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Cephalometric Outcomes of A New Orthopaedic Appliance For Class III Malocclusion Treatment

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European Journal of Orthodontics, 2019, 1–6

doi:10.1093/ejo/cjz037
Original article

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Original article

Cephalometric outcomes of a new orthopaedic


appliance for Class III malocclusion treatment
Roberto Martina1, Vincenzo D’Antò1, Vittoria De Simone1,
Angela Galeotti2, Roberto Rongo1, and Lorenzo Franchi3,
1
School of Orthodontics, Department of Neurosciences, Reproductive Sciences and Oral Sciences, University of
Naples ‘Federico II’, 2Department of Pediatric Surgery, Bambino Gesù Children’s Hospital, Rome and 3Department
of Surgery and Translational Medicine Experimental and Clinical Medicine, University of Florence, Florence, Italy

Correspondence to: Roberto Martina, Department of Neuroscience, Reproductive Sciences and Oral Sciences, University
of Naples ‘Federico II’, Via Pansini 5, 80131 Naples, Italy. E-mail: martina@unina.it

Summary
Objective:  To evaluate dental and skeletal effects of a new orthopaedic appliance for the treatment
of Class III malocclusion in growing patients.
Material and methods: This retrospective cephalometric study was performed on a sample of
18 patients with a skeletal Class III malocclusion (4 males; 14 females; mean age 8.8 ± 1.5 years)
treated with the Pushing Splints 3 (PS3) protocol. The control group consisted of 18 subjects (5
males; 13 females; mean age 9.1 ± 1.8 years) selected from a database of subjects with untreated
Class III malocclusion. The cephalometric analysis was performed at the beginning (T0) and the
end of the orthopaedic therapy (T1). Significant differences between the treated and control groups
were assessed with independent samples t-test (P < 0.05).
Results:  In the PS3 group, the post-treatment cephalometric values showed a forward
displacement of the maxilla, resulting in a statistically significant increase of the SNA angle. ANPg
and Wits appraisal improved significantly compared with the control group. Lingual inclination
of mandibular incisors and buccal inclination of the upper incisors were significantly increased
in comparison with the control group. No significant differences were recorded for backward
mandibular rotation.
Limitations:  This study presents a short-term evaluation of the treatment and the use of a historical
control group.
Conclusions:  The PS3 was effective for the treatment of Class III malocclusion in growing patients,
with favourable maxillary advancement and control of the vertical skeletal relationships.

Introduction of orthopaedic/orthodontic treatment in growing subjects can be


achieved in about 70% of patients (5,7,8). In fact, the early intercep-
The treatment of Class  III malocclusion is one of the more con-
tion of this type of malocclusion can reduce the need for treatment in
troversial topics in orthodontics (1). Skeletal Class  III malocclu-
permanent dentition and prevent later surgical interventions (9,10).
sion includes mandibular prognathism or macrognathia, maxillary
Various treatment strategies for Class  III malocclusion can be
retrognathism or micrognathia, or a combination of these features
found in the literature (11,12). Facemask (FM) therapy now repre-
(2,3). Several studies suggested that environmental or hereditary
sents one of the most widespread orthopaedic approaches considered
factors can play a substantial role in the aetiology of this maloc-
for the Class III malocclusions (13,14). FM protocol includes the use
clusion (4), compromising the long-term stability of the treatment
of heavy elastics attached from the vestibular hooks of the expander
(5,6). Despite this, the correction of Class III malocclusion by means

© The Author(s) 2019. Published by Oxford University Press on behalf of the European Orthodontic Society.
1
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2 European Journal of Orthodontics, 2019

to the support bar of the FM, with a downward and forward vec- The sample size was computed considering α  =  0.05,
tor (5). FM therapy has been extensively evaluated either alone (15) power = 0.80, an effect size of 1 considering an average difference
or in conjunction with rapid maxillary expansion (RME/FM) (16). between groups of 1.5 degrees and a pooled standard deviation of
The systematic reviews by Rongo et al. (12) and Cordasco et al. (17) 1.5 degrees for the intermaxillary sagittal discrepancy (ANB) derived
showed that FM therapy could produce a clockwise rotation of the from a previous study (23). Hence, a sample size of at least 34

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mandible, resulting in a potential increase in the divergence and patients (17 patients for each group) was determined to be adequate
compromising the aesthetic profile in dolichofacial patients (18–20). comparing the groups with an unpaired t-test.
Furthermore, the FM could be adequate in the short-term therapy of The treated group comprised 18 subjects (14 females and 4 males)
mesofacial and brachyfacial individuals, but it might also produce with skeletal Class III malocclusion, who were treated consecutively
unwanted or unfavourable effects in dolichofacial subjects (19,21). (between 2013 and 2018) using the PS3 at the Section of Orthodontics,
In 1980, Ferro et al. (20) proposed a new orthopaedic approach for University of Naples ‘Federico II’, and at the Department of Paediatric
Class  III treatment: Splints, Class  III Elastics, and Chin-cup (SEC Surgery, Bambino Gesù Children’s Hospital, Rome, Italy. Lateral
III). This appliance is based on two occlusal acrylic splints combined cephalograms were taken before (T0) and at the end of the treatment
with Class III elastics and a chin-cup; the use of the chin-cup aims to (T1). The active phase of the treatment ended when a positive overjet
reduce the clockwise rotation of the mandible (20). The force vector between 2 and 4  mm, with an overcorrection towards the Class  II
of Class III elastics generates a vertical and sagittal component. The molar relationship, were achieved. After this active phase (on average
vertical component induces a clockwise rotation of the mandible due 12  months), patients were asked to use the appliance only during
to the extrusion of the upper molars (12). In some cases, where the night hour as retention period (on average 3 months) and then the
overbite is already reduced or where the mandible is growing with T1 lateral cephalogram was taken. The average age of the treated
a dolichofacial pattern, this extrusion is undesired. Hence, a force group was 8.8 ± 1.5 years at T0, 10.5 ± 1.4 years at T1, and the mean
that intrudes the lower molars could prevent this side-effect and T0–T1 interval was 1.6 ± 0.5 years (Supplementary Figures 1 and 2).
control the mandibular divergence. We describe here the Pushing All patients presented the following inclusion criteria before
Splints 3 (PS3), a new orthopaedic device composed of two acrylic therapy (T0): Caucasian ethnicity, early or late mixed dentition
splints and a Forsus™ Fatigue Resistant Device (3M Unitek Corp, (6–12 years), mesial step deciduous molar relationship or Class III
Monrovia, CA, USA) L-pin module per side. This inverted position permanent molar relationship, and pre-treatment Wits appraisal of
of the Forsus™ Fatigue Resistant Device was also recently used in −2.0 mm or less.
the treatment of Class  III malocclusion with fixed appliances and Exclusion criteria were craniofacial anomalies, systemic disease
miniscrews (22). The Forsus™ L-pin produces a distalizing and affecting the normal growth patterns, clinically evident (less than 5%)
intrusive vector on the lower molar and a mesializing and intrusive facial and/or mandibular asymmetry, previous orthodontic treatment,
vector on the upper canine (Figure 1). impacted teeth, anomalies in teeth morphology, periodontal disease,
The present cephalometric study was carried out to evaluate the and signs and symptoms of temporomandibular disorders.
dentoskeletal effects produced by this new orthopaedic appliance for A control group of 18 untreated subjects (13 females and 5 males)
the treatment of Class III malocclusion. with skeletal Class  III malocclusion was obtained from a database
of longitudinal records of subjects with untreated Class  III maloc-
clusion collected at the Section of Dentistry, Department of Surgery
Materials and methods and Translational Medicine of the University of Florence, Florence,
Subjects Italy and described in detail in Zionic Alexander et al. (24). The con-
The present investigation was designed as a retrospective study. The trol group matched the treated group as to type of skeletal disharmony,
study protocol was approved by the Ethics Committee of Bambino gender distribution, age at the first observation, age at the second
Gesù Children’s Hospital (479_OPBG_2012). observation, and mean duration of observation intervals. Mean age
at T0 for the control sample was 9.1 ± 1.8 years and it was 10.8 ±
1.8 years at T1. Mean duration of T0–T1 interval was 1.7 ± 0.7 years.

Appliance design
The PS3 appliance consists of three components: two removable
acrylic splints and one Forsus™ L-pin module per side (Figure 1;
Supplementary Figures 1–3). The two splints cover all the tooth
crowns—usually 6 to 6—in both the arches. The Forsus™ modules
were used to deliver a force of 200 grams per side in a forward direc-
tion to the upper splint and in a backward direction to the lower splint.

Cephalometric analysis
Cephalometric analysis (Figure 2) was done using the Dolphin
Imaging 11.0 software (Dolphin Imaging, Chatsworth, CA, USA).
Each cephalogram was traced and 14 variables (5 linear and 9
angular) were measured. Linear measurements were Wits appraisal
Figure 1.  (A) Pushing Splints 3 appliance frontal intraoral, (B) left-side intraoral,
(Ao-Bo, distance between the two points of intersection of the
(C) right-side intraoral, and (D) diagram with force vectors. The main force
vectors produced by the Forsus™ L-pin (black arrow) present four different
two perpendicular lines from points A and B to the functional occlusal
components, distalizing and intrusive components on the lower molar (white plane, mm), Co-Gn (mandibular length, mm), Co-Go (ramus length,
arrows) and mesializing and intrusive components on the upper canine (white mm), overjet (mm), and overbite (mm). Angular measurements were
arrows). This force produces a counter-clockwise moment (black arrow). SNA (degree), SNPg (degree), ANPg (degree), SN/palatal plane
R. Martina et al. 3

and 0.43  mm for linear measurements. There was no systematic


error for any measurements (Student’s t-test: P > 0.05).
Descriptive data and statistical comparisons for starting forms
and cephalometric changes in the two groups from T0 to T1 are
given in Tables 1 and 2, respectively. Analysis of the starting forms

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(Table 1) showed that the two groups had similar craniofacial char-
acteristics at T0 with no statistically significant differences for any
of the variables.
The statistical comparisons of the T0–T1 changes in the treated
group versus the control group (Table 2; Figure 3) showed sig-
nificant treatment effects produced by the PS3 protocol. Sagittal
maxillomandibular relations improved significantly in the treat-
ment group. In particular, the Wits appraisal and the ANPg angle
increased by 5.7 mm (P < 0.001) and 2.8 degrees (P < 0.001), respec-
tively, compared with the control group. Regarding the advancement
of the maxilla, SNA showed a significant increase of 2.4  degrees
(P  <  0.001) in the treatment group over the controls. No statisti-
cally significant differences were reported between the groups for
vertical skeletal measurements. The treatment did not determine any
clinically and statistically relevant mandibular clockwise rotation
as compared to controls (SN/mandibular plane, 0.6  degrees). The
appliance determined an improvement of sagittal dental relation-
ships as compared with controls. The PS3 group showed a statis-
Figure 2.  Cephalometric tracings for evaluation of changes with treatment/ tically significant proclination of the maxillary incisors (U1/palatal
observation periods. Measured variables: Wits appraisal (Ao-Bo, distance plane, 5.6 degrees, P = 0.037) and retroclination of the mandibular
between the two points of intersection of the two perpendicular lines from
incisors (L1/mandibular plane, −5.0 degrees, P = 0.001). Treatment
points A and B to the functional occlusal plane), Co-Gn (mandibular length),
effects also occurred in the interdental relation with a significantly
Co-Go (ramus length), overjet, overbite, SNA (degree), SNPg (degree),
ANPg (degree), SN/palatal plane (degree), SN/mandibular plane (degree), improved overjet (4.1 mm, P = 0.001) in the treatment group with
palatal plane/mandibular plane (degree), CoGoMe (degree), U1/palatal plane respect to controls. No significant differences between groups could
(degree), and L1/mandibular plane (degree). be found for the overbite.

(degree), SN/mandibular plane (degree), palatal plane/mandibular


plane (degree), CoGoMe (degree), U1/palatal plane (degree), and L1/
Discussion
mandibular plane (degree). All linear measures were standardized to The aim of this cephalometric study was to evaluate the effects of
an enlargement of 0% (life size). a new orthopaedic appliance for the treatment of Class  III maloc-
clusion. The main purpose of the PS3 is to counteract the possible
Method error tendency towards posterior rotation of the mandible. Contrary to
The technical errors of measurement were calculated from 10 ran- Class  III elastics, the vertical component of the force delivered by
domly selected patients at both T0 and T1. The same examiner re- the Forsus™ L-pin module produces an intrusion on upper canines
digitized the same set of landmarks after a memory washout period and lower molars that helps in controlling the mandibular clock-
of at least 6 weeks. The method error for all measurements was calcu- wise rotation. This study showed that the PS3 appliance was able
lated using Dahlberg’s formula (25). Systematic differences between to produce favourable modifications in terms of intermaxillary
duplicated measurements were tested using a paired Student’s t-test sagittal skeletal relationships due to significant maxillary protrac-
with the type I error set at P < 0.05. tion in absence of any backward mandibular rotation. The sagittal
skeletal changes induced by the PS3 appliance are consistent with
Statistical analysis the outcomes of several studies that evaluated the effects of RME/
Descriptive statistics included mean and standard deviation (SD) FM therapy in growing patients (1,12,26). Changes in the maxilla
of cephalometric measurements at T0, T1, and for the T0–T1 and the mandible in the treatment groups resulted in a significant
interval. The normal distribution of the data was confirmed by increase in ANPg, which could highlight the orthopaedic effect of
the Shapiro–Wilk test. An independent samples t-test was used this new protocol.
to compare the cephalometric variable at baseline (T0) and the In clinical studies with FM therapy, forward movement of the
changes during the T0–T1 interval between the two groups. All maxilla and clockwise rotation of the mandible were reported as
statistical tests were two sided. P values less than 0.05 were con- typical skeletal effects of the appliance (12). Ngan et  al. (1) and
sidered significant. Standard statistical software package (SPSS Vaughn et  al. (26) showed that the RME/FM samples presented,
version 22.0, SPSS, IBM, Armonk, NY, USA) was used for statisti- at the end of therapy, an increase in intermaxillary divergency of
cal analysis. 2.0 and 2.2  degrees, respectively, when compared with untreated
Class  III controls. Rongo et  al. (12) showed that FM therapy
determined a clockwise rotation of the lower jaw that leads to
Results an increase in vertical skeletal relationships; hence, even if early
The method error for the cephalometric variables ranged between orthopaedic treatment of Class  III malocclusion is effective in the
0.35 and 0.61 degrees for angular measurements and between 0.03 short term, it may produce unfavourable side-effects, particularly
4 European Journal of Orthodontics, 2019

Table 1.  Descriptive statistics and statistical comparisons of baseline characteristics 

Treated group Control group

n = 18 n = 18

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Cephalometric measures Mean SD 95% CI Mean SD 95% CI P

Sagittal skeletal
  SNA (°) 79.5 4.3 77.3; 81.6 80.0 4.1 77.9; 82.1 0.716
  SNPg (°) 80.2 3.7 78.3; 82.0 81.5 3.2 79.9; 83.1 0.268
  ANPg (°) −0.7 2.0 −1.7; −0.2 −1.4 2.3 −2.6; −0.3 0.312
  Wits (mm) −6.3 2.7 −7.6; 4.9 −6.0 2.6 6.7; 9.7 0.782
  Co-Gn (mm) 107.7 6.6 104.3; 110.9 105.7 6.9 102.3; 109.2 0.410
Vertical skeletal
  SN/palatal plane (°) 8.3 3.0 6.7; 9.7 8.1 2.8 6.7; 9.6 0.928
  SN/mandibular plane (°) 35.1 5.5 32.3; 37.8 33.4 4.7 31.0; 35.8 0.338
  Palatal plane/mandibular plane (°) 26.9 4.9 24.3; 29.3 25.3 4.6 22.9; 27.5 0.326
  CoGoMe (°) 132.7 5.9 129.6; 135.6 133.6 4.1 131.6; 135.7 0.554
  Co-Go (mm) 50.4 5.0 47.8; 52.8 47.3 4.1 45.3; 49.4 0.056
Interdental
  Overjet (mm) −1.2 2.2 −2.3; −0.1 −2.3 2.3 −3.5; −1.1 0.171
  Overbite (mm) 0.4 2.6 −0.9; 1.7 0.9 1.7 0.0; 1.7 0.500
Maxillary dentoalveolar
  U1/palatal plane (°) 111.3 8.2 107.2; 115.4 112.1 6.0 109.1; 115.1 0.889
Mandibular dentoalveolar
  L1/mandibular plane (°) 89.1 6.5 85.8; 92.3 84.6 7.3 81.0; 88.3 0.067

Significance level was set at P < 0.05. Data are reported as mean ± standard deviation (SD) and 95% confidence interval (95% CI)

Table 2.  Descriptive statistics and statistical comparisons of the T1–T0 changes 

Treated group Control group

n = 18 n = 18

Cephalometric measures Mean SD 95% CI Mean SD 95% CI Diff. P

Sagittal skeletal
  SNA (°) 2.2 2.0 1.2; 3.1 −0.3 1.4 −0.9; 0.4 2.4 0.000
  SNPg (°) 0.6 1.9 −0.4; 1.7 1.0 1.2 0.3; 1.6 −0.4 0.538
  ANPg (°) 1.5 1.5 0.7; 2.3 −1.3 1.3 −1.9; −0.5 2.8 0.000
  Wits (mm) 4.9 2.6 3.5; 6.2 −0.8 1.9 −1.7; 0.1 5.7 0.000
  Co-Gn (mm) 3.8 2.2 2.7; 4.9 4.4 2.0 3.3; 5.3 −0.5 0.463
Vertical skeletal
  SN/palatal plane (°) −0.3 1.9 −1.2; 0.7 −0.3 0.8 −0.7; 0.1 0.0 0.956
  SN/mandibular plane (°) −0.5 2.8 −1.8; 0.9 −1.1 1.9 −2.0; -0.0 0.6 0.469
  Palatal plane/mandibular plane (°) −0.2 2.8 −1.6; 1.1 −0.8 1.6 −1.7; 0.2 0.6 0.195
  CoGoMe (°) −0.3 3.7 −2.1; 1.5 −0.8 1.9 −1.7; 0.1 0.5 0.700
  Co-Go (mm) 2.7 2.7 1.3; 4.0 3.0 2.0 1.9; 4.0 −0.3 0.524
Interdental
  Overjet (mm) 5.0 2.3 3.7; 6.1 0.9 4.2 −1.1; 3.0 4.1 0.001
  Overbite (mm) 0.1 3.0 −1.3; 1.6 0.4 0.9 0.0; 0.9 −0.3 0.672
Maxillary dentoalveolar
  U1/palatal plane (°) 8.7 9.1 4.2; 13.2 3.1 6.2 0.0; 6.2 5.6 0.037
Mandibular dentoalveolar
  L1/mandibular plane (°) −5.1 4.9 −7.5; −2.6 −0.1 3.2 −1.7; 1.4 −5.0 0.001

Significance level was set at P < 0.05. Data are reported as mean ± standard deviation (SD) and 95% confidence interval (95% CI). Bold type: statistically
significant.

in hyperdivergent Class  III patients (12). To reduce the amount of in vertical skeletal relationships in the short-term was only about
clockwise mandibular rotation produced by FM protocols, some 1.0 mm (5,27). With the SEC III protocol, no mandibular rotation
authors have proposed the concurrent use of either posterior splints was observed, although the protocol requires further compliance
incorporated in the expansion appliance or removable posterior bite with the chin-cup (20). The new PS3 appliance, instead, demon-
blocks (5,27). These studies showed that the amount of increase strated a favourable control of skeletal vertical relationships in the
R. Martina et al. 5

Supplementary material
Supplementary material is available at European Journal of
Orthodontics online.

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Conflict of interest
Authors declare no conflict of interest.

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