Professional Documents
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Keywords:
1. Introduction
computer-aided design, computer-
Temporomandibular disorder (TMD) is a common clinical entity [1,2]. The
aided manufacturing, additive manufacturing, prevalence of TMD in the adult population ranges from 25 to 50 per cent [3].
rapid prototyping, rapid manufacturing There is an increased risk for TMD in patients suffering from malocclusion,
such as cross bite, open bite or crowding [4,5], deep bite or mandibular retro-
gnatia [6]. Also bruxism, significant teeth wear, temporomandibular joint
(TMJ) problems or facial traumas may lead to TMD [7,8]. Traditionally, TMD
Author for correspondence:
treatment starts with an occlusal splint. Usually, if there is no response
Mika Salmi during the first one to six months, there is a need for additional examination
e-mail: mika.salmi@aalto.fi and treatment [9]. The conventional process to produce an occlusal splint com-
prises inter-occlusal wax bite registration and alginate impressions of the upper
and lower dentition to make working models. The manufacturing process when
performed by a dental technician is labour intensive. Digital manufacturing
processes are suggested as an alternative to a hand-made occlusal splint. Addi-
tive manufacturing (AM, Rapid Prototyping, Layer Manufacturing, Freeform
Fabrication) is a process where parts are manufactured directly from a digital
three-dimensional model by adding material, usually on a layer-by-layer
basis as opposed to subtractive manufacturing methodologies, such as tra-
ditional machining [10]. One of the advantages of an automated AM process
†
These authors contributed equally to this comes from the ability to print a large number of individual splints in a
study. short time period.
Indirect AM has been used for clear and hard tooth aligners by digitizing
teeth, virtually straightening them and fabricating a pattern for vacuum heat
process by AM [11]. A combination of computed tomography and rapid proto-
typing has been used to produce a physical copy of unusual tooth root anatomy
& 2013 The Author(s) Published by the Royal Society. All rights reserved.
[12]. A computer-assisted method for design and fabrication 2
of hard occlusal splints was developed by scanning for stone patient
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casts and milling for manufacturing [13]. AM has been used
for rapid tooling to create soft oral appliances by moulding
[14]. There are commercially available hard clear aligners, plaster model
which are made by digitizing dentition, virtual straightening, from teeth
fabricating a mould by AM, vacuum forming and finishing
[15]. The accuracy of wax patterns for facial prostheses pro- digitization of intraoral
plaster model scanner
duced by AM has been found to be better than conventional
duplication [16]. An AM model has been used as a mock-up
for manufacturing obturator prosthesis from acrylic poly- three dimensional
methyl methacrylate [17]. Laser surface digitizing with
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appliance use. This phase of the process and patient reporting
started with a standard dentist visit, where the occlusal splint
was trimmed to fit to the upper dental arch and to get optimal
contact with the lower dental arch. The patient was advised to
use the appliance every night, as is done with a conventional
bite splint, and to report on his own observations. The appliance
was cleaned every morning with water and tooth brush and once
a week with Corega Tabs (GlaxoSmithKline plc, UK).
After one, three and six months, the splint was examined for
possible wear and other changes. The final occlusal splint in use
2.6. Evaluation
Figure 3. The three-dimensional model of the occlusal splint. Dimensional accuracy of stereolithography in medical model
production has been found to be better than 1 per cent when com-
in the three-dimensional model were extruded to a thickness of pared with a three-dimensional model and manufactured model
2.0 mm. This can be done with the software’s extrude surface [30,31]. The accuracy of medical models varies between different
or offset commands. Thereafter, the extruded surfaces were cut materials, AM technologies and the machine used [32]. After six
off from the three-dimensional model, using a Boolean operation months of splint use, the GOM ATOS II Triple scan 3D scanner
to obtain a cover for teeth for a rough three-dimensional model of (GOM mbH, Germany) was used to capture a virtual three-
the splint. At this stage, it is important to cut the edges so that the dimensional model of the product used. The scanner employs
splint will not touch the gingivae, but still has enough contact structured blue light and cameras to record three-dimensional
with the teeth. Finally, the rough three-dimensional model of surfaces. The accuracy of the measurement was not less than
the splint was cut to the desired shape using the trim and cut 0.02 mm. A mixture of titanium oxide and alcohol was sprayed
tool. The smoothing command was used to achieve good surface over the splint before measuring to gain better response for the
quality for the three-dimensional model. Smoothing, which optical scanner. The geometry of the splint after use was com-
removes sharp corners and self-locking forms, was also used to pared with the geometry of the three-dimensional design using
remove too tight fitting to the teeth. The absolute minimum GOM Inspect V7 SR2 (GOM mbH, Germany), since the accuracy
wall thickness for laser-based AM systems would be the width of the stereolithography process is well known, and it can still be
of a single cured line and this is related to the diameter of laser estimated after use from the appliance’s surroundings where there
beam and the cure depth [29]. Therefore, the slight residual is no wear or trimming.
roughness of the three-dimensional model tends to be smoothed
in AM, and very small errors have only insignificant influence to
the end product. The three-dimensional model of the designed
occlusal splint is shown in figure 3. 3. Results
The digitally manufactured occlusal splint was used for six
months nightly as would a conventional one made by a
2.4. Manufacturing dental technician. After 5 days, the splint was trimmed, since
AM is a material-adding fabrication process, which suits manu- signs of slight pressure on the upper right canine and pressure
facturing complex geometries for either one piece or small series between the upper and lower right premolars were noted. The
production. The parts are produced automatically according to a patient felt the splint to be tight after a couple of minutes from
digital three-dimensional model. The selected additive process the beginning of every usage, which is typical also with a con-
for manufacturing was stereolithography (SL, SLA) because
ventional splint. No other problems were detected, and the
of its good accuracy and availability of suitable materials.
patient adapted to the splint well and found it comfortable to
Stereolithography is a process where laser hardens curable
photopolymer resin layer by layer. Parts are manufactured on use. It also relieved his bite muscle tension. No sign of tooth
the building platform, which is located in liquid resin. After a wear or significant splint wear was detected after the six-
layer is cured, the build platform descends by one layer thick- month test period. The splint after a test period of six months
ness, and a new layer of resin is spread over the previous one. is shown in figure 5.
This procedure is repeated until the parts are completely built. Figure 6 compares the splint, after six months of use, with
The machine employed was SLA 350 (3D Systems, USA). For the three-dimensional model. The overall accuracy of the
the material, Somos WaterShed XC 11122 (DSM Functional described system can be estimated from those areas with no
Materials, USA) was selected because it complies with the ISO wear of trimming. The maximum trim needed was approxi-
10993-5 Cytotoxicity, ISO 10993-10 Sensitization and ISO mately 1 mm. Wear can be estimated to be smaller than
10993-10 Irritation regulations. It also has USP Class VI approval.
0.2 mm. When comparing the physical model with the
The SLA 350 laser beam diameter is 100 mm, and features smaller
three-dimensional design, dimensional errors of approxi-
than that disappear. The layer thickness of the current process
was 0.05 mm. After the manufacturing phase, the splint was mately 1 mm were found at thin walls and sharp corners.
soaked in pure isopropanol for 20 min, and clean towels were The accuracy in other areas seems to be better than 0.3 mm.
used to scrub off any excess resin. Dry, compressed air was
used to blow excess solvent from the surface of the splint. The
splint was placed in a post-cure apparatus for 60 min after clean-
ing. The manufacturing can be done automatically overnight,
4. Discussion
and the current cost of manufacturing one splint is approxi- Oral appliances are frequently suggested as a treatment
mately 60 euros. option in the management of obstructive sleep apnoea,
4
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Figure 4. The occlusal splint in use.
(mm) 0.917
0.600
0.300
trimmed areas 0
wear areas
–0.300
–0.600
–1.139
Figure 6. The accuracy, wear and the trim needed can be assessed when comparing the used splint with the designed three-dimensional model.
TMD and for teeth protection in bruxism. The prevalence of a novel digital process for manufacturing occlusal splints.
TMD in adult population ranges from 25 to 50 per cent [3]. So far, the evidence of clinical applicability of this occlusal
Therefore, an increasing number of occlusal splints are cur- splint is limited to a single patient, and testing in a patient
rently manufactured for these purposes, using traditional series is needed before considering commercial production.
labour intensive process. This warranted us to design a However, production of a physical prototype and indivi-
novel method to produce these appliances more rapidly dual testing usually lead to further developing phases of
and with reduced costs. This study describes the process of the process and the product before further clinical experience
designing and manufacturing a novel occlusal splint and is obtained.
also the first subjectively reported experiences of its use. As A commonly used and well-known CAD/CAM technol-
in case of a conventional splint, the patient reported the pre- ogy for manufacturing of ceramic inlays in odontology is
sent occlusal splint being slightly tight when first put in place Cerec (Siemens, Germany) [33]. It has been pointed out
but after a few minutes it felt comfortable. This may occur that AM is the next revolution in dental device manufactur-
due to absorption of oral fluid to the splint material or ing [34]. By using and developing this kind of technology,
because of simple teeth adjusting. there is a possibility to use milling to manufacture occlusal
The aim of the present study was to describe the multi- splints from a solid block. Also, oral sleep apnoea appliances
disciplinary process that is needed to develop and evaluate could be partly or fully manufactured using digital
technology and AM technologies. Scanning or the software optimal. Also, mechanical properties could stand the forces 5
used could track occlusion and movement of jaws. Thereby, from teeth and jaws. The material was biocompatible with
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movement of the device and interface to the teeth could be low water absorption. Further, the accumulation of dental
more accurate. plaque on various splint materials used in the AM process
Traditionally, an occlusal splint is hand-made in a dental should be investigated. We noted only minimal plaque
laboratory. Therefore, the costs are fairly high, and the lead deposits on the tested splint after six months.
time is approximately one week before the patient is able The fast development of AM processes and materials poten-
to use it. Modern digital technology, including three- tially offers more and more direct applications in medicine.
dimensional scanning and AM, opens up a possibility to Possibilities of AM have not been used sufficiently as this
manufacture these splints more efficiently and to achieve requires multidisciplinary processes. In the future, new materials
shorter lead times. Digital technology may also improve the and technologies offer the medical and dental professions
accuracy of the final occlusal splint. This improved accuracy new treatment options, and therefore provide faster and more
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