PIIS0889540619306262
PIIS0889540619306262
PIIS0889540619306262
Introduction: The aim of this research was to compare compressive mechanical properties and geometric inac-
curacies between conventionally manufactured thermoformed Duran clear dental aligners and 3D printed Dental
Long Term (LT) resin-based clear aligners using 3D modeling and printing techniques. Methods: Impressions of
the patient's dentition were scanned and using 3D modeling software, dental models were designed and 3D
printed. These printed models then underwent vacuum thermoforming to thermoform a clear Duran thermoplastic
sheet of 0.75-mm thickness into clear dental aligners of the same thickness of 0.75 mm. For the same dental
model, aligners were also designed and 3D printed to 0.75-mm thickness creating biocompatible clear dental
aligners using Dental LT resin utilizing a Formlabs 3D printing machine for direct usage by the patients. Five
observers calculated teeth height for both types of aligners for evaluation of geometric deviations. Both types of
aligners were subjected to compression loading of 1000 N to evaluate their load vs displacement behavior.
Results: 3D printed cured clear dental aligners were found to be geometrically more accurate with an average rela-
tive difference in tooth height of 2.55% in comparison with thermoformed aligners (4.41%). Low standard devia-
tions (0.03-0.09 mm) were observed for tooth height measurements taken by all the observers for both types of
aligners. 3D printed aligners could resist a maximum load of nearly 662 N for a low displacement of 2.93 mm;
whereas, thermoformed aligners could resist a load on only 105 N for 2.93-mm displacement. Thermoformed
aligners deformed plastically and irreversibly for large displacements; whereas, 3D printed aligners deformed
elastically with reversibility for lower displacements. Conclusions: 3D printed and suitably cured Dental LT
resin-based clear dental aligners are suggested to be more suitable for patient use as they are geometrically
more accurate; this presents an opportunity to make processing time savings while ensuring an aligner is
mechanically stronger and elastic in comparison with the conventionally produced thermoplastic-based
thermoformed clear dental aligners. (Am J Orthod Dentofacial Orthop 2019;156:694-701)
T
he demand for superior and esthetic orthodontic attracting patients to treat even minor functional disorders
treatment has risen dramatically because of an in an attempt to raise their confidence as a result of an es-
increased awareness toward oral hygiene. Improve- thetically superior dentofacial appearance. Because of the
ments in orthodontic treatments and appliances have led availability of this treatment, there has been an increase in
to enhancements within the dentofacial sector. Seventy- demand for superior functional and esthetic orthodontic
five percent of adult patients are dissatisfied with their appliances. With the advent of Rapid Prototyping (RP)
dental appearance.1 Improvements in patient esthetic technologies, revolutionary advancements have taken
appearance are therefore becoming more frequent and place in the manufacturing of products in several fields
such as medical, dentistry, automobiles, machines, artistry,
a
University Institute of Engineering and Technology, Panjab University, Chandi- etc. From the dentistry applications viewpoint, RP is one
garh, India.
b
of the most efficient tools for 3D printing of complex
Medical Engineering Design Research Group, Nottingham Trent University,
Nottingham, United Kingdom.
anatomical structures2 to manufacture models that can
All authors have completed and submitted the ICMJE Form for Disclosure of Po- replace plaster models which are vulnerable to environ-
tential Conflicts of Interest, and none were reported. mental conditions, storage, breakage, and human errors.
Address correspondence to: Philip Breedon, Director of Medical Engineering
Design Research Group, Nottingham Trent University, Nottingham, NG1 4FQ,
RP also allows the reproduction of a physical 3D model
United Kingdom; e-mail, [email protected]. by adding material layer-by-layer, this is referred to as ad-
Submitted, September 2018; revised and accepted, May 2019. ditive manufacturing.3 Common RP techniques include
0889-5406/$36.00
Ó 2019 by the American Association of Orthodontists. All rights reserved.
stereolithography, selective laser sintering, and Fused
https://doi.org/10.1016/j.ajodo.2019.05.012 Deposition Modeling (FDM).4
694
Jindal et al 695
Hazeveld et al5 introduced RP as an approach to Manufactured aligners could have inherent limita-
fabricate replica dental plaster models. Initially, plaster tions such as dimensional instability, low strength,
models were scanned using a dual-sensor scanner to and reduced wear resistance. These issues could be
form 3D surface models in a Standard Tessellation Lan- associated with material characteristics and with the
guage (STL) format. These STL files then underwent manufacturing processes. The manufacturing process
various RP methods such as a jetted photopolymer, dig- could also introduce unexpected limitations in the re-
ital light processing, and 3D printing to generate 3D sulting aligners, which would be a critical element to
models. These models were then compared for dimen- control in order to establish resulting forces on teeth.
sional accuracies using a set of digital calipers. Mean dif- Several studies demonstrated that the aligner thickness
ferences in measurements of clinical crowns were found could significantly influence resulting forces.10 Tensile
to be 0.04 mm for digital light processed models, tests were conducted on polymer materials before and
0.02 mm for jetted photopolymer models and after thermoforming to understand the effect of the
0.25 mm for 3D printed models. Because the dimen- manufacturing process. The effects of aging under hu-
sional errors were minimal, it was concluded that 3D man saliva were also evaluated. With aging, both tensile
printed models could be a suitable replacement for con- yield stress (49.49 MPa) and elastic modulus (1368 MPa)
ventional plaster models. decreased in comparison with the thermoformed spec-
El-Katatny et al6 reported superior geometric accu- imen (53.52 MPa and 1693 MPa). For specimens tested
racies obtained using FDM printing for the fabrication before thermoforming, both yield stress (49.29 MPa) and
of anatomical replicas using models of different human elastic modulus (1531 MPa) were weaker than thermo-
sizes and gender. The results indicated an overall abso- formed specimens.
lute average deviation of 0.24% and an average standard Ahn et al11 described the inherent limitations (dimen-
deviation of 0.16% for the skull models, thereby empha- sional instability, low strength, poor wear resistance) of
sizing the impact of 3D printing in medical applications. thermoplastic polymer materials used in orthodontics
Lee et al7 evaluated the accuracy of teeth printed using and suggested using multi-hybrid materials with a 3
FDM and PolyJet printing techniques. Molar teeth were layer combination of polyethylene terephthalate glycol,
extracted, scanned, and printed. Geometric comparisons thermoplastic polyurethane, and reinforced resin core
of the height of printed and original molar teeth to overcome these limitations. Tensile testing was per-
(17.226 mm) indicated superior accuracy of PolyJet formed on rectangular specimens for these hybrid layers
printing (17.219 mm) in comparison with FDM materials and the maximum tensile load-bearing capac-
(17.083 mm). ity enhanced by nearly 80%. The testing findings
Clear dental aligners are widely used in orthodontics presented by Ahn et al,11 demonstrated that improve-
as an esthetic solution for alignment of misaligned teeth ments in dental aligners could be achieved if optimal
by developing various stages of aligner models.8 The material and manufacturing methods are used.
conventional process of fabricating an aligner is based Johal et al12 reported the significance of geometric
on obtaining a dental impression on plaster models inaccuracies related to proper fitment of dental aligners
from the patient and then thermoforming a biocompat- on models. Four thermoformed clear aligners were used
ible thermoplastic transparent sheet using a vacuum with specific biomarkers and statistical analysis used to
thermoforming machine.9 Geometric inaccuracies are analyze the results. Subsequent scanning and analyzing
common and are often caused during the impression of the casts and thermoformed retainers were performed
collection and thermoforming processes; this could be in a dedicated area using a coordinate measuring ma-
minimized through the utilization of digital technolo- chine in order to calculate their respective fit at the
gies, 3D modeling, and RP techniques. incisor and first molar regions. Statistically significant
Plaster models can be scanned and modeled to differences were observed in the fit behavior of all 4 ther-
develop various alignment stages. These stages can moform materials.
then be 3D printed with superior accuracies and accord- Cone-beam computed tomography, and 3D printing
ingly, a thermoformed aligner sheet can be used to fabri- proved to be efficient methods for designing and fabri-
cate aligners with minimal geometric errors. To further cating thermoplastic retainers in comparison with the
reduce these errors, if a clear biocompatible aligner could conventional thermoformed alternatives in terms of
be 3D printed for direct patient usage, then all the inter- geometric measurements.13 However, for thermoformed
mediate steps compromising the inaccuracies could be and 3D printed retainers, strong statistical agreement in
eliminated. In addition, direct aligner printing presents measurements was also observed.
an opportunity to save on time, workforce, and exper- Commercially available aligners perform differently
tise. depending on their thickness and construction material.
American Journal of Orthodontics and Dentofacial Orthopedics November 2019 Vol 156 Issue 5
696 Jindal et al
In an ideal situation, an aligner should apply a light force description of all the significant steps used for designing
that is constant over time. For an aligner to exert safe but and fabrication of dental aligners are given below.
efficacious forces, the ideal material should be fairly stiff Scans of the mandibular region of the patient's denti-
with high yield strength capable of ensuring that the tion were taken using negative impressions; following
force applied is within the elastic range. The stress relax- this, a model using alginate was created. The negative
ation curve should, therefore, be reasonably flat, demon- impression was taken with complete care, taking into
strating its ability to exert constant and continuous consideration the required size of the tray to fit the denti-
forces over time. Duran and F22 Aligner materials ex- tion and properly mixing the catalyst with putty so that
hibited faster stress decays during the 24-hour stress no swirls exist in the original putty color. Deep biting
relaxation period compared with Erkoloc-Pro and was carried out to ensure even pressure from both the
Durasoft.14 front and the back sides of the mouth. Adequate time
Aligners fabricated from thicker materials (.0.75 mm) was given for the putty to settle and stabilize to ensure
always produced significantly higher forces than those an accurate impression could be acquired. The cast or
fabricated from thinner material (\0.5 mm). A strong cor- mold of the teeth was statically scanned using a 3Shape
relation was shown between mechanical properties of E1 Blue LED Multi-line laboratory scanner with an accu-
the thermoplastic materials and force produced by the racy of 10-12 mm16 to generate an STL file for carrying
aligners. Duran and Erkodur aligner materials were sug- out the further phases of computer-aided design and
gested to be more effective for teeth movements in com- computer-aided manufacturing.
parison with Hardcast as their hardness, and elastic The scanned STL file of the patient's teeth was loaded
modulus was nearly twice to that of Hardcast.15 into the computer-aided design and computer-aided
Based on the results reported on mechanical proper- manufacturing software (Maestro Studio, Pontedera,
ties of different aligner materials, it has been shown that Italy) which was used to study and analyze the phases
3D printing technologies provide superior geometric for treatment. A series of steps were performed on the
configurations in manufacturing, especially related to original dentition as required by the predicted successive
dentistry applications. However, no work has been pub- stages while planning the treatment process. The steps
lished on the compressive properties of dental aligners, that were performed included the loading of the STL
especially when considering that mastication and biting file, marking of the missing teeth, measuring the width
processes in a human jaw are frequent and demanding. of each tooth and identifying the ideal arch length to
In addition, compressive forces generated by excessive check the interproximal reduction. The boundary of
clenching are also presented in other conditions. To the teeth over the dentition was marked by point plot-
date, there are limited findings relating to the compari- ting; this is a necessary process as there should be no
son of mechanical and geometric properties between 3D sharp edges or overlapping of the aligner with the gums.
printed and thermoformed clear aligners. For the fabrication of the thermoformed aligners, this
In this article, we aimed to use a biocompatible initially requires the 3D printing of the dental models.
Dental Long Term (LT) resin material for printing clear The scanned STL files were loaded into the 3D printer
dental aligners using a stereolithography Form 2 printer interfacing software to print the physical dental models
and compare its compressive and geometric properties (Fig 1, A).
with a conventional Duran based thermoformed aligner To manufacture the clear thermoformed dental
for proposing its suitability to a patient suffering from aligner, the 3D printed models were used under vacuum
the problem of teeth misalignment. thermoforming process with a pressure of 4 bar at 70 C
to thermoform clear thermoplastic Duran17 sheet 0.75-
mm thickness into a clear dental aligner of the same
MATERIAL AND METHODS thickness as 0.75 mm (Fig 1, B). A total of 5 aligners
The fabrication of dental aligners using 3D printing of were thermoformed.
biocompatible materials is an exploratory research area During the software modeling of the teeth, an aligner
that involves numerous factors to be considered including is generated based on the negative impression of the
minimizing human error, discarding outliers (gums) from dental model. The thickness of an aligner that can provide
aligners, maintaining balanced environmental factors, the required alignment was defined as 0.75 mm, and the
and hygienic maintenance. The production of aligners in- final STL file format compatible for 3D printing was
volves various crucial phases from the scanning of the generated accordingly for 3D printing. Dental LT clear
dentition to the usability testing of aligners to ensure it resin material is a Class IIa long-term biocompatible resin
can perfectly fit over the teeth to achieve the required with high resistance to fracture and wear is ideal for hard
teeth alignments across every stage. The detailed splints, retainers, and other direct-printed long-term
November 2019 Vol 156 Issue 5 American Journal of Orthodontics and Dentofacial Orthopedics
Jindal et al 697
Fig 1. A, 3D printed dental models; B, vacuum thermoformed thermoplastic Duran clear dental aligner.
orthodontic appliances.18 It conforms to the essential re- For post cure treatment, the optimal settings for 3D
quirements and provisions of the Council Directive 93/42/ printed parts are dependent on the material used, the
EEC and Medical Device Directive 2007/47/EC.19,20 This size of the model, and the model's geometry. Optimal
material was used to directly print 0.75-mm thick clear postcuring is also dependent on the type of equipment
dental aligners obtained from a modeled image of the used to cure the parts. For this study, the Form Cure
misaligned mandible stage of a patient using the For- was used; this postcuring solution uses a 405-nm light
mlabs Form 2 3D printer (Somerville, Mass). source (13 multidirectional light-emitting diodes) in
The aligners were orientated to ensure that minimal combination with a heated cure chamber capable of
support material was applied within the internal struc- temperatures reaching 80 C.22,23
ture to allow quick postprocessing finishing. Each The Form Cure is an automated postcuring chamber
aligner was rotated to 25o within the x-axis to that uses UV-light treatment to ensure materials obtain
ensure standardization throughout all the 3D printed full polymer conversion. The specification for the Dental
dental aligners. Rotation cannot exceed 30o as this will LT clear material used for this study states that printed
compromise precision and lead to poorly fitting parts.21 parts require curing using a Blue UV-A 315-400 nm or
The anterior portion of the dental aligner must always be UV-Blue 400-550 nm source for 10 minutes to
directed upward, and away from the build platform, fail- ensure biocompatibility.21 Postcuring the parts for a
ure to do so can result in a suction cup error being pre- duration .10 minutes allows the material to reach its
sent (Fig 2, A) and inaccurate parts being printed. optimal mechanical properties.23 However, finding a
The PreForm software (Version 2.17.1, Formlabs) can correct combination between temperatures and time
automatically generate the support structure required; duration during postcuring is required based on the
however, manual manipulation is still often required to desired applications and acceptable mechanical proper-
ensure optimization of the 3D printing process. Before ties for each task.
set up, the correct orientation and layout position (models Variable curing conditions were set up to quantify
spaced .5 mm) was established and within the defined the effects of temperature and time on the mechanical
specification to ensure successful 3D printing. The sup- properties of these aligners. Five specimens were printed
port structure is fundamental, and if parts fail to be suf- for 2 curing conditions stated as 80 C for 20 minutes
ficiently supported, the part will either fail to print or and 80 C for 15 minutes.
produce a model with many inaccurate features or bodies. Compression testing was conducted utilizing an Ins-
Unsupported 3D models with minima errors are dis- tron 3367 universal testing machine (Instron Corp, Wil-
played using red markers as demonstrated in (Fig 2, B); mington, De) for applying a maximum of 1000 N
manual support structure corrections were made accord- compressive force on all the aligner specimens, these
ingly to overcome these errors, thus allowing the aligners were compressed between 2 flat plates, with the lower
to be adequately supported. Upon successful printing of plate stationary and upper plate moving at a rate of
the dental aligners (Fig 3, A), the parts are washed using 50 N/min under a 1000 N load cell. The behavior of
isopropyl alcohol (96% or higher) and then initially dried us- aligner deformation with load application was obtained
ing compressed air to ensure no excess resin or isopropyl using the compatible data acquisition software.
alcohol remains on the model which can result in splotches
of unwanted material curing on the models. The washed
RESULTS
and dried models are then cured, which then is followed
by postprocessing tasks, which include the removal of the It is challenging to assess the effect of improved
support structure (Fig 3, B) using the standard cutting tools. learning acquired by individuals when completing a
American Journal of Orthodontics and Dentofacial Orthopedics November 2019 Vol 156 Issue 5
698 Jindal et al
Fig 3. A, Printed and cured dental aligner with supports; B, supports removed from dental aligner.
November 2019 Vol 156 Issue 5 American Journal of Orthodontics and Dentofacial Orthopedics
Jindal et al 699
which were close to the mean values of tooth enhancements in the technologies are possible with the
heights. evolution of 3D printing. Orthodontics is one of the major
Compression testing conducted and presented in domains in which 3D printing has evolved the treatment
figure 5 shows the load resistance behavior with displace- methods. Up until now, the use of 3D printing in orthodon-
ment among uncured 3D printed clear aligners, cured 3D tics has mostly been limited to the fabrication of physical
printed aligners, and thermoformed clear aligners. Un- models of upper and lower dentition, which are clinically
cured aligners exhibited plastic flow with high deforma- accurate for treating patients.10 This methodology could
tion as the load increased attaining a maximum load of be used for fabrication of clear orthodontic retainers by
380 N and displacement nearly 6.1 mm. Aligners cured 3D printing the dental models and thermoforming of
at 80 C for 20 minutes could resist a maximum load of aligners.24 In this article, the mechanical and geometric
nearly 662 N before suddenly fracturing into brittle comparison between the cured 3D printed aligner, uncured
pieces. Aligners subjected to 80 C for 15 minutes indi- 3D printed aligner, and thermoformed aligner has been
cated maximum resistance load of 531 N with a brittle discussed.
fracture in the end. Cured aligners deformed elastically Cured aligners that were 3D printed exhibited supe-
and final deformation was nearly 2.93 mm. Thermo- rior dimensional accuracy and compressive mechanical
formed aligners’ deformation with increased load was strength in comparison with uncured 3D printed aligners
similar to uncured 3D printed aligners. The deformation and thermoformed aligners. Dental LT resin used to
was plastic with larger and irreversible deformation up fabricate clear dental aligners is an approved biocompat-
to nearly 8.6 mm with a maximum load of 584 N. Plastic ible material whose monomer is based on the acrylic
flow without any resistance to the external load indicates ester.25 The limited chain mobility of the cross-linked
poor resistance to deformation. polymer network and higher flux during curing gener-
ates a large number of radicals.18 The mobility of un-
reacted double bonds becomes a limiting condition in
DISCUSSION the overall conversion of double bonds during postcur-
Advancements in the product-based industries are ing. The kinetic chain generated because of propagating
becoming more prominent, and many of the radical leads to extra cross-linking of the resin during
American Journal of Orthodontics and Dentofacial Orthopedics November 2019 Vol 156 Issue 5
700 Jindal et al
printing. The behavior ultimately enhances the mechan- processes have become a regular practice among scien-
ical properties of the printed parts.26 tists, medical professionals, and industrialists. Clear
Postcuring enhanced the compressive strength of the dental aligners provide a long-term treatment process
3D printed aligner material in comparison with the uncured for aligning misaligned teeth of patients for their perfect
aligner. The maximum resistant load was nearly 75% higher esthetic smile. However, because the conventional pro-
than uncured and maximum deformation was nearly 70% cess of thermoforming is time-consuming, an RP solu-
less, thus indicating that cured printed aligners are more tion for directly printing a mechanically strong and
rigid and brittle. The average magnitude of the biting force biocompatible aligner could always be preferred. Dental
of a human is nearly 500 N.27 Hence, the cured printed LT resin is an approved Class IIa biocompatible material,
aligners can reliably sustain the mastication and biting and its mechanical strength is ensured with the postcur-
force. Thermoformed aligners are fabricated out of thermo- ing conditions.
plastic Duran, and their plastic deformation with load appli- The experimental studies conducted have provided
cation showed excessive irreversible deformation. significant insight into the procedure of designing and
Deformation beyond 10%-15% strain causes irreversibility printing of clear aligners that can be used by the
because of its yielding. With displacements found to be be- patients. Clear findings are reported related to the
tween 1.5-2.5 mm for the Duran thermoformed aligners, effects of varying the curing temperatures and time du-
the maximum load resistance was found to be nearly rations that can provide sufficient mechanical strength
200 N, which holds more importance than maximum to these clear dental aligners. Thermoformed aligner
load resistance of 584 N. manufacturing is time-consuming and requires a high
Because human biting and mastication is a continuous level of expertise. In addition, patients need to repeat-
process, and the aligner is not supposed to be a one-time edly remove and wear them during different periods
use product, its reversibility factor is critical. For safe and and activities of eating, biting, and mastication. The pri-
effective usage, an ideal aligner material should be stiff mary reasons for thermoformed aligners demonstrating
with a high yield strength and have a flat relaxation curve.14 weaker compression strength and more extensive irre-
Thermoformed aligners exhibited a fairly flat curve, but versible deformation are because of the fact these are
because displacement and deformation were much higher thermoplastic-based materials.
than recovery. We suggest that it remains unsuitable during In comparison, a high yielding, higher load resist-
mastication and biting processes. Conversely, cured printed ing, and lower deforming clear dental aligners ob-
aligners were found to be stiff with higher-yielding and tained from 3D printing could provide a superior
lower displacement with reversible deformation. Thus, alternative solution to this established practice. In
cured printed aligners could be recommended to be used this article, we have been able to successfully suggest
as a clear dental aligner under all conditions. the suitability of 3D printed and cured clear biocom-
patible dental aligners instead of thermoformed
CONCLUSIONS aligners because of their superior geometric accuracy,
With the advent of 3D printing techniques, accurate load resistance, yielding, stiffness, and lower deforma-
orthodontic products and time-saving dentistry tion. Curing conditions can be further engineered to
November 2019 Vol 156 Issue 5 American Journal of Orthodontics and Dentofacial Orthopedics
Jindal et al 701
design customized strength clear dental aligners for Catania, Italy Cham. Berlin: Springer International Publishing;
suitability of patients based on their variable biting 2017. p. 437-46.
11. Ahn HW, Kim KA, Kim SH. A new type of clear orthodontic retainer incor-
forces, which could further assist in reducing
porating multi-layer hybrid materials. Korean J Orthod 2015;45:268-72.
manufacturing costs. 12. Johal A, Sharma NR, McLaughlin K, Zou LF. The reliability of ther-
moform retainers: A laboratory-based comparative study. Eur J
ACKNOWLEDGMENTS Orthod 2015;37:503-7.
13. Nasef AA, El-Beialy AR, Mostafa YA. Virtual techniques for
The authors thank the Commonwealth Scholarship designing and fabricating a retainer. Am J Orthod Dentofacial Or-
Commission for supporting Dr. Prashant Jindal as a thop 2014;146:394-8.
Commonwealth Rutherford Fellow (CSC ID: INRF- 14. Lombardo L, Martines E, Mazzanti V, Arreghini A, Mollica F,
2017-146) within the Medical Engineering Design Siciliani G. Stress relaxation properties of four orthodontic
aligner materials: A 24-hour in vitro study. Angle Orthod
Research Group Nottingham Trent University, Notting-
2017;87:11-8.
ham, United Kingdom. The authors thank the Ministry 15. Kohda N, Iijima M, Muguruma T, Brantley WA, Ahluwalia KS,
of Human Resource Development, Govt of India for Mizoguchi I. Effects of mechanical properties of thermoplastic ma-
funding this project under Design Innovation Centre terials on the initial force of thermoplastic appliances. Angle Or-
subtheme Medical Devices & Restorative Technologies. thod 2013;83:476-83.
16. Juneja M, Thakur N, Kumar D, Gupta A, Bajwa B,
The authors thank Ms. Judith Kipling (Nottingham Trent
Jindal P. Accuracy in dental surgical guide fabrication us-
University) for providing valuable assistance about ing different 3-D printing techniques. Addit Manuf 2018;
compression testing and Total Dental Care Clinic, New 22:243-55.
Delhi, India, for providing patient data. 17. Ryu JH, Kwon JS, Jiang HB, Cha JY, Kim KM. Effects of thermo-
forming on the physical and mechanical properties of thermo-
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American Journal of Orthodontics and Dentofacial Orthopedics November 2019 Vol 156 Issue 5