European Journal of Orthodontics, 2019, 1–9

doi:10.1093/ejo/cjz059
Randomized Controlled Trial (RCT)

Randomized Controlled Trial (RCT)

Post-treatment cephalometric changes in

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adolescent patients with Class II malocclusion
treated using two different functional appliance
systems for an extended time period: a
randomized clinical trial
Andrew T. DiBiase1, Luisa Lucchesi2, Usman Qureshi2 and
Robert T. Lee1,2
1
Maxillofacial Unit, East Kent Hospitals University NHS Foundation Trust, Kent, 2Orthodontic Department, Dental
Institute, Barts Health NHS Trust, London, UK

Correspondence to: Andrew DiBiase, Maxillofacial Unit, William Harvey Hospital, Kennington Road, Willesborough,
Ashford, Kent TN24 0LZ, UK. E-mail: andrewdibiase@nhs.net

Summary
Objectives:  To assess the post-treatment changes in Class II adolescent patients treated with two
different functional appliances for an extended time period.
Design:  Randomized clinical trial.
Setting:  One university and one district general hospital in the UK.
Participants:  Caucasian adolescent patients with a Class II malocclusion.
Methods:  Pairs of patients of similar age and gender were randomly allocated to one of two
functional appliance systems, the Twin Block or Dynamax appliance. The appliances were used for
15 months full time. Changes were measured from lateral cephalograms taken at the start (T1) and
at the end of treatment at 15 months (T2) and 30 months (T3).
Results:  Hundred patients completed the trial, 52 Twin Block and 48 Dynamax. Mandibular forward
movement was 3.5 mm (±2.5) in the Twin Block group and 1.7 mm (±2.1) in the Dynamax group
(P < 0.01; T1–T2) and, subsequently, by 0.3 mm (±2.6) and 0.9 mm (±2.5), respectively (P = 0.3; T2–
T3). Mandibular length increased by 6.3 mm (±2.7) in the Twin Block group and 4.0 mm (±2.5) in the
Dynamax group (P < 0.01; T1–T2) with treatment and, subsequently, by 0.5 mm (±2.3) and 1.5 mm
(±3.1; P = 0.05). Anterior face height increased in both groups.
Conclusions:  Treatment resulted in greater mandibular growth with the Twin Block than the
Dynamax. In the follow-up period, there was less growth in the Twin Block group compared to the
Dynamax
Trial Registration:  This trial was not registered on any major database of clinical trial.
Protocol:  The protocol was not published before the commencement of the trial but can be given
on request.

© 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
Introduction
Fixed and removable functional appliances are effective in cor-
recting Class  II malocclusion (1). Over the last two decades, the
results of several long-term prospective clinical studies have been
published showing little benefit of early treatment in childhood
with this type of appliance (2–4). However, these studies focussed
on the effects of treatment in childhood and there is less evidence
of the long-term effects in patients treated comprehensively in
adolescence.
The changes found with functional appliance treatment seem
to be primarily dento-alveolar, with limited skeletal change, which
appears to be transient rather than additional bony growth (2–4).
Similarly, a number of studies using the removable Twin Block
appliance have identified skeletal change in the antero-posterior
dimension and an increase in the vertical face height in the short
term (5–7). In the majority of these studies, the functional phase of
treatment was under a year. Following appliance withdrawal, some
dental and skeletal relapse occurred (6).
Biological investigations on animals have highlighted vari-
ability in responses to functional appliance therapy, particularly
with regard to maturation of the animals. A  study of primates
highlighted that cartilage proliferation occurs at the condyles
and glenoid fossae, with considerable delay in replacement of
the cartilage by bone (8). Similarly, chemical and biological in-
vestigations on rats clarify the changes required in cartilage to
become stable, before it is converted to bone at the condyles (9).
To improve the response and stability of functional appliance
therapy, it could be argued that treatment needs to be under-
taken over a longer treatment period in human adolescent sub-
jects. Therefore, the present study looks at subjects treated with
two different functional appliances for a longer time period of
15 months and then followed up for a further 15 months to as-
sess the stability of the treatment outcomes both skeletally and
dentally. The results of the first part of this study have already
been published, showing greater changes with an extended treat-
ment time, which appeared to be stable in the immediate post-
treatment period (10). In this paper, we report on the follow-up
after a further 15 months.
Objectives
The objective of this study is to evaluate the treatment and post-
treatment changes in patients who were treated with either Twin
Block or Dynamax functional appliances for an extended period of
15 months. The null hypothesis was that there is no difference in the
effects of the Twin Block and Dynamax appliance in a randomized
sample during the treatment period and following treatment.
Subjects and methods
Trial design and changes after commencement
This is a follow-up study of a two-arm parallel randomized clin-
ical trial comparing the post-treatment changes following treat-
ment with two different functional appliances in adolescent patients
undergoing orthodontic treatment for the correction of Class II mal-
occlusion in two centres in the UK. Ethical approval was obtained
from the UK National Research Ethics Service (East London REC
P/00006 27/11/03, Kent REC 23/02/04). There were no changes to
the trial protocol or methods after the trial commencement. The first
part of the study has been already reported on (10). The results are
presented as outlined by the CONSORT statement (11).
Participants, eligibility criteria and settings
Participants were recruited from patients referred to the ortho-
dontic departments at the Dental Institute, Royal London Hospital
and the Kent and Canterbury Hospital, Canterbury, East Kent
Hospitals University NHS Foundation Trust from September 2004
to May 2006. The former is a dental school, while the latter is a
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district general hospital, both offering comprehensive orthodontic
services and treatment for children, adolescents and adults. The in-
clusion criteria were: 1. Caucasian patients; 2. females aged 11–13
and males 12–14; 3. an initial overjet of 7 mm or more; 4. no ex-
treme vertical facial phenotypes; 5. no previous orthodontic treat-
ment and 6.  no medical contraindications. To avoid any bias in
selection in age, skeletal morphology or features of malocclusion,
all patients presenting to the department satisfying the selection
criteria were invited to participate in the trial. Cephalometric re-
cords were not taken until after allocation to appliance type again
to try and avoid any bias.
Interventions
The trial protocols have already been reported on and will be sum-
marized here (10). Patients were treated with either a Twin Block
appliance or a Dynamax appliance. The Twin Block appliance sub-
jects had the bite recorded with maximal forward protrusion using a
standardized bite gauge, with anterior opening of 3–4 mm. Patients
were asked to wear the appliances full time, including during eating,
from the first fitting (Figure 1).
The Dynamax appliance was designed to produce a small
amount of mandibular posture from the outset of not more than
3  mm as per recommended clinical protocols (12). The appliance
was worn full time, apart from eating and the bite gradually ad-
vanced by activation of the lingual springs 2–3 mm at three monthly
intervals. (Figure 2).
All appliances were maintained with full-time wear for the
period of 15 months and then completely withdrawn and removed
prior to further cephalometric records. The patients were subse-
quently examined 3 months later and a clinical assessment for fu-
ture management was taken at that time. The patients were then
treated according to perceived clinical need, with the majority
moving into fixed appliances. The nature of any further treat-
ment is shown in Supplementary Table 1. Final stage records were
taken at a further 12 months, 30 months from the initial records
and 15  months from the completion of the functional appliance
therapy.
Cephalometric analysis and the primary outcome
measures
The primary outcome measured was the skeletal difference be-
tween the two groups as measured from lateral cephalograms.
Lateral cephalograms were taken at the start of treatment (T1),
at 15 months at the end of functional appliance therapy (T2) and
at 30  months (T3). All radiographs were traced and digitized by
one individual (LL). Radiographic measurements were adjusted to
allow for magnification factors, which was 7%. Horizontal and
vertical measurements were assessed using a previously described
technique, involving the use of horizontal line at 7 degrees to S–N,
with a vertical line being constructed 90 degrees to the horizontal
A. T. DiBiase et al. 3

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Figure 1.  Twin Block design with clasps on premolars and molars and a standardized bite opening anteriorly.

Figure 2.  Dynamax appliance with a fixed lower lingual arch and vertical extensions to the upper appliance to gradually encourage forward mandibular posture.

line at sella (5) (Figure 3). All linear measurements were recorded
from this vertical line as in the previous study (10). No changes
were made to the outcomes measured after commencement of
the trial
Sample size calculation
The trial sample size was calculated using the Stata 10.0 pro-
gramme for calculation of sample size for two samples based on
the comparison of means (StataCorp LLC, College Station, Texas,
USA). Sample size was calculated a priori for expected treatment
changes of a minimum 2 mm difference in total anterior face height
dimensions, as this was the most likely expected clinically significant
difference between the two appliances based on a previous study (6).
With the power of test set at 90 per cent and the alpha level as 5 per
cent, it was calculated that 100 patients would be required at the end
of the trial, equally distributed between the two groups.
4 European Journal of Orthodontics, 2019
Figure 3. Linear and angular cephalometric measurements (S  =  sella,
Na = nasion, Ar = articulare, A = A point, B = B point, ANS = anterior nasal
spine, Pog = pogonion, GN = gnathion, Mn = menton, TAFH = total anterior
face height, LAFH = lower anterior face height).
Randomization
Randomization was stratified according to gender and age. Participants
were identified from treatment waiting lists in the two sites. Suitable
pairs of male and female participants were then selected with birth date
within 3 months of each other from the waiting lists in each depart-
ment. Following recruitment and consent, each member of a pair was
randomly allocated to one of the two treatment groups using sealed en-
velopes by the principal investigator at each site (RTL and ATD).
Blinding
While clinicians and participants could not be blinded to the ap-
pliance being used, the extracted data was coded so the outcome
assessor (LL) and statistician were blinded to subject analysis. The
coding of the data was broken after the end of the analysis and no
breach of blinding was identified.
Statistical methods
Descriptive statistics, including means and standard deviations were
used to present the demographic data for each group. All analyses
were carried out prior to code breaking using Social Sciences for
Windows version 16.0 (SPSS Inc., Chicago, Illinois, USA). Data was
normally distributed and, therefore, parametric statistical testing was
applied. Paired t-tests were used to explore any statistical differences
for each appliance group between the start and end of functional
treatment and the post-functional observation period. Independent
t-tests were used to analyse any differences between the two appli-
ances groups.
The results were also analysed by gender within each appliance
group. As the sample size for statistical testing was reduced to the number
in each appliance group, using Shapiro–Wilk test, the assumption of
normal distribution, which is applied to parametric testing, was not met.
Therefore the Mann–Whitney U-test was used to analyse gender within
each appliance group at both the T1–T2 and T2–T3 periods.
To assess repeatability lateral cephalograms of 20 randomly
selected cases were retraced and re-digitized 2 weeks following their
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Figure 4.  Participant flow through study.
first analysis by the same assessor (LL) to assess reliability. Analysis
was conducted using limits of agreement (13).
Results
Recruitment and participant flow
A total of 150 patients were invited to participate in the study, with
the objective of having 75 matched pairs by gender and age. However,
due to failure of initial attendance or refusal of treatment following
consent and randomization, 78 patients were initially allocated for
Twin Block therapy and 72 for Dynamax therapy. The number of
patients who completed the initial 15 months therapy was 127, 68
Twin Block and 61 Dynamax. The overall number of patients who
consented to the trial and have full records throughout the trial to the
end of the analysis after 30 months was 100 patients, 52 Twin Block
and 48 Dynamax. Participant flow through the study broken down
for gender is shown in the CONSORT flow diagram (Figure 4).
Baseline data
The ages of the total sample are shown in Supplementary Table 2,
whilst the baseline cephalometric data is shown in Supplementary
Table 3. This shows both groups were very similar at the start of
treatment with no extremes in either short- or long-faced individuals.
Changes 0–15 months (T1–T2)
A mean overjet reduction occurred of 7  mm (±2.3) with the Twin
Block and 5.8 mm (±2.1) with the Dynamax (Tables 1–3). This was
associated with retroclination of the upper incisors by −5.8 degrees
(±10.0) in the Twin Block group and −5.7  degrees (±11.2) in the
Dynamax group (P  =  0.97). The lower incisors were proclined by
5.3 degrees (±4.8) in the Twin Block group and by 5.4 degrees (±6.0)
in the Dynamax group (P = 0.96)
Over the 15 months treatment period, the maxilla had a mean
forward movement at A  point of 0.8  mm (±1.7) with the Twin
Block and 0.2  mm (±1.5) with the Dynamax (P  =  0.06) (Tables
1–3). Statistically, significant differences were found in the forward
movement of the chin at pogonion of 3.5 mm (±2.5) with the Twin
Block and 1.7  mm (±2.1) with the Dynamax (P  <  0.01). The ver-
tical dimension of total anterior face height was increased by a mean
of 6  mm (±2.8) with the Twin Block and 4.6 (±2.8) mm with the
Dynamax (P = 0.02). There was an increase in the mandibular length
A. T. DiBiase et al. 5

Table 1.  Paired t-tests showing cephalometric changes in time periods 0–15 and 15–30 months for Twin Block group. CI, confidence interval;
SD, standard deviation.

Twin Block (n = 52)

T1–T2 T2–T3

95% CI 95% CI
Sig. Sig.
Cephalometric variables Mean diff SD Lower Upper (two-tailed) Mean diff SD Lower Upper (two-tailed)

Linear measurements (mm)

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  Pogonion to sella-vertical 3.5 2.5 2.8 4.2 0.00 0.3 2.6 −0.4 1.0 0.40
  Articulare to gnathion 6.2 2.5 5.5 7.0 0.00 0.7 2.3 0.1 1.4 0.03
  Articulare to pogonion 6.3 2.7 5.5 7.1 0.00 0.5 2.3 −0.2 1.1 0.16
  A point to sella-vertical 0.8 1.7 0.3 1.2 0.00 0.7 1.6 0.2 1.1 0.01
  B point to sella-vertical 3.5 2.3 2.9 4.2 0.00 0.2 2.3 −0.5 0.8 0.57
  Articulare to ANS 1.7 2.2 1.1 2.3 0.00 1.4 2.2 0.8 2.0 0.00
Angular measurements (°)
 SNA 0.0 1.5 −0.4 0.4 0.99 −0.1 1.3 −0.5 0.2 0.50
 SNB 2.1 1.4 1.8 2.5 0.00 −0.4 1.3 −0.7 0.0 0.05
 ANB −2.2 1.4 −2.6 −1.8 0.00 0.3 1.0 0.1 0.6 0.02
Vertical measurements (mm)
  Lower anterior face height 4.8 1.9 4.3 5.4 0.00 0.5 2.4 −0.2 1.2 0.13
  Total anterior face height 6.0 2.8 5.2 6.8 0.00 0.8 2.6 0.1 1.5 0.03
 Overbite −4.0 2.1 −4.6 −3.4 0.00 1.3 2.2 0.7 1.9 0.00
Dental measurements (° or mm)
  Upper incisor to maxillary plane −5.8 10.0 −8.6 −2.9 0.00 0.0 5.8 −1.7 1.6 0.97
  Lower incisor to mandibular plane 5.3 4.8 4.0 6.7 0.00 −2.9 5.6 −4.4 −1.3 0.00
 Overjet −7.0 2.3 −7.7 −6.3 0.00 1.1 1.8 0.6 1.6 0.00
  Upper incisor tip to sella-vertical −1.4 2.1 −2.0 −0.9 0.00 0.4 2.4 −0.3 1.1 0.24
  Lower incisor tip to sella-vertical 5.3 2.5 4.6 6.0 0.00 −0.8 2.5 −1.5 −0.1 0.04
  Lower incisor to A pogonion 1.7 2.9 0.9 2.5 0.00 −1.2 1.8 −1.7 −0.7 0.00

ANB, A point - nasion - B point; SNA is Sella-nasion-A point; SNB is Sella- nasion - B point.

Table 2.  Paired t-tests showing cephalometric changes in time periods 0–15 and 15–30 months for Dynamax group. CI, confidence interval;
SD, standard deviation.

Dynamax (n = 48)

T1–T2 T2–T3

95% CI 95% CI
Sig. Sig.
Cephalometric variables Mean diff SD Lower Upper (two-tailed) Mean diff SD Lower Upper (two-tailed)

Linear measurements (mm)

  Pogonion to sella-vertical 1.7 2.1 1.0 2.3 0.00 0.9 2.5 0.1 1.6 0.02
  Articulare to gnathion 4.1 2.6 3.4 4.9 0.00 1.8 3.0 0.9 2.6 0.00
  Articulare to pogonion 4.0 2.5 3.3 4.8 0.00 1.5 3.1 0.6 2.4 0.00
  A point to sella-vertical 0.2 1.5 −0.3 0.6 0.48 1.0 1.8 0.5 1.5 0.00
  B point to sella-vertical 1.7 2.0 1.1 2.3 0.00 0.6 2.2 −0.1 1.2 0.08
  Articulare to ANS 0.4 2.3 −0.2 1.1 0.21 1.5 2.6 0.7 2.2 0.00
Angular measurements (°)
 SNA −0.7 1.6 −1.2 −0.3 0.00 −0.1 1.4 −0.5 0.3 0.80
 SNB 0.8 1.1 0.5 1.2 0.00 −0.2 1.2 −0.5 0.2 0.31
 ANB −1.4 1.2 −1.7 −1.1 0.00 0.2 0.9 −0.1 0.4 0.21
Vertical measurements (mm)
  Lower anterior face height 3.3 1.6 2.9 3.8 0.00 0.8 2.2 0.2 1.5 0.01
  Total anterior face height 4.6 2.8 3.8 5.4 0.00 1.7 3.2 0.8 2.6 0.00
 Overbite −3.0 1.9 −3.5 −2.4 0.00 1.4 1.7 0.9 1.9 0.00
Dental measurements (° or mm)
  Upper incisor to maxillary plane −5.7 11.2 −8.9 −2.4 0.00 0.6 6.2 −1.2 2.4 0.50
  Lower incisor to mandibular plane 5.4 6.0 3.6 7.1 0.00 −3.4 6.1 −5.2 −1.7 0.00
 Overjet −5.8 2.1 −6.5 −5.2 0.00 0.9 2.1 0.3 1.6 0.00
  Upper incisor tip to sella-vertical −2.2 2.2 −2.9 −1.6 0.00 0.9 2.9 0.0 1.7 0.04
  Lower incisor tip to sella-vertical 3.3 2.0 2.7 3.9 0.00 0.0 2.6 −0.7 0.8 0.96
  Lower incisor to A pogonion 0.9 2.3 0.2 1.5 0.01 −0.8 1.6 −1.2 −0.3 0.00

ANB, A point - nasion - B point; SNA is Sella-nasion-A point; SNB is Sella- nasion - B point.
6 European Journal of Orthodontics, 2019

Table 3.  A comparison between Twin Block (TB) and Dynamax (Dx) at the start, end of treatment and 15 months post-functional appliance
therapy using independent t-testing. CI, confidence interval; SD, standard deviation.

TB vs. Dx T1–T2 TB vs. Dx T2–T3

95% CI 95% CI
Std. error Sig. Std. error Sig.
Cephalometric variables Mean diff diff Lower Upper (two-tailed) Mean diff diff Lower Upper (two-tailed)

Linear measurements (mm)

  Pogonion to sella-vertical 1.8 0.5 0.9 2.7 0.00 −0.6 0.5 −1.6 0.5 0.30

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  Articulare to gnathion 2.1 0.5 1.1 3.1 0.00 −1.1 0.5 −2.2 0.0 0.04
  Articulare to pogonion 2.3 0.5 1.2 3.3 0.00 −1.1 0.5 −2.2 0.0 0.05
  A point to sella-vertical 0.6 0.3 0.0 1.3 0.06 −0.3 0.4 −1.0 0.4 0.35
  B point to sella-vertical 1.8 0.4 1.0 2.7 0.00 −0.4 0.5 −1.4 0.5 0.37
  Articulare to ANS 1.3 0.5 0.4 2.2 0.01 −0.1 0.5 −1.1 0.9 0.83
Angular measurements (°)
 SNA 0.7 0.3 0.1 1.3 0.02 −0.1 0.3 −0.7 0.4 0.68
 SNB 1.3 0.3 0.8 1.8 0.00 −0.2 0.3 −0.7 0.3 0.43
 ANB −0.8 0.3 −1.3 −0.3 0.00 0.2 0.2 −0.2 0.5 0.43
Vertical measurements (mm)
  Lower anterior face height 1.5 0.4 0.8 2.2 0.00 −0.3 0.5 −1.3 0.6 0.50
  Total anterior face height 1.4 0.6 0.2 2.5 0.02 −0.9 0.6 −2.0 0.3 0.13
 Overbite −1.0 0.4 −1.8 −0.2 0.01 0.0 0.4 −0.8 0.8 0.98
Dental measurements ( ° or mm)
  Upper incisor to maxillary plane −0.1 2.1 −4.3 4.2 0.97 −0.6 1.3 −3.2 1.9 0.61
  Lower incisor to mandibular plane −0.1 1.1 −2.2 2.1 0.96 0.5 1.2 −1.9 2.9 0.67
 Overjet −1.2 0.5 −2.1 −0.3 0.01 0.2 0.4 −0.7 1.0 0.69
  Upper incisor tip to sella-vertical 0.8 0.4 −0.1 1.6 0.08 −0.5 0.5 −1.6 0.6 0.37
  Lower incisor tip to sella-vertical 2.0 0.5 1.1 2.9 0.00 −0.8 0.5 −1.9 0.2 0.11
  Lower incisor to A pogonion 0.8 0.5 −0.2 1.9 0.13 −0.4 0.4 −1.1 0.3 0.25

ANB, A point - nasion - B point; SNA is Sella-nasion-A point; SNB is Sella- nasion - B point.

of 6.2 mm (±2.5) with the Twin Block and 4.1 mm (±2.6) with the
Dynamax (P = 0.007).
During T1–T2, the only significant difference between the males
and females in the Twin Block sample was the change in vertical di-
mension (Supplementary Table 4). The males had 2 mm (P = 0.02)
more growth compared to the females during T1–T2.
Within the Dynamax group, there were more significant changes
between the males and females during T1–T2 period, with more pro-
nounced changes occurring for the males (Supplementary Table 5).
The females demonstrated more maxillary restraint than the males
(females: A point-sella-vertical: −0.3 mm, articulare-ANS: −0.4 mm;
males: A point-sella-vertical: 0.8 mm (−0.3, 1.9; P = 0.02), articulare-
ANS: 1.3 mm (−0.4, 2.8; P = 0.02) and more restraint than the males
and females of the Twin Block group. However, the males had more
significant vertical growth and mandibular growth compared to the
females with statistically significant increase in articulare-gnathion
5.7 mm (4.2, 7.2; P < 0.01) and articulare-pogonion 5.2 mm (3.6,
6.5; P < 0.01). SNB was also seen to increase significantly more in
the males compared to the females, 1.2 degrees (0.7, 1.8) and 0.7 de-
grees (0.0, 1.4), respectively (P = 0.05).
Changes 15 to 30 months (T2–T3)
The majority of the sample continued to have further orthodontic
treatment with a mean increase in overjet of approximately 1 mm
in both groups. There were minimal changes in the inclination
of the upper incisors, and the lower incisors were subject to re-
lapse, moving back by a mean of −2.9 degrees (±5.6) with the Twin
Block group and −3.4 degrees (±6.4) in the Dynamax group. In the
equivalent 15 month period, the lateral cephalograms indicate re-
duced subsequent growth in both groups (Tables 1–3), the Twin
Block group showing less increase in mandibular length than the
Dyanamax group −0.7  mm (±2.3) compared to 1.8  mm (±3.0;
P = 0.04).
During T2–T3, the males continued to show greater changes than
the females in both appliance groups, with the males and females
of the Dynamax group displaying greater changes compared to the
males and females of the Twin Block group. This was significant for
mandibular length (articulare to gnathion) and total anterior face
height for both groups (Supplementary Tables 4 and 5).
Repeated measurements and harms
The repeated measurements are shown in Supplementary Table 6.
The limits of the 95 per cent confidence intervals (CIs) for the dif-
ference in repeated measures were less than 1 mm for the horizontal
and vertical measurements and less than 1  degree for the angular
measurements showing good repeatability for all measurements.
There were no harms reported in this study.
Discussion
Main findings
While both groups were very similar at the start of the study (T1),
there were significant differences between the two appliances at both
time points and, therefore, the null hypothesis can be rejected. At T2,
the patients treated with the Twin Block appliance showed greater
reduction in the overjet and greater skeletal change for all param-
eters except horizontal movement of A point. At T3, most of these
differences had disappeared with the exception of measurements of
overall mandibular length. As with most studies reporting on the use
of functional appliances, large variations in individual response to
treatment were found.
A. T. DiBiase et al.
Fifteen months therapy with the Twin Block was associated with
a forward movement of the chin of 3.5 mm, similar to that reported
in other studies (14–16). The forward growth of the chin with the
Dynamax was limited to 1.7 mm. There was some evidence of re-
straint in the maxillary growth in the Dynamax group with a for-
ward movement of A point of only 0.2 mm over 15 months.
The main skeletal change, however, is in the mandibular length,
which increased by 6.2  mm in the Twin Block and 4.1  mm in the
Dynamax. The Twin Block finding is similar to that of Lund and
Sandler (16) with an increase in length of 5.1 mm and De Vincenzo
of 6  mm (17). This mandibular length increase was primarily ex-
pressed as an increase in lower face height, the Twin Block group
showing an increase in the vertical dimension of 6  mm compared
with 4.6 mm in the group treated with the Dynamax appliance.
All appliances were withdrawn and removed at the end of the
15 months for a 3 month period to assess stability of the correction
achieved and allow spontaneous correction of any residual open-
bites particularly in the Twin Block group prior to further treat-
ment. None of the patients had orthodontic treatment other than
the functional appliances described during the clinical trial period
(T1–T2). Following this, the treating clinicians were then free to
apply or prescribe further treatment as necessary to resolve the out-
standing features of the malocclusion, which in the majority of cases
required fixed appliances (Supplementary Table 1). Extractions were
prescribed if needed to relieve crowding and, in the majority of cases,
this was the extraction of four premolars. It was not considered clin-
ically necessary in any of the sample to re-treat with a functional
appliance and the majority of the sample subsequently had 1 year of
fixed appliance therapy. Although most of these patients who under-
went further treatment still had fixed appliances in place at the final
assessment, after a 15 month period, any skeletal relapse from the
initial treatment with the functional appliance should have occurred
as previous research has shown most relapse in sagittal correction
occurs within the first 6 months following treatment (18). Therefore,
a lateral cephalogram taken 15 months following withdrawal of the
functional appliance should allow evaluation of the overall effects
on skeletal growth of the treatment with a functional appliance.
The overall change over a 30 month period was slightly more for-
ward movement of the chin and pogonion in the Twin Block group
(3.8 mm) compared with the Dynamax (2.6 mm), although this was
not statistically significant. The vertical changes, however, were sig-
nificant with an overall increase of 6.8  mm in Twin Block group
and 4.1 mm in the Dynamax group. There was a mean increase in
the mandibular length of 7  mm with the Twin Block and 5.9  mm
with the Dynamax, mostly expressed vertically. This increase in the
vertical dimension has also been observed by Mills and McCulloch,
who reported a 7 mm increase with the Twin Block over 3 years (19).
The initial overjet correction produced by both functional appli-
ances appeared stable, although there was a tendency for the lower
incisors to return towards their original position. This is similar
to that found by Mills and McCulloch with a proclination of the
lower incisors of 5.2 degrees following a relapse of 1.5 degrees (19).
However, the overjet correction was maintained despite the upright-
ing of the lower incisors in the post-functional phase.
Comparing effects of the different appliances in males and fe-
males, the main differences were the changes in mandibular length
and vertical growth. In both instances, the males displayed more
growth in both dimensions than the females
It had been observed in an evaluation of Skeletal II untreated
patients, between 8.8 and 17.8 years, from the Burlington Growth
Centre, that no change in overjet occurred with growth despite add-
itional forward growth of the mandible, which was 4  mm greater
7
than that of the maxilla over this period (20). This additional for-
ward growth of the chin has also been reported in other growth stud-
ies (21,22). The failure of favourable mandibular forward growth to
reduce the overjet was considered to be due to the intercuspation of
teeth and the occlusion maintaining the Class II malocclusion.
It has been postulated that functional appliance therapy results
in overjet reduction and a correction of the buccal segment relation-
ship primarily due to a period of growth acceleration during the
treatment combined with the establishment of a new occlusal re-
lationship (23). In the post-treatment period, normal but reduced
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growth is re-established, resulting in no overall increase in man-
dibular length. This theory is supported by this study, as during the
follow-up period, while there was on-going forward growth of the
mandible in the Dynamax group, there was minimal forward growth
in the Twin Block group. This would suggest that additional overall
growth in the mandible length is not a significant feature of func-
tional appliance treatment. However, both appliances resulted in an
increase in lower face height, particularly in the Twin Block group.
It is possible, therefore, that alveolar bone development associated
with tooth eruption in patients treated with functional appliances
may well be a significant and stable change. It was notable in the
study of Mills and McCulloch that the vertical growth following
treatment was also greater than would have been expected in an his-
toric growth sample (19,20).
The changes found following 15  months of treatment in this
study has previously been reported to be greater than those following
just 9 months of treatment for the Twin Block appliance, particularly
in relation to increase in the vertical dimension and antero-posterior
movement of pogonion (6,10). The question is whether these differ-
ences persist following the functional phase of treatment resulting in
greater long-term skeletal effects of the appliances, justifying their
extended use and the overall extension of treatment time. After the
follow-up period at 30 months, there had been minimal further man-
dibular growth, meaning the overall mean antero-posterior move-
ment of pogonion in relation to the constructed vertical was 3.8 mm
and mandibular length from articulare to gnathion was 6.9 mm. In a
systematic review looking at the short-term effects of the Twin Block
functional appliance, a random effects meta-analysis found that the
mean changes in mandibular length as measured from condylion
to gnathion were an increase of 2.9  mm (95% CI: 1.9, 4.0) (7).
In younger patients treated with Twin Block appliances, Mills and
McCulloch found a mean increase of mandibular length as meas-
ured from condylion to gnathion of 6.5 mm and an advancement of
B point to a constructed vertical of 3.8 mm a year into treatment,
similar to that found in this study. The patients were followed up
for just under 3 years, a mean of 14 months out of active treatment,
which showed a further 6 mm of growth in mandibular length and
2.8 advancement of B point, which is considerably larger than in this
study (19). However, patients started their treatment prior to the
adolescent growth spurt, most were still in treatment with the Twin
Block appliance when the initial follow-up cephalogram was taken,
the overall follow-up period was longer and it was a retrospective
study with a small sample group being compared to an historic, un-
matched control group. It is, therefore, probable that this study over-
estimated the treatment effects of the appliance.
In a prospective study looking at adolescent patients treated with
Twin Block appliances, O’Brien et al. found following comprehen-
sive treatment, including fixed appliances, a mean increase in man-
dibular base length of 4.42 mm using Pancherz analysis measuring
to pogonion (14). The mean treatment time in this study with the
Twin Block appliance was just over 11  months. It, therefore, ap-
pears that, in this study, the overall skeletal effects of the Twin Block
8 European Journal of Orthodontics, 2019
appliance, which has been subjected to greater investigation, are
similar to those reported in other studies. Therefore, the extended
treatment time reported here cannot be justified based on any evi-
dence of greater effects on growth in the long term or enhanced sta-
bility of the sagittal correction.
Limitations
As with all studies involving use of removable appliances, one of
the main limitations in this study was drop out and the potential
for attrition bias. The failure to complete the 15 months treatment
and be available for final records was 13 per cent with the Twin
Block and 15 per cent with the Dynamax. This compares favour-
ably with patients who had treatment with similar appliances in the
same departments over a period of 9 months in the previous study,
where non-compliance was 9 per cent with both the Twin Block and
Dynamax appliances in a 9 month period (6). Higher non-compli-
ance rates over a similar time period have been reported by O’Brien
et al. with the Twin Block at 33 per cent (14), while the study re-
ported had less problems with the Dynamax appliance than have
previously been reported (24).
The subsequent unavailability of patients for follow-up at the
30  month period resulted in full records being available for 100
patients from the original sample. The overall final sample, there-
fore, had minor gender differences and numbers, with more males
in the Twin Block group (56%) compared with the Dynamax group
(44%). The mean age at the outset was 12.8 (±0.9) Twin Block and
12.6 (±1.0) Dynamax. However, the overall dropout was similar in
both groups and, therefore, considered random and unlikely to in-
fluence the final outcome.
Another potential limitation of this study is the lack of a stand-
ardization protocol for further treatment following the initial treat-
ment with functional appliances. By the very nature of variation
in presentation of Class  II malocclusions that are initially treated
with functional appliances, the treatment aims of further treatment
were varied and dependent on the clinical presentation. As shown in
Supplementary Table 1, the majority of patients moved into fixed ap-
pliances if clinically indicated to complete their treatment. A smaller
number received no further treatment if it was not indicated clinic-
ally, they did not want any further treatment or if it was considered
inappropriate on the grounds of poor oral hygiene or compliance.
One patient received further treatment with a removable appliance.
While ideal to fully assess the long-term effects of the initial treat-
ment, further treatment should have been withheld for the duration
of the study, considering the age of the patients as this was con-
sidered unethical. However, this is a real-world study reflecting the
use of functional appliance in contemporary orthodontic practice
and it is unlikely that any further treatment undertaken for the rest
of the study of approximately 1 year would have had a major impact
on further skeletal growth, allowing assessment of the long-term ef-
fects of the functional appliance treatment.
Another limitation is the lack of a control group. However, as
previously stated, it was considered unethical to withhold treat-
ment and, therefore, a matched control group was not available for
analysis. The use of a control group from a historic growth study
was considered inappropriate as those available were from different
populations and time periods and, therefore, not suitable for com-
parison (25).
Finally, this trial was not registered on any trial database because
at the time when the study was granted ethical approval and started
data collection, this was not mandatory. However, publishing in this
journal makes the results accessible for comparison and critical ap-
praisal in relation to other research.
Generalizability
This investigation was carried out in a clinical environment typical
of many where issues of compliance are encountered on a daily basis
with a large sample using appliances that are routinely used in con-
temporary orthodontic practice. Therefore, despite the levels of drop
out, we feel the results are still applicable to orthodontic practice in
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the wider setting and should be reported.
Conclusions
1. Functional appliance therapy produces significant skeletal changes
in 15 months, mainly with the Twin Block and particularly in the
vertical dimension.
2. In the subsequent 15  months, minimal antero-posterior skeletal
growth change occurs after the Twin Block and a little catch-up
growth occurs after the Dynamax appliance.
3. Vertical skeletal increased during treatment with the Twin Block
and Dynamax and continue after treatment has been completed.
4. Occusal changes appear stable following functional appliance
therapy.
5. The use of functional appliances appears to result in accelerated
mandibular growth during the treatment period followed by re-
duced mandibular growth in the post-treatment period.
Supplementary material
Supplementary material is available at European Journal of
Orthodontics online.
Supplementary Table 1 Further treatment undertaken following
initial treatment with functional appliance.
Supplementary Table 2 Age of sample.
Supplementary Table 3 Cephalometric angular and linear meas-
urements at the start of treatment, end of treatment (15 months) and
final observation (30 months).
Supplementary Table 4 Twin Block cephalometric changes
Mann–Whitney U-test for males and females.
Supplementary Table 5 Dynamax cephalometric changes Mann–
Whitney U-test for males and females.
Supplementary Table 6 Error study.
Funding
No funding to be declared.
Conflict of interests
None to declare.
References
1. Koretsi,  V., Zymperdikas,  V.F., Papageorgiou,  S.N. and Papadopou-
los, M.A. (2015) Treatment effects of removable functional appliances in
patients with Class II malocclusion: a systematic review and meta-analysis.
European Journal of Orthodontics, 37, 418–434.
2. Tulloch,  J.F., Proffit,  W.R. and Phillips,  C. (2004) Outcomes in a
2-phase randomized clinical trial of early Class II treatment. American
Journal of Orthodontics and Dentofacial Orthopedics, 125, 657–667.
A. T. DiBiase et al.
3. Dolce, C., McGorray, S.P., Brazeau, L., King, G.J. and Wheeler, T.T. (2007)
Timing of Class  II treatment: skeletal changes comparing 1-phase and
2-phase treatment. American Journal of Orthodontics and Dentofacial
Orthopedics, 132, 481–489.
4. O’Brien, K., et al. (2009) Early treatment for Class II Division 1 malocclu-
sion with the Twin-block appliance: a multi-center, randomized, controlled
trial. American Journal of Orthodontics and Dentofacial Orthopedics,
135, 573–579.
5. Gill, D.S. and Lee, R.T. (2005) Prospective clinical trial comparing the ef-
fects of conventional Twin-block and mini-block appliances: Part 1. Hard
tissue changes. American Journal of Orthodontics and Dentofacial Ortho-
pedics, 127, 465–472; quiz 517.
6. Lee, R.T., Kyi, C.S. and Mack, G.J. (2007) A controlled clinical trial of the
effects of the Twin Block and Dynamax appliances on the hard and soft
tissues. European Journal of Orthodontics, 29, 272–282.
7. Ehsani, S., Nebbe, B., Normando, D., Lagravere, M.O. and Flores-Mir, C.
(2015) Short-term treatment effects produced by the Twin-block appli-
ance: a systematic review and meta-analysis. European Journal of Ortho-
dontics, 37, 170–176.
8. Voudouris,  J.C., Woodside,  D.G., Altuna,  G., Angelopoulos,  G., Bour-
que, P.J., Lacouture, C.Y. and Kuftinec, M.M. (2003) Condyle-fossa modi-
fications and muscle interactions during Herbst treatment, Part 2. Results
and conclusions. American Journal of Orthodontics and Dentofacial
Orthopedics, 124, 13–29.
9. Rabie,  A.B., Zhao,  Z., Shen,  G., Hägg,  E.U., Dr,  O. and Robinson,  W.
(2001) Osteogenesis in the glenoid fossa in response to mandibular ad-
vancement. American Journal of Orthodontics and Dentofacial Ortho-
pedics, 119, 390–400.
10. Lee, R.T., Barnes, E., DiBiase, A., Govender, R. and Qureshi, U. (2014) An
extended period of functional appliance therapy: a controlled clinical trial
comparing the Twin Block and Dynamax appliances. European Journal of
Orthodontics, 36, 512–521.
11. Moher,  D., Hopewell,  S., Schulz,  K.F., Montori,  V., Gøtzsche,  P.C.,
Devereaux, P.J., Elbourne, D., Egger, M. and Altman, D.G. (2010) CON-
SORT 2010 explanation and elaboration: updated guidelines for reporting
parallel group randomised trials. BMJ, 340, c869.
12. Bass, N.M. and Bass, A. (2003) The Dynamax system: a new orthopedic
appliance. Journal of Clinical Orthodontics, 37, 268–277.
13. Bland, J.M. and Altman, D.G. (1986) Statistical methods for assessing agree-
ment between two methods of clinical measurement. Lancet, 1, 307–310.
14. O’Brien, K., et al. (2003) Effectiveness of treatment for Class II malocclu-
sion with the Herbst or twin-block appliances: a randomized, controlled
9
trial. American Journal of Orthodontics and Dentofacial Orthopedics,
124, 128–137.
15. O’Brien, K., et al. (2003) Effectiveness of early orthodontic treatment with
the Twin-block appliance: a multicenter, randomized, controlled trial.
Part 1: dental and skeletal effects. American Journal of Orthodontics and
Dentofacial Orthopedics, 124, 234–243; quiz 339.
16. Lund,  D.I. and Sandler,  P.J. (1998) The effects of Twin Blocks: a pro-
spective controlled study. American Journal of Orthodontics and Dentofa-
cial Orthopedics, 113, 104–110.
17. DeVincenzo, J.P. (1991) Changes in mandibular length before, during, and
Downloaded from https://academic.oup.com/ejo/advance-article-abstract/doi/10.1093/ejo/cjz059/5553715 by guest on 26 August 2019
after successful orthopedic correction of Class  II malocclusions, using a
functional appliance. American Journal of Orthodontics and Dentofacial
Orthopedics, 99, 241–257.
18. Pancherz,  H. and Hansen,  K. (1986) Occlusal changes during and after
Herbst treatment: a cephalometric investigation. European Journal of
Orthodontics, 8, 215–228.
19. Mills, C.M. and McCulloch, K.J. (2000) Posttreatment changes after suc-
cessful correction of Class II malocclusions with the twin block appliance.
American Journal of Orthodontics and Dentofacial Orthopedics, 118,
24–33.
20. You, Z.H., Fishman, L.S., Rosenblum, R.E. and Subtelny, J.D. (2001) Den-
toalveolar changes related to mandibular forward growth in untreated
Class  II persons. American Journal of Orthodontics and Dentofacial
Orthopedics, 120, 598–607; quiz 676.
21. Bjork, A. (1963) Variations in the growth pattern of the human mandible:
longitudinal radiographic study by the implant method. Journal of Dental
Research, 42(Pt 2), 400–411.
22. Bishara, S.E., Jakobsen, J.R., Vorhies, B. and Bayati, P. (1997) Changes in
dentofacial structures in untreated Class II division 1 and normal subjects:
a longitudinal study. The Angle Orthodontist, 67, 55–66.
23. Johnston,  L.E. (2005) If wishes were horses: functional appliances and
growth modification. Progress in Orthodontics, 6, 36–47.
24. Thiruvenkatachari, B., Sandler, J., Murray, A., Walsh, T. and O’Brien, K.
(2010) Comparison of Twin-block and Dynamax appliances for the treat-
ment of Class  II malocclusion in adolescents: a randomized controlled
trial. American Journal of Orthodontics and Dentofacial Orthopedics,
138, 144.e1–9; discussion 144.
2 5.
Antoun,  J.S., Cameron,  C., Sew  Hoy,  W., Herbison,  P. and
Farella, M. (2015) Evidence of secular trends in a collection of his-
torical craniofacial growth studies. European Journal of Orthodon-
tics, 37, 60–66.