materials

Article
Utilization of a 3D Printed Orthodontic Distalizer for
Tooth-Borne Hybrid Treatment in Class II
Unilateral Malocclusions
Andrej Thurzo 1, * , Wanda Urbanová 2 , Bohuslav Novák 1 , Iveta Waczulíková 3 and Ivan Varga 4

1 Department of Stomatology and Maxillofacial Surgery, Faculty of Medicine,

Comenius University in Bratislava, 81250 Bratislava, Slovakia; [email protected]
2 Department of Orthodontics and Cleft Anomalies, Dental Clinic 3rd Medical Faculty Charles University,
Faculty Hospital Kralovske Vinohrady, 10034 Prague, Czech Republic; [email protected]
3 Department of Nuclear Physics and Biophysics, Faculty of Mathematics, Physics and Informatics,
Comenius University, Mlynska Dolina F1, 84248 Bratislava, Slovakia; [email protected]
4 Institute of Histology and Embryology, Faculty of Medicine, Comenius University in Bratislava,
81372 Bratislava, Slovakia; [email protected]
* Correspondence: [email protected]; Tel.: +421-903-110-107

Abstract: This paper introduces a novel method of 3D designing and 3D printing of a hybrid
orthodontic tooth-borne personalized distalizer for treatment of unilateral Class II malocclusion.
Research objectives were to clinically utilize 3D printed distalizers, appraise feasibility of this tech-
nique and compare two different biocompatible photopolymers (white and transparent). Frequency



of distalizers’ debonding and patients’ aesthetical perception was evaluated on the set of 12 com-


plete orthodontic treatments. The mean duration of treatment period with a bonded distalizer was
Citation: Thurzo, A.; Urbanová, W.;
Novák, B.; Waczulíková, I.; Varga, I.
6.4 months. All cases were adults with unilateral Class II malocclusion managed with a hybrid
Utilization of a 3D Printed approach as a part of Invisalign® comprehensive treatment. Results showed that such perspective
Orthodontic Distalizer for practice is feasible for 3D design and in-office 3D printing of a personalized distalizer. Results also
Tooth-Borne Hybrid Treatment in showed no clinically significant differences between both studied biopolymers. The paper discusses
Class II Unilateral Malocclusions. an evaluation of such personalized distalizer functionality with regard to the current state of the
Materials 2022, 15, 1740. https:// art and compares to conventional prefabricated alternatives like a Carriere® Distalizer™ appliance.
doi.org/10.3390/ma15051740 Research showed a preference of patients towards transparent biocompatible photopolymer instead
Academic Editors: Maria of the white A2 shade. The paper concludes that additive manufacturing from dental resins is a
Francesca Sfondrini, viable method in personalization and in-office 3D printing of orthodontic auxiliaries, particularly
Andrea Scribante and distalizers. New materials for orthodontic 3D printing endow enhanced individualization, thus more
Florin Miculescu efficient treatment.

Received: 24 November 2021

Keywords: distalizer; dental photopolymers; orthodontics; biocompatible 3D printing; CAD/CAM;
Accepted: 21 February 2022
Published: 25 February 2022
personalized treatment; device customization; computer modelling; unilateral class II

Publisher’s Note: MDPI stays neutral

with regard to jurisdictional claims in
published maps and institutional affil-
1. Introduction
iations.
Recent progress in digital workflows facilitated countless opportunities in customiza-
tion of orthodontic devices. Advance of the material research of dental composites, includ-
ing the dental composite resins intended for 3D printing, brought a rapid advance in more
Copyright: © 2022 by the authors. personalized and thus more effective orthodontic treatment. The last decade brought signif-
Licensee MDPI, Basel, Switzerland. icant improvements of mechanical material properties as well as surface characteristics and
This article is an open access article biocompatibility of composites used in dentistry [1–8]. Focus on new bioactive compounds
distributed under the terms and in composites to prevent dental caries development and progression has led researchers
conditions of the Creative Commons to the use of nanotechnologies [9,10]. Composite configuration has significant impact not
Attribution (CC BY) license (https:// only on 3D-printed appliance properties [11–13] but also on adhesion efficacy when used
creativecommons.org/licenses/by/ as adhesive for an appliance [14,15].
4.0/).

Materials 2022, 15, 1740. https://doi.org/10.3390/ma15051740 https://www.mdpi.com/journal/materials

Materials 2022, 15, 1740 2 of 27

This paper introduces a novel approach based on 3D designing and printing of a

personalized distalizer in Class II malocclusions, for which the prevalence and orthodontic
treatment need are well studied [16].
Biomechanical principles of such 3D-printed personalized distalizer are not different
from Carriere Motion 3D Appliances (CMA) even in combinations with CAT [17,18].
Various techniques have been introduced in orthodontic therapy of Class II maloc-
clusions. In some protocols, maxillary molar distalization can be applied to correct molar
relationships in orthodontic patients with maxillary dentoalveolar protrusion [19,20]. To
prevent an unnecessary extraction of upper premolars, the upper molars can be distalized
by means of orthodontic forces [21]. In addition, different techniques have been presented
to reduce the dependence on patient compliance. However, all devices produce undesirable
tipping of the maxillary molars as well as the loss of anterior anchorage to some extent
during distalization movement [22,23]. The Carriere Motion Appliance (CMA) in the treat-
ment of Class II malocclusion results mostly in dentoalveolar effects [19,23]. Patients today
pursue orthodontic treatment with a desire for an aesthetic and comfortable alternative
to conventional fixed appliances [24]. CAT was introduced as a reaction to this demand.
The patient compliance is the prime weakness of CAT. A 3D printed “CMA-like” distalizer
concept intended as a tooth-borne fixed appliance bonded with adhesive on tooth enamel
surface is shown in Figure 1a,b.

Figure 1. Examples of bonded 3D printed distalizers with an individual base for a tooth-borne hybrid
approach in Class II unilateral malocclusions’ treatment and comparison of two biocompatible resins
(a) transparent resin- Dental LT Clear V2; (b) opaque white Denture Teeth resin.

It is known that maxillary molar distalization up to 2.5 mm is one of the most pre-
dictable movements with CAT [19,25,26]. Such significant predictability can be achieved
with arrangement of an intelligent aligner sequence, the use of an appropriate attach-
ment arrangement, and full-day Class II elastics [19,26]. CAT that includes difficult tooth
movements like significant distalization is even more sensitive to patient compliance [27].
Class II treatments with CAT require mean treatment times of approximately 20 months
during which Class II elastics must be utilized all day from treatment beginning until the
class I canine relationship has been achieved [19,28]. Auxiliary devices (like distalizers)
should be comfortable, provide rapid and effective treatment, and favour patient compli-
ance with such hybrid orthodontic treatment. This is one of the reasons this paper presents
the assessment of two different biocompatible materials—a clear (transparent) composite
resin and an opaque white (A2 shade) resin. Clear aligners are aesthetically acceptable and
comfortable [19,29,30], albeit the patient compliance is found to be better in the early stages
of CAT [19,31]. With understanding of the importance of patient compliance during CAT,
its weakness linked with removability and the advantage of fixed orthodontic devices for
particularly difficult tooth movements, we can summarize:
1. patient compliance can be improved with aesthetical and comfortable devices;
2. combination of CAT and fixed orthodontic devices can result in optimized patient
adherence to therapy, reducing the time required to wear Class II elastics;
3. treatment effectivity can be improved by the employment of a fixed appliance.
Materials 2022, 15, 1740 3 of 27

This combined clinical approach has been named hybridization of aligner therapy [19].
Among others, temporary tooth-borne distalization devices are the most popular hybridiza-
tion approaches in CAT. Typically, they are not intended for the whole duration of the
orthodontic treatment.
Several types of molar distalization appliances (distalizers) are presented in the lit-
erature, such as the Carriere Motion 3D Appliance (CMA) (Henry Schein Orthodontics,
Carlsbad, CA, USA), the Pendulum device, and the Distal Jet appliance (Figure 2).

Figure 2. Examples of molar distalization appliances—distalizers (a) Carriere Motion 3D Appliance

(CMA); (b) Pendulum appliance; (c) Distal Jet appliance.

Distalizers shown in Figure 2a–c are believed to be easy to mount intraorally and can
promote distal movement of the maxillary molars. Nevertheless, most of these distalizers
show undesirable reciprocal loss of anchorage in the premolars and incisors during distal
molar movement [19,32,33]. Furthermore, molar tipping is frequently observed in most of
the cases. The Distal Jet appliance (Figure 2c) is composed of two bilateral tubes joined to a
Nance appliance [19]. On the tube, there is a stainless-steel coil spring and a clamp that can
slide toward the molar and be tightened to compress the coil. The force exerted by the spring
begins at 150 g and decreases as space is opened [34]. The Pendulum appliance (Figure 2b)
introduced by Hilgers in 1992 [35] is still one of the most used distalizing devices. It is a
fixed appliance composed of a plastic pad in contact with palatal rugae. Both the Distal
Jet and Pendulum produce an increase in the face vertical dimension due to a backward
rotation of the mandible [19,36–38]. These vertical changes comprise a slight opening of the
mandibular plane angle and an increase in lower anterior facial height [19,39]. Ghosh and
Nanda reported that the increase in lower anterior facial height was significantly greater
in patients with higher pre-treatment mandibular plane angles [19,40]. CMA (Figure 2a)
consists of a rigid bar attached to the maxillary canine and first molar. Posteriorly, the
pad with a ball-and-socket joint is bonded to the molar at the centre of its clinical crown
to facilitate molar derotation and distalization. The frontal canine pad with a built-in
mesial hook used for placement of intermaxillary elastics is bonded to the anterior third
of the clinical crown [19,41–43]. The activation of CMA is usually obtained using two
types of elastics: the first one being 0.25 in, 6 oz; the second one 0.19 in, 8 oz, to be used
from the second month of treatment until the molar and canine class I relationships are
established [44]. The principle of this appliance is like a cantilever-based fixed appliance
previously shown by Nanda [45] who described the system as an effective way to correct
molar Class II in nongrowing patients [19].
Previous retrospective clinical studies demonstrated the possibility of obtaining a max-
illary molar distalization between 1.6 and 5.1 mm [44] with treatment time mean duration
of about 4 to 5 months [19,44]. When compared to other Class II correction methods, CMA
showed the same results obtained with Class II elastics in terms of molar distalization but
in less time [46]. One clinically important effect of treatment with CMA appeared in the
lower anterior facial height—an increase in the mandibular plane angle [19,47]. The results
of the study published in The Angle Orthodontist showed that the CMA is an effective way
of correcting the sagittal component of Class II malocclusion within the first half-year of
Materials 2022, 15, 1740 4 of 27

treatment. Proclination of the lower incisors resulting from the Class II elastics mechanics
was also observed and resulted in a significant amount (4 degrees) [19,41].
All the tooth-borne appliances mentioned above create some side effects that need to
be controlled during the hybrid aligner therapy. Research published by Khosravi et al. [48]
regarding overbite management with Invisalign aligners indicated that overbite correction
is mostly related to anterior teeth movement without any significant posterior intrusion or
extrusion [19,48]. In addition, Ravera et al. described the bite block effect of the aligners
causing an intrusive effect on posterior teeth of 0.5 mm [19,22]. These findings were
confirmed by Mantovani et al. [49].
The Carriere® Motion 3D™ appliance (CMA; Henry Schein Orthodontics, Carlsbad,
CA, USA) has become more popular during the past decade as a versatile intermaxillary
Class II corrector. CMA was introduced by its developer, Luis Carriere, in 2004 as the
Carriere® Distalizer™, and the renamed Carriere® Motion 3D™ appliance consists of two
rigid bars bonded bilaterally to the maxillary canines and first molars. Regarding the long-
term treatment stability: dental and skeletal treatment results of distalization accomplished
with the Carriere Distalizer appliance followed by fixed appliance therapy displayed
minor changes four years after treatment [50–52]. Publication about CMA modifications
from 2021 from Wilson et al. in The Angle Orthodontist came to the conclusion that
shortly CMA achieved Class II correction similarly to the standard CMA, with less change
in overjet and distal tipping movement of the maxillary canines. The straightforward
design makes CMAs more comfortable than the Forsus appliance [53,54]. The unilateral
application of the Carriere Distalizer is possible and can be utilized for non-extraction Class
II treatment [41,51]. We know that the CMA corrects Class II malocclusion through distal
tipping and rotational movement of maxillary canines and molars and corrected mesial
tipping of mandibular molars [55]. Material research of dental resins for 3D printing in
orthodontics was mostly oriented on 3D printing of clear aligners [56–58]. Only recently, a
wider range of Class IIa biocompatible dental resins for 3D printing has been introduced
and fully certified in Europe. The goal of the procedure introduced in this paper is the
materialization of personalized shape of biomechanical orthodontic auxiliary (distalizer) to
increase the speed or comfort of the orthodontic treatment. Such 3D printed distalizer is
unique in every patient, with appropriate length, curvature and most notably its terminal
pads with individualized bases for bonding.
The main purpose of this paper was to show the entire procedure of 3D designing,
printing and application of distalizer (CDA-like) for hybrid Class II CAT. The secondary
objective was to compare two popular biocompatible materials and evaluate their clinical
performance as well as the patient appraisal. The major conclusion of this paper is that an
individual distalizer can be designed and materialized with little effort, achieving clinical
objectives and high patient comfort.

2. Materials and Methods

2.1. Digital Workflow for Personalized 3D Design and Printing
The biocompatible Additive Manufacturing (AM) brings better personalization of
various orthodontic auxiliaries like power-arms, power-caps, retainers, and many other
applications. The scheme in Figure 3 describes the entire workflow.
Two photopolymers were evaluated in this research within the application of the de-
scribed novel method of design and manufacturing for a personalized distalizer. Materials
and distalizers were clinically evaluated on the complete distalization treatment procedures
on 12 patients with a unilateral Class II occlusal relationship. Twelve patients were chosen
upon strict criteria from the total set of 387 monitored patients. Material distribution was
random. The objective for the strict criteria was the elimination of possible bias caused by
clinical differences.
Materials 2022, 15, 1740 5 of 27

Figure 3. Scheme describing new digital workflow for orthodontists utilizing certified biocompatible
dental resins for 3D printed personalized distalizers for hybrid treatment.

To professionally design, print and apply personalized distalizer for hybrid treatment,
the more complex clinical picture and target shall be comprehended for each particular
case (Figure 4). Example shows that not necessarily whole extent of distalization trajectory
must be achieved only with a distalizer. Its combination with CAT allows for a wider scope
of approaches for the orthodontist (Figure 1a–c).

Figure 4. Planning of a personalized unilateral distalizer for upper teeth distalization in a clinical
hybrid approach (a) initial setup with Class II. elastics in the CAT (Invisalign® ) to achieve distalization
of two terminal molars 18 and 17; (b) situation evaluated for a 3D printed personalized distalizer
application with a similar biomechanical effect to CMA. The “Button cut-outs” in the aligner on
teeth 13 and 16 are intended for 3D printed distalizer custom base fixed adhesion on tooth surface;
(c) planned clinical target of hybrid treatment with CAT + distalizer with 15% overcorrection.
Materials 2022, 15, 1740 6 of 27

2.2. Patients—Selection Criteria

To correctly compare both materials clinically, the strict criteria were defined to mini-
malize possible bias. Bias could result from a non-homogenous group affected by growth or
skeletal discrepancies or extreme extents for distalization or application of different types
of CAT or poor monitoring caused by patients’ non-compliance. Patients for evaluation of
the described tooth-borne hybrid treatment approach with Class II unilateral malocclusions
were chosen by the following selection criteria:
1. Patients must be adults;
2. Unilateral Class II occlusion measurable on molars and canines with a class I relation-
ship on the opposite side and no skeletal Class II values (Figure 4);
3. Skeletal cephalometric values of SNA = 81 ± 3◦ , SNB = 78 ± 3◦ , ANB = 3 ± 2◦ ;
4. Target of planned linear distance of the frontal cusp of upper molar translation
(distalization and distorotation) had to be between 2.5 and 6 mm (Figure 5);
5. Patients were compliant with dental monitoring on a weekly basis;
6. Patients had a distalizer combined with CAT (all patients were using an Invisalign
type of appliance).

Figure 5. Digital measurement of planned clinical target (amount) of distalization in Autodesk

Meshmixer—free software for working with 3D objects—in this case, the digital intra-oral scan.

The exclusion criterium for skeletal Class II was based on published variability of
distalizers’ effects in between skeletal Class I and Class II cases. In addition, exclusion
criterium for planned extent of upper molar distalization over 6 mm and under 4 mm al-
lowed better harmonization of patient samples. Differences in distalization difficulty or the
distalization setup would be the source of significant bias between both compared groups.
After application of these criteria from 385 A.I. monitored patients, only the final
12 adults in skeletal Class I that were acknowledged with Invisalign treatment were selected
as suitable. These patients were randomly divided into two groups according to the type of
dental resin used for distalizer manufacturing. All patients were monitored on a weekly
basis by video-scans evaluated by an artificial intelligence algorithm and no significant
differences in compliance were observed in these patients. Dental monitoring was able to
identify immediately a drop or damage of orthodontic auxiliary (distalizer) so we were not
dependent on patient self-reporting. The follow-up duration varied in patients as each case
required a different amount of distalization under specific clinical anatomy.
Materials 2022, 15, 1740 7 of 27

2.3. Materials, Handling, 3D Printing and Post-Printing Protocols

Two long-term biocompatible composite resins, intended for 3D printing, were chosen
to be compared:
1. Dental LT Clear Resin (RS-F2-DLCL-02 from Formlabs) [59–61];
2. Denture Teeth Resin (FLDTA101,PKG-RS-F2-DT Formlabs/Dentca) [61–64].
The reason for choosing these two materials was to evaluate if such a small difference
of material properties does have significant impact on the clinical performance of 3D
printed distalizer. The second reason was to evaluate the patient feedback for whether the
transparent or the opaque distalizer is considered more aesthetical.
Dental LT Clear Resin (RS-F2-DLCL-02 from Formlabs) [59] is designed for hard splints
and retainers with high resistance to fracture and wear. This resin is Class IIa biocompatible.
3D printing layer accuracy of this material is only 100 microns, which is sufficient for
expected details of the distalizer; however, it was relevant to compare to second material,
which was printed on a resolution of 50 microns. This biocompatible photopolymer resin is
intended for a Form 2–3D printer. The advantage of this material is that it is highly durable
and resistant to fracture and has high optical transparency, with resistance to discoloration
over time.

Post-Processing after 3D Printing

After printing the distalizer, it must be washed, and the support removed. Dental LT
Clear Resin V2 shall be washed in IPA with a concentration of 99% or higher to comply
with biocompatibility regulations. In our protocol, we have washed the clear distalizer
parts for 15 min, then removed and soaked in fresh IPA for 5 min. For optimum mechanical
properties, it must not be washed for more than 20 min. After washing, it must be light
cured ideally in the Form Cure that helps 3D printed parts achieve their highest possible
strength and stability. Optimal post-curing settings depend on equipment and the geometry
of the part. In our case, the recommended settings can be applied [61]. This means
that the distalizer from material Dental LT Clear V2 shall be light cured for 60 min in
temperature of 60 ◦ C. This cure setting ensures that it achieves both biocompatibility and
optimum mechanical properties. This material has been updated in 2020 and clinicians
shall remember this. The FLDLCL02 resin (available since 6/2020) is a new version of
FLDLCL01 (was available since 10/2017). This new resin was used in this research and,
in comparison to an older version of this composite material, it has reduced yellowing,
improved durability and higher resistance to fracture. Further technical details about this
material are summed up in Table 1 in addition to its technical and safety sheets online [59,62]

Table 1. Material properties of LF Dental clear V2.

Post-Cured
Mechanical Properties Post-Cured Dental LT Clear Method
Resin (V2)
Ultimate Tensile strength 52 MPa ASTM D638-10 (type IV)
Young’s modulus 2080 MPa ASTM D638-10 (type IV)
Elongation 12% ASTM D638-10 (Type IV)
Flexural Strength at 5% Strain 84 MPa ASTM D790-15 (Method B)
Flexural Modulus 2300 MPa ASTM D790-15 (Method B)
Hardness Shore D 78 D ASTM D2240-15 (Type D
Water Absorption 0.54% ASTM D570-98 (2018)

Denture teeth Resin (FLDTA101, PKG-RS-F2-DT from Formlabs/Dentca) [60,61,63].

Formlabs Denture Resins are certified biocompatible materials for 3D printing digital
dentures and their parts. This white resin is also Class IIa biocompatible. 3D printing
layer accuracy of this material is 50 microns, which allows double accuracy compared to
previous transparent resin and better for expected details of the distalizer. Upon research
and sending an inquiry to the official Formlabs support, we have learned that this resin is
Materials 2022, 15, 1740 8 of 27

exceptionally not their proprietary and its original manufacturer is Dentca, Inc. located in
Torrance, CA, USA. Composition of this resin matches DENTCA Denture Teeth resin, an
FDA cleared biocompatible photocurable material with performance and strength matching
conventional acrylic. DENTCA is a manufacturer of medical and healthcare devices focused
on denture base and teeth products and was the first to receive FDA approval for such 3D
printing resins.
Form wash setting for this application were different than in previous material. In
previous transparent resin, the wash time was 20 min; in this denture-teeth resin, it is
only 10 min.
Form Cure settings for this material is specific. In our protocol, we have followed
the official guidelines [63,64], and we have used a glass container with glycerine. After
preheating the glycerine to 80 ◦ C in Form Cure, we have used our own heat resistant to
keep the distalizers fully submerged in the glycerine and kept the container inside Form
Cure for 30 min. After the first 30-min post-cure, we have flipped the small distalizers to
the opposite side and Post-cure again for 30 min.
Composites are complex materials and finding the right one for our specific application
requires balancing multiple attributes. Distalizer is a small part with a need for rapid prototyp-
ing. Mechanical properties of Denture teeth resin are Flexural Strength >65 Mpa (method ISO
20795-1) and density of the material of 1.15 g/cm3 (method ASTM D792-00). The Denture Base
ISO Standard used is EN-ISO 20795-1:2013 (Dentistry—Base Polymers—Part 1: Denture Base
Polymers), which is summarized in Table 2.

Table 2. Known properties of Denture Teeth Resin (Formlabs, Dentca).

Post-Cured
Properties
Denture Teeth Resin (Shade A2)
Density of the material 1 1.15 g/cm3
Flexural Strength 2 90 Mpa
Relative worn volume % of ∆V 3 70%
1 Method ISO 20795-1; 2 Method EN-ISO 20795-1:2013; 3 Method ISO/TR 14569-1: 2007.

Material properties can vary with part geometry, print orientation, print settings and
temperature. Data in Tables 1–3 refer to post-cured properties obtained after exposing parts
to 108 watts each of Blue UV-A (315–400 nm), in a heated environment at 80 ◦ C (140 ◦ F)
and 1 h, with six 18 W/78 lamps (Dulux blue UV-A) [59–65].

Table 3. Chemical composition of Dental LT clear and Denture teeth Resin (Formlabs, Dentca).

Post-Cured Denture
Post-Cured Dental LT Clear Resin (V2) (% w/w) (% w/w)
Teeth Resin (Shade A2)
7,7,9-trimethyl-4,13-dioxo-3,14-dioxa-
Proprietary
5,12- diazahexadecane-1,16-diyl 50–75 40–60
methacrylate monomer
bismethacrylate
Diurethane
2-hydroxyethyl methacrylate 10–20 30–50
dimethacrylate
Reaction mass of
Bis(1,2,2,6,6-pentamethyl-4-piperidyl)
Trimethylolpropane
sebacate and Methyl <10 3–10
trimethacrylate
1,2,2,6,6-pentamethyl-4-piperidyl
sebacate
Diphenyl (2,4,6- trimethylbenzoyl)
1–5 Initiator <3
phosphine oxide
Acrylic acid, monoester with
0.1–1 Stabilizer <1
propane-1,2-diol
ethylene dimethacrylate <10 Pigment <0.7

2.4. 3D Printing and Costs

3D stereolithography printer—Form 2 (Formlabs) was used for 3D printing with a
standard setting. Its technical parameters are available online [65].
Materials 2022, 15, 1740 9 of 27

In every case, we have been printing on the highest resolution available (0.1 mm for
clear or 0.05 mm for white resin). In every case, we have printed three clones in total, for
practical reasons anticipating the situation of possible damage to the distalizer, to be able
to immediately replace the damaged/debonded part. For simplicity, the shade of Denture
teeth resin was chosen as A2.
The approximate costs regarding prefabricated “CARRIERE Motion 3D Class II Ap-
pliances Distalizer” on eBay is $50–$60. Printing costs per one triple-set of distalizers is
approximately $15 ($3–$5 a part). This calculation is approximation and relates to denture
teeth resin costs, which are $399 per litre. Dental LT clear also costs $399 per litre. Costs
for 3D printing with both materials do not differ significantly and neither do material
mechanical properties.
A toothbrush wearing test was performed by Dentca company to review the abrasion
resistance of preformed DENTCA Denture Teeth compared with commercial artificial
polymer teeth. Relative worn volume % of ∆V to reference artificial acrylic tooth (100%)
was 70%. This means that the DENTCA Denture Teeth are less worn than the commercial
artificial acrylic tooth. Stain Resistance was assessed by Dentca to review the staining
resistance of preformed Denture Teeth resin compared with commercial artificial polymer
teeth by soaking into two different solutions. Staining resistance of DENTCA Denture
Teeth is equivalent to an artificial polymer tooth.
Despite the resin manufacturing company, Dentca does not publish detailed material
properties of their 3D printing denture teeth resin; it has been fortunately well researched [5,
66]. Yoo-Jin Chung et al. in their article “3D Printing of Resin Material for Denture Artificial
Teeth: Chipping and Indirect Tensile Fracture Resistance” evaluated chipping and indirect
tensile fracture resistance of this resin.
Both materials have similar properties; however, they differ significantly in their
clinical appearance (one is opaque white another is transparent). Participating patients
were questioned about their satisfaction with distalizer appearance/aesthetics. Patients
at the end of the treatment had an option to reference if the next distalizer would prefer
to be the same colour or if they would prefer another (still choosing only between white
and transparent).

2.5. Method of Digital Design of the Personalized Orthodontic Distalizer

One of the goals of this paper is to demonstrate that the making of personalized
distalizer is not complicated and time-consuming. The whole hybrid treatment workflow
is shown in the scheme in Figure 3. For designing a personalized orthodontic distalizer, we
have followed these steps:
• The first step is to register an intraoral situation with a digital intraoral scan and
exporting it in a common 3D format. For example, the STL file format is suitable
and can be processed in various simple 3D modelling programs like Meshmixer
(from Autodesk).
• The second step is to coordinate the distalizer and CAT planned effects and plan the
placement of distalizer in harmony with CAT. In this research, all CAT were performed
using Invisalign appliances (Figure 6).
• The third step was to design the body of the distalizer, including movable joints and
individual bases on the terminal pads of the distalizer.
• The fourth step was clinical application and distalizer activation followed by weeks of
movement Dental monitoring.
• The fifth step was performed after achieving planned occlusal correction. Removal of
the distalizer was followed by stabilization of the result.
Materials 2022, 15, 1740 10 of 27

Figure 6. Overlay of intraoral scan (a) with a software model from CAT planning (b) is important to
identify the areas of aligner cut-outs. These will be the contacts of distalizer with teeth surfaces.

Planning of the complex hybrid treatment requires coordinating the distalizer and
CAT. Their effects shall be in synergy and the placement of distalizer might be on teeth
covered with aligner or, less frequently, not. One of the possible steps is overlay of intraoral
scan with the CAT treatment model to identify the planned aligner cut-outs for 3D printed
distalizer adhesive individualized bases (Figure 6). In this paper, we explain the advantage
of a customized distalizer for a particular clinical situation (unilateral Class II) and particular
clinical approach (tooth-borne hybrid treatment with an orthodontic distalizer and CAT).
After identification of the areas for distalizer bonding, the body, joint and bases shall
be designed. To start designing the distalizer, the plane shall be defined on which the
distalizer long axis will lie crossing the middle of the areas intended for bonding of the
distalizer. Placing a 2D plane in the program like Meshmixer is sufficient. Placing and
reshaping two spheres in these spots will represent future bodies of the individualized pads
with bases copying the surface of the teeth in these locations (Figure 7a). After placements
and resizing the spheres, a contour of the distalizer body shall be drawn on the plane,
keeping a distance from premolar teeth surfaces of around 0.4–0.8 mm (Figure 1b).
Materials 2022, 15, 1740 11 of 27

Figure 7. Method of designing personalized distalizer. (a) placing a plane for the upper border
of arm of the distalizer and spheres overlaying teeth surfaces in the areas of future individualized
adhesion pads; (b) optimized border and deleting the rest of the plane; (c) 4.5 mm extrusion of the 2D
plane selection creates the arm of distalizer; (d) new sphere (d = 5 mm) on the distal end of the arm
represents the terminal joint of the distalizer’s arm. New sphere, with the same centre is created with
0.1 mm bigger diameter and represents the future socket for the joint; (e) extrusion of the spherical
socket for the joint in the direction of the arm, liberating its movement during distorotation of the
molar; (f) extending the hiatus of the distalizer’s arm access to the joint socket; (g) visualization of
the future joint socket and its access together with a distalizer’s arm distal ending with a spherical
joint; (h) creation of final coverage of the joint with a new sphere resized as necessary to cover the
joint socket at least by 0.6 mm.
Materials 2022, 15, 1740 12 of 27

After definition of the arm’s 2D contour (Figure 7b) extrusion follows. Subsequently
with smoothing and rounding the edges of a created bar (in the Meshmixer program by
pressing Ctrl + F), an arm of the distalizer is formed (Figure 7c). It can be directly merged
with the future adhesive base on the canine. Another step is creating a new sphere with a
diameter of 5 mm with a centre identical to the centre of the terminal sphere for joint of the
distalizer’s arm. This sphere will represent the terminal joint socket for the distalizer’s arm.
The difference between both spheres (joint head and joint socket) shall be between 0.1 mm
up to 0.2 mm. New sphere, created will be extruded in arm accessing the joint (Figure 7e,f).
Spherical socket is extended in this direction to allow the distalizer’s joint movements,
liberating the arm during distorotation of the molar (Figure 7g). The final step in designing
the juncture of both parts of the distalizer is the creation of final coverage of the joint with a
new sphere resized as necessary to cover the joint socket by at least 0.6 mm (Figure 7h).
The scheme in Figure 8 describes the main parts of the juncture of both distalizers
parts located on the smaller part of the distalizer intended for molar placement. (1) is the
final encapsulation of the joint when merged with the base (3). This creates the body of the
smaller part of the distalizer, intended for bonding on the vestibular surface of the molar
crown. Part (2) represents the socket of the joint, where the pressure of the distalization is
applied, allowing the distorotational movements of the molar. The last part (5) represents
a curved terminal part of the distalizer’s arm entering the socket with a sufficient gap
around it.

Figure 8. Main parts of the junction of both distalizers parts located on the smaller part intended for
molar adhesion. (1) final encapsulation of the joint when merged with the base; (3) the body of the
smaller part of the distalizer with a surface complementary to the surface of the molar, thus creating
an individual base; (2) the socket of the joint; (4) extended neck of the accessory channel for the arm
ending in the socket, liberating arm orientation during distalization and distorotation of the molar;
(5) terminal part of the distalizer’s arm entering the socket with a sufficient gap around it;.

Figure 9 visualizes the final merge of the distalizer parts, creating individualized bases,
arm, and the socket in regard to the teeth (Figure 9a–c).
Materials 2022, 15, 1740 13 of 27

Figure 9. Visualization of the juncture of both parts of the distalizer (bigger part with the arm and
joint and the smaller part with the socket). (a) visual of the molar part of the distalizer including the
socket; (b) visualization of ending of the arm of the distalizer in the body of the distal part; (c) profile
of the layers of the distalizer’s body, socket and the joint.

The individual base of the distalizer is responsible for a perfect match to the tooth sur-
face. Both ends of the connected distalizer are intended to be bonded as a fixed orthodontic
auxiliary for a necessary period of time during orthodontic treatment. Figure 10a shows
how such an individual base looks. Figure 10b shows a hiatus in the tunnel leading to
the socket. A small circular step results in a “click-in” function, where slight pressure is
necessary to “click-in” the arm of the distalizer with a spherical joint into the socket.
Further steps explained in the Figure 11a–h describe a creation of feature supporting
anchorage of the elastic bands. Figure 11a shows a more rounded surface in contrast
with Figure 9c. Such slight adaptations can be made wherever an operator considers it
appropriate with the goal to achieve a more comfortable shape for the patient and better
resiliency during chewing. The authors of this paper used the Meshmixer program from
Autodesk and mode Sculpt → Surface → brush (robust-smooth). The step in connecting
area between distalizer’s arm and the canine base is smoothed.
Materials 2022, 15, 1740 14 of 27

Figure 10. Vestibular and lingual side of the molar part of distalizer. (a) Wireframe appearance of the
individual base that matches the tooth surface in the exact area that is helping in the exact positioning.
(b) The tunnel that leads to the socket with a visible hiatus—a small circular step that is causing a
“click-in” function, where slight pressure is necessary to “click-in” the arm of the distalizer with a
spherical joint into the socket—both parts of distalizer shall be connected before bonding.

Elastic Bands Attachment and Distalizer Activation

Placement and removal of the elastic bands are performed by the patient. The elastics
shall be changed for new ones at least three times per day. Activation of the distalizer is
done immediately after bonding. The activation is obtained using two types of elastics: the
first month 0.25 in, 6 oz; and 0.19 in, 8 oz, to be used from the second month of treatment.
Loading with these heavy-force elastic bands (6 oz and 8 oz) is tooth borne from
the pad on the maxillary canine to a mandibular molar button or precision cut in the
lower aligner.
A full-time wear from the patient (22 h) is expected. There are various ways of creating
a button or another form of retentive feature on the canine pad. Figure 11 shows only
one of them. This method and design of attachment for an elastic band are presented in
Figure 11b–f. We consider very practical, comfortable and resilient. Figure 11g shows the
arm of the distalizer with the individual base intended for the canine mesial–cervical part
of maxillary canine.
Final distalizer is ready for 3D printing as a separate 3D layer in the program and is
exported to 3D printing program as a separate STL file (Figure 12).

2.6. Practical Aspects of Post-Prints Handling

Post-prints handling with visual explanations are shown in Figures 13–16. Figure 13
shows a 3D printed example of the distalizer designed in the previous chapter. The material
Denture teeth Resin Formlabs/Dentca [60,61,63] requires washing in IPA for only 10 min
(Figure 13a,b). We have used a sonic IPA bath for 10 min. The second step is post-curing of
the prints; for this material, it is quite specific. In our protocol, we have followed the official
guidelines [63,64], and we have used a glass container with glycerine. After preheating
the glycerine to 80 ◦ C in Form Cure, we have used our own heat resistant gear to keep
the distalizers fully submerged in the glycerine during post-curing. We kept the container
inside Form Cure for 30 min as prescribed. After the first 30-min post-cure, we have flipped
the small distalizers to the opposite side and post-cured them again for another 30 min
(Figure 13c). It is important to remember that the glycerine during this process will get
very hot (80 ◦ C), and heat resistant silicone tongs shall be used to insert and remove the
distalizers from the solution.
2022, 15, x FOR PEER REVIEW 16 of 29
Materials 2022, 15, 1740 15 of 27

(a) (b)

(c) (d)

(e) (f)

(g) (h)
Figure 11. Creation of feature supporting anchorage of the elastic bands. (a) Step in connecting area
Figure 11. Creation of feature supporting anchorage of the elastic bands. (a) Step in connecting area
between distalizer’s arm and the canine base is smoothed—different from Figure 9c. The purpose is
between distalizer’s arm and the canine base is smoothed—different from Figure 9c. The purpose
better comfort and resiliency during chewing; (b) Import of a primitive donut shape from basic
Meshmixer galleryisallows
better faster
comfort and resiliency
subtraction during
of desired chewing;
shape (b) Import
for loaded elasticofband;
a primitive donut shape from basic
(c) Quadrant
not necessary for elastic retention shall be preserved to increase the strength of this part of the band;
Meshmixer gallery allows faster subtraction of desired shape for loaded elastic dis- (c) Quadrant not
necessary for elastic retention shall be preserved to increase the strength
talizer; (d) Reshaping of the reduced donut intended for Boolean subtraction (Select both objects of this part of the distalizer;
and apply Boolean(d) Difference
Reshaping in of
a precise Solution
the reduced mode,
donut preferably
intended using Intersection
for Boolean subtraction curves, oth- objects and apply
(Select both
erwise default setting in Meshmixer)
Boolean Difference Quadrant
in a precisenot necessary
Solution forpreferably
mode, elastic retention shall be preserved
using Intersection curves, otherwise default
to increase the strength of this part of the distalizer; (e) before subtraction
setting in Meshmixer) Quadrant not necessary for elastic retention position properly
shall besopreserved
the to increase
long axis of futuretheloaded elastic is pointing towards the lower anchor point—button or precision
strength of this part of the distalizer; (e) before subtraction position properly so the long axis of
cut; (f) result of Boolean difference subtraction of the adapted donut shape; (g) result of Boolean
future loaded elastic is pointing towards the lower anchor point—button or precision cut; (f) result of
difference between intraoral scan and the canine part of the distalizer—base of the canine pad is
Boolean difference subtraction of the adapted donut shape; (g) result of Boolean difference between
now fully individualized; (h) profile view of the mesial end of distalizer with the groove intended
intraoral scan and the canine part of the distalizer—base of the canine pad is now fully individualized;
for the elastic band.
(h) profile view of the mesial end of distalizer with the groove intended for the elastic band.
Materials 2022, 15, 1740 16 of 27

Figure 12. Final distalizer before 3D printing; (a) lateral view; (b) apical view; (c) 3D printing set-up
for 50 µm printing resolution with visible supports; three clones were always printed for possible
servicing reasons, material Denture teeth, shade A2.

Figure 13. (a) Fresh 3D printed three clones of a distalizer from Denture teeth resin material; (b) sonic
IPA bath for 10 min; (c) post-curing submerged in glycerine in 80 ◦ C.
Materials 2022, 15, 1740 17 of 27

Materials 2022, 15, x FOR PEER REVIEW 19 of 29

Figure 14. Three clones of a 3D printed distalizer from material Denture Teeth, shade A2.

(a) (b)

(c) (d)

(e) (f)

(g) (h)
Figure 15. Clinical application of a personalized 3D printed distalizer in combination with CAT
Figure 15. Clinical application of a personalized 3D printed distalizer in combination with CAT
(Invisalign®);®(a) Initial “try-out” of the mesial part of distalizer with its “arm”; (b) “try-out” of the
distal smaller );
(Invisalign (a)of
part Initial “try-out”
distalizer; of thesandblasting
(c) circular mesial part 5ofs distalizer
each of thewith its “arm”;
surface; (b) “try-out”
this is proven to of the
distal smaller
significantly part bond
increase of distalizer;
adhesion (c) circular
strength [67];sandblasting 5 s eachetching
(d) standard enamel of thewith
surface;
37.5%this is proven to
phos-
phoric acid, rinsing
significantly and drying;
increase (e) application
bond adhesion of 7th[67];
strength generation Single Bond
(d) standard Universal
enamel fromwith
etching ESPE;37.5% phos-
(f) Standard Light curing of the bond; (g) Standard Light curing for final adhesion of the
phoric acid, rinsing and drying; (e) application of 7th generation Single Bond Universal from ESPE; distalizer
with a micro layer of 3M™ Transbond™ PLUS Color Change Adhesive; (h) final appearance of the
(f) Standard Light curing of the bond; (g) Standard Light curing for final adhesion of the distalizer
distalizer before activation.
with a micro layer of 3M™ Transbond™ PLUS Color Change Adhesive; (h) final appearance of the
distalizer before activation.
Materials 2022, 15, 1740 18 of 27

Figure 16. 3D printed distalizer. (a) fixed distalizer in hybrid treatment with CAT (Invisalign® );
before activation; (b) fixed distalizer in hybrid treatment with CAT (Invisalign® ); after activation.

Figure 14 shows a sharp contrast zoomed view of post-cured distalizers from Denture
Teeth resin material in shade A2. The surface shows remnants of the supports, and these
can be polished by a doctor during clinical application if necessary. Two of the clones
are spares.

2.7. Method of Clinical Application

Clinical application takes advantage from the individualized base on each terminal
pad of the distalizer. The surface of such individualized base exactly matches the tooth
surface in pre-planned particular position and orientation. Figure 15 describes the sequence
of trying out, sandblasting, etching and final bonding of the distalizer.
The last step before distalizer activation is to remove possible excessive remnants of the
adhesive with the dental bur softer than enamel and harder than the polymerized Transbond™
glue. Removal of upper aligner is followed by the cleaning procedure (Figure 16a). The planned
gap for the adhesive between tooth surfaces and the distalizer is usually 50 microns.
The last step is activation of the distalizer, which means that the forces from the elastics
will be applied. The activation is obtained by the use of two types of elastics: the first
month 0.25 inch (6.35 mm), 6 oz (170 g); and, from the second month 0.19 inch (4.8 mm),
8 oz (227 g), to be used from the second month of treatment. Figure 16b shows the distalizer
with an elastic band from the canine pad to the button on tooth 47.

3. Results
The main goal of this paper was to introduce and practically accomplish the novel
approach of a 3D printed distalizer in hybrid orthodontic treatment. This has been achieved
and is documented in the procedure description in the previous chapter.
The secondary objective was to evaluate if any of the tested photopolymers is inap-
propriate for this intention, showing significantly more frequent debonding or breakage.
Table 4 shows this evaluation of the set of 12 complete treatments with the described
method, where two groups of six patients were treated with the distalizer from one of the
observed biocompatible photopolymers. To complete a statistically more useful, larger set
of treatments under such strict election criteria, it would require many more years. Only
standard testing of the significance of the difference is feasible. The interpretation of the test
results would be statistically better on a larger dataset; however, the time necessary for such
extensive treatment in combination with clinical selection criteria (unilateral distalization)
would require many more years of observation. As the pace of development of advanced
photopolymers in dental 3D printing domain is quick, years-long research would most
probably bring information on already obsolete and discontinued dental materials.
The results of the classic testing showed no significant findings due to the small num-
bers. Results are shown in the summary in Table 5. There is a combination of descriptive
statistics and testing (only those p-values without an asterisk are “outcomes”). Poisson re-
gression is a regression in which the dependent variable has a Poisson distribution (number
of events in each region or a given time interval).
Materials 2022, 15, 1740 19 of 27

Table 4. Results of clinical evaluation for secondary objectives.

Time in
What Material
Distalization Weeks Total Material
ID Sex Age a Patient Would
Target until Target Failiures 1 Patient Had
Prefer Next Time
Achieved
# [M/F] [years] [mm] [weeks] # [CLEAR/WHITE] [CLEAR/WHITE]
1 F 25 2.50 19 2 CLEAR CLEAR
2 F 26 3.00 22 2 WHITE WHITE
3 F 31 3.50 20 0 WHITE CLEAR
4 M 23 3.00 24 0 CLEAR WHITE
5 M 29 4.50 33 1 CLEAR CLEAR
6 F 30 4.00 32 0 CLEAR CLEAR
7 F 31 2.50 21 0 WHITE CLEAR
8 F 37 3.00 25 0 CLEAR CLEAR
9 M 28 3.50 26 0 WHITE CLEAR
10 F 20 5.00 30 1 WHITE CLEAR
11 F 21 5.50 36 1 CLEAR CLEAR
12 F 26 3.00 20 0 WHITE CLEAR
1 Total sum of debonding and breaking.

Table 5. Patients’ characteristics and bivariate analysis with Poisson regression.

Variable Statistics or Category Group p-Value Statistical Test

WHITE CLEAR
n 6 6 n.a.
Age [years] mean ± SD 27.0 ± 4.10 27.5 ± 5.79
0.866 * t-test
median (range) 27 (20–31) 27 (21–37)
Sex male 1 2
female 5 4 0.591 * Fisher exact test
Side of oral cavity left 3 3
right 3 3 0.999 * Fisher exact test
Distance to distalization
mean ± SD 3.42 ± 0.861 3.75 ± 1.129
target [mm] 0.578 t-test
median (range) 3.25 (2.5–5.0) 3.5 (2.5–5.5)
Time until target
mean ± SD 23.2 ± 4.01 28.2 ± 6.49
achieved [weeks] 0.223 Mann–Whitney test
median (range) 21.5 (20–30) 28.5 (19–36)
a
Total failures Mean b (Poisson CI) 0.5 (0.10–1.46) 0.67 (0.18–1.71) 0.706 Poisson regression
Material preference white 1 1
clear 6 6 0.999 Fisher exact test

Abbreviations: SD—standard deviation, CI—confidence interval. * For descriptive (not inferential) purpose only.
a Total sum of debonding and breaking. b Expected number of events.

The results on debonding characteristics and their distribution in patients show seven
failures in total. Characteristics are:
• A total of seven failures consisted of four debonding incidents and three breaks of material;
• Only in two patients did double failure happen (one debonding and one breaking);
• Both patients with double failures preferred the same material in the final question;
• Another three failures were separate incidents in separate patients.
Figure 17 shows the extent of distalization for both groups. The range of data shown
in Figure 17 may be viewed as an estimate of the range of possible outcomes, and the
difference between two mean data points on the graph as an estimate of the expected
difference between these two materials (the estimates were made using bivariate analysis,
i.e., without taking into account the influence of other factors on the outcomes). Medians
are depicted as lines within the boxes and the respective mean with a diamond sign. The
“whiskers” extend from the ends of the box to the minimum and maximum data values. The
circle denotes an observation whose value is far from the rest of the sample. Considering
the range of clinically observed values, this data point is not a genuine outlier; instead, it is
a consequence of the small number of observations.
Materials 2022, 15, 1740 20 of 27

Figure 17. Data distribution of distance to distalization target stratified by type of photopolymer.
Data are presented as the median (horizontal line) and mean (diamond sign), the lower-upper quartile
range, minimal and maximal values. The red circle denotes an observation with a large but legitimate
value that fell outside of the presumed normal distribution. A two-sample t-test verified by its
non-parametric alternative was used to test the between-group differences in the distance. The
difference between group means was not statistically significant (p = 0.578). Finally, tertiary objective
was to examine patients’ preference after they had completed treatment with either white or clear
(transparent) material. Only two patients out of a total of 12 patients (16.7%) preferred white resin
over the transparent one. The question was “Which of these two materials would you consider more
aesthetically appeasing for a distalizer if you can choose?”. They were shown examples of both
materials together.

Since the proportions of patients preferring transparent material were the same, with
a maximum difference of 3.2 % assessed by the binomial test for independent proportions
(approximate Miettinen 95% confidence interval = −0.4679 to 0.4679), we can conclude
that the preferences were comparable in the study arms. In other words, our findings
suggest that patients have preferred transparent material independently of the material
used for treatment.
Clinical evaluation of the 3D printed distalizer effect was obvious and measured
digitally on intraoral scan—as shown in Figure 5. In some cases, an option occurred where
both intraoral and CBCT scans were available after accomplishment of the distalization with
an opportunity to evaluate root positions before and after distalization. Figure 18a shows
comparison of the intraoral scan of the upper jaw with distalized teeth 23–27 by means of a
3D printed distalizer bonded on teeth 23 and 26. The achieved result, visible intraorally,
could have been analysed on segmented CBCT (Figure 18b) where: the first picture shows a
scan before distalization with a red overlay of a new CBCT after distalization superimposed
through basis cranii volume matching in the software Invivo Dental 6.5.0 (Anatomage,
Santa Clara, CA, USA). This figure shows the resulting orientation of the teeth roots with
a more visible 3rd palatal root of the tooth 26 in the final position. This is caused with
distorotation movement of this tooth, exposing a palatal root from a lateral view (shown by
red arrows).
Materials 2022, 15, 1740 21 of 27

Figure 18. Result of distalization of teeth segments 23–27 with a 3D printed distalizer. (a) intraoral
scan of one of the results with teeth positions before and after distalization phase. Distorotation
of the crown of 26 is shown with a red arrow with an occlusal 2.5–3.0 mm effect circled in blue;
(b) comparison of original and new (red) CBCT with a visible distal position of teeth in the 2nd
quadrant, the second picture is CBCT before treatment, the third picture CBCT after distalization
phase followed by contours of teeth 23 and 26 from CBCT, where blue is before and the red contour is
a new distalized position.

4. Discussion
This paper introduced a personalized distalizer treatment of a Class II malocclusion in
adults. Current evidence suggests that orthodontic treatment of such malocclusion should
be provided during adolescence. However, early treatment of Class II has been advocated
to reduce the risk of incisal trauma—for example, use of a Forsus Fatigue Resistant Device
as a non-compliance mandibular advancer after rapid palatal expansion was found to be
effective at reducing the sagittal jaw discrepancy, successful at controlling the patient’s
unfavourable growth pattern and beneficial for the child aesthetics Goracci, Cacciatore
2017 [68]. This paper proves that non-compliance orthodontic devices are more achievable
with personalized 3D printing.
This research has introduced a novel method of personalized orthodontic treatment
with a 3D printed distalizer from photopolymer resin. This has been never published
before. The closest research on this topic is research published in the journal of clinical
orthodontics in 2020 by Simon Graf on the account of CAD/CAM metallic printing of a
skeletally anchored upper molar distalizer [69]. This research is about a skeletally borne
metallic palatal distalizer. This paper is about a photo-polymeric 3D printed tooth borne
vestibular distalizer.
The authors of this paper have recently published research focused on 3D printed
orthodontic auxiliary—power-arm [70] using a Finite Element Analysis approach for 3D
design. Similar research, also implementing the Finite Element Method to evaluate the tooth
movement efficacy of retraction springs made of a new β-titanium alloy, was published with
Tamaya et al. [71]. The Finite Element Method with a combination of advanced Artificial
Intelligence features like 3D Convolution Neural Networks has a bright perspective for
the future of an individualized approach for 3D design of intraoral appliances and is thus
effective orthodontic treatment [72].
Results showed no significant clinical difference between both tested materials. Despite a
white photopolymer being 3D printed on better resolution (50 microns versus 100 microns),
there was no clinical impact. Debonding incidents were mostly caused by patient-admitted non-
compliance during eating, and material damage was rare. An interesting aspect of this study is
that all orthodontic patients’ intraoral situations were monitored remotely with a tele-Health
solution—Dental Monitoring, which is judged positively with orthodontists [73] Small differ-
ences in material properties had no clinically relevant impact on the distalizers’ performance.
Materials 2022, 15, 1740 22 of 27

Implication of these findings might suggest wider possibility of suitable materials—dedicated

dental resins. In 3D modelling of individualized distalizers, we recommend using Open-Source
free software like MeshMixer or Blender. In addition, for creation of other orthodontic devices
confirmed with the recent publication of Canova et al. 2021, these are preferred with younger
clinicians with more extensive digital skills [74].
3D printing in orthodontics now has great focused albeit not limited to orthodontic
aligners, and recent research of Zinelis et al. 2021 shows that mechanical properties are
dependent not only on the type of resin but also on the method of 3D printing affecting
their clinical efficacy [75].
The results can be interpreted from the perspective of previous studies mentioned
in the Introduction that photo-polymeric dental resins can be used for 3D printing of an
individualized distalizer with the comparable clinical efficiency. From the perspective
of extraordinary personalization of intraoral appliances with biocompatible 3D printing,
this approach has high potential also in addressing issues linked with cleft therapy with
dynamically changing intraoral morphology [76].
Results of research presented by this paper evaluated clinical performance of 3D printed
distalizers upon the frequency of their deboning and suggest that there is no significant
difference in this parameter between both compared resins. It is known that nanohybrid resin
composites, which are well tested, show good clinical/mechanical performance intraorally.
Therefore, the bonding failure, as a clinical issue frequently encountered in orthodontic practice,
will be rather effect of failure of adhesives than a material breakage [77,78].
The general findings of this paper are that 3D printed biocompatible personalized
distalizers can be successfully applied in tooth-borne hybrid treatment in Class II unilateral
malocclusions. Results of the comparison of two biocompatible photopolymers showed that
small differences in their material properties are not crucial to their clinical performance.
Implications resulting from these findings could advocate future wide use of these materials
as the dental resins gain better properties and thus intraoral resiliency [79,80].
This research showed preference of patients towards transparent biocompatible ma-
terial instead of white A2 shade, as the final tertiary objective was to evaluate patient
preference of material. Surprisingly, only one patient who was treated with a clear distal-
izer preferred white appliance “for the next time”. Furthermore, only one of the patients
wearing white shade A2 distalizers preferred white distalizer again; the rest would prefer a
transparent one if possible. Despite it seeming obvious that transparent material for distal-
izers was aesthetically more pleasing, the limitation of this consideration is that patients
were confronted only with one particular dental shade (A2).
Another limitation of this study is a small set of clinical treatments observed. To widen
the set to gather statistically useful numbers of clinical application, it would be necessary
to either:
1. reduce strictness of clinical conditions like I. skeletal class patients or bilateral distal-
ization situations;
2. or prolong the research for more years.
As these biocompatible dental resins are continuously updated, prolonged research
would bring results that would be already obsolete.
A future contribution of this paper might be relying on the realization of orthodontists
that individualization of the orthodontic treatment might be the key for efficient treatment
as it was in the past. The incoming smart materials for 3D printing might return the
treatment back into their hands. Orthodontics is an emerging field in which polymers
have attracted the enormous attention of researchers. In particular, thermoplastic materials
have a great future utility in orthodontics, both as aligners and as retainer appliances. The
most promising polymeric smart materials are also discussed for their relevance to future
orthodontic applications.
With possibilities sourcing from digital workflows and 3D printing, this new method
could have been introduced in this paper—empowering orthodontists with a feasible way
to create a fully personalized 3D printed distalizer based on a digital intra-oral scan.
Materials 2022, 15, 1740 23 of 27

To date, no other study has elaborated on the possibilities of biocompatible 3D printing

of customized orthodontic auxiliaries like distalizers. No study focused on hybrid Class
II treatment with CAT or introduced such a novel method of additive manufacturing
of a custom distalizer for every patient. Only recently has a wider range of Class IIa
biocompatible dental resins for 3D printing been introduced and fully certified in Europe.
An interdisciplinary approach is necessary to invent and establish this prospective approach
that includes 3D digital scanning, 3D software modelling, 3D biocompatible printing and
orthodontic knowledge of biomechanics.
This paper shall inspire orthodontists to take advantage of intraoral scans, and they
do routinely and utilize them in their routines for in-office 3D printing of personalized
orthodontic auxiliaries, not necessarily only distalizers. There is another significant as-
pect of this paper—the encouragement of orthodontists to develop their own customized
auxiliaries for hybrid treatments or even in wider clinical context, returning treatment indi-
vidualization back into their hands with the opportunity to fully personalize the treatment
of their patients as they did in the past in the times of legendary “wire-benders”, with every
appliance being in-office individualized.

5. Conclusions
An in-office 3D printed biocompatible individualized distalizer can be utilized for
tooth-borne hybrid orthodontic treatment of Class II unilateral malocclusion.
Upon evaluation of the frequency of debonding of the distalizers on the set of 12
complete orthodontic treatments, we can conclude that there was no significant difference
between materials regarding this measure.
Patient evaluation of the most aesthetically pleasing material for the distalizer selected
the clear (transparent) material compared to an alternative white (A2) material.

Author Contributions: Conceptualization, A.T. and I.V.; methodology, A.T., I.W.; software, A.T.,
I.W.; validation, A.T., B.N., I.W.; formal analysis, A.T., I.W.; investigation, A.T.; resources, A.T.; data
curation, A.T., I.W.; writing—original draft preparation, A.T.; writing—review and editing, A.T., I.W.,
B.N., W.U.; visualization, A.T.; supervision, I.V.; project administration, A.T.; funding acquisition, I.V.
All authors have read and agreed to the published version of the manuscript.
Funding: This research was funded by the KEGA grant agency of the Ministry of Education, Science,
Research, and Sport of the Slovak Republic (Grant No. 081UK-4/2021); Data analysis was supported
by the grants APVV: SK-BY-RD-19-0019 and KEGA: 041UK-4/2020.
Institutional Review Board Statement: The study was conducted according to the guidelines of the
Declaration of Helsinki, and no approval was necessary by the Ethics Committee. Ethical review and
approval were waived for this study, due to the fact that no experimental materials or approaches
were used. All used materials and machines were fully certified and are still available in the market.
Dental LT Clear is tested at NAMSA, Chasse sur Rhône in France, and is certified as biocompatible per
EN-ISO 10993-1:2009/AC:2010. The biocompatible resin material follows ISO Standards: EEN ISO
1641:2009, EN-ISO 10993-1:2009/AC:2010, EN-ISO 10993-3:2009, EN-ISO 10993-5:2009, EN 908:2008.
3D printer—Formlabs Form 2 was the first and only stereolithography 3D printer to be validated
by Materialise as part of the Materialize first FDA-cleared process to create accurate patient-specific
anatomical models for diagnostic use. Formlabs electrical equipment is manufactured in facilities
with the following QMS certifications. Form 2 (Quality system standards) ISO 9001:2015 and ISO
14001:2015. Formlabs, Inc., located in Somerville, MA, USA, certifies that: Formlabs Form 2 3D
printers are assembled within the European Union in Hungary and Formlabs Dental SG Resin and
LT Clear Resin are manufactured within the European Union in The Netherlands.
Informed Consent Statement: Written informed consent was obtained from all subjects involved in
the study.
Data Availability Statement: Data available in a publicly accessible repository that does not issue DOIs.
Publicly available datasets were analyzed in this study. This data can be found here [https://docs.google.
com/spreadsheets/d/1zfHNou0FCatt7g9R1NFVZhhRL9-JPiza/edit?usp=sharing&ouid=1127570142017
77395361&rtpof=true&sd=true], accessed on 23 February 2022.
Materials 2022, 15, 1740 24 of 27

Acknowledgments: We acknowledge technological support of digital dental lab infrastructure of

3Dent Medical s.r.o company as well as dental clinic Sangre Azul s.r.o.
Conflicts of Interest: The authors declare no conflict of interest.

Abbreviations

3D Three-Dimensional
AM Additive Manufacturing
CAT Clear Aligner Therapy
CDA Carriere Distalizer Appliance
CMA Carriere Motion 3D Appliance (Another name for CDA. Table of used abbreviations
in alphabetical order.)
STL Standard Tessellation Language, describes only the surface geometry of a
three-dimensional object without any representation of colour or texture

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