13. Study Visit Checklists including one for Rescue Therapy and Dental 
Prophy 
14. Taste Test Scoring Form 
10.5 Indicate whether or not individual subject results, such as results of 
investigational diagnostic tests, genetic tests, or incidental findings will be 
shared with subjects or others (e.g., the subject’s primary care physician) 
and if so, describe how these will be shared. 
Response: The results of the blood tests for diabetes status will be shared with 
participants when received.  The results of the dental examinations will be 


 
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shared with participants, and their dentists, or a dentist we refer them to, if 
they wish.  The results of the testing if samples collected during the study will 
not be shared with participants.  Testing will be completed after it could be 
of use to participants and it has not been determined how specific results 
affect individuals. 
 
10.6 Indicate whether or not study results will be shared with subjects or others, 
and if so, describe how these will be shared. 
Response: Study results will not be available until participants are finished 
with the study.  If they ask about study results later, they will be given 
information on where to find publications or presentation.  If this study is 
registered at ClinicalTrials.gov they will be told of this and given the study 
number. 
 
11.0 
Study Timelines 
11.1 Describe the anticipated duration needed to enroll all study subjects. 
Response: We estimate it will take 12-18 months to recruit and enroll 104 
participants with complete data. 
 
11.2 Describe the duration of an individual subject’s participation in the study. 
Include length of study visits, and overall study follow-up time. 
Response: Each participant’s duration of participation is approximately 12-
13 months, slightly longer if study visits are not completed as scheduled. 
 
11.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected and all analyses have been completed). 
Response: Approximately 12-24 months. 
 
12.0 
Setting 
12.1 Describe all facilities/sites where you will be conducting research 
procedures.  Include a description of the security and privacy of the 
facilities (e.g. locked facility, limited access, privacy barriers).  Facility, 
department, and type of room are relevant.  Do not abbreviate facility 
names.   
NOTE:  Examples of acceptable response may be:  “A classroom setting in the 
Department of Psychology equipped with a computer with relevant survey 
administration software,” “The angiogram suite at Buffalo General Medical 
Center, a fully accredited tertiary care institution within New York State with 
badge access,” or, “Community Center meeting hall.” 


 
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Response: The Periodontal Disease Research Center (PDRC), 120 Foster 
Hall, UB, 3435 Main Street, Buffalo, NY 14214.  Research procedures will be 
performed in the operatories in the PDRC. 
The Periodontal Disease Research Center at Buffalo was funded by the 
National Institutes of Health as one of their specialized clinical research 
centers for the study of periodontal disease.  The center has been operational 
since 1977.  The center comprises six operatories, an x-ray room, clean room 
for sterilizing instruments, an office, a waiting room and areas for support 
staff to have offices and places for meetings.  Two of the operatories have 
doors allowing for additional privacy. 
The PDRC's staff provides opportunities for dental and medical students, 
graduate students, and visiting scientists to participate in clinically oriented 
research projects.  Since consistency of evaluations of periodontal status is 
necessary to limit measurement error in studies, the staff is regularly trained 
and calibrated in periodontal measurements.  The staff also has provided 
training for many other examiners for other studies.  As such, they are 
organized to provide this service. 
 
12.2 For research conducted outside of UB and its affiliates, describe: 
• Site-specific regulations or customs affecting the research 
• Local scientific and ethical review structure 
NOTE:  This question is referring to UB affiliated research taking place outside 
UB, i.e. research conducted in the community, school-based research, 
international research, etc.  It is not referring to multi-site research.  UB affiliated 
institutions include Kaleida Health, ECMC, and Roswell Park Cancer Institute.   
Response:  
 
☒ 
N/A:  This study is not conducted outside of UB or its affiliates. 
13.0 
Community-Based Participatory Research 
13.1 Describe involvement of the community in the design and conduct of the 
research.  
NOTE:  Community-Based Participatory Research (CBPR) is a collaborative 
approach to research that equitably involves all partners in the research process 
and recognizes the unique strengths that each brings.  CBPR begins with a 
research topic of importance to the community, has the aim of combining 
knowledge with action and achieving social change to improve health outcomes 
and eliminate health disparities. 
Response:  
 


 
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☒ 
N/A:  This study does not utilize CBPR. 
13.2 
Describe the composition and involvement of a community advisory 
board. 
Response:  
 
☒ 
N/A:  This study does not have a community advisory board. 
14.0 
Resources and Qualifications 
14.1 Describe the qualifications (e.g., education, training, experience, expertise, 
or certifications) of the Principal Investigator and staff to perform the 
research.  When applicable describe their knowledge of the local study sites, 
culture, and society.  Provide enough information to convince the IRB that 
you have qualified staff for the proposed research.  
NOTE:  If you specify a person by name, a change to that person will require prior 
approval by the IRB.  If you specify a person by role (e.g., coordinator, research 
assistant, co-investigator, or pharmacist), a change to that person will not usually 
require prior approval by the IRB, provided that the person meets the 
qualifications described to fulfill their roles. 
Response: Principal Investigator: Robert E. Schifferle, DDS, PhD:  Dr. 
Schifferle is an Associate Professor in two departments in the UB 
School of Dental Medicine, Periodontics & Endodontics and Oral 
Biology.  He is also Clinical Director of the Periodontal Disease 
Research Center; Clinical Group Director for Periodontics, and 
Director of the Pre-Doctoral Periodontics program for the 3rd and 4th 
year dental students.  He is on editorial board of the NYS Dental 
Journal, and on the Peer Review Panel for the Journal of 
Periodontology.  He is a consultant for ADA Council for Scientific 
Affairs, as well as being a periodontist with many years of clinical, 
laboratory, research and teaching experience.  He has been an 
investigator and clinician for several clinical studies and has led or 
participated in calibration of examiners and treating of research 
study participants.  He has been responsible for assuring that 
protocols were followed and data collected according to the protocol 
and MOP. 
Dr. Schifferle has a long history of clinical and educational 
experiences and conduct of clinical and laboratory studies.  His 
expertise in clinical and theoretical periodontal disease make him well 
qualified to be Principal Investigator of this study.  He will lead 
analysis and interpretation of the data.  He will also lead and 
contribute to the preparation of preliminary and final reports, 
manuscripts and presentations.  He is eminently qualified to serve as 
the Principal Investigator of this study. 
 


 
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Patricia I. Diaz, DDS, MS, PhD, Investigator: Dr. Diaz is Professor in the 
Department of Oral Biology, School of Dental Medicine and Director of 
the UB Microbiome Center.  She is a periodontist and microbiologist with 
expertise in the study of the ecology and host interactions of the oral 
microbiome.  As Investigator, Dr. Diaz will support this study and act as 
lead analyst of the data generated.  She will be responsible for the overall 
analytic plan including preparation of preliminary and final reports, 
manuscripts and presentations. 
 
Karen L. Falkner, PhD, Project Coordinator:  Dr. Falkner is an 
epidemiologist with a background in nursing, education and research 
and has many years of experience with epidemiologic, cardiovascular 
and dental studies.  In the past, she was Recruitment Coordinator for 
the Women’s Health Initiative in Buffalo and regional recruitment 
chair for the Northeast area.  She was project director of the study, 
Cognition in Long-term Recall of Physical Activity, and an 
international study of childhood leukemia in children exposed to 
fallout from the Chernobyl accident, conducted in Belarus, Ukraine 
and the Bryansk oblast in Russia.  More recently, she has coordinated 
the BioCycle Study, the ExCel clinical trial for breast cancer 
prevention, and EAGeR (the Effects of Aspirin in Gestation and 
Reproduction), and several dental studies: the Biomarkers of 
Periodontal Disease Progression study, a study of the Effects of a 
Mouthwash Containing Chlorine Dioxide on Bacterial Plaque, the 
Periodontal Disease Screening Study, and the study, Screening of 
Patients in a Dental Setting for Diabetes Mellitus.  Earlier studies 
were the Periodontal Infection and Risk for Myocardial Infarction 
study, the PAVE study, and the Sunstar Periocline and Wm. J. 
Wrigley Chewing Gum clinical trials.  Dr. Falkner also has more than 
10 years of experience coordinating studies where Dr. Genco is/was 
PI.  Dr. Falkner has worked closely with multiple teams to organize 
and conduct dental training and calibrations sessions for dental 
examiners and training sessions for study protocol, for monitoring of 
study protocols, and to write and carry out procedures and policies 
for specimen collection, processing, storage and shipping. 
Dr. Falkner will administer day-to-day activities of the study, and will 
oversee the logistical aspects of the project.  She will monitor protocol, 
and assist in assuring that study activities and data collection are 
conducted in a timely and accurate manner.  She will work with the 
other investigators and study staff at other centers for all aspects of 
the study.  Dr. Falkner is well qualified to be study coordinator of this 
study. 
 
Shannon H. Cervi, RDH, BA. Research Assistant:  Ms. Cervi will be 
responsible for patient recruitment, explaining and obtaining study 


 
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informed consent, administering study questionnaires, and providing 
ancillary support to the clinical staff preparatory to study evaluations, 
examinations, and treatments.  She will provide administrative 
support with processing reports, scheduling appointments and will 
also be available to answer participant questions about the study.  She 
has great skill and facility with the data systems and will work to 
ensure compliance with the study protocol.  Ms. Cervi is or has been a 
study manager for several dental studies conducted at the Periodontal 
Disease Research Clinic.  She has established relationships with many 
potential study participants which will assist with recruitment.  She, 
with Mr. Dunford, will be responsible for the data entry of study 
questionnaires and other information.  She is familiar with the 
conduct of clinical dental research, can take the oral radiographs for 
the study, and is well qualified to be a Research Assistant on this 
project. 03-29-2021: Since R. Dunford retired, Ms. Cervi will take on 
data management duties and give up many of her clinical duties.  She 
will/has taken over all creation of data entry files, supervision of the 
process of double data entry with reconciliation of mismatches.  Ms 
Cervi has been doing many data management tasks for several years 
and is well prepared to proceed as data manager. 
Suzanne J. Andrusz, RDH, Dental Examiner:  Mrs. Andrusz will serve 
as one of the dental examiners/hygienist for the study.  She has been 
trained and calibrated for many studies and is familiar with research 
study protocol and MOP rules and regulations.  She can recruit and 
consent participants.  Mrs. Andrusz is a dental hygienist with more 
than 30 years of experience.  She is trained to do all parts of an oral 
health examination including radiographs, and can serve as an 
assistant and recorder if needed. 
Yoshiko Okada, BA, Research Assistant: Ms. Okada is a Senior 
Researcher and Microbiologist at Sunstar Inc. in Japan.  She is 
currently a Research Scholar in the School of Dental Medicine at UB.  
She has worked on laboratory and clinical studies, especially 
microbial and immunological analyses for evaluation of oral care 
products and functional materials.  She has training in culturing 
techniques and bacterial identification.  More recently she has 
investigated the oral microbiome in subjects with specific conditions 
such as dry mouth, cancer and diabetes by using 16S rRNA gene 
sequencing, and also conducted randomized clinical trials on the 
effects of a mouthwash containing antibiotics for gingivitis and the 
effects of probiotics for hypo-salivation.  Ms. Okada will contribute to 
developing the protocol and study procedures, and microbiome and 
statistical analyses.  Ms. Okada is well qualified to be a Research 
Assistant of this study.  She has completed all IRB-required CITI 
training and a conflict of interest management plan was developed 
and completed. 
 


 
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Dental Assistant: TBN, they will be CITI trained and added to Click 
as a Study Team Member via a Modification once they are selected. 
Describe other resources available to conduct the research.  
14.2 Describe the time and effort that the Principal Investigator and research 
staff will devote to conducting and completing the research. 
NOTE:  Examples include the percentage of Full Time Equivalents (FTE), hours 
per week.  The question will elicit whether there are appropriate resources to 
conduct the research. 
Response: The PI and Investigator will contribute approximately 5% effort to 
this study. 
 
14.3 Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the human research, if 
applicable. 
NOTE:  One example includes: on-call availability of a counselor or psychologist 
for a study that screens subjects for depression. 
Response:  
All staff are trained in CPR and procedures are in place for emergencies.  
The School of Dental Medicine is also available for referrals for dental needs 
and referrals not addressed in the study. 
14.4 Describe your process to ensure that all persons assisting with the research 
are adequately informed about the protocol, the research procedures, and 
their duties and functions. 
Response: We have extensive training sessions with staff reading the protocol, 
Informed Consent and all procedural SOPs before and after the training 
sessions.  Examiners are calibrated to the Gold Standard Examiner, 
consistency of exams is checked, and examination of the data is completed 
regularly every six months.  These training sessions will be documented using 
a Training Log (included in the revised IRB package #3).  All staff who 
consent participants must demonstrate to a PI representative skilled in 
correct consenting procedures before they can consent “real” participants.  
Updates are provided and checks made of proficiency as needed and yearly. 
 
15.0 
Other Approvals 
15.1 Describe any approvals that will be obtained prior to commencing the 
research (e.g., school, external site, funding agency, laboratory, radiation 
safety, or biosafety). 
Response:  
 


 
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☒ 
N/A:  This study does not require any other approvals. 
16.0 
Provisions to Protect the Privacy Interests of Subjects 
 
16.1 Describe how you will protect subjects’ privacy interests during the course 
of this research. 
NOTE:  Privacy refers to an individual’s right to control access to him or herself.  
Privacy applies to the person.  Confidentiality refers to how data collected about 
individuals for the research will be protected by the researcher from release.  
Confidentiality applies to the data.   
Examples of appropriate responses include:  “participant only meets with a study 
coordinator in a classroom setting where no one can overhear”, or “the 
participant is reminded that they are free to refuse to answer any questions that 
they do not feel comfortable answering.”   
Response:  
Potential and enrolled participants will interact with the study staff, dentists, 
registered dental hygienists, dental assistants, laboratory technicians, 
research associates and data manager.  Participants may choose not to 
answer questions, but if those questions provide critical information needed 
to answer the research questions, the person will not be allowed to remain in 
the study.  When exams are performed, privacy is provided via individual 
examination rooms; when participants have samples such as saliva and 
plaque collected, they are provided privacy from the view of others; blood is 
collected and height and weight measured out of the view of others as well. 
Participants are told they may withdraw from the study at any time with no 
adverse effects on them.  They are told we need certain data and that data 
need is explained prior to enrollment (at the time of consenting). 
16.2 Indicate how the research team is permitted to access any sources of 
information about the subjects.   
NOTE:  Examples of appropriate responses include:  school permission for review 
of records, consent of the subject, HIPAA waiver.  This question does apply to 
records reviews. 
Response: Consent of the participant. 
 
17.0 
Data Management and Analysis 
17.1 Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
Response:  
16S rRNA Microbiome Sequencing: Samples will be analyzed to determine 
their bacterial composition using MiSeq (Illumina, Inc.) metagenomic 
sequencing technology, which is available through the Next-Generation 


 
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Sequencing and Expression Analysis Core Laboratory.  This method can 
evaluate the bacterial composition of the microbiome, including those not 
previously cultivated.  We will sequence V4 hyper-variable region of the 16S 
rRNA gene specific for bacterial analyses.  Briefly, bacterial DNA will be 
isolated from all samples and will be processed by polymerase chain reaction 
(PCR) with control samples into sequencing libraries compatible with the 
MiSeq sequencer.  There are techniques to tag specific samples so that every 
participant sample can be independently characterized.  We will incorporate 
quality assurance checks on the microbiome analyses by using standardized 
mock plaque and other sample controls containing known oral organisms, as 
well as standard reagent control samples and negative controls.  We will 
process the control samples with participant samples using the same 
procedures to determine if any bias is introduced in the DNA preparation, 
amplification or sequencing procedures.  DNA isolation and PCR 
development of libraries for sequencing will be carried out using microbiome 
optimized, clean technique and microbial free reagents. 
16S rRNA Sequence Analysis: Methods for microbial composition 
analysis will follow the general approaches described by Caporaso9 
and Sun10 relying on two separate strategies, taxonomy-independent 
and -dependent analyses.  Taxonomy-independent analysis provides a 
basic description of the bacterial composition defined in operational 
taxonomic units (OTU), while taxonomy-dependent analysis relates 
the bacterial composition (OTU data) to known bacterial 
classifications defined by shared characteristics of bacterial groups 
(taxonomy).  This two-pronged approach allows analysis of known 
bacteria using reference databases and discovery of unknown bacteria 
in the sample.  This aspect of the MiSeq sequence analysis allows for 
more complete characterization of bacterial composition than older 
available technology used in previous studies. 
Prior to either analysis, the data will be pre-processed for error-correction to 
remove low quality reads9. A BLAST search will assign sequences to known 
reference sequences using regularly updated databases10.   Analyses will be 
performed to group sequences into an OTU table using computational 
methods developed by members of our group10.   The OTU table provides a 
global view of the bacterial composition comprising the microbiome.  The 
2000-processor Dell P4 (64-bit) Linux cluster at UB’s Center for 
Computational Research (CCR) can process the large quantity of data 
generated in this pilot project. 
Data Analysis: Statistical procedures will be limited to descriptive analyses in 
this pilot study. Following the 16S rRNA sequencing and data reduction 
steps, we will describe the subgingival microbiome composition and relative 
abundance (OTU table).  To begin to understand potential differences in the 
groups, univariate statistical analysis and descriptive statistics will be 
performed to identify oral bacteria associated with diabetes status and 
treatment group.  Numerical, graphical (boxplots, scatterplots), and formal 


 
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comparisons (Student’s t-test, ANOVA, regression, or non-parametric 
equivalents for sparse bacteria) will be produced for visualization of results. 
Other analytic techniques will be utilized as well10. 
Descriptive statistics as well as univariate statistical analysis will be 
performed to identify oral bacteria associated with diabetes status and 
treatment group.  Multivariable logistic regression will be conducted to 
control for other risk factors.  Principal Component Analysis (PCA) or 
Hierarchical Cluster Analysis (HCA) also will be used to further understand 
potential associations with diabetes status and treatment group. 
The analyses planned for this pilot study will provide preliminary data for 
preparation of a larger more definitive study. 
17.2 If applicable, provide a power analysis.   
NOTE:  This may not apply to certain types of studies, including chart/records 
reviews, survey studies, or observational studies.  This question is asked to elicit 
whether the investigator has an adequate sample size to achieve the study 
objectives and justify a conclusion.  
Response:  
A minimum of 104 subjects will be enrolled in the study, with at least 26 
participants per group.  The study was powered to detect a difference in 
probing pocket depth (PPD) of 35% between groups, and a standard 
deviation (SD) of 0.5 for the distribution of 6 month changes.  A sample size 
of 24 per group was estimated assuming approximately 80% power (alpha = 
0.05).  A minimum 26 subjects per group with an attrition rate of 10% will 
be enrolled in this study.17 
10-14-2021: We are continuing recruitment to greater than 100 participants 
in order to balance the numbers of participants per cell, to increase the size 
of the control group (no perio disease and no diabetes), and to increase the 
numbers with diabetes but no perio disease so that we have a more solid base 
on which to complete vigorous data analyses. 
 
17.3 Describe any procedures that will be used for quality control of collected 
data. 
Response: Double entry of data collected, for example clinical measurements 
and demographic information, will also be completed and compared for 
accuracy, and discrepancies will be resolved prior to data analysis. 
Samples will be selected and testing results reported by laboratory number 
only.  Laboratory number can be linked to ID number from limited-access 
study files with the linkage data stored on password protected computers. 
Procedures are in place for quality control of the 16S sequencing and for 
data analysis. 
 


 
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18.0 
Confidentiality 
 
A. Confidentiality of Study Data 
 
Describe the local procedures for maintenance of confidentiality of study data 
and any records that will be reviewed for data collection.   
 
18.1 
A.  Where and how will all data and records be stored?  Include 
information about:  password protection, encryption, physical controls, 
authorization of access, and separation of identifiers and data, as applicable.  
Include physical (e.g. paper) and electronic files. 
Response:  
Paper records are kept in locked cabinets and/or in locked rooms in 120 and 
B20 Foster Hall.  Computerized data sets are stored in study computers 
accessible only to authorized study personnel and are password protected. 
Identity is coded and is not/will not be associated with any published results.  
Code number and identity will be kept in secured files of the Principal 
Investigator (see above).  The only way participant identity would be 
revealed is through an on-site review, by an IRB representative, of clinical 
records to assess the accuracy and consistency with study/research records.  
S/he might see a name with other information, but they would not be allowed 
to take any clinical record with a name on it out of the secured area unless 
mandated by a judicial court.  HIPAA policies and practices will be followed 
in the handling of patients’ dental records and study documents. 
Identifying data are kept in files separate from study data files for as long as 
there is any interest in re-contacting participants, such as for a follow-up 
study of some kind. 
If data files will be used by others outside of the IRB-approved study group, 
the data files will be the modified to include only identifiers permitted in the 
“de-identified” classification: gender, ethnicity, age (up to 89 years), year of 
birth and the first three digits of the zip code as long as the certification of 
de-identification criteria are met.  Additional address information, telephone 
numbers, email addresses, social security numbers will not be included.  We 
do not collect insurance data, vehicle identifiers, device identifiers, URLs, IP 
address numbers, voice or finger prints, or photos of participants so they will 
not be included in the saved data files. 
All study staff are trained in all study procedures and must receive all 
training required of the Institutional Review Board at UB and School of 
Dental Medicine.  All data files are stored on password-protected computers 
and access to those computers is limited to authorized study staff only. 
Study/research files will be kept by identification (ID) number only.  
Laboratory numbers are different than ID numbers and the linkage will be 
stored in limited access files on password-protected computers. 


 
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Informed Consents are kept separate from study/research charts in limited 
access (locked) rooms. 
18.2 
A.  How long will the data be stored? 
Response: Until analyzed or indefinitely. 
 
18.3 
A.  Who will have access to the data? 
Response: Authorized study staff. 
 
18.4 
A.  Who is responsible for receipt or transmission of the data? 
Response: The PI or authorized PI representative. 
 
18.5 
A.  How will the data be transported? 
Response: Data will be transported on CDs or flash drives in password 
protected files.  If needed, the CDs can be sent via USPS, FedEx or UPS for 
data transfer to a more distant person. 
 
B. Confidentiality of Study Specimens 
 
Describe the local procedures for maintenance of confidentiality of study 
specimens.   
 
☐ 
N/A:  No specimens will be collected or analyzed in this research.   
(Skip to Section 19.0) 
 
18.6 
B.  Where and how will all specimens be stored?  Include information 
about:  physical controls, authorization of access, and labeling of specimens, as 
applicable.   
Response: Samples are labeled with participant study number, sample 
number, type of sample, study visit, date and study.  Only authorized study 
personnel handle samples. 
Samples will be stored, by study, in -80° C freezers in B20 Foster Hall until 
tested.  These rooms are locked, and access is limited to authorized study 
staff.  All freezers are monitored daily for temperature and are on a 
University alarm system in case they fail. 
 
18.7 
B.  How long will the specimens be stored? 
Response: Until tested or indefinitely. 


 
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18.8 
B.  Who will have access to the specimens? 
Response:  
Authorized study personnel. 
18.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response:  
Authorized study personnel. 
18.10 B.  How will the specimens be transported? 
Response: 
Samples and data will be labeled and identified only by ID number.  Samples 
will be transported frozen on dry ice unless the frozen state is not needed.  
Data will be housed on limited-access password-protected computers backed 
up by UB systems.  If needed, data will be copied onto CDs and sent via 
USPS, FedEx or UPS. 
 
19.0 
Provisions to Monitor the Data to Ensure the Safety of 
Subjects 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
 
NOTE:  Minimal risk studies may be required to monitor subject safety if the research 
procedures include procedures that present unique risks to subjects that require 
monitoring.  Some examples include:  exercising to exertion, or instruments that elicit 
suicidality or substance abuse behavior.  In such cases, N/A is not an acceptable 
response. 
 
19.1 Describe the plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 
Response:  
Data collected during the study will be reviewed by the PI and investigators 
(primarily for clinical issues).  These reviews will take place after six months 
of participant recruitment and every six months thereafter. 
19.2 Describe what data are reviewed, including safety data, untoward events, 
and efficacy data. 
Response: Study accrual, reports of adverse and serious adverse events and 
unanticipated problems will be reviewed by the investigators. 
 
19.3 Describe any safety endpoints. 
Response:  


 
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Adverse and serious adverse events, untoward events will be assessed by 
asking about changes in status and new events since last visit. 
19.4 Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
Response: When subjects return for study visits, they will be queried about 
changes in their medical and dental status, untoward events, new 
medications etc.  This information will be recorded on study visit checklists 
and progress notes and used when data are reviewed by the PI, investigators 
and study staff. 
 
19.5 Describe the frequency of safety data collection. 
Response: Data will be collected at the study visits and will start at the 
beginning of the study. 
 
19.6 Describe who will review the safety data. 
Response: The PIs and Investigators, coordinator. 
 
19.7 Describe the frequency or periodicity of review of cumulative safety data. 
Response:  
After six months and every six months thereafter. 
19.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response: All adverse events (serious and non-serious) reported during a 
study will be taken into account when analyzing study data, and will be 
included in the final study report.  Identification of serious adverse effects 
(SAEs) will be used to identify, during the conduct of the study, those adverse 
events that may require an expedited reporting procedure to regulatory 
authorities.  No testing of drugs will be used.  Therefore, statistical tests will 
be used to evaluate SAEs only if events are serious. 
 
19.9 Describe any conditions that trigger an immediate suspension of the 
research. 
Response:  
Faulty equipment and mass terminations of staff, for example. 
20.0 
Withdrawal of Subjects 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 


 
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20.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 
Response: If it is not in the best clinical interest of the participant or if the 
participant is unable to comply with study requirements, s/he will be 
withdrawn from the research, and notified of such withdrawal.  This will be 
determined by the PI, investigators and coordinator. 
 
20.2 Describe any procedures for orderly termination.   
NOTE:  Examples may include return of study drug, exit interview with clinician.  
Include whether additional follow up is recommended for safety reasons for 
physical or emotional health. 
Response: Inform the participant verbally and document in chart progress 
notes. 
 
20.3 Describe procedures that will be followed when subjects withdraw from the 
research, including retention of already collected data, and partial 
withdrawal from procedures with continued data collection, as applicable. 
Response: Participants will be asked if they wish to withdraw from all 
components of the study or if they will allow follow-up activities.  For 
observational studies such as this one, withdrawal is not likely, but 
participants who want to withdraw will be asked if any samples already 
collected may be used in the research.  If participant does NOT want those 
samples used, those samples will be destroyed. 
 
21.0 
Risks to Subjects 
21.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related to their participation in the research. 
Consider physical, psychological, social, legal, and economic risks.  Include 
a description of the probability, magnitude, duration, and reversibility of the 
risks.  
NOTE:  Breach of confidentiality is always a risk for identifiable subject data. 
Response: None of the study procedures (e.g., oral health examination, 
periodontal measurements, collection of biological specimens) are considered 
experimental.  They are all considered standard of care.  Known possible 
risks of participating in this study are described below.  As with all clinical 
procedures, this study may also involve unforeseen risks to participants. 
Periodontal Examination:  The periodontal examination will involve 
procedures that are routine in dental practice.  A licensed dentist or 
dental hygienist will perform the procedures.  The risks from the 
periodontal examination include minor discomfort or pain during and 


 
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after the procedures and minor bleeding, inflammation, and swelling 
of the gums. 
 
Collection of Samples from the Mouth:  During the study, we will take 
samples of saliva and plaque.  The saliva will be collected by having 
participants spit into a container.  Both of these procedures have very 
little risk.  Collecting plaque samples has a small risk of causing 
minor bleeding of the gums.  This risk is low because all the 
examiners are experienced and skilled in proper collection technique. 
 
Blood Sample Collection:  Blood samples will be drawn by trained 
and experienced health care personnel.  There may be some 
discomfort and bruising at the site where the needle enters the skin, 
and there is a very small risk of fainting.  Infection in the area of 
needle insertion is rare. 
 
Vaginal Swab Sample Collection:  There is little risk to the 
participant in collecting vaginal swabs. 
 
Stool Collection:  There is little risk to the participant in collecting a 
stool sample.  Specific instructions and supplies will be provided to 
minimize mess and unpleasantness. 
 
Dental radiographs:  About 18 radiographs will be taken.  These x-
rays will not be taken if suitable x-rays taken in the past two years are 
available to review, or if the dental clinician feels there is no clinical 
need for them.  The amount of radiation exposure from the dental x-
rays in this study is about 17.1 millirem (or 0.017 rem).  This amount 
is below the 5 rem per year allowed for research participants by the 
National Institutes of Health (NIH) Radiation Safety Committee.  The 
average person in the United States has a radiation exposure of about 
0.36 rem per year from natural sources, such as the sun, outer space, 
and earth’s air and soil.  When taking x-rays, the lowest dose possible 
will be used and participants will wear a lead apron to reduce 
exposure. 
 
Although there is no direct evidence that the amount of radiation 
exposure from participating in this study is harmful, there is indirect 
evidence that it may not be completely safe.  There may be a very 
slightly increased risk of cancer. 
 
Paroex® is a non-alcohol chlorhexidine preparation.  With use of 
chlorhexidine, there is risk of reversible staining of teeth and the 
possibility of some alteration in taste.  There is increased likeliness of 
staining in smokers, coffee drinkers and those who are susceptible to 
teeth staining in general.  The cleaning of the front teeth that will be 


 
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provided at the 3-month visit will help to reduce any staining that 
may occur.  If there is any alteration in taste, it should go away when 
use of chlorhexidine stops.  Paroex®was approved by the FDA 
November 29, 2005 (application # (ANDA) 076434). 
 
Soft-Picks may cause some bleeding of the gums at first usage, but the 
bleeding should lessen and stop as use is continued (as gums heal).  
Soft-Picks are a readily available consumer product sold in 
supermarkets and drug stores.  They are “510(k) exempt” from 
requiring FDA approval. 
 
Taste Test:  There is minimal risk to taking the Taste Test. 
21.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 
Response: See above (21.1), well trained and experienced study staff, and 
below. 
The electronic data files for study data do NOT include general identifiers 
except study Identification (ID) number.  Examples of these files are Medical 
History file, Dental History file, medications file, blood testing results, 
periodontal examination data file where the results of the clinical 
examination are recorded and saved by ID number only.  These files do not 
have names or other contact information though the medical history file does 
have date of birth (DOB).  One study file has demographic information 
needed to identify participants and for communications and correspondence 
with the participants (names, address information, telephone numbers, email 
addresses).  Another file has gender, ethnicity, age (up to 89 years), year of 
birth and the first three digits of the zip code by study ID number.  Social 
security numbers are obtained for reimbursement purposes as required by 
Research Foundation, but are not included in data files.  We do not collect 
insurance data, vehicle identifiers, device identifiers, URLs, IP address 
numbers, voice or finger prints, or photos of participants so they will not be 
included in the saved data files. 
21.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
Response: Unknown. 
 
21.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response: None known. 
 
21.5 If applicable, describe risks to others who are not subjects. 
Response: None known. 


 
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22.0 
Potential Benefits to Subjects 
22.1 Describe the potential benefits that individual subjects may experience by 
taking part in the research.  Include the probability, magnitude, and 
duration of the potential benefits.  Indicate if there is no direct benefit.   
NOTE:  Compensation cannot be stated as a benefit. 
Response: : Participants will gain information about the results of their 
laboratory blood tests, the health and status of their mouths, as well as 
information about their periodontal status and degree of periodontal disease.  
They will also receive a copy of their radiographs, if they wish. 
Participants will receive treatment and monitoring of their periodontal 
disease for one year, a significant benefit to their oral health.  If they do not 
respond to the standard study treatments either SRP alone of SRP + SPT, 
they will receive additional treatment (Rescue Therapy) that will be 
determined by the study dentist(s)/periodontist(s)).  Blood for fasting glucose, 
hemoglobin A1c, insulin, and hs-CRP will be measured during the study and 
results will be shared with participants thereby providing them with status 
updates. 
23.0 
Compensation for Research-Related Injury 
☐ 
N/A:  The research procedures for this study do not present risk of 
research related injury (e.g. survey studies, records review studies).  This 
section does not apply.   
23.1 
If the research procedures carry a risk of research related injury, 
describe the available compensation to subjects in the event that such injury 
should occur.   
Response:  Risk is minimal. See below contract language regarding Sunstar Inc 
responsibility. 
 
 
23.2 
Provide a copy of contract language, if any, relevant to compensation for 
research related injury. 


 
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NOTE:  If the contract is not yet approved at the time of this submission, submit the 
current version here.  If the contract is later approved with different language regarding 
research related injury, you must modify your response here and submit an amendment 
to the IRB for review and approval. 
Response: See above, 23.1 
 
24.0 
Economic Burden to Subjects 
24.1 Describe any costs that subjects may be responsible for because of 
participation in the research.   
NOTE:  Some examples include transportation or parking. 
Response: We do not anticipate any added expenses for participants 
beyond those needed to attend study visits.  Anticipated expenses for 
participants are the cost of transportation to and from the study 
center, cost of meals while at the study center (if needed; we provide 
light snacks such as muffins, breakfast bars, coffee, and juice), and 
cost of lodging if an overnight stay is required for the study visit (the 
latter is not likely because recruitment is local and most participants 
in previous studies have lived nearby).  Groups A and B will have the 
products, Paroex® and Soft-Picks, provided. 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
25.0 
Compensation for Participation 
25.1 
Describe the amount and timing of any compensation to subjects, 
including monetary, course credit, or gift card compensation. 
Response: $50 each for Baseline, 3-month, 6-month and 9-month visits; $100 
for 12-month visit for a total of $300 per participant. 
 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records 
review procedures only.  This section does not apply. 
☐ 
N/A:  There is no compensation for participation.  This section 
does not apply. 
26.0 
Consent Process 
26.1 Indicate whether you will be obtaining consent.   
NOTE:  This does not refer to consent documentation, but rather whether you will 
be obtaining permission from subjects to participate in a research study.   
Consent documentation is addressed in Section 27.0. 
☒ 
Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 27.0) 
 


 
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26.2 Describe where the consent process will take place.  Include steps to 
maximize subjects’ privacy. 
Response: An operatory in the PDRC. 
 
26.3 Describe how you will ensure that subjects are provided with a sufficient 
period of time to consider taking part in the research study.   
NOTE:  It is always a requirement that a prospective subject is given sufficient 
time to have their questions answered and consider their participation.  See “SOP: 
Informed Consent Process for Research (HRP-090)” Sections 5.5 and 5.6. 
Response: Subjects will be given the opportunity to ask as many questions as 
they need to be comfortable prior to signing the consent form.  Subjects will 
be asked to provide or decline consent within 24 hours of having the study 
explained in detail. 
 
26.4 Describe any process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Response: If a participant presents for a study visit we assume they 
are consenting to continue in the study; however, we will add a 
question to our study visit checklists asking, “Participation in this 
study is voluntary.  Do you continue to consent to being in this 
study?” to make sure there is not confusion regarding continuing 
consent to participate in a research study.  If it is the first visit, the 
first thing we do is obtain consent.  As we proceed through the first, 
and all visits, we ask the question above.  At the end of the first visit, 
we make the appointment for the second visit and we also make a 
reminder phone call the day or two before the second visit.  We 
usually speak to the participants during the call so they again have the 
opportunity to say they do not want to continue or they need a new 
appointment date and/or time. 
 
If a participant does not show up for a visit and cannot be reached 
and continues this behavior, we try to reach them by phone and email 
and, if no response, eventually by registered mail with a postage-paid 
envelope so they can send us an answer about continuation.  In the 
past, some participants have had personal or family problems arise 
and some have continued with adjustment of visit timing; others have 
chosen to withdraw or we withdrew them. 
For participants who show up to study visits and do not ask questions 
about procedures we assume they want to continue.  BUT, we will ask 
the new question and we are sensitive to non-verbal signs of problems 
and would probe and give extra time for questions, answers and try to 
solve “issues” if verbal or non-verbal signs of decreased interest or 
concerns about the study were evident.  In addition, when it is time to 


 
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begin different aspects of the visit, we also say, “Is it OK to begin…?”  
If they need more time or want to opt out of continuing they can do so 
then. 
Subjects who do not show up for two consecutive study visits and are 
unable to be reached on two different occasions at all contact numbers 
to remind them of a scheduled follow-up appointment will be deemed 
uninterested in continued participation and will be considered lost to 
follow-up. 
26.5 Indicate whether you will be following “SOP: Informed Consent Process for 
Research (HRP-090).” If not, or if there are any exceptions or additional 
details to what is covered in the SOP, describe: 
• 
The role of the individuals listed in the application who are involved in 
the consent process 
• 
The time that will be devoted to the consent discussion 
• 
Steps that will be taken to minimize the possibility of coercion or 
undue influence 
• 
Steps that will be taken to ensure the subjects’ understanding 
Response:  
 
☒ 
We have reviewed and will be following “SOP: Informed Consent Process 
for Research (HRP-090).” 
 
Non-English Speaking Subjects  
☒ 
N/A:  This study will not enroll Non-English speaking subjects.   
(Skip to Section 26.8) 
26.6 Indicate which language(s) other than English are likely to be 
spoken/understood by your prospective study population or their legally 
authorized representatives. 
 
NOTE: The response to this Section should correspond with your response to 
Section 6.4 of this protocol. 
Response:  
 
26.7 If subjects who do not speak English will be enrolled, describe the process 
to ensure that the oral and written information provided to those subjects 
will be in that language.  Indicate the language that will be used by those 
obtaining consent. 
NOTE:  Guidance is provided on “SOP:  Informed Consent Process for Research 
(HRP-090).” 


 
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Response:  
 
 
Cognitively Impaired Adults 
☒ 
N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 26.9) 
26.8   Describe the process to determine whether an individual is capable of 
consent.  
Response:  
 
 
Adults Unable to Consent 
☒ 
N/A:  This study will not enroll adults unable to consent.  
(Skip to Section 26.13) 
When a person is not capable of consent due to cognitive impairment, a legally 
authorized representative should be used to provide consent (Sections 26.9 and 
26.10) and, where possible, assent of the individual should also be solicited 
(Sections 26.11 and 26.12). 
26.9  Describe how you will identify a Legally Authorized Representative (LAR).  
Indicate that you have reviewed the “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)” for research in New 
York State.  
NOTE:  Examples of acceptable response includes: verifying the electronic 
medical record to determine if an LAR is recorded. 
Response:  
 
☐ 
We have reviewed and will be following “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).”  
26.10 For research conducted outside of New York State, provide information 
that describes which individuals are authorized under applicable law to 
consent on behalf of a prospective subject to their participation in the 
research.  One method of obtaining this information is to have a legal 
counsel or authority review your protocol along with the definition of 
“legally authorized representative” in “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).” 
Response: This study will NOT be conducted outside of New York State. 
 
26.11 Describe the process for assent of the adults: 


 
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• 
Indicate whether assent will be obtained from all, some, or none of the 
subjects.  If some, indicate which adults will be required to assent and 
which will not. 
Response: N/A. 
 
• 
If assent will not be obtained from some or all subjects, provide an 
explanation of why not. 
Response: N/A 
 
26.12 Describe whether assent of the adult subjects will be documented and the 
process to document assent. 
NOTE:  The IRB allows the person obtaining assent to document assent on the 
consent document using the “Template Consent Document (HRP-502)” Signature 
Block for Assent of Adults who are Legally Unable to Consent. 
Response: N/A 
 
Subjects who are not yet Adults (Infants, Children, and Teenagers) 
☒ 
N/A:  This study will not enroll subjects who are not yet adults.   
(Skip to Section 27.0) 
26.13 Describe the criteria that will be used to determine whether a prospective 
subject has not attained the legal age for consent to treatments or 
procedures involved in the research under the applicable law of the 
jurisdiction in which the research will be conducted (e.g., individuals under 
the age of 18 years).  For research conducted in NYS, review “SOP: 
Legally Authorized Representatives, Children, and Guardians (HRP-013)” 
to be aware of which individuals in the state meet the definition of 
“children.”  
NOTE:  Examples of acceptable responses include: verification via electronic 
medical record, driver’s license or state-issued ID, screening questionnaire. 
Response: N/A 
 
26.14For research conducted outside of New York State, provide information 
that describes which persons have not attained the legal age for consent to 
treatments or procedures involved the research, under the applicable law of 
the jurisdiction in which research will be conducted.  One method of 
obtaining this information is to have a legal counsel or authority review 
your protocol along the definition of “children” in “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013).” 
Response: N/A 


 
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26.15 Describe whether parental permission will be obtained from: 
Response: N/A 
☐  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the 
child. 
☐ 
Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for 
the care and custody of the child. 
☐ 
Parent permission will not be obtained.  A waiver of parent permission is 
being requested. 
NOTE:  The requirement for parent permission is a protocol-specific determination 
made by the IRB based on the risk level of the research.  For guidance, review the 
“CHECKLIST: Children (HRP-416).”  
26.16Describe whether permission will be obtained from individuals other than 
parents, and if so, who will be allowed to provide permission.  Describe 
your procedure for determining an individual’s authority to consent to the 
child’s general medical care. 
Response: N/A 
 
26.17 Indicate whether assent will be obtained from all, some, or none of the 
children.  If assent will be obtained from some children, indicate which 
children will be required to assent. 
Response: N/A 
 
26.18 When assent of children is obtained, describe how it will be documented. 
Response: N/A 
 
27.0 
Waiver or Alteration of Consent Process 
Consent will not be obtained, required information will not be disclosed, or the 
research involves deception. 
☒ 
N/A:  A waiver or alteration of consent is NOT being requested. 
27.1 If the research involves a waiver or alteration of the consent process, please 
review the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-
410)” to ensure that you have provided sufficient information for the IRB to 
make the determination that a waiver or alteration can be granted.   


 
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NOTE:  For records review studies, the first set of criteria on the “CHECKLIST: 
Waiver or Alteration of Consent Process (HRP-410)” applies.  
Response: N/A 
 
27.2 If the research involves a waiver of the consent process for planned 
emergency research, please review the “CHECKLIST: Waiver of Consent 
for Emergency Research (HRP-419)” to ensure you have provided sufficient 
information for the IRB to make these determinations.  Provide any 
additional information necessary here: 
Response: N/A 
 
28.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 29.0) 
28.1 Indicate whether you will be following “SOP: Written Documentation of 
Consent (HRP-091).” If not or if there are any exceptions, describe whether 
and how consent of the subject will be obtained including whether or not it 
will be documented in writing.   
NOTE:  If your research presents no more than minimal risk of harm to subjects 
and involves no procedures for which written documentation of consent is normally 
required outside of the research context, the IRB will generally waive the 
requirement to obtain written documentation of consent.  This is sometimes 
referred to as ‘verbal consent.’  Review “CHECKLIST: Waiver of Written 
Documentation of Consent (HRP-411)” to ensure that you have provided sufficient 
information.  
If you will document consent in writing, attach a consent document with your 
submission.  You may use “TEMPLATE CONSENT DOCUMENT (HRP-
502)”.  If you will obtain consent, but not document consent in writing, attach the 
script of the information to be provided orally or in writing (i.e. consent script or 
Information Sheet).   
Response:  
All study staff will be trained in the Informed Consent process 
through in-service programs, demonstrations, practice sessions, and 
demonstrations of proficiency to ensure ability to conduct the 
consenting process properly with prospective participants.  Steps that 
are taken in the Informed Consent process and to minimize the 
possibility of coercion and undue influence by study personnel include 
the following: 
1. 
An eligibility criterion of this study is to be able to read and 
sign the consent form so those not able to read the consent will be 
excluded from the study. 


 
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2. 
Discuss and explain study with potential participants. 
3. 
Have potential participant read Informed Consent form. 
4. 
Allow as much time as needed for questions. 
5. 
Answer questions; make sure the person has his/her questions 
answered to his/her satisfaction, and so they understand the study. 
6. 
Make sure the potential participant understands the number 
of study visits required, how long those appointments last and the 
total time commitment of the study for them. 
7. 
The Informed Consent form must be signed prior to ANY 
study procedures.  In addition, each page must be initialed indicating 
that participant read that page. 
8. 
Informed Consent should be signed by the person obtaining 
consent, the PI or his/her designee. 
9. 
Make sure the HIPAA consent is also signed.  It may be 
attached to or be a separate document from the study consent. 
10. 
Give copy of signed Informed Consent to participant. 
 
The time involved in the consenting process is approximately 15 to 30 
minutes. 
 
☒ 
We will be following “SOP:  Written Documentation of Consent” 
(HRP-091). 
29.0 
Multi-Site Research (Multisite/Multicenter Only) 
☒ 
N/A:  This study is not an investigator-initiated multi-site study.  This 
section does not apply. 
 
29.1 If this is a multi-site study where you are the lead investigator, describe the 
processes to ensure communication among sites, such as: 
• 
All sites have the most current version of the IRB documents, including 
the protocol, consent document, and HIPAA authorization. 
• 
All required approvals have been obtained at each site (including 
approval by the site’s IRB of record). 
• 
All modifications have been communicated to sites, and approved 
(including approval by the site’s IRB of record) before the 
modification is implemented. 
• 
All engaged participating sites will safeguard data as required by 
local information security policies. 
• 
All local site investigators conduct the study appropriately. 


 
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• 
All non-compliance with the study protocol or applicable requirements 
will be reported in accordance with local policy. 
Response: N/A 
 
29.2 Describe the method for communicating to engaged participating sites: 
• 
Problems 
• 
Interim results 
• 
Study closure 
Response: N/A 
 
29.3 
Indicate the total number of subjects that will be enrolled or records that 
will be reviewed across all sites. 
Response: N/A 
 
29.4 
If this is a multicenter study for which UB will serve as the IRB of record, 
and subjects will be recruited by methods not under the control of the local site 
(e.g., call centers, national advertisements) describe those methods.  
Response: N/A 
 
30.0 
Banking Data or Specimens for Future Use 
☐ 
N/A:  This study is not banking data or specimens for future use or 
research outside the scope of the present protocol.  This section does not 
apply. 
30.1 If data or specimens will be banked (stored) for future use, that is, use or 
research outside of the scope of the present protocol, describe where the 
data/specimens will be stored, how long they will be stored, how the 
data/specimens will be accessed, and who will have access to the 
data/specimens.  
NOTE:  Your response here must be consistent with your response at the “What 
happens if I say yes, I want to be in this research?” Section of the Template 
Consent Document (HRP-502). 
Response: Saliva, blood, plaque, skin and vaginal swabs, and feces will be 
stored in -80º C freezers in B20 Foster Hall until tested or indefinitely.  The 
samples will be stored by sample number with a central inventory kept for 
all freezer contents.  Freezers are maintained in locked rooms (B20 Foster 
Hall is a suite of rooms) with access limited to authorized study staff.  All 
freezers are on the University alarm system and are checked regularly for 
temperature. 


 
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Study data may also be kept indefinitely.  Paper files are kept in the PDRC, a 
suite of rooms in 120 and B20 Foster Hall, with study files identified only by 
study ID number, stored separately from clinical files with names and other 
identifying information.  All electronic study data are stored on password-
protect computers in locked rooms in the PDRC, and able to be accessed by 
authorized study staff only. 
30.2 List the data to be stored or associated with each specimen. 
Response: Laboratory number, specimen type, date of collection, amount and 
study.  In addition, if samples are removed, thawed and portions removed, 
this information is noted in the central inventory system.  These data will be 
stored on password-protect computers in locked rooms in the PDRC, and 
able to be accessed by authorized study staff only. 
 
30.3 Describe the procedures to release banked data or specimens for future 
uses, including: the process to request a release, approvals required for 
release, who can obtain data or specimens, and the data to be provided with 
specimens. 
Response: All requests for samples or data must be preceded by submitting a 
brief proposal to the PIs who will share it with other study investigators.  
Proposals will need project description, rationale, main hypotheses and/or 
purposes, what is needed, (samples, for example, type and how they will be 
used or tested; and data, variables desired, dependent and independent), a 
brief summary of the analytic plan, and a description of how the samples 
and/or data are to be handled and confidentiality maintained. 
Study investigators and the PIs will evaluate proposals and consider the 
propriety, priority, cost, and ease of obtaining the samples and/or data and 
advise the lead author accordingly.  If approved for data requests, 
documentation and data files will be created by the data manager and sent to 
the requestor by the PIs.  Only data identified by study ID will be shared.  
The data manager will define variables including derived variables and 
verify data as needed.  For transfer of data, CDs or flash drives will be used 
for transfer. 
For samples, costs associated with retrieval, maintenance during transport, 
and shipping will be determined.  Dates and times of preparations and 
shipping or transport will be determined by the PIs and requestor precisely 
to maintain the integrity of the samples. 
 
31.0 
Drugs or Devices 
☐ 
N/A:  This study does not involve drugs or devices.  This section does not 
apply. 


 
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31.1 If the research involves drugs or devices, list and describe all drugs and 
devices used in the research, the purpose of their use, and their regulatory 
approval status.  
Response: Paroex® mouthrinse, FDA approved and used according to 
labeling.  Soft-Picks, 510(k) exempt and available over the counter. 
Here are the links: Paroex®: http://us-professional.gumbrand.com/gumr-
chlorhexidine-gluconate-oral-rinse-4.html 
Soft-Picks:  http://www.sunstar.com/rd/story/soft-picks-advanced; 
http://www.gumbrand.com/gum-soft-picks-40-ct-632rc.html; and 
http://www.soft-picks.com/about-soft-picks. 
http://us-professional.gumbrand.com/gumr-chlorhexidine-gluconate-oral-
rinse-4.html 
Sunstar, Inc. has ownership of these products. 
 
   
31.2 Describe your plans to store, handle, and administer those drugs or devices 
so that they will be used only on subjects and be used only by authorized 
investigators. 
Response: Paroex® and Soft-Picks will be stored in our limited access, locked 
cool room adjacent to the PDRC. 
 
If the drug is investigational (has an IND) or the device has an IDE or a claim 
of abbreviated IDE (non-significant risk device), include the following 
information: 
31.3 Identify the holder of the IND/IDE/Abbreviated IDE. 
Response: The Paroex® mouthrinse and Soft-Picks to be used in this study 
are not investigational.  Paroex® mouthrinse is FDA approved and will be 
used according to labeling.  Soft-Picks are like small tooth brushes and are 
readily available over the counter. 
 
31.4 Explain procedures followed to comply with FDA sponsor requirements for 
the following:   
 


 
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Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
Response: N/A 
 
32.0 
Humanitarian Use Devices 
☒ 
N/A:  This study does not involve humanitarian use devices.  This does 
not apply. 
32.1 
For Humanitarian Use Device (HUD) uses provide a description of the 
device, a summary of how you propose to use the device, including a description 
of any screening procedures, the HUD procedure, and any patient follow-up 
visits, tests or procedures. 
Response:  
 
32.2 
 For HUD uses provide a description of how the patient will be informed 
of the potential risks and benefits of the HUD and any procedures associated with 
its use. 
Response: