Acceptance and discomfort in growing patients during treatment with two functional appliances: A randomised controlled trial

Article (PDF Available)inEuropean Journal of Paediatric Dentistry 13(3):219-24 · September 2012with141 Reads
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Abstract
To evaluate the levels of acceptance and discomfort between two types of functional appliances. Study design: Randomised controlled trial. A sample of patients who met the inclusion criteria were distributed randomly and equally into two groups: the Trainer for Kids™ made up of 26 patients with an average age of 10.3 years (Group A), and the modified Activator with 28 patients, with an average age of 10.6 years (Group B), as control. A special questionnaire including eight questions about tension, pressure, sensitive teeth, pain, impaired speech, impaired swallowing, oral constraint and lack of confidence in public caused by the appliance was administered at T1 (7 days), T2 (14 days), T3 (3 months), and T4 (6 months). The sensation of pressure, teeth sensitivity, pain and impaired speech declined significantly in Group A. All complaints decreased significantly in Group B, but the changes in 'lack of confidence in public' were not significant. Moreover the sensation of pressure, teeth sensitivity, oral constraint and impaired speech were significantly higher in Group A than in Group B. The modified Activator caused less discomfort than the Trainer for Kids™ and was more acceptable.
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EuropEan Journal of paEdiatric dEntistry vol. 13/3-2012
G. Idris, M.Y. Hajeer, A. Al-Jundi
University of Albaath Dental School, Hamah, Syria
Department of Orthodontics
e-mail: myhajeer@scs-net.org
abstract
Aim To evaluate the levels of acceptance and discomfort
between two types of functional appliances. Study
design: Randomised controlled trial.
Materials and methods A sample of patients who
met the inclusion criteria were distributed randomly
and equally into two groups: the Trainer for Kids
made up of 26 patients with an average age of 10.3
years (Group A), and the modified Activator with 28
patients, with an average age of 10.6 years (Group
B), as control. A special questionnaire including eight
questions about tension, pressure, sensitive teeth, pain,
impaired speech, impaired swallowing, oral constraint
and lack of confidence in public caused by the appliance
was administered at T1 (7 days), T2 (14 days), T3 (3
months), and T4 (6 months).
Results The sensation of pressure, teeth sensitivity,
pain and impaired speech declined significantly in Group
A. All complaints decreased significantly in Group B, but
the changes in ‘lack of confidence in public’ were not
significant. Moreover the sensation of pressure, teeth
sensitivity, oral constraint and impaired speech were
significantly higher in Group A than in Group B.
Conclusion The modified Activator caused less
discomfort than the Trainer for Kids™ and was more
acceptable.
Acceptance and
discomfort in growing
patients during
treatment with two
functional appliances:
a randomised
controlled trial
Introduction
During orthodontic treatment, patients may experience
a considerable amount of discomfort [Sergl and Zentenr,
1998; Sergl et al., 2000]. Oliver and Knappman reported
that 70% of the subjects in their study had at least some
degree of pain, regardless the type of appliance worn
[Oliver and Knappman, 1985]. It is known that removable
appliances may cause discomfort including unpleasant
tactile sensations, pressure on mucosa, stretching of
soft tissues, displacement of the tongue, soreness of the
teeth and pain [Johnson et al., 1998]. These side effects
of the appliance act as adverse stimuli disturbing the
process of adaptation and affecting acceptance of the
orthodontic device [Sergl and Zentenr, 1998].
Discomfort caused by orthodontic appliances may
significantly affect patients’ compliance with treatment.
Pain, functional and aesthetic impairment are the primary
reasons for poor cooperation [Egolf et al., 1990] and
treatment discontinuation [Oliver and Knappman, 1985]
or early termination [Brattström, 1991]. Clinicians might
improve acceptance by selecting an appliance design,
which would allow comfortable wear and facilitate
adaptation to the appliance [Gosney, 1985].
Functional appliances, which are an established mode
of treatment of modern clinical orthodontics, show a
remarkable diversity of design. It appears from clinical
experience that patients do not readily adapt to these
appliances because of their large size and unfixed
position in the oral cavity, and that patient’ adaptation
might vary with the different types of functional
appliances [Graber and Neumann, 1985].
During the last decades, better functional appliances
have been developed and have been reported to
produce significant changes in oral function, as well
as to stimulate mandibular growth [Ramirez-Yanez,
2006]. In this context there are many modifications
of the original design of the Activator which have
been shown to produce better results with less bulky
components. One of those modifications was suggested
by Schmuth to reduce the size of the original Activator
[Stockfisch, 1995] that made the appliance simpler
and more acceptable [Sergl and Zentner, 1998]. The
modified Activator has been used widely in Syria as
an important functional appliance in the treatment of
Class II deformities in growing patients. More recently,
the Trainer for Kids (T4K™, Myofunctional Research Co,
Australia) has been introduced for early orthodontic
treatment of functional problems. The T4K™ is a
polyurethane prefabricated functional appliance, which
is claimed to correct malocclusions at an early age by
acting on muscular dysfunction and repositioning the
mandible, and it is claimed by the manufacturer to be of
easy use and multipurpose [Ramirez-Yanez, 2006; Das
and Reddy, 2010]. The effects of functional appliances
have been widely studied, and many comparisons were
made between different types and designs of functional
Keywords Pain; Discomfort; Acceptance; Modified
Activator; Trainer (T4K); Questionnaire.
IDRIS G. et al.
EuropEan Journal of paEdiatric dEntistry vol. 13/3-2012
220
appliances, but it seems that few studies have attempted
to evaluate the levels of pain, discomfort and acceptance
connected to these appliances.
The aim of the current randomised controlled trial was
to compare levels of pain and discomfort during the first
six months of orthodontic treatment of skeletal Class II
division 1 malocclusion in growing patients by employing
the functional appliance Trainer for Kids (T4K™) in
comparison with the widely used modified activator.
Materials and methods
Inclusion criteria
Patients were recruited according to the following
criteria: mandibular deficiency (ANB > 4°); Class II molar
relationship; overjet more than 4 mm; Witts appraisal
more than 2 mm; normal lower incisor/mandibular plane
relationship (93±5); normal or reduced anterior facial
height; no previous orthodontic or surgical treatment; at
maximal pubertal growth at the beginning of treatment.
Subjects
Thirteen schools in Homs and Hamah cities (in the
middle of Syria) were scanned and 188 children with
Class II division 1 were invited to participate in the study.
Ethical approval was obtained from the local Ethics
Committee of AL Baath Dental School. Parents were
given an information sheet and their informed consent
was obtained. A sample of 60 skeletal Class II division
1 subjects was recruited and distributed randomly and
equally into two groups: Group A (Trainer T4k), and
group B (modified activator). However, the final sample
consisted of 54 patients because 6 patients dropped out
due to the following reasons: patient’s poor cooperation
(one patient failed to wear the appliance for the specified
time), parent’s poor cooperation (three patients missed
several appointments), leaving the country (one patient)
and occurrence of maxillofacial fracture during treatment.
The resultant Group A (Trainer T4k) included 26
patients (14 males & 12 females; with an average age of
10.3 years), whereas Group B included 28 patients (14
males & 14 females; with an average age of 10.6 years).
The modified activator
The modified activator (according to Schmuth)
consisted of acrylic body “two splints meeting each other
in the occlusal plane, upper and lower labial bows,
Coffin spring in the upper plate, and acrylic capping of
the edges of lower incisors (Fig. 1) [Stockfisch, 1995].
Patients were asked to wear this appliance at least 15
hours per day.
The Trainer (T4K)
The Trainer For Kids (T4K™) is specifically designed
to correct myofunctional habits and also to assist the
alignment of the erupting teeth in the mixed dentition
stage. T4K is claimed to correct skeletal Class II problems
by an active mandibular force [Usumez et al., 2004].
Trainer consists of the following components: tooth
channels, labial bows, tongue tag, tongue guard, and
lip bumpers (Fig. 2). T4K is a prefabricated appliance
made in universal size for all children 6-11 years, and it
is made of flexible material. Patietns were asked to wear
the appliance everyday at night as well as two hours at
least during daytime.
The questionnaire
To assess pain and discomfort levels during the
treatment a special questionnaire was used, which was
derived and further modified from the questionnaire
used by Sergl et al. [Sergl et al., 1998; Sergl et al., 2000].
fig. 1 The modified Activator used in
the current study.
fig. 2 Trainer
®
(Blue Soft appliance
used in the first stage).
AcceptAnce And discomfort connected to functionAl AppliAnces
EuropEan Journal of paEdiatric dEntistry vol. 13/3-2012
221
It consisted of eight questions covering the following
elements: feeling of tension, feeling of pressure,
teeth sensitivity, pain, speech impairment, swallowing
difficulties, oral constraint and lack of confidence in
public. Questions were answered based on a four-point
Likert scale: 1, not at all; 2, little; 3, much; 4, very much.
Prior to application of the questionnaire in the main
investigation, a pilot study was performed to detect any
difficulties in understanding words and phrases, any new
complaints caused by appliance wearing and to assess
the possible need of modifications on the layout of the
questionnaire. The sample of the pilot study consisted
of 10 skeletal Class II division 1 subjects: 5 were treated
with the T4K™ appliance and 5 with the modified
activator. These questionnaires were completed at 7 and
14 days following appliance initial wear. The pilot study
revealed that the following modifications were required:
re-phrasing of some sentences that were translated from
English into Arabic (the formal language in Syria); double-
spacing between the lines to improve questionnaire’s
readability; colour-coding of questionnaire time of
administration (T1 white, T2 blue, T3 pink, and T4 green)
to enhance children’s cooperation.
All questionnaires were completed at the Orthodontic
Department, Al-Baath University Dental School by patients
with the aid of their parents (exclusively father or mother).
Each parent was asked to sit on the doctor's chair to fill
the questionnaire while the principal researcher (G.I.) was
observing the procedure. Each subject completed the
same questionnaire at the following times: 7 days (T1),
14 days (T2), three months (T3) and six months following
initial appliance insertion (T4).
Results
The collected data were subjected to statistical
analysis using Minitab software Version 15 (Mintab Inc.,
Pennsylvania, USA). Wilcoxon matched-pairs signed-
rank tests were used for intragroup comparisons (Tables
1, 2), whereas differences between the two groups were
detected using Mann-Whitney U tests (Table 3).
The tension sensation decreased in the Activator
group significantly after six months of treatment, but
changes in the Trainer group were insignificant (Fig. 3).
The pressure on soft tissues caused by the Trainer was
significantly greater than that caused by the Activator,
and the pressure sensation decreased significantly in the
Activator group (Fig. 4). Teeth sensitivity was significantly
greater in the Trainer group compared with the Activator
group at T3. It decreased significantly in the Activator
group at T4, and this sensation was basically located in
the upper and lower incisor regions at T1 and T2, and
then moved into in the molar regions at T3. On the
other hand, the upper incisors regions were the sensitive
areas in the Trainer group at T1 and T2 (Fig. 5).
When children were asked if the appliance had been
painful or not, the answers revealed that the Activator
and the Trainer caused low levels of pain and this
sensation decreased significantly at T3 (Fig. 6). The
most disturbing complaint with the Trainer was speech
impairment; speech impairment was significantly
greater in the Trainer group than the Activator group.
Although the Activator caused a little amount of
speech impairment, it decreased significantly at T3 and
T4 (Fig. 7). The two appliances caused a little amount
of swallowing impairment (Fig. 8) after 7 and 14 days
of appliance first wear, but there were no significant
differences between the two appliances at T3 and T4.
Oral constraint was the highest uncomfortable
sensation disturbing patients with the Activator. In
general, the two appliances caused a moderate amount
of oral constraint and little constriction to the lower
jaw movements. There were no significant differences
between the two groups (Fig. 9). The two appliances
caused a little amount of ‘lack of confidence in public’
SenSation (t1-t4) (t1-t3) (t1-t2)
Tension 0.133 0.096 0.083
Pressure 0.004** 0.010** 0.812
Teeth Sensitivity 0.006** 0.747 0.673
Pain 0.034* 0.008** 0.781
Speech Impairment 0.007** 0.029* 0.112
Swallowing Impairment 0.157 0.336 1
Oral Constriction 0.165 0.196 0.405
Lack of Confidence in
Public
0.532 0.399 0.207
P Values from Wilcoxon signed-rank tests of differences
between assessment times in the Trainer group (*)Significant
differences at P < .05, (**)Significant differences at P<.01
tab. 1 Significance of differences between assessment times
in Group A.
tab. 2 Significance of differences between assessment times
in Group B.
SenSation (t1-t4) (t1-t3) (t1-t2)
Tension 0.046* 0.448 0.356
Pressure 0.001** 0.050* 0.011*
Teeth Sensitivity 0.004** 0.371 0.454
Pain 0.007** 0.002** 0.379
Speech Impairment 0.002** 0.009** 0.165
Swallowing Impairment 0.008** 0.020* 0.873
Oral Constriction 0.007** 0.012* 0.957
Lack of Confidence in
Public
0.361 0.112 1
P Values from Wilcoxon signed-rank tests of differences
between assessment times in the Activator group (*)Significant
differences at P < .05, (**)Significant differences at P<.01
IDRIS G. et al.
EuropEan Journal of paEdiatric dEntistry vol. 13/3-2012
222
(Fig. 10) and the differences between the two groups
were insignificant.
Discussion
From reviewing the literature, it can be concluded that
discomfort caused by orthodontic appliance wear has
a negative influence on the appliance acceptance and
on patient’s compliance [Egolf et al., 1990]. Reasons
given for patients’ dropping out include pain (28%),
dissatisfaction with the appearance (16%) and functional
restrictions (7%) [Oliver and Knappman, 1985]. The aim
SenSation t4 t3 t2 t1
Tension 0.467 0.105 0.182 0.951
Pressure 0.197 0.646 0.007** 0.215
Teeth Sensitivity 0.294 0.038* 0.074 0.123
Pain 0.609 0. 793 0.516 0.279
Speech Impairment 0.000** 0.000** 0.000** 0.000**
Swallowing Impairment 0.987 0.986 0.406 0.410
Oral Constriction 0.027* 0.191 0.768 0.658
Lack of Confidence in Public 0.271 0.115 0.401 0.755
P- Values from Mann-Whitney U tests when evaluating differences between the two groups at the
four assessment times (*)Significant differences at P < .05, (**)Significant differences at P<.01
tabLE 3 Significance
of differences in the
comparisons made between
the two groups at each
assessment time.
fig. 3 Intensity of the complaint ‘tension sensation’ reported
for the two appliances. The evaluation was carried out after 7
days (T1), 14 days (T2), 3 months (T3), and 6 months (T4) after
appliance insertion.
fig. 5 Intensity of the complaint ‘teeth sensitivity’ reported
for the two appliances. The evaluation was carried out after 7
days (T1), 14 days (T2), 3 months (T3), and 6 months (T4) after
appliance insertion.
fig. 4 Intensity of the complaint ‘pressure sensation’ reported
for the two appliances. The evaluation was carried out after 7
days (T1), 14 days (T2), 3 months (T3), and 6 months (T4) after
appliance insertion.
fig. 6 Intensity of the complaint ‘pain’ reported for the two
appliances. The evaluation was carried out after 7 days (T1),
14 days (T2), 3 months (T3), and 6 months (T4) after appliance
insertion.
2.50
2.00
1.50
1.00
0.50
0.00
1.79 1.57 1.64 1.32
1.65 1.88 1.96 1.42
T1 T2 T3 T4
activator
trainer
TENSION SENSATION
2.50
2.00
1.50
1.00
0.50
0.00
1.86 1.68 1.68 1.29
2.19
activator
2.12 2.15 1.46
T1 T2 T3 T4
trainer
TEETH SENSITIVITY
2.5
2.0
1.5
1.0
0.5
0.0
1.8 1.3 1.3 1.1
1.9
activator
1.9 1.5 1.4
T1 T2 T3 T4
trainer
PRESSURE SENSATION
1.00
0.80
0.60
0.40
0.20
0.00
1.68 1.57 1.18 1.07
1.42
activator
1.46 1.15 1.15
T1 T2 T3 T4
trainer
1.80
1.60
1.40
1.20
PAIN
AcceptAnce And discomfort connected to functionAl AppliAnces
EuropEan Journal of paEdiatric dEntistry vol. 13/3-2012
223
fig. 7 Intensity of the complaint ‘impaired speech’ reported
for the two appliances. The evaluation was carried out after 7
days (T1), 14 days (T2), 3 months (T3), and 6 months (T4) after
appliance insertion.
2.50
2.00
1.50
1.00
0.50
0.00
1.96 1.79 1.36 1.18
3.58
activator
3.27 3.23 3.00
T1 T2 T3 T4
trainer
4.00
3.50
3.00
SPEECH IMPAIRMENT
of this investigation was to assess pain, discomfort and
acceptance levels during orthodontic treatment of Class
II division 1 malocclusion using the recently suggested
functional appliance Trainer (T4K™) compared to the
more commonly used modified Activator in Syria.
When a patient wears the activator, the Class II facial
features improve immediately after appliance insertion
accompanied with a pleasant facial appearance because
the Activator obliges the retruded mandible to be placed
in a forward position. On the other hand, the Trainer
has a negative effect on facial appearance immediately
after appliance insertion because it stretches the labial
profile and protrudes both lips. This is probably one of
the reasons beyond the higher level of acceptance to the
activator compared to the Trainer.
The experienced pressure on facial soft tissues found
in the current study with the two appliances has been
documented in a previous study [Sergl et al., 1998],
and the decrease of this sensation at T3 and T4 may be
due to muscular adaptation with the new mandibular
position. The two appliances caused pressure on the oral
soft tissues in the first two weeks at T1 and T2. This
sensation was stronger with the Trainer and this may
due to the labial and vestibular oral screen in addition
to the lip bumber, but on the other hand there were
no equivalent elements in the activator to cause a high
degree of pressure. These findings match with those
of previous studies, which have shown that functional
appliances cause undesirable effects due to pressure
sensation [Heinen,1994; Sergl et al.,1998; Doll et
al.,2000]. This sensation occurs mainly during the short-
term after appliance insertion (i.e. at T1 and T2) [Sergl et
al., 2000], and there is a significant correlation between
pressure sensation and the type of the functional
appliance used [Heinen et al., 1994].
fig. 8 Intensity of the complaint ‘impaired swallowing’ reported
for the two appliances. The evaluation was carried out after 7
days (T1), 14 days (T2), 3 months (T3), and 6 months (T4) after
appliance insertion.
1.00
0.80
0.60
0.40
0.20
0.00
1.43 1.39 1.04 1.00
1.23
activator
1.23 1.08 1.04
T1 T2 T3 T4
trainer
1.60
1.40
1.20
IMPAIRED SWALLOWING
fig. 10 Intensity of the complaint ‘lack of confidence in public’
reported for the two appliances. The evaluation was carried out
after 7 days (T1), 14 days (T2), 3 months (T3), and 6 months
(T4) after appliance insertion.
fig. 9 Intensity of the complaint ‘oral constraint’ reported for
the two appliances. The evaluation was carried out after 7
days (T1), 14 days (T2), 3 months (T3), and 6 months (T4) after
appliance insertion.
1.00
0.80
0.60
0.40
0.20
0.00
1.50 1.50 1.25 1.32
1.58
activator
LACK OF CONFIDENCE IN PUBLIC
1.81 1.77 1.69
T1 T2 T3 T4
trainer
1.80
1.60
1.40
1.20
2.00
2.50
2.00
1.50
1.00
0.50
0.00
2.04 2.00 1.64 1.50
2.08
activator
1.96 1.88 1.88
T1 T2 T3 T4
trainer
ORAL CONSTRAINT
IDRIS G. et al.
EuropEan Journal of paEdiatric dEntistry vol. 13/3-2012
224
Teeth sensitivity may be due to the contact between
the anterior teeth and the labial bows of the Activator
in addition to its acrylic capping of the lower incisors,
so that lower incisors received the action of mandibular
anterior repositioning and the upper incisors received
the reaction. This sensation moved onto the posterior
regions at the following assessment times because of the
induced extrusion of upper and lower molars making the
occlusions resting on few posterior points. In the Trainer
group, the teeth sensitivity was mainly located at the
upper incisors, because of the elasticity of the Trainer.
These findings are in line with previous studies which
have confirmed that teeth sensitivity is a very common
consequence of wearing functional appliances [Sergl et
al., 2000]. The two appliances caused a little amount
of pain during the short term (i.e. at T1 and T2). This
has also been reported in previous studies evaluating
functional appliances [Doll et al., 2000; Sergl et al.,
2000; Sergl et al., 1998, Heinen et al., 1994].
The Activator caused a little amount of speech
impairment and this may be due to its design in which
the acrylic base extension did not cover the palatal
rugae, whereas the Trainer caused a high level of
speech impairment and this may be due to the double
barriers (lingual and buccal oral screens) in addition
to the presence of the tongue tag and tongue guard.
The current study confirms that the modified Activator
caused less speech impairment than the Trainer and
this has also been shown in a previous study comparing
different functional appliances in which the modified
Activator was considered the least to cause speech
difficulties [Sergl and Zentner, 1998]. The current
findings go in line with those of Klock et al., who found
that oral habit restricting appliances have been the most
disturbing ones [Klock et al., 2000].
‘Oral constraint’ was not a major problem stated by
participants in this study for both appliances at the first
two assessment times. The feelings of oral restrictions
decreased significantly in the Activator group and this
may be due to the fact the Activator becomes gradually
looser in the mouth after few weeks of its insertion in
addition to the gradual trimming of the acrylic occlusal
wings (which is usually performed several weeks
following its application to promote guided eruption of
posterior teeth). Therefore, adaptation in the Activator
groups occurred to a greater extent than that in the
Trainer group.
Conclusions
The two appliances caused a considerable amount of
discomfort at T1 and T2.
The highest uncomfortable sensation disturbing pa-
tients wearing the Activator was the oral constraint in
the first two weeks.
The main complaint with the Trainer was speech im-
pairment which was high at all assessment times in
spite of its significant decrease at T3 and T4.
Pressure, teeth sensitivity, impaired speech and oral
constraint were significantly higher in the Trainer
group compared to those in the Activator group at all
assessment times.
The activator is more acceptable than the Trainer in
the treatment of skeletal Class II division 1 malocclu-
sion in growing patients.
References
Brattström V, Ingresson M, Aberg E. Treatment cooperation in
ortoghodontic patients. Br J Orthod 1991;18:37-42.
Clark W.J. The Twin Block Functional Therapy (2nd ed).St. London: Mosby,
Inc; 2002 P. 323.
Das UM, Reddy D . Treatment effects produced by preorthodontic trainer
appliance in patients with class II division I malocclusion. J Indian Soc
Pedod Prev Dent 2010; 28(1):30-33
Egolf RJ, BeGole EA, Upshaw HS. Factors associated with orthodontic
patient compliance with intraoral elastic and headgear wear. Am J Orthod
Dentofacial Orthop 1990;97:336-48.
Gosney M B E. An investigation into factors which may deter patients from
undergoing orthodontic treatment. Br J Orthod 1985;12:133-138.
Graber TM, Neumann N. Removable orthodontic appliances, ed2,
Philadelphia : Saunders; 1984.
Heinen M, Pies K N S, Hegmann M, Schwarze W. A retrospective look at the
acceptability of removable appliances. J Orofac Orthop 1994;55:290-296.
Johnson P D, Cohen D A, Aiosa L, McGorray S, Wheeler T. Attitudes and
compliance of pre-adolescent children during early treatment of Class II
malocclusion. Clinical Orthodontics and Research 1998;1:20-28.
Oliver R, Knapman Y. Attitudes to orthodontic treatment. Br J Orthod
1985;12:179-88.
Quadrlli, Gheorgiu, Marchetti, Ghiglione . Early Myofunctional Approach
To Skeletal Class II. Mondo Orthodontico 2002; 2:109-122.
Ramirez- Yañez G, Sidlauskas A, Junior E, Fluter J. Dimensional Changes in
Dental Arches After Treatment with a Prefabricated Functional Appliance.
The Journal of Pediatric Dentistry 2007; 31, 4: 279-283.
Ramirez- Yañez G. Insights into Orthodontic Treatment. Dental Asia
Journal 2006; July / August:15-16.
Sergl H G, Klages U, Zentner A. Functional and social discomfort during
orthodontic treatment- effects on compliance and prediction of patients`
adaptation by personality variables. Eur J Orthod 2000;22:307-315.
Sergl H G, Klages U, Zentner A. Pain and discomfort during orthodontic
treatment: Causative factors and effects on compliance. Am J Orthod
Dentofacial Orthop 1998;114:684-91.
Sergl H G, Zentner A. A comparative assessment of acceptance of different
types of functional appliances. Eur J Orthod 1998;20:517-524.
Stocksch H . The principles and practice of dentofacial orthopedics.
Quintessence Puplishing Co,Inc; 1995 p.50-51
Usumez S, Uysal T, Sari Z, Basciftci FA, Karaman AI, Guray E.The effects
of early preorthodontic trainer treatment on Class II, division 1 patients.
Angle Orthod 2004 Oct;74(5):605-609.
    • "Four appliances were identified and tested in an 11-year old boy with class II dental and skeletal jaw relationships, the appliances were: Traditional Twinblock (Clark, 1988); Twin-block with metallic fastener (TAP R splint , SCHEU Dental Technology, Brussels, Belgium); Clear elastic Twin-block; Sham Twin-block (Figure 1). As discomfort affects adaptation and acceptance (Sergl and Zentner, 1998; Idris et al., 2012), this was evaluated in a pilot study using two assessment methods: the participant was firstly asked to report how comfortable was each appliance immediately after insertion into the oral cavity in compare to the other appliances. The four appliances were presented in pairs to compare each appliance to the remaining three (a total of 12 pairs were generated to avoid confounding caused by sequence of appliances application); the participant was instructed to insert an appliance into the mouth and he was asked to move the mandible to the right and left, front and back, and then to swallow, then to repeat the same to another appliance; after that the participant was asked to indicate which of the two appliances was more comfortable to wear. "
    [Show abstract] [Hide abstract] ABSTRACT: Background: Sleep-Disordered Breathing (SDB) varies from habitual snoring to partial or complete obstruction of the upper airway and can be found in up to 10% of children. SDB can significantly affect children's wellbeing, as it can cause growth disorders, educational and behavioral problems, and even life-threatening conditions, such as cardiorespiratory failure. Adenotonsillectomy represents the primary treatment for pediatric SDB where adeno-tonsillar hypertrophy is indicated. For those with craniofacial anomalies, or for whom adenotonsillectomy or other treatment modalities have failed, or surgery is contra-indicated, mandibular advancement splints (MAS) may represent a viable treatment option. Whilst the efficacy of these appliances has been consistently demonstrated in adults, there is little information about their effectiveness in children. Aims: To determine the efficacy of mandibular advancement appliances for the management of SDB and related health problems in children. Methods/design: The study will be designed as a single-blind crossover randomized controlled trial with administration of both an “Active MAS” (Twin-block) and a “Sham MAS.” Eligible participants will be children aged 8–12 years whose parents report they snore ≥3 nights per week. Sixteen children will enter the full study after confirming other inclusion criteria, particularly Skeletal class I or class II confirmed by lateral cephalometric radiograph. Each child will be randomly assigned to either a treatment sequence starting with the Active or the Sham MAS. Participants will wear the appliances for 3 weeks separated by a 2-week washout period. For each participant, home-based polysomnographic data will be collected four times; once before and once after each treatment period. The Apnea Hypopnea Index (AHI) will represent the main outcome variable. Secondary outcomes will include, snoring frequency, masseter muscle activity, sleep symptoms, quality of life, daytime sleepiness, children behavior, and nocturnal enuresis. In addition, blood samples will be collected to assess growth hormone changes. Trial registration: This study was registered in the Australian New Zealand Clinical Trials Registry (ANZCTR): [ACTRN12614001013651].
    Full-text · Article · Aug 2016
  • [Show abstract] [Hide abstract] ABSTRACT: Aim: To determine the degree of pain and discomfort during the orthodontic treatment of skeletal Class III malocclusion using the Removable Mandibular Retractor (RMR). Materials and methods: The sample consisted of 33 skeletal Class III patients (17 males and 16 females; average age: 7.5 ± 1.33 years) who had been assigned to the RMR treatment group in a randomised controlled trial comparing this treatment versus a control group of no treatment at the Orthodontic Department, University of Al-Baath Dental School in Syria. Pain and discomfort were assessed using standardised questionnaires at the following assessment times: 7 days (T1), 14 days (T2), 6 weeks (T3), 3 months (T4) and 6 months (T5) after appliance insertion. Results: Levels of pain and discomfort decreased gradually by time in general. No significant changes in the levels of pain, tooth sensitivity and soft tissues tension were detected, whereas a significant decrease in the levels of pressure, impaired speech, impaired swallowing and lack of confidence in public was observed two weeks following appliance insertion. Mandibular constraint feeling required three months to decrease significantly. No difference was found between males and females with regard to acceptance. Conclusion: The RMR is well accepted by Class III patients in the early mixed dentition.
    Full-text · Article · Jun 2013