J Orofac Orthop

DOI 10.1007/s00056-016-0048-y

ORIGINAL ARTICLE

Virtual setup: application in orthodontic practice

Virtuelles Setup: Anwendung in der kieferorthopädischen Praxis
Leonardo T. Camardella1 • Eduardo Kant C. Rothier1 • Oswaldo V. Vilella1 •

Edwin M. Ongkosuwito2 • Karel Hero Breuning2

Received: 8 September 2015 / Accepted: 21 March 2016

Ó Springer-Verlag Berlin Heidelberg 2016

Abstract are needed for dental professionals to master and adopt the
Background A plaster dental model is a patient’s tradi- general use of digital models and virtual setups in dentistry.
tional three-dimensional (3D) record. If the dental crowns
from a plaster model are separated and positioned in wax, Keywords Orthodontics  Dental model  Diagnosis 
this setup of the crowns can be used to simulate orthodontic Treatment outcome
treatment. The traditional way to make this dental setup
requires significant time by the orthodontist and in the Zusammenfassung
orthodontic lab. New developments in dentistry and Hintergrund Ein Gipsmodell ist die traditionelle dreidi-
orthodontics include the possibility of virtual setups. mensionale Akte des Patienten. Die vom Gipsmodell
Aim In this article, the differences between conventional getrennten und in Wachs eingebrachten Zahnkronen kön-
setups with plaster models and virtual setups are discussed. nen dazu dienen, die kieferorthopädische Behandlung zu
Methods A clinical patient is described for whom two simulieren. Das traditionelle Verfahren für dieses Setup
different setups were made and compared by model bedarf eines erheblichen Zeitaufwandes sowohl für den
superimposition with Geomagic Qualify software. Kieferorthopäden als auch für den Zahntechniker. Zu den
Results According to the literature and the results from this neuen Entwicklungen in der Zahnheilkunde und in der
study, virtual setups and conventional setups with plaster Kieferorthopädie zählt die Möglichkeit virtueller Setups.
models are equally accurate. Ziel Diskutiert wird der Unterschied zwischen konventio-
Conclusion Virtual setups present several advantages, e.g., nellen Setups mit Gipsmodellen und virtuellen Setups.
digital storage, digital models cannot be damaged, the same Methoden Für einen klinischen Patienten wurden 2 ver-
model can undergo several treatment simulations, and schiedene Setups erstellt, die anhand der Überlagerung der
communication between dental and surgical professionals Modelle unter Verwendung der Software Geomagic Qua-
and between dental professionals and patients is facilitated. lify miteinander verglichen wurden.
Despite these advantages, considerable time and training Ergebnisse Der Literatur und den Ergebnissen der Studie
zufolge ist die Genauigkeit virtueller Setups und konven-
tioneller Setups mit Gipsmodellen gleich.
Schlussfolgerung Virtuelle Setups bieten eine Reihe von
Dr. Leonardo Tavares Camardella.
Vorteilen, u. a. lassen sie sich digital archivieren, digitale
& Leonardo T. Camardella Modelle können nicht beschädigt werden, und dasselbe
[email protected] Modell kann für mehrere Behandlungssimulationen ein-
1
gesetzt werden. Ferner erleichtern sie die Kommunikation
Department of Orthodontics, Dental School, Federal
zwischen Kieferorthopäden und Kieferchirurgen sowie
Fluminense University, Mário Santos Braga Street, 30, 28
Floor, Room 214, Niteroi, RJ 24020-140, Brazil zwischen Kieferorthopäden und Patienten. Trotz dieser
2 Vorteile ist ein erhebliches Maß an Zeit- und Fortbil-
Department of Orthodontics and Craniofacal Biology and
Cleft Palate, Craniofacial Centre, Radboud University dungsaufwand notwendig, um den Einsatz von digitalen
Medical Centre, Nijmegen, The Netherlands

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Modellen und virtuellen Setups in der Zahnheilkunde zu difficult to compare two plaster models made at different
erlernen und anzuwenden. times [8]. To analyze tooth movement, dental models need to
be superimposed on a stable structure [6, 31]. Nowadays,
Schlüssewörter Kieferorthopädie  Zahnmodell  digital dental models can be made using a model scanner, a
Diagnose  Behandlungsergebnis scanned impression, or an intraoral scanner
[17, 23, 27, 28, 30, 32]. If digital models are available, they
can be superimposed using specialized software. For upper
Introduction model superimposition, the third rugae is suggested as a
stable reference landmark [31]. However, the use of a specific
Diagnosis and treatment planning are essential steps for palate volume when superimposing digital models seems to
successful orthodontic treatment. Capturing the face (if be more accurate [6]. Attempts to use stable bone structures
possible in 3D), including the patient’s dentition in pho- on the mandible to superimpose cone beam computed
tographs, radiographs, and dental models, is fundamental. tomography and digital models have been tested [22].
Dental models provide a great deal of information on the
mesiodistal dimensions of teeth, arch length discrepancies,
dental asymmetries, and arch relationships in three dimen- Versatility of a virtual setup
sions. A dental model can also be used to produce a 3D
simulation of a treatment plan called a dental ‘‘setup’’ [2]. The use of digital models in orthodontics has several
Through these simulations, potential therapeutic objectives advantages. They eliminate the need for storage space
such as the need for tooth extractions or interproximal [17, 21, 23, 25, 27, 28, 30, 32] as these models can be
stripping can be evaluated. A setup is thus a valuable stored on hard drives, memory sticks, CDs and DVDs. If
diagnostic tool that can be used to confirm, modify or reject digital models are available, they can be used to obtain
a suggested treatment plan and can be particularly valuable information for diagnosis and treatment planning [10, 29];
in complex cases. An alternative to the traditional setup they facilitate the transfer of dental models
(using a plaster model) is ‘‘the virtual setup,’’ which was [9, 12, 17, 25, 27, 28, 32] and can be used to make custom
introduced in the last decade. In this article, the advantages appliances based on a virtual setup [11, 20]. These models
and disadvantages associated with the use of the conven- also allow visualization of orthodontic treatment plans
tional setup and virtual setup are discussed and these two [5, 7, 13, 15, 18].
setup methods for a clinical case are compared by model The actual construction of a virtual setup takes less time
superimposition technique with Geomagic Qualify software than making a conventional setup in plaster. To make a
(3D SystemsÒ, Rock Hill, SC, USA). virtual setup, no actual cutting of the plaster or positioning
of the dental crowns in wax is needed. Setup accuracy can
be improved when digital models are used, because any
Setup in orthodontics loss of tooth structure during the cutting process of the
plaster is avoided during the digital dental crown separa-
Harold Kesling introduced the setup in orthodontics to tion procedure. The virtual teeth are cut from the model
manufacture a dental positioner for finishing orthodontic using virtual segmentation techniques, according to the
treatment. After the orthodontic bands were removed, the software used. In Ortho Analyzer software (3ShapeÒ,
remaining spaces could be closed with the positioner. Copenhagen, Denmark) this segmentation process starts
Shortly thereafter, Kesling realized the importance of this with marking mesial and distal points on each tooth. Then,
setup for orthodontic diagnosis and treatment planning [14]. the software draws a segmentation line along the gingival
The original technique to make a setup, using separated margin. This process is executed semi-automatically, but
plaster crowns of the dentition fixed in dental wax, has the suggested segmentation lines still need to be manually
been improved over time. One of these improvements was corrected. After that, the software separates the dental
to position of the lower incisor in the setup according to the crowns from the virtual gingiva and defines the inter-
cephalometric planning (Fig. 1) [2]. After correcting the proximal contacts. The time consuming process of lami-
position of the lower incisors, the next step traditionally nating and polishing the dental wax needed to make
was to manufacture a setup maintaining the vertical conventional setups, is not needed for virtual setups.
dimension of the patient́s dentition by keeping the posterior Plaster model duplication (as used for the traditional fab-
teeth such as third and second molars, or placing wax or rication of a setup) is also not required [12].
resin stops in the model’s posterior region. In the conventional setup, the dental arch form is plan-
A major disadvantage of plaster models and setups in ned using a brass wire or pre-established wire shape dia-
plaster is that superimposition is not possible. It is thus grams available from different companies. In virtual

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Fig. 1 The setup manufacturing process with plaster models. a Initial Abb. 1 Herstellungsprozess beim Setup mit Gipsmodellen. a Initiales
plaster model, b documenting the most protruded lower incisor Gipsmodell, b Dokumentation der stärksten Protrusion im unteren
position, c splitting the crowns and finishing, d positioning the teeth Schneidezahnbereich, c Spleißen der Kronen und Finishing/Finieren,
in wax and checking the lower incisor position, e finished conven- d Einbringen der Zähne in Wachs und Lagekontrolle der unteren
tional setup Schneidezähne, e fertiges konventionelles Setup

setups, the arch form can be easily adjusted for each differences between the original position of the dentition
individual patient using software tools that can create an and the planned teeth movement can be visualized after
individual digital arch form. As an alternative, the superimposition of the digital models in different colors.
orthodontist can select reference points on the digital dental With digital models it is even possible to make a simula-
arch and selects a digital template arch to choose the best tion video demonstrating the planned movements of the
arch form for the patient, for instance by using the WALA teeth. This virtual setup facilitates efficient communication
ridge. between the orthodontist, patients and dental professionals.
References such as dental midlines, the position of If a proposed treatment plan is not accepted, an alternative
upper and lower molars and the buccal surface of the most plan can be made within minutes.
protruded lower incisor are needed for plaster setups [2]. It is important to mention that tooth movements on
For virtual setups, the original occlusal and vertical plane computers are unlimited. Tooth alignment and levelling
serves as a reference. The orthodontist can quantify and can be planned on the computer screen but this result may
visualize the applied tooth movement in all directions not be realistic for that specific patient. Obviously, tooth
during the actual virtual setup process and, when required, movement has its biological limitations. Therefore, too
applied tooth movement can be easily reversed. The effect much expansion or compression of the dental arches as
of gradual dental arch expansion, reduction of interdental planned in virtual setups may result in unstable results and
tooth material (‘‘stripping’’), or the decision to extract teeth periodontal recessions [5]. In a setup of the custom
can be evaluated in a virtual setup for any patient. orthodontic appliance system ‘‘Insignia’’ (OrmcoÒ,
Although dental changes on a plaster setup can be com- Orange, CA, USA), the outline of the alveolar mandible
pared with the original plaster model, in a virtual setup the bone at a distance of approximately 4 mm below the

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Tab. 1 Summary of characteristics of conventional and virtual setups

Tab. 1 Zusammenfassung der charakteristischen Merkmale konventioneller und virtueller Setups
Conventional setup Virtual setup

More time-consuming Less time-consuming

Difficult to duplicate Easy to duplicate
Dental arch form planned using a brass wire or Dental arch form planned digitally
diagrams
Need for dental and facial references Digital references and quantification of the movements of all teeth
Physical comparison with initial dental model Comparison with initial model via digital superimposition
Verbal communication requiring the presence of dental Efficient digital communication between the orthodontist, patient and dental
professionals and patient professionals
Potential of tooth fracture during separation Effective digital segmentation of the teeth
Enables only one setup from each model Enables different treatment plans on the same model
Conventional orthodontic analysis Analysis facilitated by software programs
Need for storage space Digital storage and a copy in the cloud
Deteriorates over time Easy digital back-up maintaining the same quality
Difficulty of sharing diagnostic information with other Easy transfer and sharing of dental models and setups via the internet
professionals
Used only for treatment planning Also used to design and make custom appliances (aligners, fixed appliances) and
evaluation of treatment progress and result
Difficult to reproduce the same setup Possibility to reproduce the same setup according to the pre-determined records of
movements
CBCTs cannot be combined with plaster models CBCTs can be combined the digital models to make a virtual head
CBCT cone beam computed tomography

gingival margin (the so-called ‘‘Mantrough’’) can be position [19]. Digitally designed attachments can be bon-
drawn; it reveals the limitations for moving the mandibular ded on the teeth to improve the efficiency of specific tooth
dentition in the virtual setup and during treatment [4]. After movement with aligners.
adapting the lower dentition to the mandibular alveolar A digital model can also be used to virtually position
bone’s dimensions, the upper dentition can be adapted to images of a scanned series of standard brackets. This vir-
the setup of the lower arch. In some software programs tual bracket positioning can be done on the virtual dentition
such as the Ortho Analyzer, the occlusion of the dentition before treatment or on a virtual treatment setup. This
in the setup can be simulated and visualized in a virtual planned bracket position should be transferred to the den-
articulator. Obviously, all setups should be based on bio- tition before treatment and printed dental models can be
logical principles, and their utility depends on the clini- used to construct indirect bracket bonding trays [26].
cian’s experience; so although a trained dental technician Recent software programs can even be used to design a
can make an initial virtual setup, the orthodontist should virtual indirect bracket transfer bonding tray which can be
check each setup and make the corrections needed. printed with 3D printers, without the need to actually print
the dental models. A virtual setup can also be used to
design individualized (‘‘custom’’) brackets and custom
Virtual setup applications in orthodontic wires for buccal and lingual fixed appliance therapy. These
treatment virtual custom brackets can be printed in wax and casted in
a gold alloy using digital technology [11, 20]. A set of
There is ample evidence that digital models are as accurate individual wires can be bent by a wire-bending robot to
and reliable as plaster models [17, 21, 23, 25, 27, complete an individual tooth movement system such as
28, 30, 32]. With the introduction of digital models, virtual Incognito.
setups and arch wire bending robots, new individual (cus- Of course, the dental roots are not visible in a setup
tom) orthodontic appliances have been developed. The made from a plaster model or from an intraoral scan of the
virtual setup of a specific case can be used to gradually dentition. Root parallelism or bone dehiscence of the
move the dentition into the planned position. A series of alveolar ridge cannot be evaluated on these models. If both
3D printed dental models can be used to fabricate a series cone beam computed tomography (CBCT) radiographs and
of aligners which move the teeth gradually into the planned digital models are available, these 3D images can be

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Fig. 2 Initial extra-oral and

intra-oral photos
Abb. 2 Extra- und intraorale
Fotos zu Beginn

accurately superimposed [15, 18, 24]. Some current CBCT according to Larson et al. [16] the effectiveness of
machines such as the Planmeca ProMax 3D (Planmeca orthodontic treatment using SureSmile technology to
Inc., Roselle, IL, USA) can make 2D and 3D radiographs achieve predicted tooth position varies according to the
and a 3D facial scan. The software available can be used tooth types and movements needed. Table 1 illustrates the
for combined 3D information (a ‘‘virtual head’’). Evalua- advantages and disadvantages of the conventional and
tion of the available alveolar bone and the effect of planned virtual setups.
tooth movement on the soft tissues is now possible
[15, 18, 24]. Some companies, such as SureSmile
(OrametrixÒ, Richardson, TX, USA) use intraoral scans as Clinical case
well as CBCT images for treatment planning and evalua-
tion. A major advantage of a virtual treatment plan using A female patient aged 17 years and 11 months presented
the 3D documentation of the head in a 1:1 ratio is that the for consultation in the Orthodontic Clinic at the Federal
orthodontist can evaluate and plan the dentition’s correc- Fluminense University (Niterói, Brazil). Her main com-
tion and if needed, the jaws including correction of the plaint was her lip prominence. After the anamnesis and
dental roots. Progress intraoral scans and CBCTs allow a clinical examination, regular orthodontic documentation
progress setup to be made, which can be used for the was planned. The diagnosis for this patient was a Class I
fabrication of finishing wires or finishing aligners. Studies malocclusion with an anterior open bite, mild anterior
have shown that the use of computer-bent custom wires as crowding, and lip protrusion (Fig. 2). Cephalometric
used in the SureSmile system can reduce orthodontic analysis showed upper and lower incisor protrusion
treatment time and improve treatment outcomes [1]. But (Fig. 3).

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An initial plaster model was manufactured and copied to

make the conventional setup (Figs. 4, 5). The initial plaster
model was scanned with a desktop scanner (type R700,
3ShapeÒ, Copenhagen, Denmark) in order to obtain a
digital model (Fig. 6). On this digital model, a virtual setup
was made with Ortho Analyzer software (Fig. 7). One
orthodontist made the conventional setup on plaster model
and another orthodontist made the virtual setup. The fab-
rication of the conventional setup took up to 5 h, while the
virtual setup was made in 40 min.
After evaluation of the setups, the proposed final treat-
ment (extraction of the first four premolars and fixed
orthodontic appliances in the upper and lower arch) was
presented to and accepted by the patient.
Orthodontic treatment started with extraction of the first
four premolars and bonding of the upper and lower fixed
appliance. The dentition was aligned and leveled using
flexible wires. Then an 0.02000 stainless steel arch wire was
used to retract the cuspids with elastic chain. Incisor
retraction and space closure was achieved with a
0.01900 9 0.02500 stainless steel arch wire with a bubble
loop. Steel wire bends and anterior and posterior inter-
maxillary elastics were used for finishing. An upper
Fig. 3 Initial lateral cephalogram showing the upper and lower removable plate (‘‘Hawley plate’’) was used for retention in
incisor protrusion the upper arch. A lower fixed retainer was bonded in the
Abb. 3 Initiales laterales Kephalogramm zur Darstellung der unteren mandible (Fig. 8). Treatment of this patient resulted in
und oberen Schneidezahnprotrusion

Fig. 4 Initial plaster model (views: right side, front, left side, upper occlusal and lower occlusal)
Abb. 4 Initiales Gipsmodell (Ansichten: rechte Seite, Front, linke Seite, Oberkieferaufsicht, Unterkieferaufsicht)

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Virtual setup: application in orthodontic practice

Fig. 5 Conventional plaster setup (views: right side, front, left side, upper occlusal and lower occlusal)
Abb. 5 Konventionelles Gips-Setup (Ansichten: rechte Seite, Front, linke Seite, Oberkieferaufsicht, Unterkieferaufsicht)

Fig. 6 Initial digital model (views: right side, front, left side, upper occlusal and lower occlusal)
Abb. 6 Initiales digitales Modell (Ansichten: rechte Seite, Front, linke Seite, Oberkieferaufsicht, Unterkieferaufsicht)

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Fig. 7 Virtual setup (views: right side, front, left side, upper occlusal and lower occlusal)
Abb. 7 Virtuelles Setup (Ansichten: rechte Seite, Front, linke Seite, Oberkieferaufsicht, Unterkieferaufsicht)

upper and lower incisor retraction and an improvement in differences were seen in the vertical relationship of the
her profile (Fig. 9). second premolars and in the transversal dimensions of the
The conventional setup was scanned (R700 scanner), first molars. The superimposition on this model set shows
which allowed a digital superimposition of both setups similar dimensions in the canine-to-canine region.
using Geomagic Qualify software. For this model super-
imposition, only the dentition’s outline was used because
the superimposition of the gingival area results in distor- Discussion
tion. On the conventional setup, the wax does not accu-
rately represent the gingiva. On the virtual setup, In many cases, a dental setup to simulate orthodontic
distortions of the virtual gingiva caused by virtual dental treatment helps the orthodontist to decide which treatment
movements cause inaccurate representation of the gingival option is the best for a specific patient. This setup can also
region. With this software, the superimposition of the be considered a powerful communication tool to explain
dentition was achieved using the ‘‘best fit alignment possible treatment options to the patient and the referring
method’’ (the software calculates the best alignment of a dentist or a specialist such as a maxillofacial surgeon. It is
thousand identical points between the dentition of two not advisable to suggest that the orthodontic treatment
setup models). outcome will be exactly as presented in the setup because
Superimposition of the setups reveals differences during each orthodontic treatment, complications and side
between the two setups. Average positive discrepancies of effects such as individual responses to treatment mechan-
0.39 mm and average negative discrepancies of 0.46 mm ics, periodontal restrictions, lack of cooperation in the use
in the upper models, and average positive discrepancies of of extra oral appliances or elastics can affect the treatment
0.53 mm and average negative discrepancies of 0.51 mm outcome.
in the lower models can be seen in a color-coded scale of When conventional and virtual setups such as those
the superimposition (Fig. 10). The largest differences in presented in this case are compared, differences between
dimensions of the upper arch were located in the first treatment planning and actual outcome become apparent.
molars transversal dimensions and in the lateral incisors’ Such differences are unavoidable because of the side
vertical relationship. In the lower arch, the greatest effects already mentioned and inaccuracies in the setup

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Virtual setup: application in orthodontic practice

Fig. 8 Extra-oral and intra-oral

photos after treatment
Abb. 8 Extra- und intraorale
Fotos nach Behandlung

manufacturing process [7, 13]. Nevertheless, virtual setups setup versus a virtual arch form for the virtual setup).
are at least as effective and accurate as conventional setups However, the advantage of a virtual setup is that a
and are an effective tool for diagnosis and orthodontic report with a script of all movements performed during
treatment planning, appliance fabrication, and treatment the setup fabrication can be generated; thus, an identical
assessments [3]. setup can be made.
According to the literature, significant differences in For each setup, references to the original dental position
the Original American Board of Orthodontics Objective are needed. In the conventional setup, the second molar
Grading System (ABO-OGS) scores between two virtual position was maintained to preserve the vertical occlusion
setups of the same original models made by a single dimension. In the virtual setup, all posterior teeth were
clinician were reported [7]. Virtual setups of the same moved but the original occlusal and transversal plane were
original model made by different clinicians differed also used as a reference. Tooth movement limitations (con-
[7]. Such differences also occur if conventional setups strained movement) can be selected in the planning soft-
with plaster models are made, because dental setups ware to prevent very large and clinically impossible tooth
depend on a practitioner’s subjective decisions. In this movements.
article, two different orthodontists made the conven- As progress in digital imaging techniques and tools to
tional and virtual setups. The differences between these plan medical treatments accelerates, the use of virtual
setups, especially those in the transversal posterior setups in orthodontics before and during treatment will
relationship, are influenced by how the planned arch become the ‘‘main stream’’ in orthodontics. If intra-oral
form had been selected (brass wire for the conventional color scanners are used, traditional intra-oral photographs

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are no longer needed. If facial scanners are used, those

scans can replace traditional extra-oral photographs. A
potential obstacle for the transition into virtual treatment
planning and appliance design may be that these techniques
are more expensive and the orthodontic lab and
orthodontist should buy the hardware and software needed
for making virtual setups. Another problem is the adequate
training of the orthodontic technician, the dentist and/or
orthodontist to use this new technology. However, because
of the growing demand for well-planned efficient
orthodontic treatment, the use of digital models and virtual
treatment planning will increase. The progress documented
during treatment will help to correct side effects of
orthodontic mechanics with orthodontic appliances. Pro-
gress scans after active orthodontic treatment can be used
to design and fabricate custom orthodontic retention devi-
ces. These new developments will make orthodontic ther-
apy more efficient and predictable.

Conclusion

Simulating orthodontic treatment outcomes before the

actual treatment has started is desirable and now actually
possible. There is a genuine demand for customized
orthodontic appliances to achieve planned orthodontic
treatment results in an efficient and predictable way.
Despite the fact that virtual setups have many advantages,
the high cost of the hardware and software as well as the
Fig. 9 Cephalogram after treatment showing the correction of the
inclination of upper and lower incisors lack of training (in making the dental virtual setup and
Abb. 9 Kephalogramm nach der Behandlung: Darstellung der using the software to design and manufacture custom
korrigierten Inklination von oberen und unteren Inzisiven

Fig. 10 Superimposition of conventional and virtual setups. Abb. 10 Überlagerung konventioneller und virtueller Setups.
a Digital model from the conventional setup. b Digital model a Digitales Modell vom konventionellen Setup. b Digitales Modell
from the virtual setup. c Superimposition of the scanned conven- vom virtuellen Setup. c Überlagerung des gescannten konven-
tional setup and virtual setup using the ‘‘best fit alignment’’ tionellen Setups und des virtuellen Setup unter Verwendung der
method. d Color code representing differences between the setup Methode ‘‘best fit alignment’’. d Farbkodierung zur Darstellung
models der Unterschiede zwischen den Setup-Modellen

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orthodontic appliances) currently limit the use of this 14. Kesling H (1956) The diagnostic setup with consideration of the
technology in orthodontics. third dimension. Am J Orthod 42:740–748
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Compliance with ethical guidelines orthodontic setup models on a computer. Am J Orthod Dentofac
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Conflict of interest L. T. Camardella, E. K. C. Rothier, O. V. Vilella,
computer-assisted orthodontic treatment technology to achieve
E. M. Ongkosuwito, and K. H. Breuning declare that they have no
predicted outcomes. Angle Orthod 83:557–562
competing interests.
17. Leifert MF, Leifert MM, Efstratiadis SS et al (2009) Comparison
All procedures performed in studies involving human participants
of space analysis evaluations with digital models and plaster
were in accordance with the ethical standards of the institutional and/
dental casts. Am J Orthod Dentofacial Orthop 136:16e1–16e4
or national research committee and with the 1964 Helsinki declaration
(discussion)
and its later amendments or comparable ethical standards. Informed
18. Macchi A, Carrafiello G, Cacciafesta V et al (2006) Three-di-
consent was obtained from all individual participants included in the
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study. Additional informed consent was obtained from all individual
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participants from whom identifying information is included in this
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