ORIGINAL ARTICLE

Evaluation of soft-tissue changes in

young adults treated with the Forsus
fatigue-resistant device
Burçin Akan and _Ilknur Veli
Izmir, Turkey

Introduction: This study aimed to evaluate the effects of the Forsus fatigue-resistant device (FRD) EZ2
appliance (3M Unitek, Monrovia, Calif) on facial soft tissues by using images obtained from cephalometric
radiographs and 3-dimensional (3D) facial scanning system. Methods: A total of 20 patients treated with the For-
sus FRD EZ2 appliance were included in this study. The cervical vertebral maturation index was used to deter-
mine growth and development stages, and the subjects were investigated at cervical vertebral maturation stages
5 and 6 (ie, postpeak period). Three-dimensional facial scanning images were obtained with 3dMD Face (3dMD
Ltd, Atlanta, Ga). Cephalometric radiographic images were taken before placement of the appliance (T0),
immediately after removal (T1), and at the 6-month (T2) follow-up after the removal of the appliance. For
comparison of the data, one-way repeated-measures analysis of variance and paired t test were used at
P \ 0.05. Results: Statistically significant changes were found in the Wits value, IMPA, L1P-NB (
), L1-NB
(mm), L1P-APog, U1P-L1P, overjet, overbite, Ls-E, and labiomental angle in T0-T1. In T0-T2, statistically
significant changes in the Wits, IMPA, L1P-NB (
), overjet, overbite and Ls-E values were observed.
Conclusions: The results revealed that the correction of malocclusion with Forsus FRD EZ2 appliance in pa-
tients at the postpeak period was mainly dentoalveolar. The soft tissues were affected to a limited extent.
Three-dimensional facial scanning demonstrated similar accuracy and precision to traditional cephalometry,
being a repeatable and accurate tool for linear and surface measurements. (Am J Orthod Dentofacial Orthop
2020;157:481-489)

S
keletal Class II malocclusion is one of the most
common anomalies and constitutes 12%-49%
of orthodontic malocclusions.1,2 In Class II maloc-
clusions, the disruption of harmony between the struc-
tures forming the craniofacial system manifests itself
in unconformity in jaw relationships in the sagittal
plane, and is caused by genetic and/or environmental
factors.3 Upper jaw protrusion, lower jaw retrusion, or
a combination of both can be seen with this malocclu-
sion in which lower jaw retardation has generally been
reported.4 Functional appliances are one of the treat-
ment alternatives for these malocclusions and can
Department of Orthodontics, Faculty of Dentistry, Izmir Katip Celebi University,
Izmir, Turkey.
All authors have completed and submitted the ICMJE Form for Disclosure of Po-
tential Conflicts of Interest, and none were reported.
Address correspondence to: Burçin Akan, Department of Orthodontics, Faculty of
Dentistry, Izmir Katip Celebi University, Izmir 35640, Turkey; e-mail, burcin.
yksel@gmail.com.
Submitted, December 2018; revised and accepted, May 2019.
0889-5406/$36.00
Ó 2020 by the American Association of Orthodontists. All rights reserved.
https://doi.org/10.1016/j.ajodo.2019.05.014
correct the skeletal imbalance and profile disharmony
in individuals with Class II malocclusion.5
Functional appliances are divided into removable and
fixed groups, with many different designs within each
group.6 These two types of functional appliances have
some advantages over each other. Because of their size
and poor stability in the mouth, patient adaptation
with removable functional appliances is difficult.7
Thus, fixed functional appliances have been developed
to eliminate the disadvantages created by removable
functional appliances.
Several systematic reviews have focused on the
treatment effects of removable functional appliances,8,9
fixed functional appliances,10,11 or both.12 A debate as
to whether fixed functional appliances can stimulate
mandibular growth and result in long-term skeletal
changes remains.
Perinetti et al11 assessed the skeletal and dentoalveo-
lar effects of fixed functional appliances, alone or in
combination with comprehensive treatment, on pubertal
and postpubertal patients with a Class II malocclusion.
The authors reported that dentoalveolar effects were
generally seen regardless of the treatment timing.
481
482
Mesial movement of the mandibular dentition,13 mesial
movement5 or tipping14 of lower first molars, and procli-
nation of lower incisors5,14 were observed in the mandible,
whereas distal movement of the maxillary dentition,13
distal tipping of upper first molars,14 and/or retroclination
of upper incisors5,14 were reported in the maxilla. These
authors also pointed out the improvement of the profile,
mainly due to soft-tissue pogonion and B-point
advancement.11
Ishaq et al15 concluded that fixed functional appli-
ances appear to have no significant positional or
dimensional skeletal effects on the mandible in
growing subjects with Class II malocclusion. They also
pointed out that a slightly greater skeletal dimensional
effect was observed in the pubertal period than in the
postpubertal period, although this difference was not
statistically significant.
Forsus fatigue-resistant device (FRD; 3M Unitek,
Monrovia, Calif), which requires minimum patient
cooperation, is a fixed functional appliance developed
in recent years and preferred by some orthodontists
because of its ease of application.
Franchi et al16 assessed the dental, skeletal, and soft-
tissue effects of Forsus FRD in growing patients with
Class II malocclusion using lateral cephalograms. The
authors concluded that the Forsus FRD was effective in
correcting Class II malocclusion with a combination of
skeletal (mainly maxillary) and dentoalveolar (mainly
mandibular) modifications. In addition, the authors
reported that soft-tissue measurements showed a signif-
icantly greater backward movement of the soft tissue A
point in the Forsus FRD group.
Gunay et al17 used lateral cephalograms to evaluate
the short-term dentoalveolar and soft-tissue changes
in late adolescent patients treated with the Forsus
FRD. The authors reported that the Forsus FRD slightly
improved the profile, and the soft tissue reflected the
majority of the dentoalveolar changes (ie, the backward
movement of the upper lip following the retrusion of
maxillary incisors and no longer position of the lower
lip behind the maxillary incisors).
Flores-Mir et al18 evaluated facial soft-tissue
changes after the use of fixed functional appliances
in patients with Class II Division 1 malocclusion
through a systematic review of the literature. The au-
thors reported that although fixed functional appli-
ances produce some statistically significant changes
in the soft-tissue profile, the magnitude of the changes
may not be perceived as clinically significant. They also
pointed out that 3-dimensional (3D) quantification of
the soft-tissue changes was required to understand
the soft-tissue changes obtained with the use of fixed
functional appliances.
April 2020  Vol 157  Issue 4 American Journal of Orthodontics and Dentofacial Orthopedics
Akan and Veli
Several articles using Forsus FRD have been previ-
ously published. In these studies, 2-dimensional evalua-
tions of dental, skeletal, and soft-tissue changes after
the use of appliance were made. However, to our knowl-
edge, no articles using 3D evaluations were found in the
literature.
Traditional orthodontic records include patient
photographs, lateral cephalometric and panoramic ra-
diographs, and dental models. However, with the devel-
oping technology, the deficiencies of these methods are
emerging. Thus, extraoral photographs can be limited to
reflect real 3D images.
Currently, stereophotogrammetry, which is a 3D
facial scanning system, has become commonly used
with growing popularity among plastic surgeons, ortho-
dontists, and maxillofacial surgeons. This system has
become a valuable recording tool for diagnostic records
because it allows the face to be assessed on all 3 planes
of space.
The purpose of this retrospective clinical archive
study was to evaluate the soft-tissue effects of Forsus
FRD appliance by using cephalometric radiographs
and images obtained from 3D facial scanning system
in patients with skeletal and dental Class II anomalies
characterized by mandibular retrognathia in postpeak
period.
MATERIAL AND METHODS
A power analysis using G*Power software (version
3.1.3; Franz Faul University, Kiel, Germany) determined
that a sample size of 16 subjects per group would pro-
vide a power of 97% to detect significant differences
with an 0.45 effect size and a value of 0.05 (critical
c2 5 3.3403; noncentrality parameter l 5 19.44).
The records of T0 and T1 for 20 patients were
completely available. The records of the T2 period were
reviewed and evaluated for 16 patients because of 4 pa-
tients' records not being available. Thus, for 2 periods,
a total of 20 patients (10 boys, 10 girls) were included.
As a routine protocol in our clinic, dental models, facial
and intraoral photographs, and a set of 2D radiographs
including cephalometric and panoramic radiographs
are obtained from patients for orthodontic diagnosis
and treatment planning.
The selection criteria were as follows: (1) no history
of previous orthodontic treatment; (2) cervical verte-
bral maturation (CVM) stage 5 or 6 as determined
by cephalometric radiographs19; (3) skeletal Class II
relationship (ANB . 4
)20; (4) normal position of
the maxilla to the cranial base; (5) mandibular retro-
gnathy (SNB \ 78
)20; (6) Class II molar and canine
relationship; (7) normal or diminished vertical growth;
Akan and Veli 483

Fig 1. The Forsus FRD EZ2.

(8) lower incisor position should be upright on basal

bone or suitable for uprighting; (9) minimal crowding
in dental arches (# 4 mm); and (10) body mass index
is within normal limits.
All patients included in the study remained in similar
body mass index values during the study period.
Maxillary and mandibular arches were bonded with
0.022 3 0.028-in MBT prescribed appliances. Leveling
and aligning stages started with 0.016-inch nickel-
titanium (Ni-Ti) and continued with 0.016 3 0.022-in
Ni-Ti, 0.019 3 0.025-in Ni-Ti, and 0.019 3 0.025-in
stainless steel (SS) archwires, respectively. Once leveling
and aligning were achieved, the Forsus FRD EZ2 with
suitable rod length were mounted on 0.019 3 0.025-in
SS archwires bilaterally at both maxillary and mandibular
arches (Fig 1). A transpalatal arch was placed and the SS
archwire was cinched back in the lower arch at the stage
of appliance insertion. The lower parts of the Forsus FRD
were placed distal to the mandibular canine teeth.
To evaluate the effects of Forsus appliance, the re-
cords were taken before the insertion of the appliance
(T0), immediately after appliance removal (T1), and at Fig 2. The landmarks on the frontal view of the 3dMD
6 months follow-up (T2). The Forsus appliance was image.
removed when the Class I or super Class I molar and
canine relationship is achieved, and anterior teeth are optimized patient dose. The landmarks are shown in
mostly in a t^ete-a-t^ete position. In these 3 different Figures 2-4; definitions are available in Supplementary
time intervals, efficacy of the treatment on soft tissues Tables I and II.
was evaluated with lateral cephalometric radiography The positions and rotations on the 3D face image
and 3D facial images, respectively. were controlled and regulated in the coordinate system
3D facial images were obtained by using the 3dMD as suggested by Plooji et al21 for analysis. In order to su-
Face system (3dMD Ltd, Atlanta, Ga). All records were perimpose the 3D facial images, the registration protocol
obtained at the same posture and position. Patients was performed on the forehead, upper nasal dorsum,
were positioned on an adjustable chair and instructed and zygoma, which was reported by Maal et al22 as the
to look into his or her eyes in a mirror placed between most stable regions over time.
the cameras with eyes open and facial musculature The root mean square (RMS) value, which is specified
relaxed.21 All images were saved as TSB files and manip- in the software manually and determines how consistent
ulated using 3dMD Vultus software (3dMD, Atlanta, Ga). the registration process is, was recorded for each individ-
Skeletal and dental changes were evaluated using ual, and the superimpositions with the RMS value below
lateral cephalometric radiographs. All radiographs were 1 were re-evaluated. The RMS value has been applied so
taken with the same device (Orthopantomograph that it reaches the smallest possible value as in the study
OP300; Instrumentarium Dental, Tuusula, Finland) in of Taylor et al.23 Positive values in the measurements
10 seconds with an exposure time of 2.3 seconds and indicate that the anatomical point moves anteriorly after

American Journal of Orthodontics and Dentofacial Orthopedics April 2020  Vol 157  Issue 4
484
Fig 3. The landmarks on the lateral view of the 3dMD
image.
treatment on the anteroposterior plane, and negative
values indicate that the anatomical point moves back-
ward (posteriorly) in the anteroposterior plane.
Both the changes in the color histogram and the
millimetric changes between the 2 images were exam-
ined. The color histogram provides a visual assessment
of the difference between the 2 superimposed images.
When the result is positive, the second image topog-
raphy is more apparent and when the result is negative,
it is the opposite. The differences are represented along a
color spectrum with values associated with each color.
When comparing 2 images, the overpositive change is
represented by the red code and the overnegative change
is represented by the blue code (Fig 5).
Statistical analysis
Data were analyzed using the SAS 9.3 Software (SAS
Institute, Cary, NC). The Shapiro-Wilks test was used to
determine whether the data containing the cephalo-
metric and 3D facial image recordings in 3 different
periods comply with the normal distribution. Parametric
tests were used to compare the data after normal distri-
bution of the data was determined (P . 0.05), and
descriptive statistics were shown as mean 6 standard
deviation. These values were tested using a one-way
analysis of variance. Comparisons of the obtained re-
cords at different time intervals and binary comparisons
were made with Bonferroni correction with a paired t test
April 2020  Vol 157  Issue 4 American Journal of Orthodontics and Dentofacial Orthopedics
Akan and Veli
Fig 4. The landmarks on lateral cephalometric radio-
graph.
in SAS proc mixed procedure. For P \ 0.05, the results
were considered statistically significant.
RESULTS
The same author repeated the measurements 1 week
after the first measurements on 20 3D images and 20
cephalograms randomly selected from 10 patients. In-
traclass correlation coefficients ranged from 0.9 to
1.00. No significant errors were found when repeated
measurements were evaluated with paired t tests.
The cephalometric changes obtained with the Forsus
FRD were shown in Table I. The changes in the Wits
value were statistically significant between T0-T1 and
T0-T2. Although there was no statistically significant
change in the upper incisors, changes observed between
T0-T1 and T0-T2 periods in IMPA, L1-NB (
), L1-NB
(mm), and L1P-APog values, which express the antero-
posterior position and inclination of the lower incisors,
were statistically significant. Also, the increase in L6P-
MD value, which indicates the vertical position of the
lower incisors, was statistically significant (P \ 0.05).
Although the OB and OJ values decreased significantly
between T0-T1, they increased between T1 and T2
(P \ 0.001).
The soft-tissue changes obtained with the Forsus
FRD were shown in Table II. The results showed no sta-
tistically significant differences between all periods
(P . 0.05).
Akan and Veli
Fig 5. Superposition of 3dMD images in 2 different periods.
DISCUSSION
This study aimed to determine the soft-tissue effects
of Forsus FRD appliance in patients with skeletal and
dental Class II anomalies characterized by mandibular
retrognathia in the postpeak period.
Clinical studies with fixed functional appliances have
reported no gender discrimination.24-26 Jones et al27
individually evaluated the efficacy of the Forsus device
and intermaxillary elastics in female and male patients
and found no gender differences in treatment efficacy.
In our study, the patients were restricted to postpu-
bertal growth period. In this way, the compounding fac-
tor of growth was eliminated from treatment effects.
According to Hassel and Farman,19 an insignificant
amount of growth was expected in CVM stage 5 and
growth is completed in CVM stage 6. Because the active
growth of the craniofacial skeleton is mostly complete in
CVM stages 5 and 6, a control group was not included
in the current study. Franchi et al16 similarly reported
that the amount of craniofacial growth occurring after
postpubertal stages (ie, CS5 or CS6) was very limited in
subjects with Class II malocclusion. More importantly,
growth differences between Class II malocclusion
and normal occlusion subjects after late puberty are
insignificant.28
Because patients with different growth and devel-
opment potentials can negatively affect the outcome
of our research, bone age was taken into consideration.
In order to reduce the number of radiographs taken
from patients and thus exposure to radiation, hand-
wrist radiographs were not taken, and bone age was
American Journal of Orthodontics and Dentofacial Orthopedics
485
determined by the CVM index using the lateral cepha-
lometric radiographs of the patients included in the
study.19,29
The first records were taken immediately before the
insertion of the appliance, and the second records were
taken immediately after the appliance removal. In similar
investigations by other researchers, lateral cephalometric
radiographs were taken just before the application
and immediately after appliance removal.14-30 In our
study, the third records were taken 6 months after the
appliance removal (T2). In this way, the continuity of
the effects resulting from appliance use was examined.
The mean treatment duration of patients included in
our study was 5.11 6 1.6 months. Weiland and Ban-
tleon31 and Blackwood32 reported that fixed functional
appliances provided sufficient efficacy over 6 months.
In this study, the 3dMD Face system was used as 3D
digital photogrammetry. In our practice, scanning time
with 3dMD Face imaging system is 1.5 milliseconds
so that the distortions caused by motion are avoided
and more accurate measurements can be made. Clinical
reproducibility was reported at 98.5%, while the sensi-
tivity is \ 0.2 millimeters.33 Baysal et al34 reported
that 3dMD Face system and soft-tissue points have
high reproducibility and reliability in both intergroup
and intragroup comparisons.
Heinig and G€ oz35 reported an increased SNB angle in
patients treated with the Forsus appliance. In a thesis
project by G€ unay,36 Forsus appliances applied in the
postpeak period did not change the ANB angle, indi-
cating that this appliance had no skeletal effects.
April 2020  Vol 157  Issue 4
486 Akan and Veli

Table I. Comparison of cephalometric changes

T0 (n 5 20) T1 (n 5 20) T2 (n 5 16)

Parameter Mean SD Mean SD Mean SD P T0-T1 T1-T2 T0-T2

Skeletal
SNA 79.265 3.440 78.645 3.554 78.218 3.316 0.524 NS NS NS
SNB 75.255 3.542 75.005 3.325 74.793 3.241 0.746 NS NS NS
ANB 4.010 1.865 3.640 1.877 3.425 1.445 0.545 NS NS NS
Wits 2.245 2.573 0.19 1.763 0.318 1.531 \0.0001 *** NS ***
A-Na perp –1.760 3.530 2.465 3.379 2.431 3.587 0.277 NS NS NS
Pog-Na perp –7.945 5.839 8.655 5.469 8.243 6.915 0.613 NS NS NS
FH-NA 88.260 3.467 87.685 3.155 87.743 3.585 0.418 NS NS NS
N-CF-A 59.935 3.104 60.085 3.475 60.112 2.840 0.577 NS NS NS
Sgn-FH 60.415 3.669 60.760 3.205 60.343 4.221 0.614 NS NS NS
SN/Go-Gn 32.790 5.140 32.960 5.660 33.275 5.649 0.835 NS NS NS
PFH/AFH 63.280 4.525 62.960 5.528 62.731 4.371 0.726 NS NS NS
FMA 23.760 5.361 23.905 5.414 23.775 5.699 0.912 NS NS NS
SN-PP 10.285 3.194 10.405 3.616 10.425 3.161 0.403 NS NS NS
PP-MP 25.350 4.904 25.430 6.116 25.743 4.991 0.361 NS NS NS
NA-APog 5.215 5.164 4.855 4.798 4.375 4.252 0.537 NS NS NS
Sum total 395.645 5.083 396.015 5.580 396.125 5.409 0.759 NS NS NS
S-Go 72.115 7.134 72.575 7.028 72.668 6.320 0.788 NS NS NS
ANS-Me 62.570 5.847 63.685 6.081 63.587 5.335 0.139 NS NS NS
CoA 83.155 4.444 83.870 4.598 83.681 4.501 0.485 NS NS NS
Co-gn 107.505 7.009 108.835 7.633 108.631 6.610 0.236 NS NS NS
Mx-Md 24.350 4.105 25.385 4.208 24.956 4.111 0.102 NS NS NS
Dental
U1-SN 103.505 4.845 101.705 5.589 102.668 5.942 0.087 NS NS NS
U1-PP 113.810 5.414 112.185 5.823 112.768 6.497 0.23 NS NS NS
U1-NA 24.240 4.564 23.075 5.335 24.450 5.348 0.297 NS NS NS
U1-NA 4.870 1.769 4.010 1.937 4.087 1.796 0.063 NS NS NS
U1-MxOP 55.825 3.420 55.575 3.026 54.731 3.801 0.332 NS NS NS
L1-MdOP 66.025 4.286 64.645 4.054 64.568 3.731 0.065 NS NS NS
IMPA 92.430 5.318 97.965 4.811 96.800 5.343 \0.0001 *** NS **
L1-NB 23.335 5.156 28.475 4.438 27.937 4.340 \0.0001 *** NS ***
L1-NB 4.685 1.918 6.260 1.556 5.712 1.641 \0.0001 *** NS **
L1-APog 1.165 2.165 3.045 1.681 2.531 1.499 \0.0001 *** NS ***
U1-L1 128.430 6.221 124.665 5.441 124.375 5.949 0.002 ** NS *
U1-PP 26.790 3.095 27.455 3.247 27.487 3.241 0.319 NS NS NS
U6-PP 20.615 2.443 20.130 2.324 20.062 2.713 0.539 NS NS NS
L1-MP 34.510 3.252 33.790 2.877 34.006 3.149 0.306 NS NS NS
L6-MP 25.245 3.216 26.395 2.818 26.062 2.795 0.02 * NS NS
OB 2.570 0.91 0.99 0.869 1.468 0.755 \0.0001 *** NS ***
OJ 5.830 1.588 2.905 0.843 3.112 0.755 \0.0001 *** NS ***
Soft tissue
Nasal projection 13.955 2.072 14.635 2.266 14.668 2.251 0.071 NS NS NS
A0 –2.655 1.504 –2.595 2.002 –2.825 1.682 0.896 NS NS NS
B0 –13.735 3.364 –12.600 3.703 –12.737 3.227 0.063 NS NS NS
Pog‫׳‬ –12.115 3.968 –11.265 4.060 –10.987 3.413 0.065 NS NS NS
ULA 0.3 2.178 –0.02 2.340 –0.206 2.220 0.512 NS NS NS
LLA –4.245 2.808 –3.245 3.171 –3.793 2.998 0.072 NS NS NS
Soft-tissue 125.715 3.427 125.895 3.661 125.893 3.051 0.508 NS NS NS
convexity
Nasofrontal angle 137.255 9.374 135.490 8.424 134.393 8.392 0.317 NS NS NS
Nasolabial angle 113.710 10.303 114.025 11.038 110.681 12.914 0.101 NS NS NS
LCTA 106.060 7.737 106.520 7.447 109.943 5.812 0.149 NS NS NS
Nasomental angle 123.945 4.525 123.365 3.661 121.806 4.371 0.153 NS NS NS
Labiomental angle 111.795 12.005 121.900 14.110 116.737 10.401 0.0008 *** NS NS

*P \ 0.05; **P \ 0.01; ***P \ 0.001.

NS, Not significant; SD, standard deviation.

April 2020  Vol 157  Issue 4 American Journal of Orthodontics and Dentofacial Orthopedics
Akan and Veli 487

Table II. Comparison of the soft-tissue changes by 3dMD

T0 (n 5 20) T1 (n 5 20) T2(n 5 16)

Mean SD Mean SD Mean SD P

Upper lip length 22.025 2.204 21.853 3.043 22.700 2.707 0.125
Upper lip vermilion length 7.644 1.334 7.552 1.655 7.539 1.516 0.761
Lower lip length 43.583 3.465 43.300 3.962 43.198 3.267 0.8
Lower lip vermilion length 9.183 1.268 9.245 1.772 9.038 1.611 0.645
Anterior face height 113.400 7.328 113.559 8.805 116.404 6.552 0.064
Lower anterior face height 65.352 4.692 64.989 6.296 65.620 4.343 0.652
N-Me/Sn-me 1.737 0.062 1.752 0.09 1.775 0.071 0.106
Ls-Sto/Sto-Li 0.836 0.119 0.834 0.207 0.843 0.15 0.662
Sn-Sto/Sto-Me 0.508 0.054 0.505 0.057 0.526 0.665 0.205
Nasofrontal angle 152.346 6.147 152.155 6.954 152.023 6.577 0.199
Nasolabial angle 115.284 11.193 116.161 9.828 117.417 11.425 0.095
Labiomental angle 120.011 12.486 124.708 19.217 127.639 14.129 0.067
Soft-tissue convexity angle 154.804 5.127 154.977 4.180 153.594 4.416 0.64
Nasomental angle 138.723 4.907 138.348 4.460 137.976 4.484 0.862
Upper lip angle 106.752 5.282 108.022 4.712 107.043 4.642 0.233
Lower lip angle 122.114 6.507 122.822 6.604 120.373 5.775 0.061
Interlabial angle 141.913 14.849 136.458 15.492 132.865 16.541 0.071

*P \ 0.05; **P \ 0.01; ***P \ 0.001.

NS, Not significant; SD, standard deviation.

Similarly, no significant difference was found in the
sagittal position of the lower jaw in our study.
As an alternative to the ANB angle, Wits analysis,
which was developed to make measurements indepen-
dently from the cranial base, was used in the evaluation
of the relationship between cranium and mandibula.
Saraçoglu37 reported a significant decrease in the young
adult group treated with Forsus FRD. In our study, the
Wits value was statistically significant between T0-T1
and T0-T2 and showed a statistically insignificant
decrease between T1-T2.
When cephalometric vertical values were examined,
an increase between T0 and T1 periods was observed,
although this was not statistically significant. Sara-
glu37 examined the effects of Forsus FRD appliances
ço
on patients with skeletal Class II malocclusion and dental
Class II Division l anomalies accompanied by a mandib-
ular deficiency in peak and postpeak periods and
reported no significant vertical dimension changes in
young adults.
U1P-PD
, U1P-SN
, U1P-NA
, U1-NA (mm), and
U1P-MxOD
angles were used in our study in order to
evaluate the upper incisor inclinations. Although there
is a reduction in the inclination values, this was not sta-
tistically significant. In contrast to our study, Sarı38
found a significant decrease in the U1P-NA angle and
U1-NA distance on patients treated with jasper Jumper
appliance compared with the control group. In the study
of Nalbantgil,14 a statistically significant reduction in
the treatment group was reported.
We used IMPA
, L1P-NB
, L1-NB (mm), L1P-APog
and L1P-MdOD
measurements to evaluate the posi-
tion and inclination of the lower incisors. In our study,
there was a significant increase in mandibular dental
measurements except for L1P-MdOD
. Similarly,
many published articles have reported lower incisor
protrusion and proclination after fixed functional
appliance treatment.27,31,35-37 In addition, with
increasing age, dental effects are observed more
because of a reduction in skeletal response to forces
stimulating forward mandibular movement and
neuromuscular adaptation.
In our study, linear dental relationship measurements
such as overbite and overjet showed significant differ-
ences in both parameters. There was also a statistically
significant decrease in an overjet amount (2.9 mm be-
tween T0-T1 periods and 2.7 mm between T0-T2 pe-
riods). However, there was no significant increase
between T1-T2 periods.
In our study, OJ increased to a small amount between
T1-T2 periods was observed. A combination of upper
incisor retrusion and lower incisor protrusion was effec-
tive in reducing the overjet amount. Similar changes
were also observed in the amount of overbite, which in-
dicates the vertical relationship of the maxillary and
mandibular incisors. Heining and G€ oz35 reported a
reduction of overjet by 4.6 mm by retrusion of maxillary
incisors and protrusion of mandibular incisors and
reduction of overbite by 1.2 mm by intrusion and pro-
trusion of mandibular incisors.

American Journal of Orthodontics and Dentofacial Orthopedics April 2020  Vol 157  Issue 4
488
According to the soft-tissue analysis, no significant
change was observed in any of the 17 soft-tissue param-
eters examined. No statistically significant difference
between changes in histogram color scale and linear
changes in Ls, Li, Pog, Gn, Me, A and B between T0-T1
and T1-T2 periods was found. These results are because
the Forsus FRD EZ2 appliance did not cause significant
soft-tissue changes on postpeak individuals, regardless
of the device used. Because the individuals in our study
were in the postpeak development period, there was no
growth in the mandible, so no change in the jaw projec-
tion occurred. According to this finding, it can be
concluded that there is no skeletal effect of the Forsus
FRD appliance applied in the postpeak period and soft-
tissue changes are affected by dental changes only.
Furthermore, findings from Covell et al39 and Cope
et al30 were similar to the results obtained in our research.
CONCLUSIONS
(1) The FRD appliance has no statistically significant
skeletal effects on the maxilla and mandible on
sagittal and vertical planes.
(2) Changes in maxilla and mandible are found to be
dentoalveolar only.
(3) Mandibular incisors were protruded and pro-
clined.
(4) Overjet and overbite were reduced.
(5) There was only a limited impact on the soft-tissue
profile.
SUPPLEMENTARY DATA
Supplementary data associated with this article can
be found, in the online version, at https://doi.org/10.
1016/j.ajodo.2019.05.014.
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489.e1 Akan and Veli

Supplementary Table I. Definition of measurements Supplementary Table I. Continued

used in cephalometric analysis
Parameter Unit Definition


Parameter Unit Definition ANB angle The relative position of the
Vertical cephalometric maxilla to the mandible
measurements Wits appraisal mm The method entails

drawing perpendiculars
SN/Go-Gn angle Angle formed by lines S-N
and Go-Gn from points A and B on

the maxilla and
Palatal-mandibular Angle formed by lines
plane angle ANS-PNS and Go-Gn mandible, respectively,
(PP-MP) onto the occlusal plane



Y-axis (sgn-FH) Measures the angle Convexity angle Angle between NA and
between sella-gnathion (NA-APog) pogonion-A (PogA)
and Frankfort Mx-Md Difference between Co-Gn
horizontal and CoA lengths

Dental measurements
FMA (Go-Gn/FH) Angle formed by the


mandibular plane and U1/SN Angle formed by the long
Frankfort horizontal axis of the maxillary

incisor with line S-N
SN-PP Angle formed by


intersecting the palatal U1/PP Angle formed by the long
plane with the SN line axis of the maxillary

incisor with line P-P
Sum of inner angles The sum of N-S-Art, S-Art-


Go, and Art-Go-Me U1/NA Angle formed between the
S-Go mm Distance between sella and U1 long axis and NA
gonion plane
ANS-Me mm Distance between points U1-NA mm Distance between the tip of
Ans and Me the upper incisor and a
Jarabak ratio Ratio obtained by the line from nasion to
formula: posterior facial point A


height/anterior facial U1-MxOP Angle formed by the long
height 3 100 axis of the maxillary
Maxillary height Angle between N-CF and incisor with the occlusal
(N-CF-A) CF-A plane
Maxillary skeletal U1-PP mm Vertical distance from
measurements upper incisor to palatal

plane
SNA Angle formed by the
intersection of SN and a U6-PP mm Vertical distance from the
line joining nasion and U6 occlusal surface to
point A PP


A-Na Perp mm Distance between point A IMPA Angle formed by the long
and vertical line axis of the mandibular
measured perpendicular incisors and mandibular
from nasion to plane


Frankfort horizontal L1/NB Angle formed by the long
Effective maxillary mm Measured from condylion axis of the maxillary
length (Co-A) to point A incisor with line NB

L1-NB mm Vertical distance from
Maxillary depth Angle between NA and
(FH-NA) Frankfort horizontal lower incisor to NB


Mandibular skeletal L1-MdOP Angle formed by the long
measurements axis of the mandibular

incisor with the occlusal
SNB Angle between SN and NB
Pog-Na Perp mm Distance between Pg and plane
distance vertical line measured L1-MP mm Vertical distance from
perpendicular from lower incisor to
nasion to Frankfort mandibular plane
horizontal L6-MP mm Vertical distance from the
Effective mandibular mm Measured from condylion L6 occlusal surface to
length (Co-Gn) to gnathion MP


Maxillo-mandibular Interincisal angle Angle formed by the long
relation (U1P/L1P) axes of the maxillary
measurements and mandibular incisors

April 2020  Vol 157  Issue 4 American Journal of Orthodontics and Dentofacial Orthopedics
Akan and Veli
Supplementary Table I. Continued
Parameter Unit Definition
Overjet mm Horizontal distance
between the maxillary
and mandibular incisors
Overbite mm Vertical overlap of the
maxillary central
incisors over the
mandibular incisors
Soft-tissue
measurements

and labiale inferius
Nasolabial angle Angle formed by a line
(Prn-Sn-Ls) tangent to the upper lip
and a line tangent to the
columella
Upper lip to mm Distance between the most
E plane anterior point on the
curve of the upper lip
and esthetic plane
Lower lip to mm Distance between the most
E plane anterior point on the
curve of the lower lip
and esthetic plane
Nasal projection mm Distance between the tip of
the nose and subnasale
Upper lip mm Distance from the most
protrusion (ULA) anterior point on the
upper lip to subnasale-
pogonion
Lower lip protrusion mm Distance from the most
(LLA) anterior point on the
lower lip to subnasale-
pogonion
Soft tissue A mm Distance from soft tissue
point (A0 ) A point to TVL
Soft tissue B mm Distance from soft tissue
point (B0 ) B point to TVL
Soft-tissue pogonion mm Distance from soft-tissue
(Pog‫)׳‬ Pog point to TVL

(N-Prn-Pog)
Soft-tissue convexity Angle is formed by soft-
tissue nasion, subnasale,
and soft-tissue
pogonion

and left cheilion
LCTA Formed by labiale inferius,
soft-tissue pogonion,
and cervical points
American Journal of Orthodontics and Dentofacial Orthopedics
Supplementary Table II. Definition of measurements
used in 3dMD analysis
Parameter
Linear measurements
Upper lip length
Upper lip vermilion length
Lower lip length
Lower lip vermilion length
Anterior face height
Lower anterior face height
Proportional measurements
N-Me/Sn-me
Ls-Sto/Sto-Li
Sn-Sto/Sto-Me
Angular measurements
Nasofrontal angle (G-N-Prn)
Nasolabial angle (C-Sn-Ls)
Labiomental angle (Li-B-Pog)
Soft-tissue convexity
angle (N-Sn-Pog)
Nasomental angle
Upper lip angle (Chr-Ls-Chl)
Lower lip angle (Chr-Li-Chl)
Interlabial angle (Ls-Sto-Li)
April 2020  Vol 157  Issue 4
489.e2
Definition
Distance between stomion
and subnasale
Distance between stomion
and labiale superius
Distance between stomion
and soft-tissue menton
Distance between stomion
Distance between soft tissue N
and soft tissue Me
Distance between subnasale
and soft tissue Me
Ratio of the anterior face
height to the lower face
height
Ratio of the upper lip
vermilion length to the
lower lip vermilion length
Ratio of the upper lip length
to the lower lip length
Angle formed by soft-tissue
glabella, nasion, and
pronasale
Angle formed by soft-tissue
columella, subnasale, and
labiale superius
Angle formed by labiale
inferius, soft tissue B, and
Pog
Angle formed by soft-tissue
nasion, subnasale, and
soft-tissue Pog
Angle formed by soft-tissue
nasion, pronasale, and
soft-tissue Pog
Angle formed by right
cheilion, labiale superius,
Angle formed by right
cheilion, labiale inferius,
and left cheilion
Angle formed by labiale
superius, stomion, and
labiale inferius