Comparison of Porcine Collagen Membrane and Bovine Collagen Wound Dressing in Human Extraction Sites With DFDBA Graft: A Randomized Controlled Trial
Phase: NA
Conditions: Wound Heal
Sponsor: University of Nebraska

 
 
 
 
ClinicalTrials.Gov PRS Coversheet 
 
Official Title: Comparison of Porcine Collagen Membrane (Mucograft Seal) and Bovine 
Collagen Wound Dressing (HeliPlug) in Atraumatic Extraction Sites with DFDBA  Bone 
Particulate Graft: A Randomized Controlled Trial 
 
NCT Number: 0145-23-FB 
 
Document Title: Study Informed Consent Version 2 
 
Document Date: 1/16/2025 
 
 
 
 
 
 
 

2  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
IRB PROTOCOL # 0145-23-FB Page 1 of 27 
Biomedical 
SECTION I 
Therapeutic/Non-Therapeutic  
Does your research involve a drug, medical device, technique or other intervention or 
strategy (including means like diet, cognitive therapy, behavioral therapy, exercise) to 
diagnose, treat or prevent a particular condition or disease: "THERAPEUTIC 
RESEARCH"? 
Yes 
1. Title of Protocol:  
Comparison of Porcine Collagen Membrane (Mucograft Seal) and Bovine Collagen Wound 
Dressing (HeliPlug) in Atraumatic Extraction Sites with DFDBA Bone Particulate Graft: A 
Randomized Controlled Trial 
Is a OneChart/EPIC Subject Friendly Short Title needed? 
No 
2. Responsible Personnel:  
A. Principal Investigator (PI): 
 Killeen, Amy C - COD-Surgical Specialties - 402-472-7848 - akilleen@unmc.edu - alt #: 
402-472-7848 - degree: DDS - address: DENT 2329 UNL EAST (68583-0740) - phone: 
402-472-7848 
B. Secondary Investigator (SI): 
 Reinhardt, Rick (Rick) A - COD-Surgical Specialties - 402-472-1287 - 
rareinha@unmc.edu - alt #: 402-472-1287 - degree: DDS - address: DENT 2170A UNL 
EAST (68583-0740) - phone: 402-472-1287 
C. Participating Personnel: 
 Czechner, Otto Alexander - COD-Surgical Specialties - 402-472-3249 - 
oczechner@unmc.edu - alt #: 402-472-3249 - degree: DDS 

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 Davis, Richard Duke - COD-Surgical Specialties - 402-472-3249 - ridavis@unmc.edu - 
alt #: 402-472-3249 - degree: DDS 
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Institutional Review Board (IRB) 
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 Ingalsbe, Greg Greg Ryan - COD-Surgical Specialties - 402-472-1311 - 
gingalsbe@unmc.edu - alt #: 402-472-3249 - degree: DMD - address: DENT 2311 UNL 
East (68583-0740) - phone: 402-472-1311 
 Lee, Joyce Ab-Ye - COD-Surgical Specialties - 402-472-3249 - joylee@unmc.edu - alt #: 
402-472-3249 - degree: DDS 
 Scanlan, Christine I - COD-Surgical Specialties - 402-472-1311 - 
christine.scanlan@unmc.edu - alt #: 402-472-3249 - degree: DDS - address: DENT 2311 
UNL EAST (68583-0740) - phone: 402-472-1311 
 Schlemmer, Paula Christina Co - COD-Surgical Specialties - 402-472-3249 - 
pschlemmer@unmc.edu - alt #: 402-472-3249 - degree: DDS - address: DENT 2311 (Zip 
68583) - phone: 402-472-3249 
D. Lead Coordinator: 
Christiansen, Megan (Megan) M - COD-Surgical Specialties - 402-472-6770 - 
megan.christiansen@unmc.edu - alt #: 402-472-1441 - degree: BS, RDH - address: DENT 
2319 UNL EAST (68583-0740) - phone: 402-472-6770 
E. Coordinator(s): 
Are you adding a clinical trial management group? 
No 
F. Data/Administrative Personnel: 
G. Are you a student or house officer? 
No 
3. Funding Source:  

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Check all that apply and provide the source of the funding. 
Cooperative Group:  
Center for Clinical and Translational Research (CCTR)  
Federal (e.g., NIH) Grant - Provide source:  
Other Grant:  
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Institutional Review Board (IRB) 
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♦ Departmental funding 
Commercial - Provide company name:  
Department of Defense  
Other - Provide source (e.g. personal funding):  
4. Deadline for IRB Approval:  
Yes - Explain and provide date:  
♦ No 
5. Contract:  
Is there a contract associated with this study? 
No 
6. Agreements  
Is there a Material Transfer Agreement (MTA) associated with this study? 
No 
Is there a Data Use Agreement (DUA) associated with this study? 
No 
Is there a Data Transfer Agreement (DTA) associated with this study? 
No 
7. Study Sites:  
A. Provide the names and locations of all study sites where this research will be 

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conducted under the oversight of the UNMC IRB or Joint Pediatric IRB. 
UNMC College of Dentistry, Lincoln NE 
B. Will the research be conducted at external sites under the oversight of an external 
IRB? 
No 
C. Does UNMC, TNMC, CHMC or UNO serve as the lead site with responsibility for data 
and/or safety monitoring? 
No 
D. Does this study involve any international sites where the PI will either; 1) conduct 2) 
supervise or 3) receive / ship HBM or data to / from UNMC? 
No 
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E. Does this study involve face to face contact with subjects? 
Yes 
8. Principal Investigator Assurance 
The PI understands and accepts the following obligations to protect the rights 
and welfare of research subjects in this study:  
All information in this application is complete and accurate. 
I will conduct the research as described in the application and the protocol. 
I will not initiate any change without IRB approval except when it is necessary to 
reduce or eliminate a risk to the subject. 
I will ensure that all research personnel are qualified and properly trained. 
I will fulfill my responsibilities as PI, described in  
https://guides.unmc.edu/books/hrpp-policies-and-procedures/page/126-piqualifications-
and-responsibilities 

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I will follow all applicable HRPP and institutional polices, and all applicable laws, 
statutes and regulations. 
Killeen, Amy C - 2024-02-19 15:31:07.160 
9. Principal Investigator Financial Interest Disclosure  
A. As the PI, I declare: 
♦ I have no financial interest in this research. 
I have a financial interest in this research.  
B. As the PI, I understand 
♦ I must disclose any change in my financial interest during the course of this research 
within five (5) business days from the time the change becomes known. 
C. As the PI, I certify that: 
♦ No Responsible Personnel have a financial interest in this research. 
The Responsible Personnel listed below have informed me that they have a financial 
interest in this research.  
D. I have informed all Responsible Personnel that if there is any change in their 
financial interests during the course of this study it must be disclosed within five (5) 
business days from the time the change becomes known. 
Killeen, Amy C - 2024-02-19 15:31:07.160 
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Institutional Review Board (IRB) 
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SECTION II 
PROTOCOL ABSTRACT 
1. Provide a brief (less than 2500 characters) abstract of the research protocol. 
(2500 characters) 
This summary should include: 1)) a brief description of the purpose of the study, 2) 
eligibility criteria, 3) interventions and evaluations and 4) follow-up. 

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The purpose of this study is to compare the effectiveness of a porcine collagen membrane 
to a bovine collagen wound dressing for atraumatic extractions. These are both commonly 
used as a barrier and containment material over atraumatic extraction sites that are grafted 
for future implant placement. The study will include nonsmoking adults aged 18-75 
requiring 
premolar or anterior tooth extraction and graft procedures, who are in good general health 
and willing to provide informed consent. Exclusion criteria include a history of radiation 
therapy or bisphosphonate use, pregnancy or breastfeeding, systemic conditions that 
affect 
bone healing, contraindications to dental implants, and inability to attend follow-up visits. 
The study will be a double-blind randomized controlled trial involving 24 patients who will 
be 
assigned to two groups. Prior to tooth extraction, baseline data will be collected; including 
gingival crevicular fluid (GCF) sampling, and a limited field Cone Beam Computed 
Tomography (CBCT) radiograph. A reference digital scan will be taken to measure 
volumetric changes in soft tissue. Routine, atraumatic extraction of the tooth under local 
anesthetic will be performed. Following extraction, hydrated AllOss 50/50 DFDBA:FDBA 
bone particulate will be condensed following a routine protocol. One group will receive 
Mucograft Seal over the graft, and the other group will receive Integra HeliPlug. Patients will 
be seen at a standard 2-week follow up to remove sutures, have a GCF sampling at the 
adjacent teeth and take another digital scan. Patients will be seen for an additional 6-week 
follow up to take a small (2mm) incisional biopsy for histological analysis. Another digital 
scan and GCF sampling will be taken. Final evaluation will be 3 months post-extraction and 
will include a localized CBCT evaluation for implant planning and another measure of soft 
tissue changes with a digital scan. At the time of implant surgery, the core of bone removed 
during osteotomy will be histologically analyzed for percentage of vital bone. Adverse 
events 
will also be recorded at each visit. The primary outcome measure will be the histological 

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composition of tissue at 6 weeks and volumetric tissue changes. The secondary outcome 
measures will be adverse events, bone density on the post-operative CBCT and percentage 
of vital bone at implant placement. 
PURPOSE OF THE STUDY AND BACKGROUND 
2. Purpose of the Study  
What are the specific scientific objectives of the research? 
The primary objectives of this study are to compare the efficacy of a porcine collagen 
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membrane to a bovine collagen wound dressing for atraumatic extractions, in terms of their 
ability to act as a barrier and containment material over atraumatic extraction sites that are 
grafted for future implant placement. This will be measured by volumetric and linear 
dimensional changes in the soft tissue and the histological composition of keratinized 
tissue 
after healing. 
The secondary objectives of the study are to evaluate the radiographic bone density and 
percentage vital bone at implant planning and placement. 
3. Background and Rationale  
Describe the background of the study. Include a critical evaluation of existing 
knowledge, and specifically identify the information gaps that the project is intended to 
fill. 
Extraction and graft procedures are commonly performed in dental clinics where future 
implant placement is desired due to the large soft and hard tissue dimensional changes 
that 
occur as a socket heals (Araujo 2005, Chappuis 2017). While there are several techniques 
for ridge preservation, it is generally accepted that minimizing trauma from the extraction 
and flap reflection greatly decreases loss of hard and soft tissue (Fickl 2008). This is why a 

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popular method is some form of Bio-Col technique where a bone graft is condensed into 
the 
socket and then a collagen wound dressing, or plug, is used to prevent wash out of the 
graft. (Sclar 1999, Kotsakis 2014). While cost effective, and easy to place without flap 
reflection, a collagen plug can be dislodged quickly and has been shown to have a large 
soft 
tissue loss during healing (Morelli 2020, Thoma 2018). Therefore, other soft tissue 
alternatives have been investigated as an alternative membrane (Ghanaati 2017) 
Several studies have investigated the efficacy of Mucograft Seal as a barrier membrane to 
promote bone regeneration in socket preservation techniques. (Jung 2013) Mucograft Seal 
is a porcine collagen membrane that is shaped ideally for easy coverage of a socket. 
Because it is a pure matrix of Type I and Type III collagen, it is able to stay more 
dimensionally stable, making it an ideal material to combat soft tissue reduction as a site 
heals. It is currently used as a replacement for free gingival grafting coverage, such as with 
the soft tissue punch technique (Jung 2004), but has not been compared to a collagen 
wound dressing for critical early healing characteristics such as inflammatory cytokines. 
Additionally, there is limited information on the specific histological composition at 6 
weeks 
post-operative healing in patients who undergo socket preservation with Mucograft Seal or 
Colla-Plug. 
Information Gaps: The information gaps that this project is intended to fill are twofold. First, 
it aims to compare the effectiveness of Mucograft Seal and Colla-Plug in premolar and 
forward extraction and graft procedures through a randomized controlled trial, which will 
provide more conclusive evidence on the comparative efficacy of these two biomaterials. 
Second, the project aims to evaluate the histological composition of an incisional tissue 
biopsy at 6 weeks post-operative healing in patients who undergo these procedures with 
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either Mucograft Seal or Colla-Plug, which will provide valuable information on the tissue 
response to these biomaterials at an early stage of the healing process. By addressing 
these information gaps, the project aims to contribute to the development of more 
effective 
socket preservation techniques and biomaterials, which will benefit patients undergoing 
these procedures. 
CHARACTERISTICS OF THE SUBJECT POPULATION 
4. Accrual  
A. Is this study conducted solely at sites under the oversight of the UNMC IRB (e.g. 
UNMC, Nebraska Medicine, CHMC, UNO)? 
Yes 
1. How many subjects will need to be consented (per group, as applicable) in order to 
achieve the scientific objectives of the research? 
24 subjects will be enrolled - 12 in each group to account for a 10% drop out rate. 
2. What is the statistical or other justification for the total number of subjects described 
above? 
A sample size of 11 in each group provides 80% power to be able to detect an absolute 
difference in 20 percentage-points of converted mucosa between the collagen (i.e. 50%) 
and mucograft (i.e. 70%) groups at four weeks, assuming a standard deviation of 15 for 
percentage converted mucosa and an alpha level of 0.05, using a Wilcoxon Rank Sum test. 
3. How long do you estimate it will take to accrue the required number of subjects? 
9 months 
5. Gender of the Subjects  
A. Are there any enrollment restrictions based on gender? 
No 
6. Age Range of Subjects  

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A. Will adults be enrolled ? 
Yes 
1. What is the age range of the adult subjects? 
19-75 
2. What is the rationale for selecting this age range? 
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This treatment is rarely performed in children below the age of 19 and after the age of 75, 
adult subjects will typically show decreased wound healing due to age which could 
conflate 
findings. 
B. Will children (18 years of age or younger) be included in this research? 
No 
1. What is the justification for excluding children from participating in this research? 
♦ Research is irrelevant to children (e.g. disease or condition rarely encountered in 
children). 
Knowledge being sought in the research is already available for children or will be obtained 
from another ongoing study.  
A separate study in children is warranted and preferable.  
Insufficient data are available in adults to judge the potential risk in children.  
Other. Explain.  
7. Race and Ethnicity  
Are there any subject enrollment restrictions based upon race or ethnic origin? 
No 
8. Vulnerable Subjects  
A. Will prisoners be included in the research? 

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No 
B. Select from the list all of the vulnerable populations that will specifically be recruited 
to participate in this research. 
Decisionally-impaired persons  
Critically ill patients  
Students of the investigator  
Employees of the investigator  
Educationally disadvantaged individuals  
Socially or economically disadvantaged individuals  
Individuals with a stigmatizing illness or condition  
Individuals from a marginalized social or ethnic group  
Other.  
♦ No vulnerable subjects will be specifically recruited 
9. Inclusion Criteria  
What are the specific inclusion criteria? 
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1) adult patient seeking care at the UNMC College of Dentistry for extraction of a premolar 
or anterior tooth due to periodontal or endodontic defect, non-restorable caries or fracture 
2) adult patient is considering dental implant placement to replace the extracted tooth and 
requires a bone grafting procedure in preparation for a dental implant 
3) Nonsmoker 
4) 19-75 years old 
10. Exclusion Criteria  
What are the specific exclusion criteria? 
Exclusion criteria include a history of radiation therapy or bisphosphonate use, pregnancy, 

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systemic conditions that affect bone and soft tissue healing, contraindications to dental 
implants, and inability to attend follow-up visits. 
11. Pregnancy and Contraception Requirements  
A. Are women of child bearing potential (WOCBP) included in this research? 
Yes 
a. Are there any specific contraception requirements for subjects? 
No 
1. Provide justification for absence of contraception requirements 
♦ There are no interventions that are likely to be of risk to a fetus 
Investigational drug(s) is (are) not systemically absorbed  
Investigational drug(s) is (are) systemically absorbed, but there is no evidence from human 
studies, or from clinical experience, that there is risk to a fetus  
Other  
B. Are pregnant women included in this research? 
No 
1. Provide justification for excluding pregnant women 
Investigational drug(s) is (are) absorbed systemically, and there is evidence from animal or 
human studies, or from clinical experience, that there is risk to a fetus OR investigational 
drug(s) is (are) absorbed systemically, and there is a well-understood mechanism of action 
that may result in risk to a fetus  
Intervention includes a procedure expected to be of risk to a fetus (eg, exposure to ionizing 
radiation, maximal exercise test)  
Research is not relevant to pregnant women (e.g. disease or condition rarely encountered 
in 
pregnant women)  
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Knowledge being sought in the research is already available for pregnant women or will be 
obtained from another ongoing study  
A separate study in pregnant women is warranted and preferable  
♦ Physiology of pregnancy precludes generalization to other populations 
Other - explain  
2. Describe how pregnancy status will be assessed (eg, self-report, urine pregnancy 
test, blood pregnancy test) and the frequency of monitoring during participation in the 
research. 
Pregnancy status will be determined via self-report 
3. Describe the plan should a female subject, or the partner of a male subject, become 
pregnant while research interventions are on-going (or during the period that 
contraception is required following the completion of the intervention). 
Should a female subject become pregnant while research interventions are on-going, she 
will be dismissed from study. 
C. Are breast feeding women excluded in this research? 
No 
Provide justification for the inclusion or exclusion of breast feeding women. 
There are no interventions that are likely to be of risk to a nursing newborn. 
METHODS AND PROCEDURES 
12. Methods and Procedures Applied to Human Subjects  
A. Are there any evaluations or tests that will be performed for the purpose of 
determining subject eligibility which would not be routinely conducted as part of 
standard clinical care of the prospective subject? 
No 
B. Describe the research plan, including all procedures, interventions, evaluations and 
tests. 

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Patients at the UNMC College of Dentistry who are seeking care to extract a premolar 
or anterior tooth due to a periodontal defect, endodontic defect or non-restorable 
caries or fracture, and who are considering a dental implant to replace the extracted 
tooth, will be made aware of this clinical study by the dental faculty or residents 
planning the treatment. Subjects will be given the consent form to take home and 
consider, and any questions will be answered, signed and witnessed. 
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Twenty-four patients will be enrolled in this study. On the day of extraction, baseline 
data will be recorded/collected. These include the following: 
1. A limited field CBCT will be taken of the tooth to be extracted. 
2. Gingival crevicular fluid (GCF) sampling at the interproximal sites of teeth adjacent 
to the tooth to be extracted. The tooth to be extracted will be isolated with cotton rolls 
and GCF collection paper strips will be placed into the facial and lingual interproximal 
gingival sulci for 30 seconds. The paper samples will be pooled and placed in a 
plastic-capped vial labeled with the subject number and visit (example: N1-0, N2-1) 
and immediately frozen at -80° C. The GCF sample vials will not be labeled with any 
personal identifying information (subject 's name, age, tooth #, etc). 
3. A digital intraoral scan will be taken to establish baseline tissue dimensions. 
Routine atraumatic dental extraction under local anesthesia will be completed by the 
assigned periodontal resident (SM, NB, PS, JL, OC, DD) or oral surgery fellow and 
faculty (AK, RR).A statistician will generate a randomization schedule, after which 
someone not involved in the treatment of these patients will put each randomized 
treatment assignment into separate envelopes. The envelope will be given to the 
clinical provider after the extraction is completed. The extraction socket will be filled 
with 50:50 AlloOss DFDBA/FDBA allograft bone and covered with either a HeliPlug 

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collagen wound dressing or a Mucograft Seal membrane. 
Subjects will be scheduled for a routine postoperative visit two weeks following the 
extraction. At this visit, suture removal and evaluation of the healing site will occur. 
GCF collection on the remaining adjacent teeth will occur as will an intraoral digital 
scan of the extraction site. 
An additional post operative visit will occur at 6 weeks to do a final soft tissue 
healing evaluation. At this time a small (2mm) incisional biopsy will be taken and 
stored in 10% formalin that is labeled similarly to GCF sample tubes. We do not 
anticipate this tissue removal to have an impact on final healing of the underlying 
bone for the patient. This tissue will be processed with a hematoxylin and eosin stain 
and the width of keratinized tissue will be measured by a separate individual who is 
blinded to the treatment groups. GCF collection on the remaining adjacent teeth will 
also occur at this visit, as will an intraoral digital scan of the extraction site. 
The final postoperative visit will be 3 months following the extraction. A limited-field 
CBCT will be taken to begin the process of implant treatment planning and measure 
bone height, width and volume. A final GCF collection on the remaining adjacent 
teeth will also occur at this visit, as will a final intraoral digital scan of the extraction 
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site. 
GCF Cytokine Determination 
At the time of analysis, each pooled GCF samples will be eluted using 100 µl of 1× 
PBS by gently agitating the samples on a rocker plate for 1 h at 4°C. Cytokine 
concentrations will be measured using a customized human cytokine and magnetic 
bead panel (Milliplex MAP kit; Millipore, Billerica, MA), and a MAGPIX instrument and 
software (Luminex Corporation, Austin, TX) per the manufacturers recommendations. 

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Ten analytes will be measured: interleukin-1β (IL-1β), IL-4, IL-6, IL-8, IL-10, IL-13, IL-17 
granulocyte-macrophage colony-stimulating factor (GM-CSF), tumor necrosis factor 
alpha (TNF-α), interferon-gamma (INF-γ). Albumin for each sample also will be 
measured to normalize cytokine levels and control for serum contamination. The 
amounts of cytokines will be reported in picograms per albumin level and per 30-s 
sample. 
Statistical Analysis 
The percentage of converted mucosa will be documented at six weeks after an 
extraction, and differences in the width of keratinized tissue between the collagen 
and mucograft groups will be assessed using a Wilcoxon Rank Sum test. As a 
secondary analysis, we may also look at other related demographic (e.g. sex, age, 
etc.) and clinical (e.g. bone width, soft tissue volume, cytokine levels, etc.) 
characteristics to see if they have associations with the percent keratinized gingiva, 
using Spearman correlations for continuous variables, or Wilcoxon Rank 
Sum/Kruskal Wallis tests for categorical variables. 
C. Select any of the following that apply to the research: 
Phase I study  
♦ Randomization 
Placebo (or non-treatment arm)  
Washout  
Sensitive surveys or questionnaires  
None of the above  
Option chosen: Randomization 
Describe randomization process and schedule 
A statistician will generate a randomization schedule, after which someone not involved in 
the treatment of these patients will put each randomized treatment assignment into 
separate 

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envelopes, which will be given to the clinical provider close to the time the material will be 
placed, after the patient has been enrolled/consented into the study. 
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D. Identify: 
1. All procedures, interventions, evaluations and tests performed solely for research 
purposes (eg, administration of an investigational drug or a new psychological 
assessment instrument; randomization) 
Procedures performed solely for research purposes include: the collection of gingival 
crevicular fluid (GCF); soft tissue biopsy at 6-weeks post-procedure. 
2. All procedures, interventions, evaluations and tests performed for clinical indication 
but more frequently than they would be if the subject was not participating in the 
research (eg, extra blood tests; additional radiology exams) 
It is not typical to have an intraoral scan done at post-operative visits. However, this takes 
less than 2 minutes to perform and has no contraindications or risks. It is simply a data 
collection process for dentists to measure changes in our patients over time. 
E. Describe briefly the statistical methods used to analyze the data (or reference the 
appropriate section of the detailed protocol or grant). 
The percentage of converted mucosa will be documented at six weeks after an extraction, 
and differences in the width of keratinized tissue between the collagen and mucograft 
groups will be assessed using a Wilcoxon Rank Sum test. As a secondary analysis, we may 
also look at other related demographic (e.g. sex, age, etc.) and clinical (e.g. bone width, 
soft 
tissue volume, cytokine levels, etc.) characteristics to see if they have associations with 
the 
percent keratinized gingiva, using Spearman correlations for continuous variables, or 
Wilcoxon Rank Sum/Kruskal Wallis tests for categorical variables. 

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F. Does this study involve the collection of blood, urine, saliva or other human 
biological material (HBM)? 
Yes 
1. Does this research involve genetic testing including Genome Wide Association 
Studies (GWAS), Whole Genome Sequencing (WGS) or Whole Exome Sequencing 
(WES)? 
No 
G. Does this study involve the creation of a tissue bank for future unspecified 
research? This includes un-used (excess) blood, urine, or tissue, obtained for clinical 
indication or for research, or additional human biological material collected specifically 
for future research. 
No 
DRUGS, BIOLOGIC DRUGS AND DEVICES 
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13. Drugs and Biologic Drugs  
1. Does this research involve the use of drugs or biologics? 
Yes 
A. Are any of the drugs or biologics used in this research not FDA-approved? 
No 
B. Are any of the drugs used in this study FDA Approved? 
Yes 
1. Will data obtained from this research study be used to support a new indication, new 
labeling or a change in advertising of an FDA-approved drug or biologic? 
No 
2. Will the use of an FDA-approved drug in this research study involve a route of 

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administration, dosage level or patient population that significantly increases the risks 
(or decreases the acceptability of the risks) associated with the use of the drug 
product? 
No 
C. Do any of the sponsors of this research require compliance with ICH-GCP? 
No 
14. Devices  
1. Does this research involve a medical device(s) (including an in vitro device [IVD] 
(assay), and medical software)? 
No 
CONFIDENTIALITY AND PRIVACY 
15. Confidentiality and Privacy  
A. Describe where research data will be stored. Check all that apply. 
Box@unmc.edu (secure UNMC or UNO designated cloud-based storage site)  
Microsoft Office 365 application (including SharePoint, OneDrive for Business, Teams or 
Streams) (UNMC, UNO or NU system instance) (secure UNMC or UNO designated 
cloudbased storage site)  
Other secure UNMC or UNO designated cloud-based storage site - describe:  
OnCor Clinical Trial Management System (secure server at UNMC, CHMC, Nebraska 
Medicine, and/or UNO)  
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CCORDA database (biostatistics) (secure server at UNMC, CHMC, Nebraska Medicine, 
and/or UNO)  
RITO-hosted databases (for example, REDCap, CV-QOR, Onchem Trials, XNAT) (secure 
server at UNMC, CHMC, Nebraska Medicine, and/or UNO)  

21  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
Nebraska Medicine PACS (for image files) (secure server at UNMC, CHMC, Nebraska 
Medicine, and/or UNO)  
Other secure server at UNMC, CHMC, Nebraska Medicine, and/or UNO - describe:  
On an NSRI or designated high security .gov storage site  
On a VA-approved storage vehicle for a VA-approved study  
On a remote secure server and/or database maintained by the sponsor accessible through 
the internet  
On a secure server and/or database hosted and maintained by another institution 
accessible through the internet  
On a device or mobile application provided by the sponsor to upload data to a coordinating 
center or central database  
On a device or mobile application being developed by a sponsor or by a UNMC, CHMC or 
UNO investigator  
On a device or mobile application that connects to the internet through UNMC or NM 
network (wired or wireless)  
On an encrypted, password protected portable computer, or flash drive  
Other - describe:  
♦ In hard copy (other than signed Consent Forms) 
Option chosen: In hard copy (other than signed Consent Forms) 
a. Please provide justification for use of hard copies 
Data collection is easiest and most secure in our department when done with hard copies. 
The room is secured by key card access and data will be stored in locked cabinets. Only 
authorized personnel will be able to access them. 
Option chosen: In hard copy (other than signed Consent Forms) 
b. Will hard copies will be transported from one site to another, on or off campus? 
No 
B. Will any of the following subject identifiers be recorded (at any time) in association 

22  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
with the research data? 
Yes 
1) Indicate the subject identifiers that will be recorded. Check all that apply. 
Name  
♦ 
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Institutional Review Board (IRB) 
IRB PROTOCOL # 0145-23-FB Page 16 of 27 
DATES (e.g. date of study visit, date of sample collection, birth, admission, discharge) 
Postal address information: street address, city, county, precinct, ZIP code  
Telephone numbers  
Fax numbers  
Electronic mail addresses  
Social Security numbers  
♦ Medical Record numbers 
Health plan beneficiary numbers  
Account numbers  
Certificate/license numbers  
Vehicle identifiers and serial numbers, including license plate numbers  
Device identifiers and serial numbers  
Web Universal Resource Locators (URLs) Internet Protocol (IP) address numbers  
Biometric identifiers, including finger and voice print  
Full face photographic images [and any comparable images]  
No Identifier  
2) Will a unique subject identifying number (e.g., S1, S2, S3), characteristic or code be 
used to link data to any of the identifiers listed above? 
Yes 

23  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
a. Where will the key (that links the unique subject identification code to the subject's 
name or other identifier) be stored? 
The key will be stored in a locked filing cabinet within a locked room in the Cruzan Center 
for Dental Research. The unique identifier that will be sued to code the data is as follows: 
each subject will be given a number (i.e. N1, N2...N25). The specific appointment visit 
(baseline, 2 weeks, 3 months) data will be coded as follows: N1-0 (baseline), N1-2 (two 
weeks), N1-3 (3 months). 
b. Does the code number include the subject's initials or other subject identifier as part 
of the code? 
No 
3) What is the justification for recording the specific subject identifiers listed above? 
Check all that apply. 
♦ Schedule appointments 
Collect continuous clinical information from the medical records  
♦ Follow-up with subjects 
Link stored tissue with subject identification for it to be withdrawn in the future if requested  
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Institutional Review Board (IRB) 
IRB PROTOCOL # 0145-23-FB Page 17 of 27 
Compensation  
Other. Explain.  
4) How long will the subject identifiers be maintained in association with the research 
data? 
Subject identifiers will be maintained until data have been statistically analyzed and 
reports 
published and no less than 7 years following completion of research per Nebraska state 
law 
and NRPP policy. 

24  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
5) How will all of the identifiable research data be destroyed (e.g., all identifiers 
stripped from the data and destroyed, hard copies shredded etc) when the identifiable 
data is no longer required? 
Subject identifiers will be stripped from the data and destroyed once it is no longer 
required. 
C. Will research data that contain subject identifiers be disclosed to: 
Other investigators at UNMC, NM, UNO or CHMC who are not listed in Section I of this 
application? 
No 
2. Investigators outside of UNMC, NM, UNO or CHMC? 
No 
3. Will research data that contain subject identifiers be disclosed to any commercial 
sponsor or contract research organization (CRO), or to any other external organization 
or entity (e.g., NCI cooperative groups)? 
No 
D. What provisions will be in place to protect the subject's privacy? Check all that 
apply. 
♦ Ensuring that only personnel listed on the IRB application Section I.3(A-E) are present 
during the consent process. 
♦ Ensuring that the fewest number of individuals possible are aware of the subject's 
participation in the research. 
♦ Ensuring that the research activities are performed in as private of a place as possible. 
Other. Explain.  
E. Does this research involve data banking at UNMC, NM, UNO or CHMC, or by an 
outside organization (e.g. NCI Cooperative Group, pharmaceutical company) for future 
research that is not related to this study? 
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25  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
Institutional Review Board (IRB) 
IRB PROTOCOL # 0145-23-FB Page 18 of 27 
No 
RISK/BENEFIT ASSESSMENT 
16. Potential Risks  
What are the potential risks associated with each research procedure, intervention, 
evaluation and/or test? If data are available, estimate the probability that a given harm 
may occur and its potential reversibility. 
Potential risks associated with soft tissue sampling at 4-weeks includes minimal pain and 
adjacent tooth sensitivity. 
The soft tissue and GCF specimens will be collected in plastic-capped vials and frozen 
until 
analysis. These vials will be labeled with the subject's number and visit (N1-0, N2-2) and 
will 
not be labeled with any personal identifying information, thus breach of confidentiality is 
not 
at risk. 
Potential risks associated with limited view CBCT include increase exposure to radiation. 
This risk is inherent to any dental radiography and the limited-view CBCT pre-extraction and 
post-extraction is standard therapy for dental implant treatment planning. 
17. Risk Classification  
What is the overall risk classification of the research? 
Minimal risk  
♦ Greater than minimal risk 
18. Minimization of Risk  
A. Describe how the subjects of the research will be monitored by the investigators and 
other research personnel to ensure their safety. 
Subjects of the research will be monitored with follow-up phone calls. If any postoperative 

26  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
concerns develop, they will be seen in the graduate periodontal clinic for follow-up. 
B. Describe how the data collected will be monitored to ensure the safety of subjects. 
Identify who will perform the ongoing data and safety analysis, and describe the 
frequency of data analysis. If there is an independent Data and Safety Monitoring Board 
(DSMB) provide the charter, or describe (1) the composition of the DSMB membership, 
(2) the frequency of DSMB meetings and reports. 
Data collection will be monitored by study personnel and if a decline in the subject's 
periodontal condition is noted, they will be referred to the graduate periodontal residency 
at 
UNMC College of Dentistry for a full evaluation. The contact information for the study 
investigators and personnel are on the consent form that will be sent home with each 
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Institutional Review Board (IRB) 
IRB PROTOCOL # 0145-23-FB Page 19 of 27 
subject. 
C. Describe the auditing plan for research conducted. Identify who will conduct the 
audits and specify the audit frequency. 
Ten percent of the case report forms will be reviewed by the Associate Dean of Clinics, Dr. 
Amir Fahr, at the COD semi-annually and audited against the primary dental record. Any 
violations or unexpected outcomes will be reported to the IRB. 
D. Describe the specific subject withdrawal criteria. 
Subjects will be withdrawn if they are non-compliant to their postoperative appointments. 
E. Describe the stopping rules for the research (e.g., the specific criteria for halting or 
early termination of the study). 
If 10% of subjects suffer an adverse event, such as bleeding or pain associated with the 
soft 
tissue sampling greater than that expected associated with a similar extraction without 
sampling, the study will be stopped. 

27  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
F. Describe plans and resources available to promptly address any subject injury. 
The investigators are board-certified periodontists or periodontal residents, so any adverse 
effects will be addressed with a thorough evaluation and appropriate treatment. 
19. Potential Benefits to the Subject  
Is there the prospect for direct benefit (eg, research on diagnosis or treatment of 
disease)? 
No 
20. Potential Benefits to Society  
Describe the potential benefits to society that may reasonably be expected to result 
from this research. 
A potential benefit to society would be clarification and understanding of the soft tissue 
healing capabilities of common materials used for this procedure. 
FINANCIAL OBLIGATIONS AND COMPENSATION 
22. Financial Obligations of the Subject  
A. Who will pay for research procedures, interventions, evaluations and tests? Check 
all that apply. 
Sponsor  
Grant  
CRC, CCTR  
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Institutional Review Board (IRB) 
IRB PROTOCOL # 0145-23-FB Page 20 of 27 
Costs or fees waived by Nebraska Medicine, UNMC- P, CHMC or CSP  
♦ Department/Section funds 
Other. Explain  
B. Will any of the research procedures, interventions, evaluations and tests described 
above be charged to the Subject, the Subject's health insurance, or 

28  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
Medicare/Medicaid? 
Yes 
1. Provide additional detail and justification for charging as noted. 
The subject will be not be charged for any research procedures or interventions. The 
subject 
will be charged for non-research related procedures (extraction, bone graft, limited view 
CBCT). 
C. Are there any other financial obligations that the subject will incur as a result of 
participating in the study? 
No 
23. Compensation to the Subject for Participation  
A. Will the subject receive any compensation for participation? 
No 
PRIOR REVIEW 
24. Prior IRB Review  
A. Has this study (or one substantially similar) been previously submitted to the UNMC 
IRB (or the Joint Pediatric IRB) and then withdrawn by the investigator for any reason? 
No 
B. To the best of your knowledge, has this study (or one substantially similar) been 
considered by another IRB and disapproved? 
No 
SUBJECT IDENTIFICATION & RECRUITMENT 
25. Method of Subject Identification and Recruitment  
A. Will prospective subjects learn about the research and then contact the investigator 
about participation (for example, in response to a print, electronic, radio or television 
advertisement; referral by a clinician or other specifically for this research)? 
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29  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
Institutional Review Board (IRB) 
IRB PROTOCOL # 0145-23-FB Page 21 of 27 
No 
B. Will the investigator make the initial contact with the potential subject to tell him/her 
about the research (for example, by contacting existing or past previous patients or 
research participants; or by contacting prospective subjects thru school records, or 
thru support groups or other Interest Groups; or thru use of the Hospital Opt-In 
Database)? 
Yes 
1. How will prospective subjects be identified? 
Patients that meet the study criteria will be identified in the UNMC COD clinic during 
normal 
clinical treatment. 
2. Will potential subjects be screened for eligibility prior to informed consent? 
No 
3. How will potential subjects be approached and invited to participate? 
Eligible patients will be asked if they want to participate in the study. 
a. Describe the process of initial contact 
Patients that would otherwise be presenting to the clinic for extraction and grafting will be 
invited to participate in the study. 
b. Who will make the initial contact? 
One of the investigators or collaborators. 
c. Does that person have ethical access to information about potential subjects? 
Yes 
i. Describe 
All investigators and collaborators are responsible for supervising dental students in 
patient 

30  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
care in the clinic where potential subjects are treated, therefore direct contact with 
potential 
subjects and their records is part of that supervision. 
C. Will this study be listed in the clinical trial registry at www.clinicaltrials.gov? 
Yes 
1. Provide the NCT#. 
NCT application has been submitted, awaiting NCT#. Will inform the IRB when it comes 
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Institutional Review Board (IRB) 
IRB PROTOCOL # 0145-23-FB Page 22 of 27 
through. 
2. Identify who holds the NCT# 
♦ PI 
Sponsor  
OBTAINMENT OF INFORMED CONSENT 
26. Waiver or Alteration of Informed Consent  
A. Is a complete waiver or alteration of consent requested? 
No 
27. Waiver of Signed Consent  
Is a waiver to obtain signed consent requested? 
No 
29. Process of Informed Consent  
A. When will the prospective subject/parent(s)/guardian(s)/LAR be approached relative 
to their/the subject's actual participation in the study? 
Prospective subjects will be approached after it has been determined that they have a 
nonrestorable anterior or premolar tooth that needs extraction and they have expressed 
interest 
in replacing the tooth with a dental implant. Subjects will be referred to the graduate 

31  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
periodontal clinic where they will be approached by study personnel (periodontal resident) 
about their interest in participating in the study. 
B. Where will informed consent be obtained, and how will the environment be 
conducive to discussion and thoughtful consideration? 
Informed consent will be obtained in a private room in the Cruzan Center for Dental 
Research. 
C. Who will be involved in the process of consent and what are their responsibilities? 
The investigators will explain the research, ask questions to be certain that the subject 
understands the procedure, and answer any subject questions. Additionally, investigators 
will also ask questions to ensure that subjects understand their rights as research subject 
D. Is there any limitation on the amount of time allotted to the process of consent? 
No 
E. How will the process of consent be structured for subjects who are likely to be more 
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Institutional Review Board (IRB) 
IRB PROTOCOL # 0145-23-FB Page 23 of 27 
vulnerable to coercion or undue influence? 
All subjects approached about this study will already have made the decision to extract the 
tooth and have expressed interest in implant replacement of that tooth. Additionally, they 
will 
already have been counseled on the process of extraction, grafting and implant placement; 
including the costs and time required for successful treatment. 
Investigators acknowledge concerns regarding the potential subject misinterpreting the 
study as standard of care, or having his/her decision regarding participation influenced by 
concerns about disappointing or offending his/her care provider by having the introductory 
and informed consent conversations completed by study personnel who are not familiar to 
the subject. The subject will not have had previous contact with study personnel, thus 

32  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
minimizing the concern about disappointing or offending his or her provider. Additionally, 
extreme care will be taken during discussion/description of the study with the subject to 
highlight that the removal of soft tissue is not standard of care for routine extraction and 
implant preparation. 
F. Will non-English speaking subjects be enrolled in this research? 
Yes 
Describe the plan to conduct the process of informed consent in the language of the 
subject/parent(s)/guardian(s)/LAR 
The process of informed consent in the language of the subject includes utilization of 
interpretation services via video (Language Link) or in-person interpreter. 
G. How will it be determined that the subject/parent(s)/guardian(s)/LAR understood the 
information presented? 
The investigator will question the subject concerning his/her understanding of all elements 
of the informed consent. This will include having the subject describe what will be done to 
them along with the risks 
31. Information Purposely Withheld  
Will any information be purposely withheld from the subject during the research or 
after completion of the research? 
No 
RESOURCES 
33. Describe the resources available to safely conduct this study at each study 
sites specified in Section I.7.  
1. Funding for all research-related expenses have been secured through departmental 
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Institutional Review Board (IRB) 
IRB PROTOCOL # 0145-23-FB Page 24 of 27 
funds. 

33  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
2. Research procedures will be conducted in the Cruzan Center for Dental Research at the 
UNMC College of Dentistry. 
3. Laboratory space for the GCF tests will be available in the laboratory of one of our 
investigators (RR). 
4. Emergency equipment and personnel services are routinely available in the periodontal 
clinic during operation, during which all patient-based procedures will be performed. 
LITERATURE REVIEW 
34. References  
Provide a full listing of the key references cited in the background (Section II.3). The 
references should clearly support the stated purpose of the study. 
Araujo, M.G. and J. Lindhe, Dimensional ridge alterations following tooth 
extraction. An experimental study in the dog. J Clin Periodontol, 2005. 
32(2): p. 212-8. 
Chappuis, V., M.G. Araujo, and D. Buser, Clinical relevance of 
dimensional bone and soft tissue alterations post-extraction in esthetic 
sites. Periodontol 2000, 2017. 73(1): p. 73-83. 
Fickl, S., et al., Tissue alterations after tooth extraction with and without 
surgical trauma: a volumetric study in the beagle dog. J Clin Periodontol, 
2008. 35(4): p. 356-63. 
Ghanaati, S., et al., Evaluation of the tissue reaction to a new bilayered 
collagen matrix in vivo and its translation to the clinic. Biomed Mater, 
2011. 6(1): p. 015010. 
Jung, R.E., et al., Radiographic evaluation of different techniques for 
ridge preservation after tooth extraction: a randomized controlled clinical 
trial. J Clin Periodontol, 2013. 40(1): p. 90-8. 
Jung, R.E., D.W. Siegenthaler, and C.H. Hammerle, Postextraction tissue 
management: a soft tissue punch technique. Int J Periodontics 

34  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
Restorative Dent, 2004. 24(6): p. 545-53. 
Kotsakis, G., et al., Flapless alveolar ridge preservation utilizing the 
Version 2 - PROTOCOL # 0145-23-FB Page 24 of 27 
Institutional Review Board (IRB) 
IRB PROTOCOL # 0145-23-FB Page 25 of 27 
"socket-plug" technique: clinical technique and review of the literature. J 
Oral Implantol, 2014. 40(6): p. 690-8. 
Morelli, T., et al., Three-Dimensional Volumetric Changes After Socket 
Augmentation with Deproteinized Bovine Bone and Collagen Matrix. Int J 
Oral Maxillofac Implants, 2020. 35(3): p. 566-575. 
Sclar, A.G., Preserving alveolar ridge anatomy following tooth removal in 
conjunction with immediate implant placement. The Bio-Col technique. 
Atlas Oral Maxillofac Surg Clin North Am, 1999. 7(2): p. 39-59. 
Thoma, D.S., et al., Clinical and histologic evaluation of different 
approaches to gain keratinized tissue prior to implant placement in fully 
edentulous patients. Clin Oral Investig, 2018. 22(5): p. 2111-2119. 
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Institutional Review Board (IRB) 
IRB PROTOCOL # 0145-23-FB Page 26 of 27 
SECTION III 
SUBMISSION DEADLINE 
A. Full Board Review:  
The IRB meets twice monthly, on the first and third Thursday of the month, with the 
exception of January and July when the IRB meets only on the third Thursday of the 
month. No more than 15 applications (e.g., initial review of a new study, re-review of a 
tabled study) will be reviewed at each meeting. All reviews are performed on a firstcome 
first-served basis. The IRB meeting schedule and deadline dates can be found on 

35  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
the IRB website at www.unmc.edu/irb. 
B. Expedited Review  
Applications that qualify for expedited review have no submission deadline and can be 
reviewed independent of the IRB meeting schedule. Call the Office of Regulatory 
Affairs for assistance in determining if your study meets the requirements for 
expedited review. 
ADDITIONAL REVIEW REQUIREMENTS 
Final IRB approval and release of studies is contingent upon approval by the 
following UNMC committees or departments. Check the appropriate boxes:  
UNMC and NM - Pharmacy & Therapeutics (P&T) Committee (Required for studies 
involving drugs)  
Fred & Pamela Buffett Cancer Center Scientific Review Committee (SRC) (Required for 
studies involving cancer)  
Institutional Biosafety Committee (IBC) (Required for studies involving the use of gene 
transfer and vaccines)  
Investigational Device Review Committee (IDRC) Review by the IDRC is required for all 
protocols involving the use of investigational or marketed devices  
Billing Grid (Required for all studies involving billing for hospital/clinic services)  
Coverage Analysis (Departments requiring this analysis have been specified by the 
Organization)  
Conflict of Interest (COI) Management Plan (Required for all studies with declared COI by 
study personnel)  
Sponsored Programs Administration (SPA)/UNeHealth grants and contracts  
Pathology approval for collection of tissue samples required for this study  
Radiation Committee Approval 
Other Review 
♦ None of the above organizational requirements apply to this study 

36  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
Version 2 - PROTOCOL # 0145-23-FB Page 26 of 27 
Institutional Review Board (IRB) 
IRB PROTOCOL # 0145-23-FB Page 27 of 27 
SECTION IV 
COVID-19 
Human Subjects Research Safety Plan  
For studies involving face-to-face encounters, the research team under the 
responsibility of the principal investigator will agree to comply with the following safety 
measures: 
1. Masking of the researcher(s) during a face-to-face encounter 
2. Cleansing of any surface and/or equipment utilized before and after a subject 
encounter 
3. The Biosafety Officer (jenna.mckenzie@unmc.edu) will be notified if obtaining 
saliva, nasal, sputum or stools samples to ensure safe collection, handling, and 
processing plan is in place 
4. Suggest addressing the current health of the subject before commencing faceto-face 
research via questions below: 
Have you or anyone in your household tested positive or had a fever, 
chills, cough, shortness of breath, diarrhea, nausea, vomiting, recent 
loss of taste or smell, tiredness or fatigue, or muscle aches? If yes, the 
monitor will not be allowed on campus. 
Have you recently traveled to an area with a widespread outbreak or had 
close contact with a person known to have COVID-19, MERs-CoV or 
Ebola? 
Have you traveled outside of the country within the past month? If so, 
where did you travel and when did you return? 
Have you had a recent SARS-COV-2 antibody test or nasal swab and if so 

37  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
when and what were the results? 
♦ I acknowledge this requirement. 
Powered by TCPDF (www.tcpdf.org) 
Version 2 - PROTOCOL # 0145-23-FB Page 27 of 2IRB PROTOCOL # 0145-23-FB Page 1 of 27 
Biomedical SECTION I Therapeutic/Non-Therapeutic Does your research involve a drug, 
medical device, technique or other intervention or strategy (including means like diet, 
cognitive therapy, behavioral therapy, exercise) to diagnose, treat or prevent a particular 
condition or disease: "THERAPEUTIC RESEARCH"? Yes 1. Title of Protocol: Comparison of 
Porcine Collagen Membrane (Mucograft Seal) and Bovine Collagen Wound Dressing 
(HeliPlug) in Atraumatic Extraction Sites with DFDBA Bone Particulate Graft: A Randomized 
Controlled Trial Is a OneChart/EPIC Subject Friendly Short Title needed? No 2. Responsible 
Personnel: A. Principal Investigator (PI): Killeen, Amy C - COD-Surgical Specialties - 402-
472-7848 - akilleen@unmc.edu - alt #: 402-472-7848 - degree: DDS - address: DENT 2329 
UNL EAST (68583-0740) - phone: 402-472-7848 B. Secondary Investigator (SI): Reinhardt, 
Rick (Rick) A - COD-Surgical Specialties - 402-472-1287 - rareinha@unmc.edu - alt #: 402-
472-1287 - degree: DDS - address: DENT 2170A UNL EAST (68583-0740) - phone: 402-472-
1287 C. Participating Personnel: Czechner, Otto Alexander - COD-Surgical Specialties - 
402-472-3249 - oczechner@unmc.edu - alt #: 402-472-3249 - degree: DDS Davis, Richard 
Duke - COD-Surgical Specialties - 402-472-3249 - ridavis@unmc.edu - alt #: 402-472-3249 
- degree: DDS Version 2 - PROTOCOL # 0145-23-FB Page 1 of 27 Institutional Review Board 
(IRB) IRB PROTOCOL # 0145-23-FB Page 2 of 27 Ingalsbe, Greg Greg Ryan - COD-Surgical 
Specialties - 402-472-1311 - gingalsbe@unmc.edu - alt #: 402-472-3249 - degree: DMD - 
address: DENT 2311 UNL East (68583-0740) - phone: 402-472-1311 Lee, Joyce Ab-Ye - 
COD-Surgical Specialties - 402-472-3249 - joylee@unmc.edu - alt #: 402-472-3249 - 
degree: DDS Scanlan, Christine I - COD-Surgical Specialties - 402-472-1311 - 
christine.scanlan@unmc.edu - alt #: 402-472-3249 - degree: DDS - address: DENT 2311 
UNL EAST (68583-0740) - phone: 402-472-1311 Schlemmer, Paula Christina Co - COD-
Surgical Specialties - 402-472-3249 - pschlemmer@unmc.edu - alt #: 402-472-3249 - 
degree: DDS - address: DENT 2311 (Zip 68583) - phone: 402-472-3249 D. Lead Coordinator: 
Christiansen, Megan (Megan) M - COD-Surgical Specialties - 402-472-6770 - 
megan.christiansen@unmc.edu - alt #: 402-472-1441 - degree: BS, RDH - address: DENT 
2319 UNL EAST (68583-0740) - phone: 402-472-6770 E. Coordinator(s): Are you adding a 
clinical trial management group? No F. Data/Administrative Personnel: G. Are you a student 
or house officer? No 3. Funding Source: Check all that apply and provide the source of the 
funding. Cooperative Group: Center for Clinical and Translational Research (CCTR) Federal 
(e.g., NIH) Grant - Provide source: Other Grant: Version 2 - PROTOCOL # 0145-23-FB Page 2 
of 27 Institutional Review Board (IRB) IRB PROTOCOL # 0145-23-FB Page 3 of 27 ♦ 
Departmental funding Commercial - Provide company name: Department of Defense 

38  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
Other - Provide source (e.g. personal funding): 4. Deadline for IRB Approval: Yes - Explain 
and provide date: ♦ No 5. Contract: Is there a contract associated with this study? No 6. 
Agreements Is there a Material Transfer Agreement (MTA) associated with this study? No Is 
there a Data Use Agreement (DUA) associated with this study? No Is there a Data Transfer 
Agreement (DTA) associated with this study? No 7. Study Sites: A. Provide the names and 
locations of all study sites where this research will be conducted under the oversight of the 
UNMC IRB or Joint Pediatric IRB. UNMC College of Dentistry, Lincoln NE B. Will the 
research be conducted at external sites under the oversight of an external IRB? No C. Does 
UNMC, TNMC, CHMC or UNO serve as the lead site with responsibility for data and/or 
safety monitoring? No D. Does this study involve any international sites where the PI will 
either; 1) conduct 2) supervise or 3) receive / ship HBM or data to / from UNMC? No Version 
2 - PROTOCOL # 0145-23-FB Page 3 of 27 Institutional Review Board (IRB) IRB PROTOCOL # 
0145-23-FB Page 4 of 27 E. Does this study involve face to face contact with subjects? Yes 
8. Principal Investigator Assurance The PI understands and accepts the following 
obligations to protect the rights and welfare of research subjects in this study: All 
information in this application is complete and accurate. I will conduct the research as 
described in the application and the protocol. I will not initiate any change without IRB 
approval except when it is necessary to reduce or eliminate a risk to the subject. I will 
ensure that all research personnel are qualified and properly trained. I will fulfill my 
responsibilities as PI, described in https://guides.unmc.edu/books/hrpp-policies-and-
procedures/page/126-piqualifications-and-responsibilities I will follow all applicable HRPP 
and institutional polices, and all applicable laws, statutes and regulations. Killeen, Amy C - 
2024-02-19 15:31:07.160 9. Principal Investigator Financial Interest Disclosure A. As the PI, 
I declare: ♦ I have no financial interest in this research. I have a financial interest in this 
research. B. As the PI, I understand ♦ I must disclose any change in my financial interest 
during the course of this research within five (5) business days from the time the change 
becomes known. C. As the PI, I certify that: ♦ No Responsible Personnel have a financial 
interest in this research. The Responsible Personnel listed below have informed me that 
they have a financial interest in this research. D. I have informed all Responsible Personnel 
that if there is any change in their financial interests during the course of this study it must 
be disclosed within five (5) business days from the time the change becomes known. 
Killeen, Amy C - 2024-02-19 15:31:07.160 Version 2 - PROTOCOL # 0145-23-FB Page 4 of 27 
Institutional Review Board (IRB) IRB PROTOCOL # 0145-23-FB Page 5 of 27 SECTION II 
PROTOCOL ABSTRACT 1. Provide a brief (less than 2500 characters) abstract of the 
research protocol. (2500 characters) This summary should include: 1)) a brief description 
of the purpose of the study, 2) eligibility criteria, 3) interventions and evaluations and 4) 
follow-up. The purpose of this study is to compare the effectiveness of a porcine collagen 
membrane to a bovine collagen wound dressing for atraumatic extractions. These are both 
commonly used as a barrier and containment material over atraumatic extraction sites that 

39  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
are grafted for future implant placement. The study will include nonsmoking adults aged 
18-75 requiring premolar or anterior tooth extraction and graft procedures, who are in good 
general health and willing to provide informed consent. Exclusion criteria include a history 
of radiation therapy or bisphosphonate use, pregnancy or breastfeeding, systemic 
conditions that affect bone healing, contraindications to dental implants, and inability to 
attend follow-up visits. The study will be a double-blind randomized controlled trial 
involving 24 patients who will be assigned to two groups. Prior to tooth extraction, baseline 
data will be collected; including gingival crevicular fluid (GCF) sampling, and a limited field 
Cone Beam Computed Tomography (CBCT) radiograph. A reference digital scan will be 
taken to measure volumetric changes in soft tissue. Routine, atraumatic extraction of the 
tooth under local anesthetic will be performed. Following extraction, hydrated AllOss 50/50 
DFDBA:FDBA bone particulate will be condensed following a routine protocol. One group 
will receive Mucograft Seal over the graft, and the other group will receive Integra HeliPlug. 
Patients will be seen at a standard 2-week follow up to remove sutures, have a GCF 
sampling at the adjacent teeth and take another digital scan. Patients will be seen for an 
additional 6-week follow up to take a small (2mm) incisional biopsy for histological 
analysis. Another digital scan and GCF sampling will be taken. Final evaluation will be 3 
months post-extraction and will include a localized CBCT evaluation for implant planning 
and another measure of soft tissue changes with a digital scan. At the time of implant 
surgery, the core of bone removed during osteotomy will be histologically analyzed for 
percentage of vital bone. Adverse events will also be recorded at each visit. The primary 
outcome measure will be the histological composition of tissue at 6 weeks and volumetric 
tissue changes. The secondary outcome measures will be adverse events, bone density on 
the post-operative CBCT and percentage of vital bone at implant placement. PURPOSE OF 
THE STUDY AND BACKGROUND 2. Purpose of the Study What are the specific scientific 
objectives of the research? The primary objectives of this study are to compare the efficacy 
of a porcine collagen Version 2 - PROTOCOL # 0145-23-FB Page 5 of 27 Institutional Review 
Board (IRB) IRB PROTOCOL # 0145-23-FB Page 6 of 27 membrane to a bovine collagen 
wound dressing for atraumatic extractions, in terms of their ability to act as a barrier and 
containment material over atraumatic extraction sites that are grafted for future implant 
placement. This will be measured by volumetric and linear dimensional changes in the soft 
tissue and the histological composition of keratinized tissue after healing. The secondary 
objectives of the study are to evaluate the radiographic bone density and percentage vital 
bone at implant planning and placement. 3. Background and Rationale Describe the 
background of the study. Include a critical evaluation of existing knowledge, and 
specifically identify the information gaps that the project is intended to fill. Extraction and 
graft procedures are commonly performed in dental clinics where future implant 
placement is desired due to the large soft and hard tissue dimensional changes that occur 
as a socket heals (Araujo 2005, Chappuis 2017). While there are several techniques for 
ridge preservation, it is generally accepted that minimizing trauma from the extraction and 

40  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
flap reflection greatly decreases loss of hard and soft tissue (Fickl 2008). This is why a 
popular method is some form of Bio-Col technique where a bone graft is condensed into 
the socket and then a collagen wound dressing, or plug, is used to prevent wash out of the 
graft. (Sclar 1999, Kotsakis 2014). While cost effective, and easy to place without flap 
reflection, a collagen plug can be dislodged quickly and has been shown to have a large 
soft tissue loss during healing (Morelli 2020, Thoma 2018). Therefore, other soft tissue 
alternatives have been investigated as an alternative membrane (Ghanaati 2017) Several 
studies have investigated the efficacy of Mucograft Seal as a barrier membrane to promote 
bone regeneration in socket preservation techniques. (Jung 2013) Mucograft Seal is a 
porcine collagen membrane that is shaped ideally for easy coverage of a socket. Because it 
is a pure matrix of Type I and Type III collagen, it is able to stay more dimensionally stable, 
making it an ideal material to combat soft tissue reduction as a site heals. It is currently 
used as a replacement for free gingival grafting coverage, such as with the soft tissue 
punch technique (Jung 2004), but has not been compared to a collagen wound dressing for 
critical early healing characteristics such as inflammatory cytokines. Additionally, there is 
limited information on the specific histological composition at 6 weeks post-operative 
healing in patients who undergo socket preservation with Mucograft Seal or Colla-Plug. 
Information Gaps: The information gaps that this project is intended to fill are twofold. First, 
it aims to compare the effectiveness of Mucograft Seal and Colla-Plug in premolar and 
forward extraction and graft procedures through a randomized controlled trial, which will 
provide more conclusive evidence on the comparative efficacy of these two biomaterials. 
Second, the project aims to evaluate the histological composition of an incisional tissue 
biopsy at 6 weeks post-operative healing in patients who undergo these procedures with 
Version 2 - PROTOCOL # 0145-23-FB Page 6 of 27 Institutional Review Board (IRB) IRB 
PROTOCOL # 0145-23-FB Page 7 of 27 either Mucograft Seal or Colla-Plug, which will 
provide valuable information on the tissue response to these biomaterials at an early stage 
of the healing process. By addressing these information gaps, the project aims to 
contribute to the development of more effective socket preservation techniques and 
biomaterials, which will benefit patients undergoing these procedures. CHARACTERISTICS 
OF THE SUBJECT POPULATION 4. Accrual A. Is this study conducted solely at sites under 
the oversight of the UNMC IRB (e.g. UNMC, Nebraska Medicine, CHMC, UNO)? Yes 1. How 
many subjects will need to be consented (per group, as applicable) in order to achieve the 
scientific objectives of the research? 24 subjects will be enrolled - 12 in each group to 
account for a 10% drop out rate. 2. What is the statistical or other justification for the total 
number of subjects described above? A sample size of 11 in each group provides 80% 
power to be able to detect an absolute difference in 20 percentage-points of converted 
mucosa between the collagen (i.e. 50%) and mucograft (i.e. 70%) groups at four weeks, 
assuming a standard deviation of 15 for percentage converted mucosa and an alpha level 
of 0.05, using a Wilcoxon Rank Sum test. 3. How long do you estimate it will take to accrue 
the required number of subjects? 9 months 5. Gender of the Subjects A. Are there any 

41  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
enrollment restrictions based on gender? No 6. Age Range of Subjects A. Will adults be 
enrolled ? Yes 1. What is the age range of the adult subjects? 19-75 2. What is the rationale 
for selecting this age range? Version 2 - PROTOCOL # 0145-23-FB Page 7 of 27 Institutional 
Review Board (IRB) IRB PROTOCOL # 0145-23-FB Page 8 of 27 This treatment is rarely 
performed in children below the age of 19 and after the age of 75, adult subjects will 
typically show decreased wound healing due to age which could conflate findings. B. Will 
children (18 years of age or younger) be included in this research? No 1. What is the 
justification for excluding children from participating in this research? ♦ Research is 
irrelevant to children (e.g. disease or condition rarely encountered in children). Knowledge 
being sought in the research is already available for children or will be obtained from 
another ongoing study. A separate study in children is warranted and preferable. 
Insufficient data are available in adults to judge the potential risk in children. Other. 
Explain. 7. Race and Ethnicity Are there any subject enrollment restrictions based upon 
race or ethnic origin? No 8. Vulnerable Subjects A. Will prisoners be included in the 
research? No B. Select from the list all of the vulnerable populations that will specifically 
be recruited to participate in this research. Decisionally-impaired persons Critically ill 
patients Students of the investigator Employees of the investigator Educationally 
disadvantaged individuals Socially or economically disadvantaged individuals Individuals 
with a stigmatizing illness or condition Individuals from a marginalized social or ethnic 
group Other. ♦ No vulnerable subjects will be specifically recruited 9. Inclusion Criteria 
What are the specific inclusion criteria? Version 2 - PROTOCOL # 0145-23-FB Page 8 of 27 
Institutional Review Board (IRB) IRB PROTOCOL # 0145-23-FB Page 9 of 27 1) adult patient 
seeking care at the UNMC College of Dentistry for extraction of a premolar or anterior tooth 
due to periodontal or endodontic defect, non-restorable caries or fracture 2) adult patient 
is considering dental implant placement to replace the extracted tooth and requires a bone 
grafting procedure in preparation for a dental implant 3) Nonsmoker 4) 19-75 years old 10. 
Exclusion Criteria What are the specific exclusion criteria? Exclusion criteria include a 
history of radiation therapy or bisphosphonate use, pregnancy, systemic conditions that 
affect bone and soft tissue healing, contraindications to dental implants, and inability to 
attend follow-up visits. 11. Pregnancy and Contraception Requirements A. Are women of 
child bearing potential (WOCBP) included in this research? Yes a. Are there any specific 
contraception requirements for subjects? No 1. Provide justification for absence of 
contraception requirements ♦ There are no interventions that are likely to be of risk to a 
fetus Investigational drug(s) is (are) not systemically absorbed Investigational drug(s) is 
(are) systemically absorbed, but there is no evidence from human studies, or from clinical 
experience, that there is risk to a fetus Other B. Are pregnant women included in this 
research? No 1. Provide justification for excluding pregnant women Investigational drug(s) 
is (are) absorbed systemically, and there is evidence from animal or human studies, or from 
clinical experience, that there is risk to a fetus OR investigational drug(s) is (are) absorbed 

42  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
systemically, and there is a well-understood mechanism of action that may result in risk to 
a fetus Intervention includes a procedure expected to be of risk to a fetus (eg, exposure to 
ionizing radiation, maximal exercise test) Research is not relevant to pregnant women (e.g. 
disease or condition rarely encountered in pregnant women) Version 2 - PROTOCOL # 
0145-23-FB Page 9 of 27 Institutional Review Board (IRB) IRB PROTOCOL # 0145-23-FB 
Page 10 of 27 Knowledge being sought in the research is already available for pregnant 
women or will be obtained from another ongoing study A separate study in pregnant 
women is warranted and preferable ♦ Physiology of pregnancy precludes generalization to 
other populations Other - explain 2. Describe how pregnancy status will be assessed (eg, 
self-report, urine pregnancy test, blood pregnancy test) and the frequency of monitoring 
during participation in the research. Pregnancy status will be determined via self-report 3. 
Describe the plan should a female subject, or the partner of a male subject, become 
pregnant while research interventions are on-going (or during the period that contraception 
is required following the completion of the intervention). Should a female subject become 
pregnant while research interventions are on-going, she will be dismissed from study. C. 
Are breast feeding women excluded in this research? No Provide justification for the 
inclusion or exclusion of breast feeding women. There are no interventions that are likely to 
be of risk to a nursing newborn. METHODS AND PROCEDURES 12. Methods and 
Procedures Applied to Human Subjects A. Are there any evaluations or tests that will be 
performed for the purpose of determining subject eligibility which would not be routinely 
conducted as part of standard clinical care of the prospective subject? No B. Describe the 
research plan, including all procedures, interventions, evaluations and tests. Patients at 
the UNMC College of Dentistry who are seeking care to extract a premolar or anterior tooth 
due to a periodontal defect, endodontic defect or non-restorable caries or fracture, and 
who are considering a dental implant to replace the extracted tooth, will be made aware of 
this clinical study by the dental faculty or residents planning the treatment. Subjects will be 
given the consent form to take home and consider, and any questions will be answered, 
signed and witnessed. Version 2 - PROTOCOL # 0145-23-FB Page 10 of 27 Institutional 
Review Board (IRB) IRB PROTOCOL # 0145-23-FB Page 11 of 27 Twenty-four patients will be 
enrolled in this study. On the day of extraction, baseline data will be recorded/collected. 
These include the following: 1. A limited field CBCT will be taken of the tooth to be 
extracted. 2. Gingival crevicular fluid (GCF) sampling at the interproximal sites of teeth 
adjacent to the tooth to be extracted. The tooth to be extracted will be isolated with cotton 
rolls and GCF collection paper strips will be placed into the facial and lingual interproximal 
gingival sulci for 30 seconds. The paper samples will be pooled and placed in a plastic-
capped vial labeled with the subject number and visit (example: N1-0, N2-1) and 
immediately frozen at -80° C. The GCF sample vials will not be labeled with any personal 
identifying information (subject 's name, age, tooth #, etc). 3. A digital intraoral scan will be 
taken to establish baseline tissue dimensions. Routine atraumatic dental extraction under 

43  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
local anesthesia will be completed by the assigned periodontal resident (SM, NB, PS, JL, 
OC, DD) or oral surgery fellow and faculty (AK, RR).A statistician will generate a 
randomization schedule, after which someone not involved in the treatment of these 
patients will put each randomized treatment assignment into separate envelopes. The 
envelope will be given to the clinical provider after the extraction is completed. The 
extraction socket will be filled with 50:50 AlloOss DFDBA/FDBA allograft bone and covered 
with either a HeliPlug collagen wound dressing or a Mucograft Seal membrane. Subjects 
will be scheduled for a routine postoperative visit two weeks following the extraction. At 
this visit, suture removal and evaluation of the healing site will occur. GCF collection on the 
remaining adjacent teeth will occur as will an intraoral digital scan of the extraction site. An 
additional post operative visit will occur at 6 weeks to do a final soft tissue healing 
evaluation. At this time a small (2mm) incisional biopsy will be taken and stored in 10% 
formalin that is labeled similarly to GCF sample tubes. We do not anticipate this tissue 
removal to have an impact on final healing of the underlying bone for the patient. This 
tissue will be processed with a hematoxylin and eosin stain and the width of keratinized 
tissue will be measured by a separate individual who is blinded to the treatment groups. 
GCF collection on the remaining adjacent teeth will also occur at this visit, as will an 
intraoral digital scan of the extraction site. The final postoperative visit will be 3 months 
following the extraction. A limited-field CBCT will be taken to begin the process of implant 
treatment planning and measure bone height, width and volume. A final GCF collection on 
the remaining adjacent teeth will also occur at this visit, as will a final intraoral digital scan 
of the extraction Version 2 - PROTOCOL # 0145-23-FB Page 11 of 27 Institutional Review 
Board (IRB) IRB PROTOCOL # 0145-23-FB Page 12 of 27 site. GCF Cytokine Determination 
At the time of analysis, each pooled GCF samples will be eluted using 100 µl of 1× PBS by 
gently agitating the samples on a rocker plate for 1 h at 4°C. Cytokine concentrations will 
be measured using a customized human cytokine and magnetic bead panel (Milliplex MAP 
kit; Millipore, Billerica, MA), and a MAGPIX instrument and software (Luminex Corporation, 
Austin, TX) per the manufacturers recommendations. Ten analytes will be measured: 
interleukin-1β (IL-1β), IL-4, IL-6, IL-8, IL-10, IL-13, IL-17 granulocyte-macrophage colony-
stimulating factor (GM-CSF), tumor necrosis factor alpha (TNF-α), interferon-gamma (INF-
γ). Albumin for each sample also will be measured to normalize cytokine levels and control 
for serum contamination. The amounts of cytokines will be reported in picograms per 
albumin level and per 30-s sample. Statistical Analysis The percentage of converted 
mucosa will be documented at six weeks after an extraction, and differences in the width of 
keratinized tissue between the collagen and mucograft groups will be assessed using a 
Wilcoxon Rank Sum test. As a secondary analysis, we may also look at other related 
demographic (e.g. sex, age, etc.) and clinical (e.g. bone width, soft tissue volume, cytokine 
levels, etc.) characteristics to see if they have associations with the percent keratinized 
gingiva, using Spearman correlations for continuous variables, or Wilcoxon Rank 
Sum/Kruskal Wallis tests for categorical variables. C. Select any of the following that apply 

44  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
to the research: Phase I study ♦ Randomization Placebo (or non-treatment arm) Washout 
Sensitive surveys or questionnaires None of the above Option chosen: Randomization 
Describe randomization process and schedule A statistician will generate a randomization 
schedule, after which someone not involved in the treatment of these patients will put 
each randomized treatment assignment into separate envelopes, which will be given to the 
clinical provider close to the time the material will be placed, after the patient has been 
enrolled/consented into the study. Version 2 - PROTOCOL # 0145-23-FB Page 12 of 27 
Institutional Review Board (IRB) IRB PROTOCOL # 0145-23-FB Page 13 of 27 D. Identify: 1. 
All procedures, interventions, evaluations and tests performed solely for research 
purposes (eg, administration of an investigational drug or a new psychological assessment 
instrument; randomization) Procedures performed solely for research purposes include: 
the collection of gingival crevicular fluid (GCF); soft tissue biopsy at 6-weeks post-
procedure. 2. All procedures, interventions, evaluations and tests performed for clinical 
indication but more frequently than they would be if the subject was not participating in the 
research (eg, extra blood tests; additional radiology exams) It is not typical to have an 
intraoral scan done at post-operative visits. However, this takes less than 2 minutes to 
perform and has no contraindications or risks. It is simply a data collection process for 
dentists to measure changes in our patients over time. E. Describe briefly the statistical 
methods used to analyze the data (or reference the appropriate section of the detailed 
protocol or grant). The percentage of converted mucosa will be documented at six weeks 
after an extraction, and differences in the width of keratinized tissue between the collagen 
and mucograft groups will be assessed using a Wilcoxon Rank Sum test. As a secondary 
analysis, we may also look at other related demographic (e.g. sex, age, etc.) and clinical 
(e.g. bone width, soft tissue volume, cytokine levels, etc.) characteristics to see if they have 
associations with the percent keratinized gingiva, using Spearman correlations for 
continuous variables, or Wilcoxon Rank Sum/Kruskal Wallis tests for categorical variables. 
F. Does this study involve the collection of blood, urine, saliva or other human biological 
material (HBM)? Yes 1. Does this research involve genetic testing including Genome Wide 
Association Studies (GWAS), Whole Genome Sequencing (WGS) or Whole Exome 
Sequencing (WES)? No G. Does this study involve the creation of a tissue bank for future 
unspecified research? This includes un-used (excess) blood, urine, or tissue, obtained for 
clinical indication or for research, or additional human biological material collected 
specifically for future research. No DRUGS, BIOLOGIC DRUGS AND DEVICES Version 2 - 
PROTOCOL # 0145-23-FB Page 13 of 27 Institutional Review Board (IRB) IRB PROTOCOL # 
0145-23-FB Page 14 of 27 13. Drugs and Biologic Drugs 1. Does this research involve the 
use of drugs or biologics? Yes A. Are any of the drugs or biologics used in this research not 
FDA-approved? No B. Are any of the drugs used in this study FDA Approved? Yes 1. Will 
data obtained from this research study be used to support a new indication, new labeling 
or a change in advertising of an FDA-approved drug or biologic? No 2. Will the use of an 

45  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
FDA-approved drug in this research study involve a route of administration, dosage level or 
patient population that significantly increases the risks (or decreases the acceptability of 
the risks) associated with the use of the drug product? No C. Do any of the sponsors of this 
research require compliance with ICH-GCP? No 14. Devices 1. Does this research involve a 
medical device(s) (including an in vitro device [IVD] (assay), and medical software)? No 
CONFIDENTIALITY AND PRIVACY 15. Confidentiality and Privacy A. Describe where 
research data will be stored. Check all that apply. Box@unmc.edu (secure UNMC or UNO 
designated cloud-based storage site) Microsoft Office 365 application (including 
SharePoint, OneDrive for Business, Teams or Streams) (UNMC, UNO or NU system 
instance) (secure UNMC or UNO designated cloudbased storage site) Other secure UNMC 
or UNO designated cloud-based storage site - describe: OnCor Clinical Trial Management 
System (secure server at UNMC, CHMC, Nebraska Medicine, and/or UNO) Version 2 - 
PROTOCOL # 0145-23-FB Page 14 of 27 Institutional Review Board (IRB) IRB PROTOCOL # 
0145-23-FB Page 15 of 27 CCORDA database (biostatistics) (secure server at UNMC, 
CHMC, Nebraska Medicine, and/or UNO) RITO-hosted databases (for example, REDCap, 
CV-QOR, Onchem Trials, XNAT) (secure server at UNMC, CHMC, Nebraska Medicine, 
and/or UNO) Nebraska Medicine PACS (for image files) (secure server at UNMC, CHMC, 
Nebraska Medicine, and/or UNO) Other secure server at UNMC, CHMC, Nebraska 
Medicine, and/or UNO - describe: On an NSRI or designated high security .gov storage site 
On a VA-approved storage vehicle for a VA-approved study On a remote secure server 
and/or database maintained by the sponsor accessible through the internet On a secure 
server and/or database hosted and maintained by another institution accessible through 
the internet On a device or mobile application provided by the sponsor to upload data to a 
coordinating center or central database On a device or mobile application being developed 
by a sponsor or by a UNMC, CHMC or UNO investigator On a device or mobile application 
that connects to the internet through UNMC or NM network (wired or wireless) On an 
encrypted, password protected portable computer, or flash drive Other - describe: ♦ In 
hard copy (other than signed Consent Forms) Option chosen: In hard copy (other than 
signed Consent Forms) a. Please provide justification for use of hard copies Data collection 
is easiest and most secure in our department when done with hard copies. The room is 
secured by key card access and data will be stored in locked cabinets. Only authorized 
personnel will be able to access them. Option chosen: In hard copy (other than signed 
Consent Forms) b. Will hard copies will be transported from one site to another, on or off 
campus? No B. Will any of the following subject identifiers be recorded (at any time) in 
association with the research data? Yes 1) Indicate the subject identifiers that will be 
recorded. Check all that apply. Name ♦ Version 2 - PROTOCOL # 0145-23-FB Page 15 of 27 
Institutional Review Board (IRB) IRB PROTOCOL # 0145-23-FB Page 16 of 27 DATES (e.g. 
date of study visit, date of sample collection, birth, admission, discharge) Postal address 
information: street address, city, county, precinct, ZIP code Telephone numbers Fax 

46  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
numbers Electronic mail addresses Social Security numbers ♦ Medical Record numbers 
Health plan beneficiary numbers Account numbers Certificate/license numbers Vehicle 
identifiers and serial numbers, including license plate numbers Device identifiers and 
serial numbers Web Universal Resource Locators (URLs) Internet Protocol (IP) address 
numbers Biometric identifiers, including finger and voice print Full face photographic 
images [and any comparable images] No Identifier 2) Will a unique subject identifying 
number (e.g., S1, S2, S3), characteristic or code be used to link data to any of the identifiers 
listed above? Yes a. Where will the key (that links the unique subject identification code to 
the subject's name or other identifier) be stored? The key will be stored in a locked filing 
cabinet within a locked room in the Cruzan Center for Dental Research. The unique 
identifier that will be sued to code the data is as follows: each subject will be given a 
number (i.e. N1, N2...N25). The specific appointment visit (baseline, 2 weeks, 3 months) 
data will be coded as follows: N1-0 (baseline), N1-2 (two weeks), N1-3 (3 months). b. Does 
the code number include the subject's initials or other subject identifier as part of the 
code? No 3) What is the justification for recording the specific subject identifiers listed 
above? Check all that apply. ♦ Schedule appointments Collect continuous clinical 
information from the medical records ♦ Follow-up with subjects Link stored tissue with 
subject identification for it to be withdrawn in the future if requested Version 2 - PROTOCOL 
# 0145-23-FB Page 16 of 27 Institutional Review Board (IRB) IRB PROTOCOL # 0145-23-FB 
Page 17 of 27 Compensation Other. Explain. 4) How long will the subject identifiers be 
maintained in association with the research data? Subject identifiers will be maintained 
until data have been statistically analyzed and reports published and no less than 7 years 
following completion of research per Nebraska state law and NRPP policy. 5) How will all of 
the identifiable research data be destroyed (e.g., all identifiers stripped from the data and 
destroyed, hard copies shredded etc) when the identifiable data is no longer required? 
Subject identifiers will be stripped from the data and destroyed once it is no longer 
required. C. Will research data that contain subject identifiers be disclosed to: Other 
investigators at UNMC, NM, UNO or CHMC who are not listed in Section I of this 
application? No 2. Investigators outside of UNMC, NM, UNO or CHMC? No 3. Will research 
data that contain subject identifiers be disclosed to any commercial sponsor or contract 
research organization (CRO), or to any other external organization or entity (e.g., NCI 
cooperative groups)? No D. What provisions will be in place to protect the subject's 
privacy? Check all that apply. ♦ Ensuring that only personnel listed on the IRB application 
Section I.3(A-E) are present during the consent process. ♦ Ensuring that the fewest number 
of individuals possible are aware of the subject's participation in the research. ♦ Ensuring 
that the research activities are performed in as private of a place as possible. Other. 
Explain. E. Does this research involve data banking at UNMC, NM, UNO or CHMC, or by an 
outside organization (e.g. NCI Cooperative Group, pharmaceutical company) for future 
research that is not related to this study? Version 2 - PROTOCOL # 0145-23-FB Page 17 of 

47  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
27 Institutional Review Board (IRB) IRB PROTOCOL # 0145-23-FB Page 18 of 27 No 
RISK/BENEFIT ASSESSMENT 16. Potential Risks What are the potential risks associated 
with each research procedure, intervention, evaluation and/or test? If data are available, 
estimate the probability that a given harm may occur and its potential reversibility. 
Potential risks associated with soft tissue sampling at 4-weeks includes minimal pain and 
adjacent tooth sensitivity. The soft tissue and GCF specimens will be collected in plastic-
capped vials and frozen until analysis. These vials will be labeled with the subject's number 
and visit (N1-0, N2-2) and will not be labeled with any personal identifying information, thus 
breach of confidentiality is not at risk. Potential risks associated with limited view CBCT 
include increase exposure to radiation. This risk is inherent to any dental radiography and 
the limited-view CBCT pre-extraction and post-extraction is standard therapy for dental 
implant treatment planning. 17. Risk Classification What is the overall risk classification of 
the research? Minimal risk ♦ Greater than minimal risk 18. Minimization of Risk A. Describe 
how the subjects of the research will be monitored by the investigators and other research 
personnel to ensure their safety. Subjects of the research will be monitored with follow-up 
phone calls. If any postoperative concerns develop, they will be seen in the graduate 
periodontal clinic for follow-up. B. Describe how the data collected will be monitored to 
ensure the safety of subjects. Identify who will perform the ongoing data and safety 
analysis, and describe the frequency of data analysis. If there is an independent Data and 
Safety Monitoring Board (DSMB) provide the charter, or describe (1) the composition of the 
DSMB membership, (2) the frequency of DSMB meetings and reports. Data collection will 
be monitored by study personnel and if a decline in the subject's periodontal condition is 
noted, they will be referred to the graduate periodontal residency at UNMC College of 
Dentistry for a full evaluation. The contact information for the study investigators and 
personnel are on the consent form that will be sent home with each Version 2 - PROTOCOL 
# 0145-23-FB Page 18 of 27 Institutional Review Board (IRB) IRB PROTOCOL # 0145-23-FB 
Page 19 of 27 subject. C. Describe the auditing plan for research conducted. Identify who 
will conduct the audits and specify the audit frequency. Ten percent of the case report 
forms will be reviewed by the Associate Dean of Clinics, Dr. Amir Fahr, at the COD semi-
annually and audited against the primary dental record. Any violations or unexpected 
outcomes will be reported to the IRB. D. Describe the specific subject withdrawal criteria. 
Subjects will be withdrawn if they are non-compliant to their postoperative appointments. 
E. Describe the stopping rules for the research (e.g., the specific criteria for halting or early 
termination of the study). If 10% of subjects suffer an adverse event, such as bleeding or 
pain associated with the soft tissue sampling greater than that expected associated with a 
similar extraction without sampling, the study will be stopped. F. Describe plans and 
resources available to promptly address any subject injury. The investigators are board-
certified periodontists or periodontal residents, so any adverse effects will be addressed 
with a thorough evaluation and appropriate treatment. 19. Potential Benefits to the Subject 

48  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
Is there the prospect for direct benefit (eg, research on diagnosis or treatment of disease)? 
No 20. Potential Benefits to Society Describe the potential benefits to society that may 
reasonably be expected to result from this research. A potential benefit to society would be 
clarification and understanding of the soft tissue healing capabilities of common materials 
used for this procedure. FINANCIAL OBLIGATIONS AND COMPENSATION 22. Financial 
Obligations of the Subject A. Who will pay for research procedures, interventions, 
evaluations and tests? Check all that apply. Sponsor Grant CRC, CCTR Version 2 - 
PROTOCOL # 0145-23-FB Page 19 of 27 Institutional Review Board (IRB) IRB PROTOCOL # 
0145-23-FB Page 20 of 27 Costs or fees waived by Nebraska Medicine, UNMC- P, CHMC or 
CSP ♦ Department/Section funds Other. Explain B. Will any of the research procedures, 
interventions, evaluations and tests described above be charged to the Subject, the 
Subject's health insurance, or Medicare/Medicaid? Yes 1. Provide additional detail and 
justification for charging as noted. The subject will be not be charged for any research 
procedures or interventions. The subject will be charged for non-research related 
procedures (extraction, bone graft, limited view CBCT). C. Are there any other financial 
obligations that the subject will incur as a result of participating in the study? No 23. 
Compensation to the Subject for Participation A. Will the subject receive any 
compensation for participation? No PRIOR REVIEW 24. Prior IRB Review A. Has this study 
(or one substantially similar) been previously submitted to the UNMC IRB (or the Joint 
Pediatric IRB) and then withdrawn by the investigator for any reason? No B. To the best of 
your knowledge, has this study (or one substantially similar) been considered by another 
IRB and disapproved? No SUBJECT IDENTIFICATION & RECRUITMENT 25. Method of 
Subject Identification and Recruitment A. Will prospective subjects learn about the 
research and then contact the investigator about participation (for example, in response to 
a print, electronic, radio or television advertisement; referral by a clinician or other 
specifically for this research)? Version 2 - PROTOCOL # 0145-23-FB Page 20 of 27 
Institutional Review Board (IRB) IRB PROTOCOL # 0145-23-FB Page 21 of 27 No B. Will the 
investigator make the initial contact with the potential subject to tell him/her about the 
research (for example, by contacting existing or past previous patients or research 
participants; or by contacting prospective subjects thru school records, or thru support 
groups or other Interest Groups; or thru use of the Hospital Opt-In Database)? Yes 1. How 
will prospective subjects be identified? Patients that meet the study criteria will be 
identified in the UNMC COD clinic during normal clinical treatment. 2. Will potential 
subjects be screened for eligibility prior to informed consent? No 3. How will potential 
subjects be approached and invited to participate? Eligible patients will be asked if they 
want to participate in the study. a. Describe the process of initial contact Patients that 
would otherwise be presenting to the clinic for extraction and grafting will be invited to 
participate in the study. b. Who will make the initial contact? One of the investigators or 
collaborators. c. Does that person have ethical access to information about potential 

49  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
subjects? Yes i. Describe All investigators and collaborators are responsible for supervising 
dental students in patient care in the clinic where potential subjects are treated, therefore 
direct contact with potential subjects and their records is part of that supervision. C. Will 
this study be listed in the clinical trial registry at www.clinicaltrials.gov? Yes 1. Provide the 
NCT#. NCT application has been submitted, awaiting NCT#. Will inform the IRB when it 
comes Version 2 - PROTOCOL # 0145-23-FB Page 21 of 27 Institutional Review Board (IRB) 
IRB PROTOCOL # 0145-23-FB Page 22 of 27 through. 2. Identify who holds the NCT# ♦ PI 
Sponsor OBTAINMENT OF INFORMED CONSENT 26. Waiver or Alteration of Informed 
Consent A. Is a complete waiver or alteration of consent requested? No 27. Waiver of 
Signed Consent Is a waiver to obtain signed consent requested? No 29. Process of 
Informed Consent A. When will the prospective subject/parent(s)/guardian(s)/LAR be 
approached relative to their/the subject's actual participation in the study? Prospective 
subjects will be approached after it has been determined that they have a nonrestorable 
anterior or premolar tooth that needs extraction and they have expressed interest in 
replacing the tooth with a dental implant. Subjects will be referred to the graduate 
periodontal clinic where they will be approached by study personnel (periodontal resident) 
about their interest in participating in the study. B. Where will informed consent be 
obtained, and how will the environment be conducive to discussion and thoughtful 
consideration? Informed consent will be obtained in a private room in the Cruzan Center 
for Dental Research. C. Who will be involved in the process of consent and what are their 
responsibilities? The investigators will explain the research, ask questions to be certain 
that the subject understands the procedure, and answer any subject questions. 
Additionally, investigators will also ask questions to ensure that subjects understand their 
rights as research subject D. Is there any limitation on the amount of time allotted to the 
process of consent? No E. How will the process of consent be structured for subjects who 
are likely to be more Version 2 - PROTOCOL # 0145-23-FB Page 22 of 27 Institutional Review 
Board (IRB) IRB PROTOCOL # 0145-23-FB Page 23 of 27 vulnerable to coercion or undue 
influence? All subjects approached about this study will already have made the decision to 
extract the tooth and have expressed interest in implant replacement of that tooth. 
Additionally, they will already have been counseled on the process of extraction, grafting 
and implant placement; including the costs and time required for successful treatment. 
Investigators acknowledge concerns regarding the potential subject misinterpreting the 
study as standard of care, or having his/her decision regarding participation influenced by 
concerns about disappointing or offending his/her care provider by having the introductory 
and informed consent conversations completed by study personnel who are not familiar to 
the subject. The subject will not have had previous contact with study personnel, thus 
minimizing the concern about disappointing or offending his or her provider. Additionally, 
extreme care will be taken during discussion/description of the study with the subject to 
highlight that the removal of soft tissue is not standard of care for routine extraction and 

50  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
implant preparation. F. Will non-English speaking subjects be enrolled in this research? Yes 
Describe the plan to conduct the process of informed consent in the language of the 
subject/parent(s)/guardian(s)/LAR The process of informed consent in the language of the 
subject includes utilization of interpretation services via video (Language Link) or in-person 
interpreter. G. How will it be determined that the subject/parent(s)/guardian(s)/LAR 
understood the information presented? The investigator will question the subject 
concerning his/her understanding of all elements of the informed consent. This will include 
having the subject describe what will be done to them along with the risks 31. Information 
Purposely Withheld Will any information be purposely withheld from the subject during the 
research or after completion of the research? No RESOURCES 33. Describe the resources 
available to safely conduct this study at each study sites specified in Section I.7. 1. 
Funding for all research-related expenses have been secured through departmental 
Version 2 - PROTOCOL # 0145-23-FB Page 23 of 27 Institutional Review Board (IRB) IRB 
PROTOCOL # 0145-23-FB Page 24 of 27 funds. 2. Research procedures will be conducted 
in the Cruzan Center for Dental Research at the UNMC College of Dentistry. 3. Laboratory 
space for the GCF tests will be available in the laboratory of one of our investigators (RR). 4. 
Emergency equipment and personnel services are routinely available in the periodontal 
clinic during operation, during which all patient-based procedures will be performed. 
LITERATURE REVIEW 34. References Provide a full listing of the key references cited in the 
background (Section II.3). The references should clearly support the stated purpose of the 
study. Araujo, M.G. and J. Lindhe, Dimensional ridge alterations following tooth extraction. 
An experimental study in the dog. J Clin Periodontol, 2005. 32(2): p. 212-8. Chappuis, V., 
M.G. Araujo, and D. Buser, Clinical relevance of dimensional bone and soft tissue 
alterations post-extraction in esthetic sites. Periodontol 2000, 2017. 73(1): p. 73-83. Fickl, 
S., et al., Tissue alterations after tooth extraction with and without surgical trauma: a 
volumetric study in the beagle dog. J Clin Periodontol, 2008. 35(4): p. 356-63. Ghanaati, S., 
et al., Evaluation of the tissue reaction to a new bilayered collagen matrix in vivo and its 
translation to the clinic. Biomed Mater, 2011. 6(1): p. 015010. Jung, R.E., et al., 
Radiographic evaluation of different techniques for ridge preservation after tooth 
extraction: a randomized controlled clinical trial. J Clin Periodontol, 2013. 40(1): p. 90-8. 
Jung, R.E., D.W. Siegenthaler, and C.H. Hammerle, Postextraction tissue management: a 
soft tissue punch technique. Int J Periodontics Restorative Dent, 2004. 24(6): p. 545-53. 
Kotsakis, G., et al., Flapless alveolar ridge preservation utilizing the Version 2 - PROTOCOL 
# 0145-23-FB Page 24 of 27 Institutional Review Board (IRB) IRB PROTOCOL # 0145-23-FB 
Page 25 of 27 "socket-plug" technique: clinical technique and review of the literature. J Oral 
Implantol, 2014. 40(6): p. 690-8. Morelli, T., et al., Three-Dimensional Volumetric Changes 
After Socket Augmentation with Deproteinized Bovine Bone and Collagen Matrix. Int J Oral 
Maxillofac Implants, 2020. 35(3): p. 566-575. Sclar, A.G., Preserving alveolar ridge anatomy 
following tooth removal in conjunction with immediate implant placement. The Bio-Col 
technique. Atlas Oral Maxillofac Surg Clin North Am, 1999. 7(2): p. 39-59. Thoma, D.S., et 

51  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
al., Clinical and histologic evaluation of different approaches to gain keratinized tissue 
prior to implant placement in fully edentulous patients. Clin Oral Investig, 2018. 22(5): p. 
2111-2119. Version 2 - PROTOCOL # 0145-23-FB Page 25 of 27 Institutional Review Board 
(IRB) IRB PROTOCOL # 0145-23-FB Page 26 of 27 SECTION III SUBMISSION DEADLINE A. 
Full Board Review: The IRB meets twice monthly, on the first and third Thursday of the 
month, with the exception of January and July when the IRB meets only on the third 
Thursday of the month. No more than 15 applications (e.g., initial review of a new study, re-
review of a tabled study) will be reviewed at each meeting. All reviews are performed on a 
firstcome first-served basis. The IRB meeting schedule and deadline dates can be found on 
the IRB website at www.unmc.edu/irb. B. Expedited Review Applications that qualify for 
expedited review have no submission deadline and can be reviewed independent of the IRB 
meeting schedule. Call the Office of Regulatory Affairs for assistance in determining if your 
study meets the requirements for expedited review. ADDITIONAL REVIEW REQUIREMENTS 
Final IRB approval and release of studies is contingent upon approval by the following 
UNMC committees or departments. Check the appropriate boxes: UNMC and NM - 
Pharmacy & Therapeutics (P&T) Committee (Required for studies involving drugs) Fred & 
Pamela Buffett Cancer Center Scientific Review Committee (SRC) (Required for studies 
involving cancer) Institutional Biosafety Committee (IBC) (Required for studies involving the 
use of gene transfer and vaccines) Investigational Device Review Committee (IDRC) Review 
by the IDRC is required for all protocols involving the use of investigational or marketed 
devices Billing Grid (Required for all studies involving billing for hospital/clinic services) 
Coverage Analysis (Departments requiring this analysis have been specified by the 
Organization) Conflict of Interest (COI) Management Plan (Required for all studies with 
declared COI by study personnel) Sponsored Programs Administration (SPA)/UNeHealth 
grants and contracts Pathology approval for collection of tissue samples required for this 
study Radiation Committee Approval Other Review ♦ None of the above organizational 
requirements apply to this study Version 2 - PROTOCOL # 0145-23-FB Page 26 of 27 
Institutional Review Board (IRB) IRB PROTOCOL # 0145-23-FB Page 27 of 27 SECTION IV 
COVID-19 Human Subjects Research Safety Plan For studies involving face-to-face 
encounters, the research team under the responsibility of the principal investigator will 
agree to comply with the following safety measures: 1. Masking of the researcher(s) during 
a face-to-face encounter 2. Cleansing of any surface and/or equipment utilized before and 
after a subject encounter 3. The Biosafety Officer (jenna.mckenzie@unmc.edu) will be 
notified if obtaining saliva, nasal, sputum or stools samples to ensure safe collection, 
handling, and processing plan is in place 4. Suggest addressing the current health of the 
subject before commencing faceto-face research via questions below: Have you or anyone 
in your household tested positive or had a fever, chills, cough, shortness of breath, 
diarrhea, nausea, vomiting, recent loss of taste or smell, tiredness or fatigue, or muscle 
aches? If yes, the monitor will not be allowed on campus. Have you recently traveled to an 

52  |  UNIVERSITY OF NEBRASKA MEDICAL CENTER  
 
area with a widespread outbreak or had close contact with a person known to have COVID-
19, MERs-CoV or Ebola? Have you traveled outside of the country within the past month? If 
so, where did you travel and when did you return? Have you had a recent SARS-COV-2 
antibody test or nasal swab and if so when and what were the results? ♦ I acknowledge this 
requirement. Powered by TCPDF (www.tcpdf.org) Version 2 - PROTOCOL # 0145-23-FB 
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