A Comparison Between TiNbTaZr (GUMMETAL) and Stainless-steel Alloy for Space Closure With Sliding Mechanics A Pilot Randomized Clinical Trial
Phase: NA
Conditions: Malocclusion, Angle Class I
Sponsor: State University of New York at Buffalo

 
University at Buffalo Institutional Review Board (UBIRB) 
Office of Research Compliance | Clinical and Translational Research Center Room 5018 
875 Ellicott St. | Buffalo, NY 14203 
UB Federalwide Assurance ID#: FWA00008824 
Page 1 of 36 
 
1.0 Complete Research Protocol (HRP-503) 
 
PROTOCOL TITLE: 
Include the full protocol title. 
Response: A comparison between TiNbTaZr (GUMMETAL) and stainless-steel 
alloy for space closure with sliding mechanics A pilot randomized clinical trial  
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response:  
Lubomyr Ravlyk  
Orthodontic Department at University at Buffalo School of Dental Medicine 
585-746-8599 
Lubomyrr@buffalo.edu 
 
VERSION NUMBER/DATE: 
Include the version number and date of this protocol. 
Response: Version 1.5 Date: 09-25-2021 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
1.5 
Change of 0.018” Prescription Bracket only 
used on the maxillary canines. The remaining 
dentition in the maxillary arch can have either 
0.018” or 0.022” Prescription Brackets. 
No 
changes in 
any of the 
consents  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FUNDING: 
Indicate any funding for this proposal. This should match the Funding Sources 
page in Click IRB. 

 
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Response: Currently no funding is present 
GRANT APPLICABILITY: 
Indicate whether this protocol is funded by a grant (e.g. NIH, foundation grant).  
For a grant with multiple aims, indicate which aims are covered by this research 
proposal. 
NOTE: This question does not apply to studies funded by a sponsor contract. 
Include a copy of the grant proposal with your submission.     
Response: No Grant currently funding this study  
RESEARCH REPOSITORY: 
Indicate where the research files will be kept, including when the study has been 
closed.  The repository should include, at minimum, copies of IRB 
correspondence (approval, determination letters) as well as signed consent 
documents.  This documentation should be maintained for 3 years after the study 
has been closed.   
Response:  
Location: University at Buffalo School of Dental Medicine  
Address:140 Squire Hall, Buffalo, NY 14214 
Department: Department of Orthodontics  
2.0 Study Summary 
 
Study Title 
A comparison between TiNbTaZr (GUMMETAL) and 
stainless-steel alloy for space closure with sliding 
mechanics A pilot randomized clinical trial  
Study Design 
Pilot randomized clinical trial  
Primary Objective 
1. Evaluate the total amount of canine retraction (mm) using 
GUMMETAL and Stainless-steel archwires  
2. Evaluate the rate of canine retraction (mm/month) from 
T0-T4.  
 
Secondary 
Objective(s) 
3. Assess the 3-Dimensional control of canines during 
retraction from T0-T4. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Orthodontic archwires: GUMMETAL vs. Stainless-Steel  
IND/IDE #  
N/A 
Study Population 
12-17Y11M male and female patients   
Sample Size 
16  
Study Duration for 
individual 
participants 
4 months  

 
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Study Specific 
Abbreviations/ 
Definitions  
TiNbTaZr = GUMMETAL  
SS = Stainless Steel 
NiTi = Nickel Titanium  
3.0 Objectives* 
3.1 Describe the purpose, specific aims, or objectives of this research. 
Response: To investigate the maxillary canine retraction rate using GUMMETAL 
and Stainless steel archwires for sliding mechanics. Given GUMMETAL’s 
relatively short presence in the orthodontic field with limited research on its 
various material properties and clinical applications, its potential in space closure 
by sliding mechanics warrants investigation.  
 
3.2 
State the hypotheses to be tested, if applicable. 
NOTE:  A hypothesis is a specific, testable prediction about what you expect to 
happen in your study that corresponds with your above listed objectives. 
Response: We hypothesize that GUMMETAL total retraction distance and rate 
will be lower than the Stainless-steel group. We expect a significant difference 
between the groups regarding 3-Dimensional control during retraction. 
 
4.0 Scientific Endpoints* 
 
2.1    Describe the scientific endpoint(s), the main result or occurrence under 
study.   
 
NOTE:  Scientific endpoints are outcomes defined before the study begins to determine 
whether the objectives of the study have been met and to draw conclusions from the data.  
Include primary and secondary endpoints.  Some example endpoints are:  reduction of 
symptoms, improvement in quality of life, or survival.  Your response should not be a 
date.   
Response: A decrease in the retraction rate (mm/month) / total retraction distance 
(mm) for the GUMMETAL group versus Stainless-steel group.  
 
5.0 Background* 
5.1 Provide the scientific or scholarly background, rationale, and significance 
of the research based on the existing literature and how it will contribute to 
existing knowledge.  Describe any gaps in current knowledge.  Include 
relevant preliminary findings or prior research by the investigator.  
Response:  
Space closure mechanics 
 
Space closure mechanics during the course of orthodontic treatment is 
necessary in cases with generalized spacing, congenitally missing teeth 
and when teeth are extracted. Space closure during treatment has shown a 

 
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correlation to longer treatment times.1 Orthodontist and patients prefer the 
shortest duration of treatment possible and this often requires reliable 
space closure mechanics and minimizing anchorage loss. Lack of 
knowledge and experience in appropriate space closure mechanics can 
compromise the patient’s occlusion. Thus clinician should understand that 
space closure is determined by a combination of factors including the 
biomechanical forces applied, force variation, moment-magnitude, 
moment-force ratio, force-deflection rate and anchorage unit.2 Orthodontic 
armamentarium is vast with mechanical options to achieve adequate space 
closure; thus, it is important that biomechanical selection be made on an 
individual basis. Ribeiro et al. identify six key goals which need to be 
considered for space closure: 1) differential space closure-anchorage 
control; 2) minimum patient cooperation; 3) axial inclination control; 4) 
control of rotations and arch width; 5) optimum biological response; and 
6) operator convenience.2  
 
Biomechanical systems traditionally used to close spaces have 
been friction (sliding mechanics) and frictionless (closing loop 
mechanics). Each method presents with its own advantages and 
disadvantages when it comes to space closure.  
 
Orthodontic Arch wires 
Stainless Steel and Cobalt Chromium wires 
The ability to move teeth orthodontically via conventional fixed 
appliances is possible due to the orthodontic archwires. In the earliest parts 
of the 20th century during Edward Angle’s time, gold-alloy use was 
ubiquitous, because gold itself was too soft for most dental applications. 
With the introduction of stainless-steel wires, gold-alloys became obsolete 
due to their prohibitive expense and inferior material qualities.18 Stainless 
steel wires were superior in their higher resistance to corrosion, excellent 
work-hardening properties and low coefficient of friction, making them 
the orthodontic standard for decades. The most commonly used type is the 
austenitic 18-8 stainless steel, with chromium and nickel content of 18% 
and 8%, respectively.19 Their bracket-wire frictional properties are 
relatively low making them a gold standard wire for sliding mechanics. 
The coefficient of friction can be further reduced by application of 
nanotechnology, such as coating the wire with nickel-phosphorus 
electroless film impregnated with organic fullerene-like nanoparticles of 
tungsten disulfide.20 Stainless steel’s high resistance to corrosion can be 
attributed to the formation of a passivating oxide layer that forms on its 
surface and blocks oxygen diffusion to the underlying material. 
Contemporary commercially available stainless steel wires come in wide 
variety of elastic and yield strength related properties dependent on the 
different parameters utilized during production, such as freezing and 
incandescence during cold working.19 These wires are able to produce 

 
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higher forces during a shorter period of time due to their lesser spring back 
properties, thus storing less energy than nickel-titanium and beta-titanium 
wires.19 Biomechanical attachments are able to be soldered using a 
fastening agent to stainless steel via LASER or tungsten inert gas welding 
techniques.19  
Cobalt-chromium alloys were introduced in the 1960s originally for use as 
watch spring by ELGIU national company, but were quickly manufactured 
into orthodontic wires (Elgiloy) by the United States based company in 
Denver, CO; Rocky Mountain Co.19, 21 These wires shared similar 
properties with stainless-steel in their high stiffness, however they had the 
advantage of being heat treatable and available in different tempers. These 
tempers came in four varieties (usually color-coded) depending on how 
much cold work had been done during manufacturing.19 Yellow for the 
soft or ductile tempers, green for semi-spring temper and red for high 
spring tempers.19 These tempers permitted high bendability which allowed 
for the introduction of various loops, V-bends and offsets in the 
archwire.19, 21 Heat hardening at 482°C for seven minutes, allowed for 
increasing its hardness (strength) after its been shaped into the desired 
application.19 Wires which are not heat treated have a smaller spring-back 
than stainless steel wires.22 The popularity of these wires in clinical 
practice is due to their exceptional resistance to corrosion and tarnish, 
ability to be soldered/welded and inexpensive.19 
Beta-Titanium wires 
Further research and development with titanium alloys eventually yielded 
β-Titanium archwires with molybdenum. TMA (titanium-molybdenum 
alloy; Ormco CA, USA) was introduced in the 1980s for orthodontic 
purposes. Its material characteristics consist of high springiness, strength, 
good formability, welding capabilities, and ability to hold a bend, making 
them a brilliant choice for finishing archwires in later stages of edgewise 
orthodontic treatment.19, 21, 23 Krishnan et al28, investigated the welding 
joinability properties between stainless steel wires and beta-titanium 
wires, concluding that the latter had better joinability due to their higher 
resilience and surface / structural characteristics. Beta-titanium wires have 
corrosion resistance similar to cobalt-chromium and stainless steel wires, 
along with high biocompatibility due to lack of nickel.19 This surface 
resistance can be attributed to the formation of surface passivating 
oxidation layer.19 However, this wire also has limitations and is poorly 
suited for applications that require flexibility and high surface roughness 
produces excessive friction within the bracket contact hindering sliding 
mechanics.21  
Titanium-niobium (TiNb) alloy came into the market with the designation 
of being a new “finishing wire” from Sybron Dental Specialties Inc., 
Orange, CA, USA.29 This material is cryogenic in nature, with 
superconductivity properties that have been utilized in magnets and 
magnetic nuclear resonance imaging applications.30 The alloy’s elemental 

 
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composition consists of two out of five (Ti, Nb, Ta, Zr, and Pt) non-
hypersensitive elements Ti and Nb, yielding high biocompatibility. 
Furthermore, the material has excellent resistance to corrosion. Both of 
these qualities of corrosion resistance and biocompatibility attribute Ti-
Nb’s wide use in medicine, substituting as a reconstructive material in 
implant and orthopedic surgeries.30 Additional, this material has a low 
modulus of elasticity, making it ideal for distributing stresses between 
implants and bones.31 With the incorporation of niobium, the modulus of 
elasticity is further decreased and corrosion resistance is improved.30 This 
corrosion resistance can be attributed to Nb2O5 lining the surface layer, 
inhibiting the fluoride ion action responsible for immediate corrosion in 
the oral environment.30 Dalstra et al29, investigated the load-deflection 
behavior of TiNb wires compared to stainless steel both in torsional and 
bending applications. Their results demonstrated that TiNb stiffness in 
bending is ½ of SS, and torsional properties are 1/3rd of SS. Such results 
indicate that TiNb could be used for creative bends without generating 
excessive force levels present in stainless steel wires.29 Additionally, they 
showed that TiNb spring-back was 14% lower than that of SS, whereas in 
torsion it was the same if not higher in some situations. Furthermore, this 
wire is able to be welded, thus various wire dimensions can be joined 
together to produced different force systems.29   
Introduction of GUMMETAL  
In 2003 a new β-Titanium alloy was developed at the Metallurgy Research 
Section of Toyota Central R & D Labs., Inc., Japan, named GUMMETAL. 
Its composition consists of a body-centered cubic crystal structure with 
titanium (Ti), niobium (Nb), tantalum (Ta), and zirconium (Zr).21 
GUMMETAL’s elemental composition (Ti-36%Nb-2Ta-3Zr+O) produces 
properties with extensive applications, especially in orthodontic therapy. 
These elements are contained within the IVa and Va groups on the 
periodic table of elements. “The remarkable characteristics of this material 
arise due to the juxtaposition of three electronic magic numbers: 1) a 
compositional average valance number of 4.24 valance electrons per atom, 
2) a bond order (Bo value) of 2.87 based on the DV-x alpha cluster 
method, and 3) “d” electronic-orbital energy level (Md value) of 2.45 
eV”.32This alloy merges superelasticity with superplasticity at room 
temperature without work hardening side effects.33 Additionally, its 
Young’s modulus is extremely low (40 GPa), combined with 
exceptionally high tensile strength (1100 MPa) producing a material with 
characteristics previously thought impossible.23, 34 In comparison, SS has a 
young modulus of 200 GPa, CoCr at 170 GPa, NiTi at 105 GPa, and Beta-
Titanium alloys at 85 GPa.23 When looking at tensile strength in MPa, 
stainless steel is at 860 MPa, CoCr at 1000 MPa, NiTi at 700 MPa and 
Beta-titanium alloy at 860 MPa.23  
The main feature of this material is the ease to do plastic deformation 
without disrupting the crystalline structure along with lack of stress-

 
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induced transformations such as NiTi alloys, meaning it possesses true 
elastic deformation without hysteresis. Such material characteristics result 
in a metal that does not follow Hooke’s law, with behaviors curving to and 
from the yield point.23 Unlike SS, Co-Cr, and NiTi which all possess 
either Chromium or Nickel and have been known to have biocompatibility 
and toxicity issues, GUMMETAL’s elemental constituents are 
biocompatible.23  The frictional properties between wire and bracket 
interface is approximately half that of other titanium wires with 
appropriate surface treatment according to Toyota R&D department and 
Takada et al.32, 35 
Orthodontic archwire manufactured out of GUMMETAL appeared on the 
market in 2010 by Rocky Mountain Morita Corporation.33 The 
manufacturing process avoids high temperatures and alternatively utilizes 
cold-working for diluting and wire-drawing, which produces a marble-like 
microstructure that allows the wire to be plastically deformed without 
dislocating the crystals.21, 23 Orthodontic application for this new wire is 
appears promising when considering the properties of the inherent 
material and its possibilities in tooth movement. These wires are 
extremely flexible, and super-elastic, they are able to bend with ease and 
hold that bend, there is an equal loading and unloading force without 
hysteresis (allowing for controlled orthodontic force), not susceptible to 
work hardening (intraoral breakage is rare), free of any toxic elements 
(nickel and heavy metals), generates half the friction of other titanium 
alloys and possess exceptional tensile strength.21 Until GUMMETAL, 
there was no ideal orthodontic wire with all of these characteristics, 
various wire sizes and types were used for different purposes during 
treatment (NiTi for leveling and aligning and SS/TMA for finishing and 
detailing).  
Given the low Young’s modulus, high deformation intraorally to a round 
or even a rectangular wire would produce a small force. Such small forces 
would be appropriate in early stages of treating crowded teeth. Shorter 
duration of treatment could be possible if rectangular GUMMETAL wires 
are able to be used earlier in treatment due to the high elasticity, since 
torque control could be initiated much earlier.21 Thus, the ability to control 
teeth in 3-Dimensions is very possible with GUMMETAL, since it can be 
used in all stages of active treatment, reducing treatment duration and 
office visits.21  
Current research has investigated GUMMETAL wires compared to NiTi 
wires in their effectiveness as an initial archwire in aligning teeth, 
concluding that GUMMETAL is an adequate alternative to NiTi for the 
initial orthodontic treatment.27 No research studies have been published 
regarding space closure utilizing GUMMETAL for canine retraction. 
Likewise, there is no published studies on the use of preformed 
GUMMETAL loop archwires or sliding mechanics for space closure. 
When considering loop space closure mechanics, it is important that the 

 
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archwire have high tensile strength, be able to deflect and produce light 
continuous forces during the retraction phase of treatment. Given 
GUMMETAL’s high tensile strength (1000-1100MPa), ease of 
formability and low load/deflection ratio, makes them an ideal candidate 
for complex loop configurations.12  
Properties of GUMMETAL and statement of the problem 
GUMMETAL’s non-linear superelastic properties allow for equal loading 
and unloading force delivery without any energy loss. Its ductility is 10 
times greater than conventional metals making it super-plastic and ideal 
for forming and bending. Additionally, it doesn’t experience work 
hardening during processing making it strong and durable, with little risk 
of intraoral breakage.21 Regarding friction based sliding mechanics, 
GUMMETAL’s friction properties have only been scarcely investigated. 
Some researchers21, 32 have claimed that its friction coefficient is low and 
it is therefore adequate for sliding mechanics. However, they compared 
GUMMETAL to other titanium wires, stating that the frictional coefficient 
is half for GUMMETAL depending on the surface treatment.21, 32 The 
potential for this wire to become a transitional archwire for final leveling 
and aligning and then utilized for space closure is high. Thus, it could 
have benefit to clinicians in areas of cost effectiveness with reduced need 
for multiple types of wires and potentially efficiency of treatment. Both, 
In-vitro and clinical studies are needed to understand the effects of 
GUMMETAL wires for space closure using both friction sliding 
mechanics and frictionless closing loops mechanics.  
2) PURPOSE OF THE RESEARCH 
Orthodontic biomaterials are continuously going through research and 
development, in hopes of producing an archwire that marries the 
properties of NiTi and SS.  
GUMMETAL’s introduction to the orthodontic field is relatively short. 
Limited research has been published regarding this wire and its 
application. Literature has shown that it is comparable to NiTi in the initial 
early stages of leveling and aligning and relieving crowding, in addition to 
having advantages over NiTi with its formability and lack of 
immunogenicity.27 No current publications have investigated the effects of 
GUMMETAL wires on maxillary canine retraction with sliding 
mechanics.   
The purpose of this study is to investigate the effects of GUMMETAL 
wire on space closure using sliding mechanics. Furthermore, no studies 
have compared GUMMETAL sliding mechanics to that of Stainless Steel, 
which has remained a gold standard. Evaluation of 3D tooth control by 
GUMMETAL remains to be investigated.  
5.2 Include complete citations or references.  
Response:  
 

 
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1. 
Schneider PP, Kim KB, da Costa Monini A, Dos Santos-Pinto A, 
Gandini LGJ. Which one closes extraction spaces faster: en masse 
retraction or two-step retraction? A randomized prospective clinical trial. 
Angle Orthod 2019;89(6):855-61. 
2. 
Ribeiro GL, Jacob HB. Understanding the basis of space closure 
in Orthodontics for a more efficient orthodontic treatment. Dental Press J 
Orthod 2016;21(2):115-25. 
3. 
Redlich M, Mayer Y, Harari D, Lewinstein I. In vitro study of 
frictional forces during sliding mechanics of “reduced-friction” brackets. 
American Journal of Orthodontics and Dentofacial Orthopedics 
2003;124(1):69-73. 
4. 
Besançon RM, Willis J. Encyclopedia of Physics, 3rd Edition. The 
Physics Teacher 1985;23(6):386-86. 
5. 
Sekhar JA. Tunable coefficient of friction with surface texturing in 
materials engineering and biological systems. Current Opinion in 
Chemical Engineering 2018;19:94-106. 
6. 
Shames IH, Fung YC. Engineering Mechanics. Journal of 
Biomechanical Engineering 1981;103(1):58-58. 
7. 
Kojima Y, Fukui H. Numeric simulations of en-masse space 
closure with sliding mechanics. Am J Orthod Dentofacial Orthop 
2010;138(6):702 e1-6; discussion 02-4. 
8. 
Southard TE, Marshall SD, Grosland NM. Friction does not 
increase anchorage loading. Am J Orthod Dentofacial Orthop 
2007;131(3):412-4. 
9. 
Kapila S, Angolkar PV, Duncanson MG, Nanda RS. Evaluation of 
friction between edgewise stainless steel brackets and orthodontic wires of 
four alloys. American Journal of Orthodontics and Dentofacial 
Orthopedics 1990;98(2):117-26. 
10. 
Charles J. Burstone RJS. Mechanics of tooth movement. American 
Journal of Orthodontics 1984;85(4):294-307. 
11. 
Kuhlberg AJ, Priebe DN. Space closure and anchorage control. 
Seminars in Orthodontics 2001;7(1):42-49. 
12. 
Miceli Beck Guimaraes Blaya GHW, Magali Beck Guimaraes, 
Luciana Mayumi Hirakata. Evaluation of tensile strength of different 
configurations of orthodontic retraction loops for obtaining optimized 
forces. Stomatologija, Baltic Dental and Maxillofacial Journal 
2009;11(2):66-69. 
13. 
Techalertpaisarn P, Versluis A. How do mechanical responses at 
closing loop ends vary when loop position changes? A systematic analysis 
of vertical, T-, and L-loops. Oral Science International 2013;10(2):58-64. 

 
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14. 
Frederik A. Booth J. Optimum Forces with Orthodontic Loops 
[Houston, Texas: The University of Texas Dental Branch at Houson; 
1971. 
15. 
William R. Proffit HWF, JR., Brent E. Larson, David M. Sarver. 
Contemporary Orthodontics 6th ed. Philadelphia, PA: Elsevier 2019. 
16. 
Saitowski RE. Continuous arch wire closing loop design, 
optimization, and verification. Part II. American Journal of Orthodontic 
and Dentofacial Orthopedics 1997;112(5):487-95. 
17. 
Andrew J. Kuhlberg CJB. T-loop position and anchorage control. 
American Journal of Orthodontic and Dentofacial Orthopedics 
1997;112(1):12-18. 
18. 
Keng FY, Quick AN, Swain MV, Herbison P. A comparison of 
space closure rates between preactivated nickel-titanium and titanium-
molybdenum alloy T-loops: a randomized controlled clinical trial. Eur J 
Orthod 2012;34(1):33-8. 
19. 
Kotha RS, Alla RK, Shammas M, Ravi RK. An overview of 
orthodontic wires. Trends in Biomaterials and Artificial Organs 
2014;28(1):32. 
20. 
Redlich M, Katz A, Rapoport L, et al. Improved orthodontic 
stainless steel wires coated with inorganic fullerene-like nanoparticles of 
WS(2) impregnated in electroless nickel-phosphorous film. Dent Mater 
2008;24(12):1640-6. 
21. 
Chang HP, Tseng YC. A novel beta-titanium alloy orthodontic 
wire. Kaohsiung J Med Sci 2018;34(4):202-06. 
22. 
Ingram SB, Jr., Gipe DP, Smith RJ. Comparative range of 
orthodontic wires. American Journal of Orthodontics and Dentofacial 
Orthopedics 1986;90(4):296-307. 
23. 
Hasegawa S. A new super elasto-plastic Ti alloy GUMMETAL-
simplyfing treatment procedure, Clinical use of GUMMETAL. Tokyo, 
Japan: Hannah Orthodontics p. 8. 
24. 
Gioka C, Eliades T. Superelasticity of nickel-titanium orthodontic 
archwires: metallurgical structure and clinical importance. Hel Orthod 
Rev 2002;5:111-27. 
25. 
Meling TR, Odegaard J. The effect of short-term temperature 
changes on superelastic nickel-titanium archwires activated in 
orthodontic bending. Am J Orthod Dentofacial Orthop 2001;119(3):263-
73. 
26. 
Burstone CJ, Qin B, Morton JY. Chinese NiTi wire—a new 
orthodontic alloy. American journal of orthodontics 1985;87(6):445-52. 
27. 
Nordstrom B, Shoji T, Anderson WC, et al. Comparison of changes 
in irregularity and transverse width with nickel-titanium and niobium-

 
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titanium-tantalum-zirconium archwires during initial orthodontic 
alignment in adolescents: A double-blind randomized clinical trial. Angle 
Orthod 2018;88(3):348-54. 
28. 
Krishnan V, Kumar KJ. Weld characteristics of orthodontic 
archwire materials. The Angle orthodontist 2004;74(4):533. 
29. 
Dalstra M, Denes G, Melsen B. Titanium‐niobium, a new finishing 
wire alloy. Clinical Orthodontics and Research 2000;3(1):6-14. 
30. 
Ilievska I, Karashanova D, Petrunov V, et al. Characterization of 
titanium–niobium orthodontic archwires used in orthodontic treatment. 
Bulgarian Chemical Communications 2016;48:183-87. 
31. 
Li Y, Yang C, Zhao H, et al. New developments of Ti-based alloys 
for biomedical applications. Materials 2014;7(3):1709-800. 
32. 
Hasegawa S. A Concept of En Bloc Movement of Teeth Using 
Gummetal Wire: Quintessence Publishing Company; 2014. 
33. 
Sato ASaS. Orthodontic Treatment of Malocclusion (using the 
GEAW system). Recontructing a functional occlusion. Tokyo, Japan: 
Kanagawa Dental Unviversity; 2014. p. 16. 
34. 
Gordin DM, Ion R, Vasilescu C, et al. Potentiality of the "Gum 
Metal" titanium-based alloy for biomedical applications. Mater Sci Eng C 
Mater Biol Appl 2014;44:362-70. 
35. 
Takada M, Nakajima A, Kuroda S, et al. In vitro evaluation of 
frictional force of a novel elastic bendable orthodontic wire. Angle Orthod 
2018;88(5):602-10. 
36. 
El-Timamy A, El Sharaby F, Eid F, et al. Effect of platelet-rich 
plasma on the rate of orthodontic tooth movement: A split-mouth 
randomized trial. Angle Orthod 2020. 
 
6.0 Study Design* 
6.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response: This will be a randomized pilot split-mouth clinical trial of 
patients with spaces ≥ 3mm distal to the maxillary canines in need of 
closure through sliding mechanics. The sample consists of adolescent 
patients regardless of Angle’s molar malocclusion who are receiving 
comprehensive full fixed appliance orthodontic treatment. Preformed 
conjoint archwires half being GUMMETAL and the other half SS, will be 
utilized. Each patient will have one side of the maxilla randomly allocated 
into the SS or GUMMETAL treatment group. The study will follow a 
split-mouth design to reduce the confounding variables from patient to 
patient on space closure mechanics. The maxillary arch in each subject 
will be randomized into a SS side or GM side using a random number 

 
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generator. Spaces will be measured at; T0 is initial records, T1 is initiation 
of space closure, T2 will be 4 weeks after the initiation of space closure, 
T3 is another 4 weeks of space closure evaluation and T4 will be the final 
evaluation of space closure after 4 weeks from T3, via 3D intraoral scans 
of maxillary arches. Space measurement and calculations will utilize 
3Shape software to measure the distance of canine movement based off 
the distal surface. Sliding mechanics will be activated through NiTi coil 
springs from the maxillary canines to the maxillary molars. The force will 
be standardized to 150 gms and will be measured each visit. The same 
provider will activate the NiTi coil spring for retraction, along with data 
collection. Superimposition of scans will be utilized to assess outcome 
measures. 
 
7.0 
Study Intervention/Investigational Agent 
1.1 Description: Describe the study intervention and/or investigational 
agent (e.g., drug, device) that is being evaluated. 
Response: Orthodontic archwire of rectangular shape with dimensions of 0.016 x 
0.022” and the following composition TiNbTaZr (GUMMETAL). Its reported 
properties include: non-linear superelasticity, ductility of 10x that of conventional 
metals, lack of work-hardening, extremely low modulus of elasticity (40 GPa), 
high tensile strength (1100 MPa), low friction, high springback without hysteresis 
and biocompatibility.  
 
7.1 Drug/Device Handling: If the research involves drugs or device, 
describe your plans to store, handle, and administer those drugs or 
devices so that they will be used only on subjects and be used only by 
authorized investigators. 
• 
If the control of the drugs or devices used in this protocol will 
be accomplished by following an established, approved 
organizational SOP (e.g., Research Pharmacy SOP for the 
Control of Investigational Drugs, etc.), please reference that 
SOP in this section. 
Response: N/A  
 
8.0 Local Number of Subjects 
8.1 Indicate the total number of subjects that will be enrolled or records that 
will be reviewed locally. 
Response: 16 patients 
 

 
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8.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response: 60-70 patients  
 
8.3 Justify the feasibility of recruiting the proposed number of eligible subjects 
within the anticipated recruitment period. For example, how many potential 
subjects do you have access to? What percentage of those potential subjects 
do you need to recruit? 
Response: We will be collaborating with the entire patient pool in our orthodontic 
residency clinic for the first- and second-year residents. Research examiner will 
instruct residents doing patient screenings and acceptance of patients on criteria 
necessary to become a subject in the current study. Research examiner will then 
evaluate all eligible subjects and see if they meet all inclusion criteria and proceed 
to inform the subjects of their eligibility and purpose of the study. Each resident 
can screen approximately 20-30 patients in the course of 2-3 months. If we utilize 
the patient pools of twelve residents, we can approximate 240 patients total of 
which the study needs only 6.67% of to get 16 subjects.  
 
9.0 Inclusion and Exclusion Criteria* 
9.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE:  This may be done in bullet point fashion. 
Response:  
• Adolescents of both gender (12-17Y11M),  
• undergoing orthodontics treatment with full fixed appliances,  
• good oral hygiene / health,  
• with bilateral spaces 3 ≥ mm distal to the maxillary permanent canines,  
• normal and hypodivergent growth patterns. 
9.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
Response:   
• Systemic diseases or syndromes,  
• abnormalities in tooth shape and/or size,  
• previous orthodontic treatment,  
• medications that can affect the outcome of the study,  

 
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• craniofacial anomalies,  
• periodontal disease or attachment loss,  
• significant root resorption prior to or during the study (more than 1/3rd root 
length). 
• Patients with known allergy to nickel 
9.3 Indicate specifically whether you will include any of the following special 
populations in your study using the checkboxes below.   
 
NOTE:  Members of special populations may not be targeted for enrollment in 
your study unless you indicate this in your inclusion criteria. 
Response:   
☐ 
Adults unable to consent 
☒ 
Individuals who are not yet adults (infants, children, teenagers) 
☐ 
Pregnant women 
☐ 
Prisoners 
 
9.4 Indicate whether you will include non-English speaking individuals in your 
study.  Provide justification if you will exclude non-English speaking 
individuals.  
In order to meet one of the primary ethical principles of equitable selection 
of subjects, non-English speaking individuals may not be routinely excluded 
from research as a matter of convenience. 
In cases where the research is of therapeutic intent or is designed to 
investigate areas that would necessarily require certain populations who 
may not speak English, the researcher is required to make efforts to recruit 
and include non-English speaking individuals.  However, there are studies 
in which it would be reasonable to limit subjects to those who speak 
English.  Some examples include pilot studies, small unfunded studies with 
validated instruments not available in other languages, studies with 
numerous questionnaires, and some non-therapeutic studies which offer no 
direct benefit. 
Response: We will not be including Non-English-speaking subjects. All of the 
treatment is available as Standard of Care and no potential benefits would be 
inequitably withheld from Non-English-speakers.  
 
10.0 
Vulnerable Populations* 
If the research involves special populations that are considered vulnerable, 
describe the safeguards included to protect their rights and welfare.   

 
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NOTE: You should refer to the appropriate checklists, referenced below, to ensure you 
have provided adequate detail regarding safeguards and protections. You do not, 
however, need to provide these checklists to the IRB. 
10.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: 
  
☒ 
N/A:  This research does not involve pregnant women. 
10.2 For research that involves neonates of uncertain viability or non-viable 
neonates, safeguards include: 
NOTE CHECKLISTS: Non-Viable Neonates (HRP-413), or Neonates of Uncertain 
Viability (HRP-414) 
Response:  
 
☒ 
N/A:  This research does not involve non-viable neonates or neonates of 
uncertain viability. 
10.3 For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
 
☒ 
N/A:  This research does not involve prisoners. 
10.4 For research that involves persons who have not attained the legal age for 
consent to treatments or procedures involved in the research (“children”), 
safeguards include:   
NOTE CHECKLIST: Children (HRP-416) 
Response:  
• Adequate provisions will be made for soliciting the permission of parents 
or guardians  
• Adequate provisions will be made for soliciting the assent of the children  
• No greater than minimal risk to children will be present  
• Permission is to be obtained from one of the parents  
 
☐ 
N/A:  This research does not involve persons who have not attained the 
legal age for consent to treatments or procedures (“children”). 
10.5 For research that involves cognitively impaired adults, safeguards include: 
NOTE CHECKLIST: Cognitively Impaired Adults (HRP-417) 
Response:  
 

 
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☒ 
N/A:  This research does not involve cognitively impaired adults. 
10.6 Consider if other specifically targeted populations such as students, 
employees of a specific firm, or educationally or economically 
disadvantaged persons are vulnerable.  Provide information regarding 
their safeguards and protections, including safeguards to eliminate 
coercion or undue influence. 
Response: We are not specifically targeting a vulnerable group  
 
11.0 
Eligibility Screening* 
11.1 Describe screening procedures for determining subjects’ eligibility.  
Screening refers to determining if prospective participants meet inclusion and 
exclusion criteria.  
Include all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaire).  
Response:  Patients will arrive to the clinic for a standard clinic screening 
appointment. Patient eligibility will be reviewed in the EMR after the intake 
appointment.  Once the treating resident and supervising faculty have diagnosed 
and treatment planned the case, the supervising research resident will be notified. 
The research resident will communicate with the treating resident about the 
patient’s diagnosis and proposed treatment plan prior to the patient’s consultation. 
Eligibility of patients to the research will be decided from the diagnostic data and 
proposed treatment plan. If the individual has a treatment plan that meets 
eligibility criteria, they will be considered as eligible subjects.  
 
☐ 
N/A:  There is no screening as part of this protocol. 
12.0 
Recruitment Methods 
☐ 
N/A:  This is a records review only, and subjects will not be 
recruited.  NOTE:  If you select this option, please make sure that 
all records review procedures and inclusion/exclusion screening 
are adequately described in other sections. 
12.1 Describe when, where, and how potential subjects will be recruited.  
NOTE:  Recruitment refers to how you are identifying potential participants and 
introducing them to the study.  Include specific methods you will use (e.g. 
searching charts for specific ICD code numbers, Research Participant Groups, 
posted advertisements, etc.). 
Response: they  
There will not be any recruitment materials utilized in this research study.   Once 
the patient is deemed eligible per the procedures in 11.1, the supervising 
researcher will be present during the treating resident’s standard clinic 
consultation with the patient. During the consultation the researcher will introduce 

 
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the research study and explain all aspects / what to expect if they were to consent 
to participate. All consent and study paperwork will be present during the 
consultation for the patient to review, ask questions and sign if they consent.   
 
12.2 Describe how you will protect the privacy interests of prospective subjects 
during the recruitment process.   
NOTE:  Privacy refers to an individual’s right to control access to him or herself.   
Response: Patients will be invited to participate in the current study in an separate 
room away from other patients, during their standard clinic consultation visit.    
 
12.3 Identify any materials that will be used to recruit subjects.  
NOTE:  Examples include scripts for telephone calls, in person announcements / 
presentations, email invitations.  
For advertisements, include the final copy of printed advertisements with your 
submission. When advertisements are taped for broadcast, attach the final 
audio/video tape.  NOTE:  You may submit the wording of the advertisement prior 
to taping to ensure there will be no IRB-required revisions, provided the IRB also 
reviews and approves the final version. 
 Response: N/A  
 
13.0 
Procedures Involved* 
13.1 Provide a description of all research procedures or activities being 
performed and when they are performed once a subject is screened and 
determined to be eligible. Provide as much detail as possible.   
NOTE:  This should serve as a blueprint for your study and include enough detail 
so that another investigator could pick up your protocol and replicate the research.  
For studies that have multiple or complex visits or procedures, consider the 
addition of a schedule of events table in in your response. 
Response: Once the subject has been screened and been deemed eligible to participate in 
the study the following procedures will take place.  
Standard of Care: 
• Conventional Full Fixed appliances will be bonded to all permanent teeth (either 
0.018” or 0.022” MBT prescription brackets), the maxillary canine bracket 
prescription will be 0.018” MBT (0.018” straight wire brackets MBT; 3M Oral 
Care, St. Paul, MN, USA) 
• Phase of leveling and aligning will proceed through standard archwire 
progression, until 0.016 x 0.022” sized wire is able to be engaged. 

 
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• Sliding mechanics of canine retraction utilizing NiTi Closed Coil Springs to 
produce 150g of retraction force, utilizing the first molars and premolars as 
anchoring units.  
• Correx Orthodontic Gauge will be utilized to verify 150g of force generation.  
Research: 
• A split mouth design will be utilized per patient, randomly assigning the upper 
left and right sides of the maxilla, through a random number generator.  
• Split archwire design will utilize a crimpable binding mechanism to allow for 
joining of the SS and GUMMETAL wires together dividing at the junction of the 
maxillary central incisors.  
• Patient’s occlusion will be discluded to prevent interferences prior to retraction 
mechanics utilizing bite-turbos on the buccal inclines of the palatal cusps of the 
maxillary first molars.  
• Intraoral scan will be taken utilizing an iTero intraoral scanner prior to beginning 
retracting mechanics on the upper canines (this will be timepoint T0).  
o Appointment date, patient name, age, sex and position of Canine T0 will 
be collected into the data sheet. 
• If there is a need for absolute anchorage, miniscrews will be utilized on a per case 
basis.  
• T1 will begin canine retraction on both side of the maxillary arch. 
o Intraoral scan will be done 
o Data collection will be done: appointment date, patient name, position of 
Canine T1  
• Each activation of the NiTi Closed Coil spring will be performed by the research 
examiner. 
• After four weeks the patient will return for an adjustment visit: 
o Intraoral scan will be done 
o Data collection will be done: appointment date, patient name, position of 
Canine T2  
o Reactivation of retraction coil will be done  
• After another four weeks the patient will return for an adjustment visit: 
o Intraoral scan and data collection will be done  
o This will mark T3 and reactivation of the retraction coil will be done by 
the research examiner.  
• Final four weeks of retraction the patient will return for an adjustment visit: 
o Final intraoral scan, intraoral photographs, radiographs and data collection 
will be done marking T4 of data collection.  
• There will be no more data collection following the T4 data collection point. The 
patient will continue orthodontic treatment per the treating resident’s treatment 
plan agreed upon during the consultation.  

 
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• Data analysis will be performed by the researcher and statistician from the data 
collected from the patient.  
o Four consecutive digital models will be superimposed using 3-Shape 
analyzer software. Color-coded superimposition will be performed to 
verify the accuracy and precision of the superimposition.  
o To evaluate rate of canine retraction, total retraction distance and 3D tooth 
control, will be measured through the superimposition models 
• Canine movement rate (mm/month) and total retraction distance (mm) will be 
assessed for the patient based on the position of the canine starting at T0 to T4.  
 
13.2 Describe what data will be collected.   
NOTE:  For studies with multiple data collection points or long-term follow up, 
consider the addition of a schedule or table in your response. 
Response:  
• Demographic (patient name, age, sex) 
• Canine Retraction Rate (mm/month) 
• Position of Canine T0-T4  
• Total retraction distance (mm)  
13.3 List any instruments or measurement tools used to collect data 
(e.g. questionnaire, interview guide, validated instrument, data collection 
form).   
 
Include copies of these documents with your submission. 
Response: Data collection spreadsheet is uploaded in Click. Intraoral 3D scans of 
the upper arch via iTero scanner 
13.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
Response: Patient data will be pulled from the University at Buffalo 
School of Dental Medicine EMR database as well as the Orthodontic 
Department at the SDM record systems. Systems used are: 
• 
Dolphin (used for imaging storage: photographs and radiographs) 
• 
OrthoCad (used for 3D model storage) 
• 
AXIUM – (medical, dental and treatment history database – EMR 
software) 
 
13.5 Indicate whether or not individual subject results, such as results of 
investigational diagnostic tests, genetic tests, or incidental findings will be 

 
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shared with subjects or others (e.g., the subject’s primary care physician) 
and if so, describe how these will be shared. 
Response: If there are any clinical findings relating to the subject’s dental health 
will be shared with the subject and guardian and will also be notified to their 
primary care provider when necessary, as per SOC protocols. If any anecdotal 
findings arise, they will be mentioned to the subject and guardians as well.  
 
13.6 Indicate whether or not study results will be shared with subjects or others, 
and if so, describe how these will be shared. 
Response: If the subjects wish to know the results of the study they will be 
notified in person once all data results have been calculated and analyzed. 
Aggregated study results can potentially be presented at conferences and / or 
published in journal articles.  
 
14.0 
Study Timelines* 
14.1 Describe the anticipated duration needed to enroll all study subjects. 
Response: 6 months (from screening to recruitment into the study)  
 
14.2 Describe the duration of an individual subject’s participation in the study. 
Include length of study visits, and overall study follow-up time. 
Response: The study will last during a specific portion of the patient’s treatment; 
it will finish before the patient’s treatment has been completed. They will have 
followed up visits to finish their orthodontic treatment. The full duration of the 
study will be four months. Initial records will be collected at T0. T1 will be the 
beginning of study, with adjustment and data collection happening every four 
weeks. Final records will be collected at T4.  
 
14.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected and all analyses have been completed). 
Response: 14 months  
 
15.0 
Setting 
15.1 Describe all facilities/sites where you will be conducting research 
procedures.  Include a description of the security and privacy of the 
facilities (e.g. locked facility, limited access, privacy barriers).  Facility, 
department, and type of room are relevant.  Do not abbreviate facility 
names.   

 
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NOTE:  Examples of acceptable response may be: “A classroom setting in the 
Department of Psychology equipped with a computer with relevant survey 
administration software,” “The angiogram suite at Buffalo General Medical 
Center, a fully accredited tertiary care institution within New York State with 
badge access,” or, “Community Center meeting hall.” 
Response: The facility where the study will be conducted is the Orthodontics 
Department at the University at Buffalo School of Dental Medicine. The facility 
has individual operatories (twenty total) for residents to administer orthodontic 
treatment. Each operatory is equipped with all standard of care equipment and 
necessary tools to treat patients in full orthodontic capacity. The entire facility and 
all of the computer systems are equipped with encrypted login devices connected 
to each operatory computer. Each computer can only be accessed via university 
issued identification badges, once activated each individual has to input their 
credentials to access our patient management software, AXIUM. Orthodontic 
department patients can only be viewed by faculty, staff and residents in the 
department, all others are restricted from accessing. Patient electronic health 
records along with schedules are not left open while treating patients to avoid any 
neighboring patients view of other’s personal information. The computers after 
thirty minutes of idle will automatically log the individual off for security 
purposes. Any input to the patient’s electronic health record, notes, diagnostic 
codes, treatment plans, etc., have to fully be reviewed by the supervising faculty 
prior to dismissal of the patient.  The facility is restricted to faculty, staff and 
residents of the Orthodontic Department. No other individuals have access to the 
facility, and patients are only allowed to enter accompanied by resident or faculty 
during appropriate clinic operating hours and supervision. The facility is 
otherwise locked outside of clinic hours and restricted only to the custodian staff 
overnight and on the weekends. Our intraoral 3D scanner has its own operatory in 
a designated corner of the facility with appropriate barriers and positioning of the 
iTero scanner to prevent disclosure of private sensitive information to those 
around. There is a designated computer laboratory for residents and faculty to 
work on research projects, data analysis, treatment planning, and for educational 
purposes. Only a certain amount of people is allowed in the room and there is 
spacing between individual computers so that there is adequate space between 
users. The same security measures are present for the computers in the laboratory 
as in the operatories.  
15.2 For research conducted outside of UB and its affiliates, describe: 
• Site-specific regulations or customs affecting the research 
• Local scientific and ethical review structure 
NOTE:  This question is referring to UB affiliated research taking place outside 
UB, i.e. research conducted in the community, school-based research, 
international research, etc.  It is not referring to multi-site research.  UB affiliated 
institutions include Kaleida Health, ECMC, and Roswell Park Cancer Institute.   
Response:  

 
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☒ 
N/A:  This study is not conducted outside of UB or its affiliates. 
16.0 
Community-Based Participatory Research 
16.1 Describe involvement of the community in the design and conduct of the 
research.  
NOTE:  Community-Based Participatory Research (CBPR) is a collaborative 
approach to research that equitably involves all partners in the research process 
and recognizes the unique strengths that each brings.  CBPR begins with a 
research topic of importance to the community, has the aim of combining 
knowledge with action and achieving social change to improve health outcomes 
and eliminate health disparities. 
Response:  
 
☒ 
N/A:  This study does not utilize CBPR. 
16.2 
Describe the composition and involvement of a community advisory 
board. 
Response:  
 
☒ 
N/A:  This study does not have a community advisory board. 
17.0 
Resources and Qualifications 
17.1 Describe the qualifications (e.g., education, training, experience, expertise, 
or certifications) of the Principal Investigator and staff to perform the 
research.  When applicable describe their knowledge of the local study sites, 
culture, and society.  Provide enough information to convince the IRB that 
you have qualified staff for the proposed research.  
NOTE:  If you specify a person by name, a change to that person will require prior 
approval by the IRB.  If you specify a person by role (e.g., coordinator, research 
assistant, co-investigator, or pharmacist), a change to that person will not usually 
require prior approval by the IRB, provided that the person meets the 
qualifications described to fulfill their roles. 
Response:  
Principle Investigator: Dr. Lubomyr Ravlyk. PGY2 Orthodontic Resident at 
University at Buffalo School of Dental Medicine. Completed his DDS training at 
University at Buffalo School of Dental Medicine, 2019. Completed his Bachelors 
in Science from St. John Fisher College, 2015. While at St. John Fisher, worked 
on two different research projects, one involving Organic Chemistry and various 
catalysts to increase product yield, and the other working with C. elegans 
nematode and fluorescent microscopy to determine effects of gene mutations that 
are analogous to cilia mutations in humans. His previous research experience will 
be advantageous to this current study along with his dental knowledge and 

 
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continuing orthodontic training / experience. Has been living in the local area for 
most of his life and is very familiar with the local culture and society.  
Supervising the Investigator: Dr. Thikriat Al-Jewair.  Dr. Thikriat Al-
Jewair is the Associate Professor and Director of the Advanced Education 
Program in Orthodontics Department of Orthodontics. In addition to her 
accomplishments in Orthodontics, Dr. Al-Jewair, has several Masters 
degrees in the fields of Business administrations, Dental Public Health, 
and Orthodontics. She also has a Certificate in Clinical Research from 
Harvard Medical School. She is a Diplomate of the American Board of 
Orthodontics and a Fellow of the Royal College of Dentists of Canada in 
both Orthodontics and Dental Public Health. Dr. Al-Jewair is the author or 
co-author of over 50 publications. She mentored over 40 MS and 
professional students and has completed multiple prospective and 
retrospective clinical studies prior to this project.  
 
Describe other resources available to conduct the research.  
17.2 Describe the time and effort that the Principal Investigator and research 
staff will devote to conducting and completing the research. 
NOTE:  Examples include the percentage of Full Time Equivalents (FTE), hours 
per week.  The question will elicit whether there are appropriate resources to 
conduct the research. 
Response: The time that will be allotted to research will be equivalent to 8 FTE 
hours per week. This time will be utilized to: 
• Develop the appropriate archwire system to facilitate a split mouth design 
with the intervention and control group  
• Collect, store and organize all records and data for each subject  
• Perform necessary orthodontic adjustments for each patient  
• Analyze data collected and work on the statistical analysis 
 
17.3 Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the human research, if 
applicable. 
NOTE:  One example includes: on-call availability of a counselor or psychologist 
for a study that screens subjects for depression. 
Response: The design of the study maintains minimal risk given that the 
orthodontic treatment is routine and there will not be a substantial increase in risk. 
All patients will have access to all resources they might need. If there are 
questions or concerns, they will have the Orthodontic department’s emergency 
hotline, which will be able to route them to the appropriate individual that can 
help them. There are emergency procedures in place as well which they can 
access if necessary, during any time in the treatment. If the patient experiences 

 
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any psychological issues there are resources available which can easily be 
accessed. 
 
17.4 Describe your process to ensure that all persons assisting with the research 
are adequately informed about the protocol, the research procedures, and 
their duties and functions. 
Response: The entire protocol will be available in hard copy and electronic copy 
for anyone who will be involved in the research study. A streamlined version of 
the protocol will also be available for all who will be involved. There will be a 
presentation before patient recruitment commences to ensure that everyone who is 
involved can ask any questions and understands the workflow of the protocol. 
During this presentation, the duties and responsibilities of those who are involved 
will be explained and addressed.  
18.0 
Other Approvals 
18.1 Describe any approvals that will be obtained prior to commencing the 
research (e.g., school, external site, funding agency, laboratory, radiation 
safety, or biosafety). 
Response:  
 
☒ 
N/A:  This study does not require any other approvals. 
19.0 
Provisions to Protect the Privacy Interests of Subjects 
19.1 Describe how you will protect subjects’ privacy interests during the course 
of this research. 
NOTE:  Privacy refers to an individual’s right to control access to him or herself.  
Privacy applies to the person.  Confidentiality refers to how data collected about 
individuals for the research will be protected by the researcher from release.  
Confidentiality applies to the data.   
Examples of appropriate responses include:  “participant only meets with a study 
coordinator in a classroom setting where no one can overhear”, or “the 
participant is reminded that they are free to refuse to answer any questions that 
they do not feel comfortable answering.”   
Response: All participants will be communicated to in a private office enclosed 
setting where there will be no one else to overhear what is discussed. The 
participants will only be meeting with research examiner and supervising faculty. 
The participants at any point are free to refuse treatment and anything during 
treatment that they do not feel comfortable with and leave the study at their own 
discretion.  
19.2 Indicate how the research team is permitted to access any sources of 
information about the subjects.   

 
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NOTE:  Examples of appropriate responses include:  school permission for review 
of records, consent of the subject, HIPAA waiver.  This question does apply to 
records reviews. 
Response:   Patients will be screened for eligibility for the study, after they have 
been diagnosed in clinic and treatment planned. We will be utilizing a partial 
HIPAA Waiver (HRP-611) for the purposes of pre-screening records. Once they 
have agreed to enroll, children will sign an assent form and their parents will sign 
an informed consent with HIPAA Authorization. 
 
20.0 
Data Management and Analysis* 
20.1 Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
Response: Statistical analysis will be performed using the Statistical Package for 
the Social Sciences (SPSS). To assess normality of all quantitative variable 
distributions the Shapiro-Wilk Test will be utilized. To evaluate statistical 
significance in the difference between experimental and control groups for 
preoperative and postoperative measurements, a paired t-test will be used36.  The 
level of significance will be set to p ≤ 0.05 and to assess inter- and intraobserver 
reliability the intraclass correlation coefficients were obtained. 
 
20.2 If applicable, provide a power analysis.   
NOTE:  This may not apply to certain types of studies, including chart/records 
reviews, survey studies, or observational studies.  This question is asked to elicit 
whether the investigator has an adequate sample size to achieve the study 
objectives and justify a conclusion.  
Response: Sample size estimation: Based on a power of 80% and a significance 
level of 0.05, it was determined that a sample of size of 16 would be sufficient to 
detect a difference of 0.5mm or greater. 
 
20.3 Describe any procedures that will be used for quality control of collected 
data. 
Response: The research examiner and supervisors will be ensuring that the data is 
good quality and is adequate for analysis. All patient records and data will be 
encrypted, deidentified and properly stored and secured on our computer network.  
 
21.0 
Provisions to Monitor the Data to Ensure the Safety of 
Subjects* 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
 

 
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NOTE:  Minimal risk studies may be required to monitor subject safety if the research 
procedures include procedures that present unique risks to subjects that require 
monitoring.  Some examples include:  exercising to exertion, or instruments that elicit 
suicidality or substance abuse behavior.  In such cases, N/A is not an acceptable 
response. 
 
21.1 Describe the plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 
Response: This study is of minimal risk. Patients’ treatment notes will be 
reviewed after each visit to ensure safety per SOC. 
 
21.2 Describe what data are reviewed, including safety data, untoward events, 
and efficacy data. 
Response: Efficacy data: canine retraction amount and monthly rate 
 
21.3 Describe any safety endpoints. 
Response: NA 
 
21.4 Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
Response: NA 
 
21.5 Describe the frequency of safety data collection. 
Response: NA 
 
21.6 Describe who will review the safety data. 
Response: NA 
 
21.7 Describe the frequency or periodicity of review of cumulative safety data. 
Response: NA 
 
21.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response: NA 
 

 
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21.9 Describe any conditions that trigger an immediate suspension of the 
research. 
Response: NA 
 
22.0 
Withdrawal of Subjects* 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
22.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 
Response: If the subjects: 
• Develop any indication of root resorption  
• Develop any periodontal issues during the course of the study 
• Develop any health-related issues during the study  
• Voluntarily want to leave the study or cease treatment 
• Do not come regularly as needed for the study 
 
22.2 Describe any procedures for orderly termination.   
NOTE:  Examples may include return of study drug, exit interview with clinician.  
Include whether additional follow up is recommended for safety reasons for 
physical or emotional health. 
Response: The subjects may withdraw their consent and discontinue their participation at 
any time. At which point, all collected data of the subject will be destroyed and discarded 
accordingly. 
22.3 Describe procedures that will be followed when subjects withdraw from the 
research, including retention of already collected data, and partial 
withdrawal from procedures with continued data collection, as applicable. 
Response: If subjects withdraw from the research, their data will not be used in 
the research study as the data will not be complete. It will be destroyed and 
discarded accordingly.  The  IRB correspondence and signed consent forms from 
withdrawn subjects will be maintained for 3 years.  
 
23.0 
Risks to Subjects* 
23.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related to their participation in the research. 
Consider physical, psychological, social, legal, and economic risks.  Include 
a description of the probability, magnitude, duration, and reversibility of the 
risks.  

 
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NOTE:  Breach of confidentiality is always a risk for identifiable subject data. 
Response: Breach of confidentiality is a risk to participating in this study. Since 
this is a clinical research study, which will be utilizing orthodontic techniques and 
mechanics to achieve orthodontic treatment, we will have inherent risks which are 
routine in orthodontic treatment. These risks will be explained to the patient as 
part of the Standard of Care protocol. 
23.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 
Response: Procedures performed to mitigate risk of confidentiality breach are 
described in the Confidentiality section. 
To reduce the probability / magnitude of risks in the standard clinical procedures, 
safety measures will be implemented per SOC protocol.  
• All biomechanical orthodontic forces will be standardized and delivered 
within standard of care parameters, keeping forces continuous but light to 
reduce any potential risk of; pain, discomfort, and root resorption.  
• Patients will be given appropriate oral hygiene tools (floss threaders, 
proxy brushes, tooth brushes, plaque disclosing tablets) and instruction 
prior to starting orthodontic treatment. This will ensure that each patient is 
aware of the hygiene required during treatment. This will also reduce the 
risk of white spot lesions, periodontal issues, and halitosis. Reduced 
inflammation will also provide more comfort to the patient during 
treatment.  
• To reduce risk of discomfort and abrasion, patients will be given 
orthodontic wax to place on brackets or wires that give them any 
discomfort. Patient’s wires will be trimmed accordingly and patient will 
be asked prior to leaving if there is anything bothering them to reduce 
discomfort.  
• Each adjustment visit patients will be assessed clinically extra orally and 
intraorally to evaluate any changes and look for pathology, inflammation, 
abrasions, and any tooth damage (white spot lesions, fractures, caries). 
Tissues will be assessed for inflammation and erythema. Radiography will 
be taken to assess the root anatomy, alveolar bone level, TMJ anatomy and 
screen for any pathology)  
• Patients will be able to communicate the research examiner if there are 
any issues between adjustment visits (discomfort, broken appliance, pain, 
difficulty chewing/eating, psychological issues). They will be either seen 
for an emergency visit to address the concern or guided via tele-dentistry 
communication to resolve the issue if possible.  
• Patients will have their medical and dental history updated at every visit to 
ensure that all appropriate changes in their health are on record. They will 
be asked about any concerns or issues they are having, which will be 
recorded and addressed accordingly.  

 
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• Regarding patients who have or develop an allergic reaction to nickel, 
there will be appropriate changes made to their treatment to prevent the 
allergy.  
 
23.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
Response: This current study is minimal risk. The general risk is a broken 
appliance, which is a risk inherent to standard clinical care for these patients.  
 
23.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response: N/A  
 
23.5 If applicable, describe risks to others who are not subjects. 
Response: Current risk of COVID-19 infection, otherwise there is risks to others 
who are not subjects. 
24.0 
Potential Benefits to Subjects* 
24.1 Describe the potential benefits that individual subjects may experience by 
taking part in the research.  Include the probability, magnitude, and 
duration of the potential benefits.  Indicate if there is no direct benefit.   
NOTE:  Compensation cannot be stated as a benefit. 
Response: There are no direct benefits to subjects on this study, they are being 
randomized to standard treatments that are available to any patient outside of the 
research context.  
 
25.0 
Compensation for Research-Related Injury 
☐ 
N/A:  The research procedures for this study do not present risk of 
research related injury (e.g. survey studies, records review studies).  This 
section does not apply.   
25.1 
If the research procedures carry a risk of research related injury, 
describe the available compensation to subjects in the event that such 
injury should occur.   
Response: This study is of minimal risk, and there is no additional anticipated 
risk for participating in this study  
 
25.2 
Provide a copy of contract language, if any, relevant to compensation for 
research related injury. 

 
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NOTE :  If the contract is not yet approved at the time of this submission, submit the 
current version here.  If the contract is later approved with different language 
regarding research related injury, you must modify your response here and 
submit an amendment to the IRB for review and approval. 
Response: NA, this study is not sponsored.  
 
26.0 
Economic Burden to Subjects 
26.1 
Describe any costs that subjects may be responsible for because of 
participation in the research.   
NOTE:  Some examples include transportation or parking. 
Response: Patients will be required to cover the following costs as part of their 
regular care: 
• Standard clinical fees associated with comprehensive orthodontic 
treatment  
• There will not be additional cost to receiving the GUMMETAL wire. 
 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
27.0 
Compensation for Participation 
27.1 
Describe the amount and timing of any compensation to subjects, 
including monetary, course credit, or gift card compensation. 
Response:  
 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records 
review procedures only.  This section does not apply. 
☒ 
N/A:  There is no compensation for participation.  This section 
does not apply. 
28.0 
Consent Process 
28.1 Indicate whether you will be obtaining consent.   
NOTE:  This does not refer to consent documentation, but rather whether you will 
be obtaining permission from subjects to participate in a research study.   
Consent documentation is addressed in Section 27.0. 
☒ 
Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 27.0) 
 
28.2 Describe where the consent process will take place.  Include steps to 
maximize subjects’ privacy. 

 
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Response: Consent will take place at the University at Buffalo School of Dental 
Medicine in the Orthodontic Department. Specifically, this will take place in the 
privacy of a faculty office which will be completely closed and private. Patients 
will be able to ask their questions and concerns with absolute privacy.  
 
28.3 Describe how you will ensure that subjects are provided with a sufficient 
period of time to consider taking part in the research study.   
NOTE:  It is always a requirement that a prospective subject is given sufficient 
time to have their questions answered and consider their participation.  See “SOP: 
Informed Consent Process for Research (HRP-090)” Sections 5.5 and 5.6. 
Response: Patients will be allotted appropriate time to discuss amongst 
themselves and appropriate parent / guardians with or without the research 
examiner present, whichever they prefer. If subjects need more time to think and 
discuss outside of the clinic and come back at a later time to make their decision 
to participate this is acceptable. Patients can take as long as needed to make their 
decision and voice their concerns, there will be no time restriction or pressure 
from the research team.  
 
28.4 Describe any process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Response: Patients will be asked at every visit if they wish to continue in their 
current research study. Patient will have full autonomy to withdraw or continue. 
There will be appropriate documentation that will be signed by the patient to 
ensure consent was given.  
 
28.5 Indicate whether you will be following “SOP: Informed Consent Process for 
Research (HRP-090).” Pay particular attention to Sections 5.4-5.9. If not, 
or if there are any exceptions or additional details to what is covered in the 
SOP, describe: 
• 
The role of the individuals listed in the application who are involved in 
the consent process 
• 
The time that will be devoted to the consent discussion 
• 
Steps that will be taken to minimize the possibility of coercion or 
undue influence 
• 
Steps that will be taken to ensure the subjects’ understanding 
Response:  
 
☐ 
We have reviewed and will be following “SOP: Informed Consent Process 
for Research (HRP-090).” 
 

 
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Non-English Speaking Subjects  
☒ 
N/A:  This study will not enroll Non-English speaking subjects.   
(Skip to Section 26.8) 
28.6 Indicate which language(s) other than English are likely to be 
spoken/understood by your prospective study population or their legally 
authorized representatives. 
 
NOTE: The response to this Section should correspond with your response to 
Section 6.4 of this protocol. 
Response: N/A  
 
28.7 If subjects who do not speak English will be enrolled, describe the process 
to ensure that the oral and written information provided to those subjects 
will be in that language, how you will ensure that subjects are provided with 
a sufficient period of time to consider taking part in the research study, and 
any process to ensure ongoing consent. Indicate the language that will be 
used by those obtaining consent.  
NOTE:  Guidance is provided on “SOP:  Informed Consent Process for Research 
(HRP-090).” 
Response: N/A   
 
 
Cognitively Impaired Adults 
☒ 
N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 26.9) 
28.8   Describe the process to determine whether an individual is capable of 
consent.  
Response:  
 
 
Adults Unable to Consent 
☒ 
N/A:  This study will not enroll adults unable to consent.  
(Skip to Section 26.13) 
When a person is not capable of consent due to cognitive impairment, a legally 
authorized representative should be used to provide consent (Sections 26.9 and 
26.10) and, where possible, assent of the individual should also be solicited 
(Sections 26.11 and 26.12). 

 
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28.9  Describe how you will identify a Legally Authorized Representative (LAR).  
Indicate that you have reviewed the “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)” for research in New 
York State.  
NOTE:  Examples of acceptable response includes: verifying the electronic 
medical record to determine if an LAR is recorded. 
Response:  
 
☒ 
We have reviewed and will be following “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).”  
28.10 For research conducted outside of New York State, provide information 
that describes which individuals are authorized under applicable law to 
consent on behalf of a prospective subject to their participation in the 
research. One method of obtaining this information is to have a legal 
counsel or authority review your protocol along with the definition of 
“legally authorized representative” in “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).” 
Response: N/A  
 
28.11 Describe the process for assent of the adults: 
• 
Indicate whether assent will be obtained from all, some, or none of the 
subjects.  If some, indicate which adults will be required to assent 
and which will not. 
Response: N/A  
 
• 
If assent will not be obtained from some or all subjects, provide an 
explanation of why not. 
Response: N/A  
 
28.12 Describe whether assent of the adult subjects will be documented and the 
process to document assent.   
NOTE:  The IRB allows the person obtaining assent to document assent on the 
consent document using the “Template Consent Document (HRP-502)” Signature 
Block for Assent of Adults who are Legally Unable to Consent. 
Response: N/A 
 
 
Subjects who are not yet Adults (Infants, Children, and Teenagers) 

 
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☐ 
N/A:  This study will not enroll subjects who are not yet adults.   
(Skip to Section 27.0) 
28.13 Describe the criteria that will be used to determine whether a prospective 
subject has not attained the legal age for consent to treatments or 
procedures involved in the research under the applicable law of the 
jurisdiction in which the research will be conducted (e.g., individuals under 
the age of 18 years).  For research conducted in NYS, review “SOP: 
Legally Authorized Representatives, Children, and Guardians (HRP-013)” 
to be aware of which individuals in the state meet the definition of 
“children.”  
NOTE:  Examples of acceptable responses include: verification via electronic 
medical record, driver’s license or state-issued ID, screening questionnaire. 
Response: Patient’s medical record, screening forms and discussion with 
parent/guardian will be utilized to assess patient’s legality to consent to treatment 
/ procedures involved in research. 
 
28.14For research conducted outside of New York State, provide information 
that describes which persons have not attained the legal age for consent to 
treatments or procedures involved the research, under the applicable law of 
the jurisdiction in which research will be conducted.  One method of 
obtaining this information is to have a legal counsel or authority review 
your protocol along the definition of “children” in “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013).” 
Response: N/A 
 
28.15 Describe whether parental permission will be obtained from: 
Response:  
☒  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the 
child. 
☐ 
Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for 
the care and custody of the child. 
☐ 
Parent permission will not be obtained.  A waiver of parent permission is 
being requested. 
NOTE:  The requirement for parent permission is a protocol-specific determination 
made by the IRB based on the risk level of the research.  For guidance, review the 
“CHECKLIST: Children (HRP-416).”  

 
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28.16Describe whether permission will be obtained from individuals other than 
parents, and if so, who will be allowed to provide permission.  Describe 
your procedure for determining an individual’s authority to consent to the 
child’s general medical care. 
Response: If there is no known living parent, then the next individual to give 
permission / consent for the patient to participate in research would have to be the 
legal guardian. To assess legitimacy of legal guardianship, appropriate 
documentation will need to be provided by said individual. Once documentation 
has been verified, authority to consent will be approved.  
 
28.17 Indicate whether assent will be obtained from all, some, or none of the 
children.  If assent will be obtained from some children, indicate which 
children will be required to assent. 
Response: Assent will be obtained from all child subjects in the research study.  
 
28.18 When assent of children is obtained, describe how it will be documented. 
Response: Assent will be documented in the same manner as consent from the 
legal guardian / parent. Appropriate documentation will provide all information 
for the subject, all questions will be answered and patient will have freedom to 
speak for themselves on their participation. Signature will be gathered from the 
child / adolescent, and paperwork will be scanned into the patient’s electronic 
health record for safe keeping. There will be separate assent paperwork for 
children ages 12 and younger and for those 13-17 years of age.  
 
29.0 
Waiver or Alteration of Consent Process 
Consent will not be obtained, required information will not be disclosed, or the 
research involves deception. 
☒ 
N/A:  A waiver or alteration of consent is not being requested. 
29.1 If the research involves a waiver or alteration of the consent process, please 
review the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-
410)” to ensure that you have provided sufficient information for the IRB to 
make the determination that a waiver or alteration can be granted.   
NOTE:  For records review studies, the first set of criteria on the “CHECKLIST: 
Waiver or Alteration of Consent Process (HRP-410)” applies.  
Response:  
 
29.2 If the research involves a waiver of the consent process for planned 
emergency research, please review the “CHECKLIST: Waiver of Consent 
for Emergency Research (HRP-419)” to ensure you have provided sufficient 

 
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information for the IRB to make these determinations.  Provide any 
additional information necessary here: 
Response:  
 
30.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 29.0) 
30.1 Indicate whether you will be following “SOP: Written Documentation of 
Consent (HRP-091).” If not or if there are any exceptions, describe whether 
and how consent of the subject will be obtained including whether or not it 
will be documented in writing.   
NOTE:  If your research presents no more than minimal risk of harm to subjects 
and involves no procedures for which written documentation of consent is normally 
required outside of the research context, the IRB will generally waive the 
requirement to obtain written documentation of consent.  This is sometimes 
referred to as ‘verbal consent.’  Review “CHECKLIST: Waiver of Written 
Documentation of Consent (HRP-411)” to ensure that you have provided sufficient 
information.  
If you will document consent in writing, attach a consent document with your 
submission.  You may use “TEMPLATE CONSENT DOCUMENT (HRP-
502)”.  If you will obtain consent, but not document consent in writing, attach the 
script of the information to be provided orally or in writing (i.e. consent script or 
Information Sheet).   
Response:  
 
☒ 
We will be following “SOP:  Written Documentation of Consent” 
(HRP-091). 
31.0 
Multi-Site Research (Multisite/Multicenter Only)* 
☒ 
N/A:  This study is not an investigator-initiated multi-site study.  This 
section does not apply.