Evaluation of Soft-Tissue Changes in Young Adults Treated With The Forsus Fatigue-Resistant Device
Evaluation of Soft-Tissue Changes in Young Adults Treated With The Forsus Fatigue-Resistant Device
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 correct the skeletal imbalance and profile disharmony
common anomalies and constitutes 12%-49% in individuals with Class II malocclusion.5
of orthodontic malocclusions.1,2 In Class II maloc- Functional appliances are divided into removable and
clusions, the disruption of harmony between the struc- fixed groups, with many different designs within each
tures forming the craniofacial system manifests itself group.6 These two types of functional appliances have
in unconformity in jaw relationships in the sagittal some advantages over each other. Because of their size
plane, and is caused by genetic and/or environmental and poor stability in the mouth, patient adaptation
factors.3 Upper jaw protrusion, lower jaw retrusion, or with removable functional appliances is difficult.7
a combination of both can be seen with this malocclu- Thus, fixed functional appliances have been developed
sion in which lower jaw retardation has generally been to eliminate the disadvantages created by removable
reported.4 Functional appliances are one of the treat- functional appliances.
ment alternatives for these malocclusions and can 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
Department of Orthodontics, Faculty of Dentistry, Izmir Katip Celebi University,
Izmir, Turkey. mandibular growth and result in long-term skeletal
All authors have completed and submitted the ICMJE Form for Disclosure of Po- changes remains.
tential Conflicts of Interest, and none were reported. Perinetti et al11 assessed the skeletal and dentoalveo-
Address correspondence to: Burçin Akan, Department of Orthodontics, Faculty of
Dentistry, Izmir Katip Celebi University, Izmir 35640, Turkey; e-mail, burcin. lar effects of fixed functional appliances, alone or in
yksel@gmail.com. combination with comprehensive treatment, on pubertal
Submitted, December 2018; revised and accepted, May 2019. and postpubertal patients with a Class II malocclusion.
0889-5406/$36.00
Ó 2020 by the American Association of Orthodontists. All rights reserved. The authors reported that dentoalveolar effects were
https://doi.org/10.1016/j.ajodo.2019.05.014 generally seen regardless of the treatment timing.
481
482 Akan and Veli
Mesial movement of the mandibular dentition,13 mesial Several articles using Forsus FRD have been previ-
movement5 or tipping14 of lower first molars, and procli- ously published. In these studies, 2-dimensional evalua-
nation of lower incisors5,14 were observed in the mandible, tions of dental, skeletal, and soft-tissue changes after
whereas distal movement of the maxillary dentition,13 the use of appliance were made. However, to our knowl-
distal tipping of upper first molars,14 and/or retroclination edge, no articles using 3D evaluations were found in the
of upper incisors5,14 were reported in the maxilla. These literature.
authors also pointed out the improvement of the profile, Traditional orthodontic records include patient
mainly due to soft-tissue pogonion and B-point photographs, lateral cephalometric and panoramic ra-
advancement.11 diographs, and dental models. However, with the devel-
Ishaq et al15 concluded that fixed functional appli- oping technology, the deficiencies of these methods are
ances appear to have no significant positional or emerging. Thus, extraoral photographs can be limited to
dimensional skeletal effects on the mandible in reflect real 3D images.
growing subjects with Class II malocclusion. They also Currently, stereophotogrammetry, which is a 3D
pointed out that a slightly greater skeletal dimensional facial scanning system, has become commonly used
effect was observed in the pubertal period than in the with growing popularity among plastic surgeons, ortho-
postpubertal period, although this difference was not dontists, and maxillofacial surgeons. This system has
statistically significant. become a valuable recording tool for diagnostic records
Forsus fatigue-resistant device (FRD; 3M Unitek, because it allows the face to be assessed on all 3 planes
Monrovia, Calif), which requires minimum patient of space.
cooperation, is a fixed functional appliance developed The purpose of this retrospective clinical archive
in recent years and preferred by some orthodontists study was to evaluate the soft-tissue effects of Forsus
because of its ease of application. FRD appliance by using cephalometric radiographs
Franchi et al16 assessed the dental, skeletal, and soft- and images obtained from 3D facial scanning system
tissue effects of Forsus FRD in growing patients with in patients with skeletal and dental Class II anomalies
Class II malocclusion using lateral cephalograms. The characterized by mandibular retrognathia in postpeak
authors concluded that the Forsus FRD was effective in period.
correcting Class II malocclusion with a combination of
skeletal (mainly maxillary) and dentoalveolar (mainly
mandibular) modifications. In addition, the authors MATERIAL AND METHODS
reported that soft-tissue measurements showed a signif- A power analysis using G*Power software (version
icantly greater backward movement of the soft tissue A 3.1.3; Franz Faul University, Kiel, Germany) determined
point in the Forsus FRD group. that a sample size of 16 subjects per group would pro-
Gunay et al17 used lateral cephalograms to evaluate vide a power of 97% to detect significant differences
the short-term dentoalveolar and soft-tissue changes with an 0.45 effect size and a value of 0.05 (critical
in late adolescent patients treated with the Forsus c2 5 3.3403; noncentrality parameter l 5 19.44).
FRD. The authors reported that the Forsus FRD slightly The records of T0 and T1 for 20 patients were
improved the profile, and the soft tissue reflected the completely available. The records of the T2 period were
majority of the dentoalveolar changes (ie, the backward reviewed and evaluated for 16 patients because of 4 pa-
movement of the upper lip following the retrusion of tients' records not being available. Thus, for 2 periods,
maxillary incisors and no longer position of the lower a total of 20 patients (10 boys, 10 girls) were included.
lip behind the maxillary incisors). As a routine protocol in our clinic, dental models, facial
Flores-Mir et al18 evaluated facial soft-tissue and intraoral photographs, and a set of 2D radiographs
changes after the use of fixed functional appliances including cephalometric and panoramic radiographs
in patients with Class II Division 1 malocclusion are obtained from patients for orthodontic diagnosis
through a systematic review of the literature. The au- and treatment planning.
thors reported that although fixed functional appli- The selection criteria were as follows: (1) no history
ances produce some statistically significant changes of previous orthodontic treatment; (2) cervical verte-
in the soft-tissue profile, the magnitude of the changes bral maturation (CVM) stage 5 or 6 as determined
may not be perceived as clinically significant. They also by cephalometric radiographs19; (3) skeletal Class II
pointed out that 3-dimensional (3D) quantification of relationship (ANB . 4 )20; (4) normal position of
the soft-tissue changes was required to understand the maxilla to the cranial base; (5) mandibular retro-
the soft-tissue changes obtained with the use of fixed gnathy (SNB \ 78 )20; (6) Class II molar and canine
functional appliances. relationship; (7) normal or diminished vertical growth;
April 2020 Vol 157 Issue 4 American Journal of Orthodontics and Dentofacial Orthopedics
Akan and Veli 483
American Journal of Orthodontics and Dentofacial Orthopedics April 2020 Vol 157 Issue 4
484 Akan and Veli
treatment on the anteroposterior plane, and negative in SAS proc mixed procedure. For P \ 0.05, the results
values indicate that the anatomical point moves back- were considered statistically significant.
ward (posteriorly) in the anteroposterior plane.
Both the changes in the color histogram and the RESULTS
millimetric changes between the 2 images were exam- The same author repeated the measurements 1 week
ined. The color histogram provides a visual assessment after the first measurements on 20 3D images and 20
of the difference between the 2 superimposed images. cephalograms randomly selected from 10 patients. In-
When the result is positive, the second image topog- traclass correlation coefficients ranged from 0.9 to
raphy is more apparent and when the result is negative, 1.00. No significant errors were found when repeated
it is the opposite. The differences are represented along a measurements were evaluated with paired t tests.
color spectrum with values associated with each color. The cephalometric changes obtained with the Forsus
When comparing 2 images, the overpositive change is FRD were shown in Table I. The changes in the Wits
represented by the red code and the overnegative change value were statistically significant between T0-T1 and
is represented by the blue code (Fig 5). T0-T2. Although there was no statistically significant
change in the upper incisors, changes observed between
Statistical analysis
T0-T1 and T0-T2 periods in IMPA, L1-NB ( ), L1-NB
Data were analyzed using the SAS 9.3 Software (SAS (mm), and L1P-APog values, which express the antero-
Institute, Cary, NC). The Shapiro-Wilks test was used to posterior position and inclination of the lower incisors,
determine whether the data containing the cephalo- were statistically significant. Also, the increase in L6P-
metric and 3D facial image recordings in 3 different MD value, which indicates the vertical position of the
periods comply with the normal distribution. Parametric lower incisors, was statistically significant (P \ 0.05).
tests were used to compare the data after normal distri- Although the OB and OJ values decreased significantly
bution of the data was determined (P . 0.05), and between T0-T1, they increased between T1 and T2
descriptive statistics were shown as mean 6 standard (P \ 0.001).
deviation. These values were tested using a one-way The soft-tissue changes obtained with the Forsus
analysis of variance. Comparisons of the obtained re- FRD were shown in Table II. The results showed no sta-
cords at different time intervals and binary comparisons tistically significant differences between all periods
were made with Bonferroni correction with a paired t test (P . 0.05).
April 2020 Vol 157 Issue 4 American Journal of Orthodontics and Dentofacial Orthopedics
Akan and Veli 485
American Journal of Orthodontics and Dentofacial Orthopedics April 2020 Vol 157 Issue 4
486 Akan and Veli
April 2020 Vol 157 Issue 4 American Journal of Orthodontics and Dentofacial Orthopedics
Akan and Veli 487
Similarly, no significant difference was found in the We used IMPA , L1P-NB , L1-NB (mm), L1P-APog
sagittal position of the lower jaw in our study. and L1P-MdOD measurements to evaluate the posi-
As an alternative to the ANB angle, Wits analysis, tion and inclination of the lower incisors. In our study,
which was developed to make measurements indepen- there was a significant increase in mandibular dental
dently from the cranial base, was used in the evaluation measurements except for L1P-MdOD . Similarly,
of the relationship between cranium and mandibula. many published articles have reported lower incisor
Saraçoglu37 reported a significant decrease in the young protrusion and proclination after fixed functional
adult group treated with Forsus FRD. In our study, the appliance treatment.27,31,35-37 In addition, with
Wits value was statistically significant between T0-T1 increasing age, dental effects are observed more
and T0-T2 and showed a statistically insignificant because of a reduction in skeletal response to forces
decrease between T1-T2. stimulating forward mandibular movement and
When cephalometric vertical values were examined, neuromuscular adaptation.
an increase between T0 and T1 periods was observed, In our study, linear dental relationship measurements
although this was not statistically significant. Sara- such as overbite and overjet showed significant differ-
glu37 examined the effects of Forsus FRD appliances
ço ences in both parameters. There was also a statistically
on patients with skeletal Class II malocclusion and dental significant decrease in an overjet amount (2.9 mm be-
Class II Division l anomalies accompanied by a mandib- tween T0-T1 periods and 2.7 mm between T0-T2 pe-
ular deficiency in peak and postpeak periods and riods). However, there was no significant increase
reported no significant vertical dimension changes in between T1-T2 periods.
young adults. In our study, OJ increased to a small amount between
U1P-PD , U1P-SN , U1P-NA , U1-NA (mm), and T1-T2 periods was observed. A combination of upper
U1P-MxOD angles were used in our study in order to incisor retrusion and lower incisor protrusion was effec-
evaluate the upper incisor inclinations. Although there tive in reducing the overjet amount. Similar changes
is a reduction in the inclination values, this was not sta- were also observed in the amount of overbite, which in-
tistically significant. In contrast to our study, Sarı38 dicates the vertical relationship of the maxillary and
found a significant decrease in the U1P-NA angle and mandibular incisors. Heining and G€ oz35 reported a
U1-NA distance on patients treated with jasper Jumper reduction of overjet by 4.6 mm by retrusion of maxillary
appliance compared with the control group. In the study incisors and protrusion of mandibular incisors and
of Nalbantgil,14 a statistically significant reduction in reduction of overbite by 1.2 mm by intrusion and pro-
the treatment group was reported. trusion of mandibular incisors.
American Journal of Orthodontics and Dentofacial Orthopedics April 2020 Vol 157 Issue 4
488 Akan and Veli
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