THE KOREAN JOURNAL of

Original Article ORTHODONTICS

pISSN 2234-7518 • eISSN 2005-372X

https://doi.org/10.4041/kjod.2018.48.5.316

Effects of thermoforming on the physical and

mechanical properties of thermoplastic materials
for transparent orthodontic aligners

Jeong-Hyun Ryua,b Objective: The aim of this systematic multiscale analysis was to evaluate
Jae-Sung Kwona,b the effects of thermoforming on the physical and mechanical properties of
Heng Bo Jiangc thermoplastic materials used to fabricate transparent orthodontic aligners
Jung-Yul Chad (TOAs). Methods: Specimens were fabricated using four types of thermoplastic
Kwang-Mahn Kima,b materials with different thicknesses under a thermal vacuum. Transparency,
water absorption and solubility, surface hardness, and the results of three-point
bending and tensile tests were evaluated before and after thermoforming. Data
were analyzed using one-way analysis of variance and Student’s t -test. Results:
After thermoforming, the transparency of Duran and Essix A+ decreased, while
a
Department and Research Institute the water absorption ability of all materials; the water solubility of Duran, Essix
for Dental Biomaterials and
A+, and Essix ACE; and the surface hardness of Duran and Essix A+ increased.
Bioengineering, Yonsei University
College of Dentistry, Seoul, Korea The flexure modulus for the 0.5-mm-thick Duran, Essix A+, and eCligner
b
BK21 PLUS Project for Interdisciplinary specimens increased, whereas that for the 0.75-/1.0-mm-thick Duran and
Oral Science Graduate Program, Yonsei eClginer specimens decreased. In addition, the elastic modulus increased for the
University College of Dentistry, Seoul, 0.5-mm-thick Essix A+ specimens and decreased for the 0.75-mm-thick Duran
Korea
c
and Essix ACE and the 1.0-mm-thick Essix ACE specimens. Conclusions: Our
School of Stomatology, Taishan findings suggest that the physical and mechanical properties of thermoplastic
Medical University, Tai’an, Shandong,
PR China materials used for the fabrication of TOAs should be evaluated after thermo­
d
Department of Orthodontics, The
forming in order to characterize their properties for clinical application.
Institute of Craniofacial Deformity, [Korean J Orthod 2018;48(5):316-325]
Yonsei University College of Dentistry,
Seoul, Korea Key words: Thermoplastic materials, Physical properties, Mechanical properties,
Aligner

Received November 7, 2017; Revised May 14, 2018; Accepted May 29, 2018.

Corresponding author: Kwang-Mahn Kim.

Professor, Department and Research Institute for Dental Biomaterials and Bioengineering,
Yonsei University College of Dentistry, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722,
Korea.
Tel +82-2-2228-3082 e-mail [email protected]

How to cite this article: Ryu JH, Kwon JS, Jiang HB, Cha JY, Kim KM. Effects of
thermoforming on the physical and mechanical properties of thermoplastic materials for
transparent orthodontic aligners. Korean J Orthod 2018;48:316-325.

© 2018 The Korean Association of Orthodontists.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License
(http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and
reproduction in any medium, provided the original work is properly cited.

316
Ryu et al • Post-thermoform, thermoplastic materials and transparent orthodontic aligners

INTRODUCTION an aligner. However, one study reported that orthodon-

tic treatment with TOAs was not effective because the
With an increase in the demand for adult orthodon- delivered force was only 60% to 70% of the required
tics, the demand for esthetic orthodontic appliances that force.19
can replace the commonly used metal brackets is also The majority of current aligner manufacturers use
increasing.1 Conventional orthodontic brackets frequent- modified polyethylene terephthalate glycol (PETG), al-
ly increase the risk of carious lesions and cause gingi- though polypropylene, polycarbonate, thermoplastic
vitis and periodontitis because of surrounding plaque polyurethanes, copolyester, and many other materials are
accumulation.2 This results in impaired oral health in also used.20-22
addition to poor esthetics during orthodontic treat- In the present study, we focused on thermoplastic ma-
ment.3 To remedy this problem, transparent orthodontic terials used for the fabrication of TOAs, which have been
aligners (TOAs) have been introduced as alternatives for evaluated for their physical and mechanical properties
fixed brackets and wires. TOAs can be easily inserted and according to the material type and thickness. Ryokawa
removed and do not affect the chewing ability of the et al.23 studied the mechanical properties of thermoplas-
patient.4 Therefore, they are widely used in adult orth- tic materials in a simulated oral environment and evalu-
odontic treatment.5 ated thickness changes after thermoforming. Min et al.24
Tooth movement without the use of bands, brackets, considered the level of forces delivered by thermoplastic
or wires was described as early as 1945 by Kesling,6 who TOAs for inducing physiological tooth movement and
reported the use of a flexible tooth positioning appli- reported that the thickness of the thermoplastic material
ance. Subsequently, Sheridan7 and other researchers,8,9 affected the amount of deflection after repeated loading
developed various types of invisible retainers. Align and stress. Moreover, the material thickness and amount
Technology, Inc. (Santa Clara, CA, USA) introduced the of deflection showed the largest effect on force and
Invisalign system two decades ago, which further devel- stress. Kwon et al.25 assessed the force delivery properties
oped the principles of Kesling, Nahoum, and other re- of thermoplastic orthodontic materials and found that
searchers using computer-aided design (CAD)/computer- the forces delivered by thin materials were greater than
aided manufacturing (CAM) technology combined with those delivered by thick materials of the same brand.
laboratory techniques that facilitated the fabrication of Another study developed a new type of transparent
a series of customized esthetic dental devices that were orthodontic appliance using hybrid thermoplastic mate-
removable and could move teeth from the beginning to rials with a multilayered structure and evaluated the me-
the end.10 Furthermore, Cassetta et al.11 developed a new chanical properties using tensile testing.26 However, there
orthodontic treatment technique in combination with are no standard methods for evaluating the mechanical
computer-guided, minimally-invasive flapless corticoto- and physical properties of thermoplastic materials used
my. for the fabrication of TOAs.
The effectiveness of TOAs for orthodontic treatment The purpose of the present study was to address
has been widely reported. These aligners have been used this gap by systematically evaluating the physical and
in clinical applications where stepped teeth have been mechanical properties of TOAs in consideration of the
moved by approximately 0.25 to 0.33 mm. Here, it was clinical environment in which they would be applied. A
shown that activation of the device every 2 weeks was multiscale evaluation was performed after the thermo-
effective for orthodontic tooth movement. 12,13 TOAs forming of various thermoplastic materials with differ-
have also been studied using simulation systems and ent thicknesses in order to test the null hypothesis that
sensors. The force applied on teeth in the x, y, and z the mechanical and physical properties of all materials
directions was measured in patients who received TOAs would remain unchanged after thermoforming.
made from thermoplastic materials based on a three-
dimensional (3D)-printed design crafted using CAD/CAM MATERIALS AND METHODS
technology.14,15 In another study, the force and torque
on the teeth were measured using a force-torque sensor Specimen preparation
after the insertion of TOAs.16 Simon et al.17 quantified The following thermoplastic materials used for the
the forces and moments delivered on incisors, premolars, fabrication of TOAs were evaluated in this study: Duran
and molars by a single aligner and a series of aligners. In (Scheu Dental, Iserlohn, Germany), eCligner (eCligner,
addition, Li et al.18 reported that the amount of activa- Seoul, Korea), Essix A+ (Dentsply Raintree Essix, Sara-
tion affected the orthodontic force imparted by aligners, sota, FL, USA), and Essix ACE (Dentsply Raintree Essix).
and that the amount of lingual bodily movement of the The properties of each material and the thermoforming
maxillary central incisor for the initial 4 or 5 days is an conditions (thicknesses, temperatures, heating times,
important aspect of orthodontic treatment incorporating and cooling times) are shown in Table 1. Specifically,

www.e-kjo.org https://doi.org/10.4041/kjod.2018.48.5.316 317

 Ryu et al • Post-thermoform, thermoplastic materials and transparent orthodontic aligners

Table 1. Properties of thermoplastic materials used for the fabrication of transparent orthodontic aligners and the
thermoforming conditions used in the present study
Brand Thickness Temperature Heating time Cooling time
Component
(manufacturer) (mm) (°C) (s) (s)
Duran PETG 0.5 220 25 20
(Scheu Dental, Iserlohn, Germany) 0.75 220 30 20
1.0 220 35 60
Essix A+ Copolyester 0.5 220 25 20
(Dentsply Raintree Essix, Sarasota, FL, USA) 0.75 220 30 20
1.0 220 35 60
eCligner PETG 0.5 220 30 20
(eCligner, Seoul, Korea) 0.75 220 35 60
Essix ACE Copolyester 0.75 220 25 60
(Dentsply Raintree Essix) 1.0 220 35 60
PETG, Polyethylene terephthalate glycol.

A B

9 mm
m
m
40
2 mm
Surface X

8.5 mm

7 mm

Figure 1. A, Thermoforming machine (Biostar®; Scheu Dental, Iserlohn, Germany) and fabrication of specimens for
evaluation of the effects of thermoforming on the mechanical and physical properties of different thermoplastic
materials with varying thicknesses. B, Surface X was cut from the models and used as a specimen for analysis.

0.5-mm-thick Duran, Essix A+, and eCligner; 0.75-mm- Measurement of transparency using spectrophotometry
thick Duran, Essix A+, Essix ACE, and eCligner; and The transparency was measured for five specimens of
1.0-mm-thick Duran, Essix A+, and Essix ACE were used. each material and thickness before and after thermo-
Models were constructed to mimic the average length forming. For measurement of the transparency of each
(2 mm), clinical crown height (8.5 mm), and width (7 specimen, visible light (400–700 nm) was used in the
mm) of the maxillary central incisor in Korean adults.24 transmittance mode of a spectrophotometer (CM-3500D;
A fabricated mold was placed in a thermoforming caster Konica Minolta, Tokyo, Japan). The transparency T was
(Biostar®; Scheu Dental). Heat and vacuum were applied calculated using the following formula:
during thermoforming as recommended by the manu-
facturer. The models generated from the deformed ther- I0
T= × 100
moplastic materials were removed, and surface X was Is
cut out from each model and used as a specimen for
analysis (Figure 1). where Is is the energy reflected by the white calibra-
tion plate on the light source and I 0 is the energy trans-
mittance through the specimen from the light source

318 https://doi.org/10.4041/kjod.2018.48.5.316 www.e-kjo.org

Ryu et al • Post-thermoform, thermoplastic materials and transparent orthodontic aligners

reflected on the white calibration plate. at a crosshead speed of 5 mm/min. The 0.5- to 1.0-
mm range was selected on the basis of a previous clini-
Water absorption and water solubility cal finding that TOAs could induce the movement of
For all four materials, tests for water absorption and stepped teeth by approximately 0.25 to 0.33 mm.12,13
solubility were performed according to International The flexure modulus was calculated using the follow-
Organization for Standardization (ISO) 20795-2 (2013). ing formula:
Five specimens of the thickest material from each brand
(1.0 mm for all except eCligner, which was 0.75 mm) (F 2 − F 1)l 3
were prepared and stored at 37oC ± 1oC for 14 days. E=
4bh 3(d 2 − d 1)
Then, water absorption (Wsp) was calculated using the
following formula: Where F 1 is the maximum force at 0.5 mm of deflec-
tion, F 2 is the maximum force at 1.0 mm of deflection,
m2 − m3 d 1 is 0.5 mm of deflection, d 2 is 1.0 mm of deflection, l
Wsp = (mg/mm3)
V is the distance, b is the width, h is the height, and E is
the flexure modulus.
where m 2 is the mass of the specimen in mg after im-
mersion in water, m 3 is the reconditioned mass of the Tensile test
specimen in mg, and V is the specimen volume in mm3. Six rectangular specimens for each material and thick-
In addition, the water solubility (Wsl) was calculated us- ness were prepared with a breadth of 5 mm and length
ing the following formula: of 40 mm. A tensile test was performed using a univer-
sal testing machine (Model 5942; Instron®). The distance
m1 − m3 between the points supporting the specimen was 20
Wsl = (mg/mm3)
V mm. The elastic modulus was determined by setting the
crosshead speed at 12 mm/min.
where m 1 is the mass of the specimen in mg before
immersion in water. Statistical analysis
All data are expressed as means ± standard deviations.
Surface hardness test Data for each material and thickness were analyzed us-
Five specimens of the thickest material from each ing one-way analysis of variance (ANOVA) with post-hoc
brand were prepared (1.0 mm for all except eCligner, analysis using Tukey’s test. Student’s t -test was used
which was 0.75 mm), and their surface hardness was to compare the values before and after thermoforming
measured using the Knoop hardness tester (DMH-2; among each material and thickness (p < 0.01). All statis-
Mastsuzawa Siki Co. Ltd., Akita, Japan). An indentation tical analyses were performed using statistical software
was created by application of a load of 9.8 N for 10 sec- (IBM SPSS Statistics for Windows, version 23.0; IBM Co.,
onds, and the size of the indentation was measured to Armonk, NY, USA).
calculate the Knoop hardness using the following for-
mula: RESULTS
14.22 × P After thermoforming, the transparency of 0.5- and
HK = (KHN)
l2 0.75-mm-thick eCligner exhibited a greater decrease
than that of Duran and Essix A+ of the same thick-
where HK is the Knoop hardness, P = 9.8 N, and l is nesses, while the transparency of 0.75-mm-thick Essix
the length of the indentation along the long axis of the ACE exhibited a greater decrease than that of 0.75-mm-
specimen. thick eCligner. Moreover, the transparency of the 0.5-,
0.75-, and 1.0-mm-thick Duran and Essix A+ specimens
Three-point bending test was significantly lower after thermoforming than before
For all four materials, a three-point bending test was thermoforming, whereas there were no significant dif-
performed according to ISO 20795-2 (2013). 32 Five ferences for the eCligner and Essix ACE specimens of all
specimens for each material and thickness were prepared thicknesses before and after thermoforming (Table 2).
with a length of 24 mm in order to take into account The water absorption ability was the highest for
the actual clinical situation. The flexure modulus of eCligner before thermoforming and Duran after ther-
each specimen was measured using a universal testing moforming. Before thermoforming, the water solubility
machine (Model 3366; Instron®, Norwood, MA, USA). A of eCligner was higher than that of Duran, Essix A+,
strain interval of 0.5 mm was set from 0.5 to 1.0 mm and Essix ACE. After thermoforming, the water solubil-

www.e-kjo.org https://doi.org/10.4041/kjod.2018.48.5.316 319

 Ryu et al • Post-thermoform, thermoplastic materials and transparent orthodontic aligners

ity of Duran was higher than that of eCligner and Essix the hardness of the eCligner specimens was greater
ACE. For all four materials, the water absorption ability than that of the Essix A+ and Essix ACE specimens after
increased after thermoforming. The water solubility of thermoforming. The Essix A+ and Essix ACE specimens
Duran, Essix A+, and Essix ACE was significantly higher exhibited greater surface hardness after thermoforming
after thermoforming than before thermoforming; the than before thermoforming. However, the Duran and
opposite was true for eCligner (Figure 2). eCligner specimens showed no significant difference be-
The surface hardness of all four materials showed no fore and after thermoforming (Figure 3).
significant difference before thermoforming. However, Table 3 shows the flexural forces and flexure moduli
for the test materials with different thicknesses. At the
0.5-mm thickness, there were no significant differences
Table 2. Comparison of the transparency of different
thermoplastic materials before thermoforming (BT) and
after thermoforming (AT) 350
Transmittance (%) Duran
Thickness Brand 300 Essix A+
(mm)

Knoop hardness number

BT AT eCligner
Aa Ab 250 Essix ACE
0.5 Duran 90.54 ± 0.11 87.73 ± 0.49
Essix A+ 90.52Aa ± 0.12 87.78Ab ± 0.21 200 Ab
Aa Bb Bb
Ba Ba Aa Aa Aa Aa
eCligner 88.01 ± 0.06 88.09 ± 0.22 150
0.75 Duran 90.12Aa ± 0.05 87.68Ab ± 0.08
100
Essix A+ 90.42Aa ± 0.05 87.65Ab ± 0.16
eCligner 87.89Ba ± 0.12 87.67Ba ± 0.17 50
Ca Ca
Essix ACE 88.12 ± 0.15 87.98 ± 0.33 0
Aa BT AT
1.0 Duran 89.92 ± 0.15 87.16Ab ± 0.20
Essix A+ Aa
90.01 ± 0.06 Ab
87.10 ± 0.27 Figure 3. Comparison of Knoop hardness values before
Essix ACE Ba
88.15 ± 0.04 Ba
88.03 ± 0.65 thermoforming (BT) and after thermoforming (AT) and
among different thermoplastic materials. All tests were
Values are presented as mean ± standard deviation.
A,B,C performed for 1.0-mm-thick Duran, Essix A+, Essix ACE,
The same capital letters in the vertical columns indicate
no difference between materials at the 1% significance level.
and 0.75-mm-thick eCligner. The same capital letter
a,b
The same lower case letters in the horizontal rows indicate indicates no difference between materials at the 1%
no difference between BT and AT at the 1% signifi­cance significance level. The same lower case letters indicate no
level. difference between BT and AT at the 1% significance level.
See Table 1 for the manufacturer of each product. See Table 1 for the manufacturer of each product.

A B
20 5
Duran Duran
Essix A+ Essix A+
Water absorption (g/mm )
3

Water solubility (g/mm )

16 4
3

eCligner eCligner
Essix ACE Essix ACE
Ab Ba
12 Ab Bb 3 Ab
Cb Ab
Aa Aa Ba Bb Bb
8 Ca 2 Aa Aa Aa

4 1

0 0
BT AT BT AT

Figure 2. Comparison of water absorption (A) and solubility (B) before thermoforming (BT) and after thermoforming (AT)
and among different thermoplastic materials. All tests were performed for 1.0-mm-thick Duran, Essix A+, Essix ACE, and
0.75-mm-thick eCligner. The same capital letters indicate no difference between materials at the 1% significance level.
The same lower case letters indicate no difference between BT and AT at the 1% significance level.
See Table 1 for the manufacturer of each product.

320 https://doi.org/10.4041/kjod.2018.48.5.316 www.e-kjo.org

Ryu et al • Post-thermoform, thermoplastic materials and transparent orthodontic aligners

Table 3. Comparison of the flexural forces and flexure moduli for different thermoplastic materials before
thermoforming (BT) and after thermoforming (AT)
Thickness Flexural force (N) Flexure modulus (MPa)
Brand
(mm) BT AT BT AT
0.5 Duran 0.53Aa ± 0.03 0.18Ab ± 0.02 2,455.8Aa ± 128.1 3,503.9Ab ± 248.5
Essix A+ 0.46Aa ± 0.07 0.16Ab ± 0.02 2,802.9Aa ± 237.2 5,540.0Bb ± 806.8
eCligner 0.48Aa ± 0.04 0.13Ab ± 0.03 2,961.4Aa ± 348.1 5,200.4Bb ± 828.3
Aa Ab Aa
0.75 Duran 1.11 ± 0.05 0.30 ± 0.04 2,024.7 ± 94.5 1,750.4Ab ±199.1
Essix A+ 1.30Ba ± 0.08 0.38Ab ± 0.06 2,273.3Ba ± 139.1 2,036.3Ba ± 166.9
eCligner 1.27Ba ± 0.06 0.36Ab ± 0.08 2,313.1Ba ± 112.2 1,897.4Bb ± 169.6
Aa Ab Ca
Essix ACE 1.07 ± 0.10 0.33 ± 0.12 1,728.4 ± 155.1 2,029.8Ba ± 242.5
1.0 Duran 3.32Aa ± 0.21 0.58Ab ± 0.16 2,548.2Aa ± 141.7 1,439.3Ab ± 344.0
Essix A+ 3.14Aa ± 0.17 0.73Ab ± 0.12 2,272.4Ba ± 112.0 1,360.5Ab ± 60.6
Ba Ab Ca
Essix ACE 2.71 ± 0.09 0.52 ± 0.05 1,796.6 ± 55.6 1,280.2Ab ± 66.4
Values are presented as mean ± standard deviation.
A,B,C
The same capital letters in the vertical columns indicate no difference between materials at the 1% significance level. a,bThe
same lower case letters in the horizontal rows indicate no difference between BT and AT at the 1% significance level.
See Table 1 for the manufacturer of each product.

in flexural forces among eCligner, Duran, and Essix A+, lowed by Essix A+ and Essix ACE (p < 0.01). However,
both before and after thermoforming (p > 0.01). At the the three materials showed no significant differences in
0.75-mm thickness, eCligner and Essix A+ showed sig- the flexure modulus after thermoforming (p > 0.01). The
nificantly higher flexural forces than did Duran and Essix modulus for all three materials significantly decreased
ACE (p < 0.01) before thermoforming, while there were after thermoforming (p < 0.01).
no significant differences among materials after thermo- Table 4 shows the tensile forces and elastic moduli for
forming (p > 0.01). At the 1.0-mm thickness, Essix ACE the different materials with different thicknesses (Ap-
showed a significantly smaller flexural force than did pendixes 1 and 2). At the 0.5-mm thickness, there were
Duran and Essix A+ before thermoforming (p < 0.01); no significant differences among materials, both before
there were no significant differences after thermoform- and after thermoforming (p > 0.01).
ing (p > 0.01). For all materials and thicknesses, flexural At the 0.75-mm thickness, Essix ACE showed a sig-
forces were significantly lowered after thermoforming (p nificantly smaller tensile force than did Duran, Essix A+,
< 0.01). and eCligner (p < 0.01) before thermoforming. There
With regard to the flexure modulus for 0.5-mm-thick were no significant differences among materials after
materials, there were no significant differences between thermoforming (p > 0.01).
Duran, Essix A+, and eCligner before thermoforming At the 1.0-mm thickness, Essix ACE showed a signifi-
(p > 0.01). However, the flexure modulus for the Duran cantly smaller tensile force than did Duran and Essix A+
specimens was significantly lower than that for the Es- before thermoforming (p < 0.01). There were no signifi-
six A+ and eCligner specimens after thermoforming (p cant differences among materials after thermoforming (p
< 0.01). Also, the flexure modulus for all three materials > 0.01). For all materials and thicknesses, tensile forces
significantly increased after thermoforming (p < 0.01). significantly decreased after thermoforming (p < 0.01).
At the 0.75-mm thickness, the flexural modulus was At the 0.5-mm thickness, the elastic modulus for Du-
significantly higher for Essix A+ and eCligner than for ran was significantly higher than that for Essix A+ and
Duran and Essix ACE before thermoforming (p < 0.01). eCligner before thermoforming (p < 0.01). However,
After thermoforming, the modulus for Duran was signif- there was no significant difference among materials af-
icantly higher than that for the other materials (p < 0.01). ter thermoforming. In addition, the elastic modulus for
Also, the flexure modulus for the Duran and eCligner Duran significantly decreased after thermoforming (p <
specimens significantly increased after thermoforming (p 0.01)
< 0.01), whereas no significant changes were observed At the 0.75-mm thickness, there were no significant
for the Essix A+ and Essix ACE specimens. differences in the elastic modulus among the four ma-
Finally, at the 1.0-mm thickness, the flexure modulus terials, both before and after thermoforming (p > 0.01).
before thermoforming was the highest for Duran, fol- The modulus for Duran and Essix ACE significantly de-

www.e-kjo.org https://doi.org/10.4041/kjod.2018.48.5.316 321

 Ryu et al • Post-thermoform, thermoplastic materials and transparent orthodontic aligners

Table 4. Comparison of the tensile forces and elastic moduli for different thermoplastic materials before thermoforming
(BT) and after thermoforming (AT)
Thickness Tensile force (N) Elastic modulus (MPa)
Brand
(mm) BT AT BT AT
0.5 Duran 119.9Aa ± 5.1 67.8Ab ± 11.0 3,054.3Aa ± 65.3 2,531.7Ab ± 288.5
Essix A+ 121.2Aa ± 2.8 104.0Ab ± 11.9 2,673.1Ba ± 86.7 3,020.6Aa ± 369.1
eCligner 119.8Aa ± 5.4 59.6Ab ± 6.6 2,691.4Ba ± 149.6 2,655.5Aa ± 398.6
Aa Ab Aa
0.75 Duran 173.0 ± 6.1 106.6 ± 5.1 2,620.0 ± 88.0 2,427.9Ab ±197.3
Essix A+ 186.5Aa ± 4.0 104.0Ab ± 11.9 2,423.8Aa ± 98.8 2,591.4Aa ± 152.7
eCligner 182.3Aa ± 5.6 103.0Ab ± 15.0 2,313.1Aa ± 112.2 2,199.5Aa ± 236.8
Ba Ab Aa
Essix ACE 168.5 ± 8.9 105.6 ± 13.5 2,556.7 ± 98.1 1,958.5Ab ± 171.5
1.0 Duran 241.3Aa ± 6.4 143.1Ab ± 10.5 2,548.2Aa ± 141.7 2,391.5Aa ± 72.4
Essix A+ 234.0Aa ± 5.9 154.0Ab ± 21.2 2,218.4Aa ± 119.0 2,392.1Aa ± 88.5
Ba Ab Aa
Essix ACE 218.0 ± 13.8 141.9 ± 8.3 2,307.8 ± 102.1 1,861.2Bb ± 145.6
Values are presented as mean ± standard deviation.
A,B
The same capital letters in the vertical columns indicate no difference between materials at the 1% significance level. a,bThe
same lower case letters in the horizontal rows indicate no difference between BT and AT at the 1% significance level.
See Table 1 for the manufacturer of each product.

creased after thermoforming (p < 0.01), whereas there manufacturers. However, there are no standard methods
were no significant changes in the modulus for Essix A+ for evaluating the mechanical and physical properties of
and eCligner. thermoplastic materials used for the fabrication of TOAs.
Finally, at the 1.0-mm thickness, there were no signif- The present study aims to establish a standard method
icant differences in the elastic modulus among materials for these evaluations.
before thermoforming (p > 0.01). After thermoforming, In the present study, transparency was evaluated to
Essix ACE showed a significantly lower elastic modulus investigate the esthetic aspect of the materials, while
than did Duran and Essix A+ (p < 0.01). The modulus water absorption and solubility were evaluated to un-
for the Essix ACE specimens was significantly lower after derstand how the thermoplastic materials absorb and
thermoforming than before thermoforming (p < 0.01). dissolve saliva when placed in the oral cavity for some
duration. The surface hardness determined the rigid-
DISCUSSION ity of the materials, while the three-point bending and
tensile tests assessed their effectiveness for tooth move-
We performed a multiscale evaluation after the ther- ment and their durability.
moforming of various thermoplastic materials (Duran, We found that the transparency of materials decreased
Essix A+, Essix ACE, and eCligner) with different thick- with an increase in their thickness. In addition, with a
nesses in order to test the null hypothesis that the me- decrease in thickness after thermoforming, the transpar-
chanical and physical properties of all materials would ency also decreased. This finding is inconsistent with that
remain unchanged after thermoforming. For different in a previous study showing an increase in transparency
materials and thicknesses, the results revealed significant with a decrease in thickness.28 In another study, however,
changes in different evaluated parameters, including the the transparency of thermoplastic plates that deformed
transparency, water absorption and solubility, surface from amorphous to crystalline structures decreased ac-
hardness, flexure and elastic moduli, and tensile and cording to the temperature, pressure, and working time,
flexural forces, after thermoforming. Thus, the null hy- while light was scattered by the thermoplastic materials
pothesis was rejected. after thermoforming.29 Therefore, structural deforma-
Thermoplastic materials used for TOAs are structurally tion of thermoplastic materials results in decreased
composed of amorphous or partially crystalline poly- transparency. Nevertheless, this transparency change
mers, which allow visible light to pass through and give did not compromise the esthetic appearance of TOAs.
a transparent appearance. In clinical applications, TOAs TOAs affect orthodontic forces through moisture ab-
are fabricated from thermoplastic materials using 3D- sorption and expansion in the oral environment. Ryoka-
printed models of teeth, in accordance with the tem- wa et al.23 reported that water absorption by both PETG
perature, pressure, and time specifications provided by and copolyester increased to 0.8 wt% in their 2-week

322 https://doi.org/10.4041/kjod.2018.48.5.316 www.e-kjo.org

Ryu et al • Post-thermoform, thermoplastic materials and transparent orthodontic aligners

experiment. In addition, water absorption by PETG dif- reasonable to use thinner thermoplastic materials for the
fered depending on the type of thermoplastic material.23 fabrication of TOAs for orthodontic treatment, consider-
Zhang et al.30 reported that water absorption increased ing they align the dentition in a step-by-step manner.35
when polyurethane was added to PETG during the de- We performed a tensile test after thermoforming in
velopment of a new thermoplastic material for TOAs. order to evaluate the durability of the tested thermo-
In the present study, all thermoplastic materials plastic materials. Ryokawa et al.23 reported that the force
showed increased water absorption abilities after ther- and elastic modulus of some thermoplastic materials
moforming. In addition, the water solubility of all ma- used for TOAs decreased in a simulated intraoral en-
terials except eCligner increased after thermoforming. vironment. In the present study, the force and elastic
If we were to propose an evaluation standard for ther- modulus of all materials decreased after thermoform-
moplastic materials used for the fabrication of TOAs, we ing. With an increase in the thickness of the materials,
would recommend following the water absorption and the force increased while the elastic modulus decreased
solubility evaluation methods specified in ISO 20795-2: (Table 4). If the thermoplastic materials were subjected
Orthodontic base polymer.27 to a temperature higher than the glass transition tem-
The hardness of the thermoplastic materials tested perature, they can easily deform and decrease in thick-
in this study changed after thermoforming. Generally, ness. Moreover, they change from the amorphous to the
external forces affect TOAs used for orthodontic treat- crystalline form with a decrease in temperature, with the
ment. Previous studies compared the surface hardness crystalline phase affecting the mechanical properties.34
values for various thermoplastic materials before ther- Therefore, the durability of thermoplastic materials used
moforming.31,32 Vickers hardness was also measured to for the fabrication of TOAs should be evaluated before
compare the transfer of force and energy according to and after thermoforming.
the type and thickness of the thermoplastic material, Generally, it is difficult to evaluate thermoplastic ma-
and it was found that the hardness affected the ortho- terials used for the fabrication of TOAs. However, we
dontics force.25,33 In the present study, the surface hard- applied the recommendations specified in ISO 20795-2:
ness of Essix A+ and Essix ACE increased after thermo- Orthodontic base polymer, using models that reflected
forming, whereas that of Duran and eCligner showed no the arrangement of the maxillary central incisors in clini-
significant changes. Previously, it has been shown that cal conditions.
thermoplastic materials crystallize from the amorphous This study also has some limitations. First, it did not
state because of the high temperature and pressure ap- fully consider intraoral conditions such as salivation and
plied to the material, with the regular polymer chains the temperature/humidity. This should be addressed
closely arranged over a relatively long distance. Accu- in future studies. In fact, we are currently considering
mulation of the secondary bonding force that holds the the effects of intraoral conditions and the actual clini-
polymer chains together results in a binding force larger cal situations in orthodontic patients for the evaluation
than that in the amorphous region.34 Thus, the surface of TOAs. Moreover, studies considering the mechanical
hardness may increase with transformation of the amor- strength under repetitive application of TOAs to assess
phous regions into crystalline regions. the fatigability of the device may provide useful infor-
To determine the feasibility for using the thermoplas- mation in the future.
tic materials as TOAs in clinical applications, we per-
formed the three-point bending test. The study by Kwon CONCLUSION
et al.25 showed that changes in the force and resilience
of such materials can affect their orthodontic use. More- In conclusion, our findings suggest that the physical
over, Min et al.24 showed that thermoplastic materials and mechanical properties of thermoplastic materials
can be affected by the deflection of load and stress ac- used for the fabrication of TOAs should be evaluated af-
cording to their thickness and resilience induced by the ter thermoforming in order to characterize their proper-
thermoforming conditions proposed by the manufactur- ties for clinical application. From the clinical perspective,
er. However, these researchers did not evaluate the ma- our results imply that TOAs should be carefully selected
terial properties before and after thermoforming. In the depending on the treatment required, because some
present study, with an increase in the thickness of the may exhibit a significant decrease in flexural forces af-
thermoplastic materials, the force increased but the flex- ter thermoforming and exhibit permanent deformation
ure modulus decreased (Table 3). The flexure modulus during treatment. On the other hand, the application of
was directly proportional to the force of the thermoplas- large forces to teeth may result in apical root absorp-
tic materials and inversely proportional to their thick- tion.
ness. Thus, the flexure modulus was higher for thinner
materials and lower for thicker materials. Therefore, it is

www.e-kjo.org https://doi.org/10.4041/kjod.2018.48.5.316 323

 Ryu et al • Post-thermoform, thermoplastic materials and transparent orthodontic aligners

CONFLICTS OF INTEREST 14. Lagravère MO, Flores-Mir C. The treatment effects

of Invisalign orthodontic aligners: a systematic re-
No potential conflict of interest relevant to this article view. J Am Dent Assoc 2005;136:1724-9.
was reported. 15. Barone S, Paoli A, Razionale AV, Savignano R. Com-
puter aided modelling to simulate the biomechani-
ACKNOWLEDGEMENTS cal behaviour of customised orthodontic removable
appliances. IJIDeM 2016;10:387-400.
This research was supported by a grant (16172MFDS335) 16. Hahn W, Zapf A, Dathe H, Fialka-Fricke J, Fricke-
from the Ministry of Food and Drug Safety in 2016. Zech S, Gruber R, et al. Torquing an upper central
incisor with aligners--acting forces and biomechani-
REFERENCES cal principles. Eur J Orthod 2010;32:607-13.
17. Simon M, Keilig L, Schwarze J, Jung BA, Bourauel C.
1. Martorelli M, Gerbino S, Giudice M, Ausiello P. A Forces and moments generated by removable ther-
comparison between customized clear and remov- moplastic aligners: incisor torque, premolar derota-
able orthodontic appliances manufactured using RP tion, and molar distalization. Am J Orthod Dentofa-
and CNC techniques. Dent Mater 2013;29:e1-10. cial Orthop 2014;145:728-36.
2. Ogaard B, Rølla G, Arends J. Orthodontic appliances 18. Li X, Ren C, Wang Z, Zhao P, Wang H, Bai Y. Chang-
and enamel demineralization. Part 1. Lesion devel- es in force associated with the amount of aligner
opment. Am J Orthod Dentofacial Orthop 1988;94: activation and lingual bodily movement of the max-
68-73. illary central incisor. Korean J Orthod 2016;46:65-
3. Featherstone J. Dental caries: a dynamic disease 72.
process. Aust Dent J 2008;53:286-91. 19. Rossini G, Parrini S, Castroflorio T, Deregibus A, De-
4. Joffe L. Invisalign: early experiences. J Orthod 2003; bernardi CL. Efficacy of clear aligners in controlling
30:348-52. orthodontic tooth movement: a systematic review.
5. Shalish M, Cooper-Kazaz R, Ivgi I, Canetti L, Tsur B, Angle Orthod 2015;85:881-9.
Bachar E, et al. Adult patients' adjustability to orth- 20. Dupaix RB, Boyce MC. Finite strain behavior of poly
odontic appliances. Part I: a comparison between (ethylene terephthalate)(PET) and poly (ethylene
Labial, Lingual, and InvisalignTM. Eur J Orthod 2012; terephthalate)-glycol (PETG). Polymer 2005;46:
34:724-30. 4827-38.
6. Kesling HD. The philosophy of the tooth positioning 21. Fang D, Zhang N, Chen H, Bai Y. Dynamic stress re-
appliance. Am J Orthod Oral Surg 1945;31:297-304. laxation of orthodontic thermoplastic materials in a
7. Sheridan JJ. The Readers' Corner. 2. What percent- simulated oral environment. Dent Mater J 2013;32:
age of your patients are being treated with Invis- 946-51.
align appliances? J Clin Orthod 2004;38:544-5. 22. Lombardo L, Martines E, Mazzanti V, Arreghini A,
8. Nahoum H. The vacuum formed dental contour ap- Mollica F, Siciliani G. Stress relaxation properties of
pliance. N Y State Dent J 1964;9:385-90. four orthodontic aligner materials: A 24-hour in vi-
9. Ponitz RJ. Invisible retainers. Am J Orthod 1971;59: tro study. Angle Orthod 2017;87:11-8.
266-72. 23. Ryokawa H, Miyazaki Y, Fujishima A, Miyazaki T,
10. Melkos AB. Advances in digital technology and or- Maki K. The mechanical properties of dental ther-
thodontics: a reference to the Invisalign method. moplastic materials in a simulated intraoral environ-
Med Sci Monit 2005;11:PI39-42. ment. Orthod Waves 2006;65:64-72.
11. Cassetta M, Altieri F, Pandolfi S, Giansanti M. The 24. Min S, Hwang CJ, Yu HS, Lee SB, Cha JY. The effect
combined use of computer-guided, minimally in- of thickness and deflection of orthodontic thermo-
vasive, flapless corticotomy and clear aligners as a plastic materials on its mechanical properties. Ko-
novel approach to moderate crowding: a case report. rean J Orthod 2010;40:16-26.
Korean J Orthod 2017;47:130-41. 25. Kwon JS, Lee YK, Lim BS, Lim YK. Force delivery
12. Boyd RL, Miller RJ, Vlaskalic V. The Invisalign sys- properties of thermoplastic orthodontic materials.
tem in adult orthodontics: mild crowding and space Am J Orthod Dentofac Orthop 2008;133:228-34;
closure cases. J Clin Orthod 2000;34:203-12. quiz 328.e1.
13. Kravitz ND, Kusnoto B, BeGole E, Obrez A, Agran B. 26. Ahn HW, Kim KA, Kim SH. A new type of clear orth-
How well does Invisalign work? A prospective clini- odontic retainer incorporating multi-layer hybrid
cal study evaluating the efficacy of tooth movement materials. Korean J Orthod 2015;45:268-72.
with Invisalign. Am J Orthod Dentofacial Orthop 27. International Organization for Standardization (ISO).
2009;135:27-35. ISO 20795-2:2013 Dentistry-base polymers--Part 2:

324 https://doi.org/10.4041/kjod.2018.48.5.316 www.e-kjo.org

Ryu et al • Post-thermoform, thermoplastic materials and transparent orthodontic aligners

orthodontic base polymers. Geneva: ISO; 2013. T. Chemical and mechanical characteristics of con-
28. Azhikannickal E, Bates PJ, Zak G. Laser light trans- temporary thermoplastic orthodontic materials. Aust
mission through thermoplastics as a function of Orthod J 2015;31:165-70.
thickness and laser incidence angle: experimental 33. Kohda N, Iijima M, Muguruma T, Brantley WA, Ah-
and modeling. J Manuf Sci Eng 2012;134:061007. luwalia KS, Mizoguchi I. Effects of mechanical prop-
29. Kattan M, Dargent E, Ledru J, Grenet J. Strain- erties of thermoplastic materials on the initial force
induced crystallization in uniaxially drawn PETG of thermoplastic appliances. Angle Orthod 2013;
plates. J Appl Polym Sci 2001;81:3405-12. 83:476-83.
30. Zhang N, Bai Y, Ding X, Zhang Y. Preparation and 34. Brazel CS, Rosen SL. Fundamental principles of
characterization of thermoplastic materials for invis- polymeric materials. 3rd ed. London: John Wiley;
ible orthodontics. Dent Mater J 2011;30:954-9. 2010. p. 53.
31. Gardner GD, Dunn WJ, Taloumis L. Wear compari- 35. Elkholy F, Schmidt F, Jäger R, Lapatki BG. Forces
son of thermoplastic materials used for orthodontic and moments applied during derotation of a maxil-
retainers. Am J Orthod Dentofacial Orthop 2003; lary central incisor with thinner aligners: an in-vitro
124:294-7. study. Am J Orthod Dentofacial Orthop 2017;151:
32. Alexandropoulos A, Al Jabbari YS, Zinelis S, Eliades 407-15.

www.e-kjo.org https://doi.org/10.4041/kjod.2018.48.5.316 325

Appendix 1. Thickness variations for different thermoplastic materials used for the fabrication of transparent
orthodontic aligners
Thickness Thickness
Brand (mm) DThickness (%) Significance
BT AT
Duran 0.5 0.55 ± 0.00 0.34 ± 0.01 38.2 *
Essix A+ 0.50 ± 0.00 0.28 ± 0.03 44.0 *
eCligner 0.50 ± 0.00 0.29 ± 0.03 42.0 *
Duran 0.75 0.75 ± 0.00 0.54 ± 0.01 28.0 *
Essix A+ 0.76 ± 0.01 0.49 ± 0.02 35.5 *
eCligner 0.75 ± 0.00 0.53 ± 0.04 29.3 *
Essix ACE 0.78 ± 0.00 0.50 ± 0.03 35.9 *
Duran 1.0 1.00 ± 0.00 0.67 ± 0.01 33.0 *
Essix A+ 1.02 ± 0.00 0.74 ± 0.03 27.5 *
Essix ACE 1.05 ± 0.01 0.68 ± 0.02 35.2 *
Values are presented as mean ± standard deviation.
Comparison of the thickness before thermoforming (BT) and after thermoforming (AT).
The asterisk indicates difference between BT and AT at the 5% significant level.

Appendix 2. Comparison of elastic deformation among different thermoplastic materials (0.75-mm thickness) using
tensile tests. Comparison of elastic deformation before thermoforming (BT) and after thermoforming (AT). A, Duran; B,
Essix A+; C, eCligner; D, Essix ACE.