European Journal of Orthodontics, 2023, 45, 271–280

https://doi.org/10.1093/ejo/cjac067
Advance Access publication 4 November 2022
Randomized Controlled Trial (RCT)

Pain and discomfort during the first week of maxillary

expansion using two different expanders: patient-reported

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outcomes in a randomized controlled trial
Stina  Hansson1,2, Eva  Josefsson3,4, Rune  Lindsten3,4, , Anders  Magnuson5 and
Farhan  Bazargani1,2,
1
Department of Orthodontics, Postgraduate Dental Education Center, Örebro, Sweden
2
Faculty of Medicine and Health, School of Medical Sciences, Örebro University, Örebro, Sweden
3
Department of Orthodontics, The Institute for Postgraduate Dental Education, Jönköping, Sweden
4
School of Health and Welfare, Jönköping University, Jönköping, Sweden
5
Clinical Epidemiology and Biostatistics, School of Medical Sciences, Örebro University, Örebro, Sweden
Correspondence to: Farhan Bazargani, Department of Orthodontics, Postgraduate Dental Education Center, P.O. Box 1126, SE-701 11 Örebro; Faculty of
Medicine and Health, Sweden and School of Medical Sciences, Örebro University, Örebro SE-701 82, Sweden. E-mail: farhan.bazargani@regionorebrolan.se

Summary
Background: Quad Helix (QH) is the appliance most preferred by orthodontists to correct unilateral posterior crossbite in the early mixed den-
tition while other orthodontists suggest rapid maxillary expansion (RME) on deciduous teeth in these patients.
Objectives: To evaluate and compare perceived pain intensity, discomfort, functional jaw impairment, and analgesic consumption during the
first week of treatment with either RME or QH appliances.
Trial design: Two-arm parallel group, two-centre, randomized controlled trial.
Material and methods: Seventy-two patients, mean age 9.5 (SD ±0.8) years, with unilateral posterior crossbite requiring maxillary expansion
were randomly allocated to either the RME (22 boys, 14 girls) or QH (22 boys, 14 girls) group. Validated questionnaires were used to assess
pain intensity, discomfort, jaw function impairment, and analgesic consumption, on the first, fourth, and seventh days after appliance insertion
and activation.
Blinding: Due to clinical limitations, only the outcome assessors were blinded to the groups to which the patients were allocated.
Results: Seventy patients completed the questionnaires. Pain from the tongue and chafe from the appliance were significantly higher in the
QH group on the first day of treatment (P = 0.003 and P = 0.000, respectively). On the fourth day, the chafe from the appliance was still signifi-
cantly higher in the QH group (P = 0.007). Speech was affected in both groups on day 1; this impairment continued and was significantly higher
in the RME group days 4 and 7. No significant difference in analgesic consumption was found between the groups at any time. The analgesic
consumption was highest at day 1 of treatment.
Harms: No harm was observed in any patient.
Limitations: Double blinding was not possible due to the clinical limitations.
Conclusion: During the initial 4 days of treatment, pain from the tongue and chafe from the appliance caused the most reported inconvenience
in the patients in the QH group. A majority of reported visual analogue scale values were in the lower mid-range, suggesting low to moderate
pain and discomfort in both groups.
Clinical Trial Registration: NCT04458506

Introduction maxillary expansion (RME) such as Haas type or hyrax type

Posterior crossbite is a common malocclusion with a preva-
lence of 11 per cent in European children (1, 2). Posterior
crossbite is defined as a malocclusion in the canine, pre-
molar, and molar regions, in which the maxillary buccal
cusps occlude lingually to the buccal cusps of the corres-
ponding mandibular teeth. The condition may be bilat-
eral or unilateral, but unilateral crossbites predominate.
Posterior crossbites can be treated with fixed or removable
expanders, where the fixed expanders are more affective
due to independence of cooperation (3). Fixed appliances
can expand slow, such as Quad Helix (QH), or with rapid
expanders. Haas type and hyrax type are considered equally
efficient (4).
What is considered the golden standard for correcting uni-
lateral crossbites differs depending on the dental stage but
also on the orthodontist’s preferences? In a survey made in
Sweden, most orthodontics preferred QH for the treatment of
unilateral crossbite, traditionally made with bands on the first
permanent molar (5). However, many authors instead suggest
RME anchored to the deciduous second molars to avoid un-
desirable effects on the permanent first molars in order to cor-
rect unilateral crossbites in the early mixed dentition (6–11).

© The Author(s) 2022. Published by Oxford University Press on behalf of the European Orthodontic Society
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272 European Journal of Orthodontics, 2023

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Figure 1. Flow diagram of the children and allocation to either rapid maxillary expansion—hyrax type (RME) or quad helix (QH) and bi-centre distribution.

Figure 2. (a) Quad helix (QH) with band on first permanent molars. Bite blocks on the second deciduous molar. (b) Rapid maxillary expansion—hyrax
type (RME) with bands on deciduous second molar. Bite blocks on the second deciduous molar.

When determining treatment for correcting unilateral
crossbite, it is also important to take into account the pa-
tient perspective on how different treatments are experienced
when choosing an appliance, especially when treating chil-
dren. Children should be given as effective and painless treat-
ment as possible to prevent the development of dental fear
(12). In the early mixed dentition, it may be easier to expand
the upper arch using less force than later in the early per-
manent dentition (13, 14) due to the facial sutural maturation
and interdigitation in the older cohorts.
At the commencement of orthodontic treatment, patients
often experience discomfort (15, 16). Pain and discomfort can
occur during the insertion of the appliance and the first 3 days
are most inconvenient for the patients. The pain and discom-
fort fade within 8 days in most cases (17, 18).
The perception of pain and discomfort in children with an-
terior crossbite treated with either fixed or removable appli-
ances has been shown to cause low to moderate discomfort
in both groups (19). Feldmann et al. also found almost the
same level of pain and discomfort treating posterior crossbite
with two different types of RME appliances in a random-
ized controlled trial (RCT) (20). However, there is still lack
of research exploring perceived pain intensity and discomfort
during posterior crossbite treatment. The need for more RCTs
with different treatment modalities was confirmed by a re-
cently published systematic review (21).
S. Hansson et al.
Thus, the aim of this RCT was to evaluate and compare
the patients’ experience of perceived pain intensity and dis-
comfort during the first week of treatment with either RME
on the second deciduous molar or QH on the permanent first
molar. The null hypothesis was that there are no significant
differences between the two appliances.
Materials and methods
This study was a two-centre RCT, with two parallel arms and
group allocation on a 1:1 ratio. The Regional Ethical Review
Board in Uppsala, Sweden, which follows the guidelines of
the Declaration of Helsinki, approved the study protocol
(Dnr: 2018/308). The patients and caregivers also had to give
their written consent to participate in the study.
Participants, eligibility criteria and setting
Seventy-two patients in the early mixed dentition with uni-
lateral posterior crossbite were examined at the Postgraduate
Dental Education Center, Region Orebro County, Sweden,
and the Institute for Postgraduate Dental Education, Region
Jönköping County, Sweden, from May 2019 to May 2021
(Figure 1).
The inclusion criteria were as follows:
• Unilateral posterior crossbite.
• Early mixed dentition: the maxillary first permanent
molars had to be erupted and the maxillary decidu-
ous canines and second deciduous molars had to be
persisting.
• Class I or Class II molar relation with maximum 5-mm
overjet.
• Ability of the patient to comprehend and answer a
questionnaire.
Patients with previous or ongoing orthodontic treatment,
craniofacial syndromes, or orofacial clefts were considered
ineligible for the study.
Randomization and allocation
All 72 participants were randomly allocated in blocks of
different sizes, using the concealed allocation principle in
a 1:1 ratio. The randomization procedure was as follows: a
computer-generated randomization list was created using SPSS
software (version 25.0; IBM SPSS, Chicago, IL, USA) and stored
with a research secretary. After receiving oral and written infor-
mation about the clinical trial, the included patients and their
parents/guardians signed the consent forms. Each time a pa-
tient gave his/her consent, the secretary was contacted to pro-
vide the information about which type of expander the patient
should receive. Thus, the allocation was concealed.
Clinical interventions
One centre used intraoral scanning (Trios 3, 3Shape,
Copenhagen Denmark) for impressions and the other
centre used alginate impression (Cavex Orthotrace, Cavex,
Haarlem, Holland). The QH (steel wire dimension 0.9 mm)
was attached with bands on the first permanent molar (Figure
2a). The RME was a hyrax type with a palatal expander, 13
mm (Leone orthodontic products, Firenze, Italy), attached
with bands on the deciduous second molar and bonded to
273
the deciduous canine (Figure 2b). On the deciduous canines, a
modest preparation was made on the palatal surface to create
a rest seat; next, the anterior arm was bonded at the palatal
surface (Tetric EvoFlow, Ivoclar Vivadent AG, Lichtenstein
or Transbond PLUS Color Change, 3M, ST Paul, MN, USA).
The bands on the QH and RME were cemented (Ketac Cem
3M, St. Paul, MN, USA). Both groups had bite blocks (Ultra
Band-Lok, Reliance, IL, USA, or Transbond Plus Light Cure
Band, 3M, St. Paul, MN, USA) placed on the maxillary second
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deciduous molar. The children’s parents/guardians were in-
structed on how to activate the RME appliance and the first
activation was done chair-side by the parent under supervi-
sion. The RME was activated a quarter turn (0.2 mm) twice a
day to normal transverse relations (the maxillary first molar’s
palatal cusp touches the buccal cusp of the mandibular first
molar). The QH was activated one molar width before cemen-
tation and controlled every 6–12 weeks until normal trans-
verse relations were achieved. All appliances were checked
7–14 days after insertion. The patients were treated by three
different experienced clinicians at two centres (SH, RL, EJ).
All three clinicians installed both appliances.
Questionnaire
The questionnaires included self-reported questions re-
garding pain intensity, discomfort, analgesic consumption,
and jaw function impairment on the first, fourth, and sev-
enth days in treatment (Supplemental Material). The ques-
tionnaires have been used previously in several studies and
are considered to have acceptable to good reliability and in-
ternal consistency (22). In this study, patients were asked to
complete the questionnaires on their own but were allowed
help from an adult to read the questions. The children re-
ceived three questionnaires at the time of inserting the ap-
pliance. The first one was to be answered on day 1 (the next
day within 24 hours after insertion), the second on day 4
and the third questionnaire 7 days after insertion. Children’s
parents/guardians helped them to understand some ques-
tions when necessary. The first questionnaire included ques-
tions about the perception of the insertion (Supplemental
Material, questions 1–3) which was not included in the
second and third questionnaires. Approximately 10 minutes
were needed to complete the questionnaires. Questions con-
cerning pain and discomfort were graded using a visual ana-
logue scale (VAS) with the end phrases ‘no pain’ and ‘worst
pain imaginable’ or ‘no discomfort’ and ‘worst discomfort
imaginable’. The VAS was measured to the nearest 0.5 mm
using a standard 100-mm metric ruler. Questions 3, 10, 14,
and 15 had a binary yes/no response with follow-up ques-
tions (with space provided for written responses). Questions
about functional jaw impairment were assessed using a five-
point verbal rating scale (VRS), with the alternatives ‘not
at all,’ ‘slightly difficult,’ ‘difficult,’ ‘much difficult,’ and ‘ex-
tremely difficult’ (22).
Primary outcome
Patients’ perception of pain and discomfort during the first
week of treatment.
Secondary outcome
Analgesic consumption between the groups and possible
gender differences within and between the groups.
274 European Journal of Orthodontics, 2023

Sample size Blinding

The calculated sample size for each group was based on a
significance level of 0.05 and 90 per cent power to detect
a difference of 10 mm (SD ±12) in pain levels between the
two groups on a VAS between the groups. The standard de-
viation was adapted from an earlier study (14). The sample
size calculation indicated that 31 patients would be required
in each group. To compensate for dropouts, we decided to
include 36 patients in each group (an addition of 15 per cent
Due to the nature of the intervention, it was not possible to
blind the patients or the practitioners to the appliances; how-
ever, the outcome assessors were blinded to the groups to
which the patients were allocated.
Statistical analysis
Mann–Whitney test was used to compare VAS- and VRS-
scaled variables between study groups. Wilcoxon paired

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per group). rank-sum test for VAS variables and marginal homogeneity
test for VRS variables were used to compare changes within
Registration groups between days 1 and 7. Chi-2 test or Fischer exact test
This trial was registered at ClinicalTrials.gov, ID when appropriate was used to compare binary variables be-
NCT04458506 and Researchweb.org project number tween groups. Because of many outcome variables evaluated,
260581. we use a significance level 0.01 for all statistical tests, to avoid
type 1 error, in other words, to reduce the risk of false signifi-
cant findings. SPSS version 27 (Armonk, NY: IBM Corp) was
used for all statistical calculations.
Table 1. Patient characteristics
Results
QH group RME group Of 72 randomized patients, one patient in the RME group
(n = 35) (n = 35) declined to start any treatment due to family reasons, and one
Age, mean (SD, min– 9.5 (0.7, 8.4–11.5) 9.5 (0.9, 8.5–12.1) in the QH group did not hand in any questionnaires. Patient
max) characteristics are displayed in Table 1. A total of 70 patients
Girls, n (%) 37.1% (13 of 35) 37.1% (13 of 35) (97 per cent) replied and handed in the questionnaires.
Age among girls, 9.3 (0.7, 8.4–10.6) 9.4 (1.0, 8.5–12.1)
Experience after insertion of the appliance
mean (SD, min–max)
(Supplemental Material, questions 1–3)
Age among boys, 9.6 (0.7, 8.5–11.5) 9.6 (0.8, 8.5–11.6)
mean (SD, min–max) The patients’ experience of inserting the dental appliance was
equal between groups, 40.3 per cent in total declared that

Table 2. Comparing experience at the first day after insertion of the appliance and pain, discomfort, daily activities variables at days 1, 4, and 7 between
quad helix (QH) and rapid maxillary expansion—hyrax type (RME) groups.

All QH group RME group P1

(n = 70) (n = 35) (n = 35)

Experience the first day after insertion of the appliance n Median (IQR) n Median (IQR) n Median (IQR)
1. Did you experience pain during the insertion of the 69 14 (0–31) 35 6 (0–31) 34 21 (2–34) 0.13
appliance?
2. Did you experience discomfort during the insertion 67 20 (4–50) 34 24 (2–52) 33 19 (4–50) 0.72
of the appliance?
3. Did you experience any part of the insertion of the 40.3% (27 of 67) 35.3% (12 of 34) 45.5% (15 of 33) 0.40
appliance as uncomfortable?
Pain and discomfort from mouth, teeth and jaws
10. Have you taken any analgesic today? (Day 1) 40.6% (28 of 69) 45.7% (16 of 35) 35.3% (12 of 34) 0.38
10. Have you taken any analgesic today? (Day 4) 15.7% (11 of 70) 17.1% (6 of 35) 14.3% (5 of 35) 0.74
10. Have you taken any analgesic today? (Day 7) 1.4% (1 of 69) 0.0% (0 of 34) 2.9% (1 of 35) >0.99
Daily activities
14. Have you stayed home from school today due to 17.4% (12 of 69) 17.1% (6 of 35) 17.6% (6 of 34) 0.96
pain from your appliance? (Day 1)
14. Have you stayed home from school today due to 1.4% (1 of 70) 2.9% (1 of 35) 0.0% (0 of 35) >0.99
pain from your appliance? (Day 4)
14. Have you stayed home from school today due to 0.0% (0 of 69) 0.0% (0 of 34) 0.0% (0 of 35) N.A.
pain from your appliance? (Day 7)
15. Have you refrained from leisure activities today 13.0% (9 of 69) 11.4% (4 of 35) 14.7% (5 of 34) 0.73
because of pain from your appliance? (Day 1)
15. Have you refrained from leisure activities today 1.4% (1 of 70) 0.0% (0 of 35) 2.9% (1 of 35) >0.99
because of pain from your appliance? (Day 4)
15. Have you refrained from leisure activities today 1.4% (1 of 69) 0.0% (0 of 34) 2.9% (1 of 35) >0.99
because of pain from your appliance? (Day 7)

Mann–Whitney test for visual analogue scale (VAS) variables and chi-2 test or Fischer exact test if appropriate for binary variables.
1

N.A., not applicable.

S. Hansson et al. 275

they experienced discomfort during the insertion (Table 2).
Free text comments were widely spread, but nine comments
were related to trying out the appliance, four mentioned the
minimal preparation on the deciduous canines as uncomfort-
able, some thought that the bite block was worst and two
children wrote that the polishing paste was most unpleasant.
There were no statistically significant differences between the
three operators concerning pain and discomfort during the
insertion of the appliances (P = 0.48).
Analgesic consumption (Supplemental Material,
question 10)
On the question if they had taken any analgesics the first day,
46 per cent answered yes in the QH group compared to 35
per cent in the RME group (P = 0.38). On day 4, 17 per cent
in the QH group answered that they had taken analgesics and
14 per cent in the RME group (P = 0.74). On day 7, no pa-
tient declared the use of analgesics (Table 2).

Pain and discomfort from mouth, teeth, and jaws
(Supplemental Material, questions 4–9, 11–13)
Pain and discomfort were most extensive on the first day after
inserting the appliance in both groups and dropped to day 7
(Table 3). On day 1, the QH group had more pain from the
tongue (P < 0.01), and more chafing from the appliance (P <
0.01) (Figure 3). On day 4, the QH group had still more chafe
from the appliance than the RME group (P < 0.01). On day
7, no significant differences were found between the groups.
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Daily activities (Supplemental Material, questions
14 and 15)
The first-day leisure activities were affected in 11 per cent
(QH group) and 15 per cent (RME group), respectively (P
= 0.73). Six children in each group answered that they had
stayed home from school due to the pain from the appliance
the first day. On day 4, one patient had stayed home from
school due to pain from the appliance (QH group) and one
had avoided leisure activities (RME group). On day 7, all chil-
dren had been to school. One patient in the RME group still

Table 3. Comparing pain and discomfort and functional jaw impairment variables between days 1 and 7 for all and for quad helix (QH) and rapid maxillary
expansion—hyrax type (RME) groups (data in figures).

All QH group RME group

(n = 70) (n = 35) (n = 35)

Pain and discomfort from mouth, teeth, and jaws (visual analogue scale [VAS])
n P1 n P1 n P1
4. Pain due to alliance 69 <0.001 35 <0.001 34 0.008
5. Pain from molars 69 <0.001 35 <0.001 34 0.18
6. Pain from incisors 68 0.31 35 0.31 33 0.52
7. Pain from jaws 68 0.097 35 0.029 33 0.91
8. Pain from palate 68 0.023 35 <0.001 33 0.83
9. Pain from tongue 67 0.31 35 0.27 32 0.95
11. Tension from jaws 66 <0.001 33 0.009 33 0.015
12. Tension from teeth 66 <0.001 33 0.006 33 0.004
13. Chafe from appliance 65 <0.001 34 <0.001 31 0.16
Functional jaw impairment (verbal rating scale [VRS])
n P1 n P1 n P2
16. Leisure activities 66 0.008 32 0.020 34 0.16
17. Speech 69 <0.001 35 <0.001 34 0.012
18. Ability to take a big bite 64 <0.001 31 0.004 33 0.047
19. Ability to chew hard food 63 <0.001 32 <0.001 31 <0.001
20. Ability to chew soft food 68 <0.001 35 <0.001 33 0.048
21. School work 62 0.003 31 0.071 31 0.011
22. Ability to drink 69 <0.001 35 0.007 34 0.001
23. Ability to laugh 67 0.011 33 0.18 34 0.025
24. Ability to yawn 69 0.039 35 0.083 34 0.26
25. Ability to swallow 69 <0.001 35 <0.001 34 <0.001
How difficult to eat
26. Crispbread 61 <0.001 32 <0.001 29 <0.001
27. Meat 61 <0.001 32 <0.001 29 0.008
28. Raw carrots 58 <0.001 30 <0.001 28 0.017
29. A French bread roll 59 <0.001 27 0.002 32 0.095
30. Peanuts 45 <0.001 22 0.003 23 0.016
31. An apple 58 <0.001 29 <0.001 29 0.007
32. A soft cake 61 <0.001 29 <0.001 32 0.083

Wilxocon paired rank-sum test.

1

Marginal homogeneity test comparing the variables on the five categorical scale (from not at all to extremely difficult).
2
276
Figure 3. Visual analogue scale (VAS) score 0–100 at days 1, 4, and 7
after inserting either quad helix (QH) or rapid maxillary expansion—hyrax
type (RME).
avoided leisure activities (ice hockey) due to the appliance
(Table 2).
Functional jaw impairment (Supplemental Material,
questions 16–25)
On day 1, no statistical differences were shown between the
groups. On day 4, speech was more affected in the RME
group than the QH group (P < 0.01) (Figure 4) as well as day
European Journal of Orthodontics, 2023
7 (P < 0.01) together with difficulties in taking a big bite (P
< 0.01).
Functional jaw impairment—eating (Supplemental
Material, questions 26–32)
On day 1, the QH group had more trouble chewing raw car-
rots (P < 0.01) and a French bread roll (P < 0.01). On day 4
as well as day 7, no statistically significant differences were
present between the groups (Figure 5).
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Gender differences
In regard to gender, no significant differences were found
(Table 4).
Discussion
This RCT has given us new knowledge about the patient
perspective during the first week of posterior crossbite
treatment, in children in the early mixed dentition. To our
knowledge, this is the first RCT comparing pain intensity
and discomfort during posterior crossbite treatment with an
RME on deciduous molars versus QH appliance. The most
important finding was that children in the QH group per-
ceived more pain from the tongue and chafe on the first day
than the RME group. The RME group experiences surpris-
ingly low levels of pain throughout the whole week despite
its orthopaedic effects (23). When planning orthodontic
treatment, we should not only think about the objective out-
come of treatment but also take into account the patient
perception of a certain treatment, especially when treating
children.
In both groups, the speech was considered at least
slightly impaired the first day, in about 90 per cent of the
patients. On days 4 and 7, however, the RME group still
had difficulties with speech, significantly more than the
QH group. One explanation could be due to the appliance
design but also due to the diastema that the RME gener-
ates between the central incisors after a couple of days.
Diastema has been correlated to have a negative effect on
speech (24).
We could not find any difference in reported analgesic con-
sumption during the first week. This finding is consistent with
a recently published non-randomized trial that compared
RME with slow maxillary expansion (25). Their study popu-
lation was children in their permanent or late mixed denti-
tion, about 3 years older than our patients; mean ages for
the QH and RME were 12.9 (SD ±1.5) and 12.7 (SD ±1.4)
years, respectively. The study had, unlike our population, a
majority of girls in both groups (QH 74 per cent and RME
82 per cent). The researchers found more pain and discomfort
with the hyrax RME at the commencement of the treatment,
even though they concluded that the differences were minor.
That they performed their study on older patients could be a
reason why our results differ. Our results give us a reason to
believe that RME treatment should not be delayed until the
permanent dentition, and children should be treated in the
early mixed dentition if possible. We can also speculate that
the RME we used with anchorage on deciduous teeth gener-
ates less pain than the QH anchored on the permanent molars
because nerves in deciduous teeth are less dense in distribu-
tion and fewer in number than those in permanent molars,
and thereby experienced less sensitive (26).
S. Hansson et al.
Figure 4. Functional jaw impairment at days 1, 4, and 7 after inserting either quad helix (QH) or rapid maxillary expansion—hyrax type (RME).
In this present study, we used questionnaire with VAS and
VRS to determine pain and discomfort during the first week
of treatment. VAS is a long-recognized way to let patients
grade their perception of pain and discomfort (27). The me-
dian level of pain on VAS was in the low to middle range
on the first day and even lower on days 4 and 7. A study
with children undergoing class II treatment with cervical
277
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headgear, the same age as our study population, experi-
enced the same levels of pain on VAS as our QH group did
on the first day. They also reported that elastic separators
were slightly more painful than headgear, the first day, even
though the difference was not statistically significant (28).
Although the median values of pain intensity and discomfort
during the first week of treatment were low in both groups,
278 European Journal of Orthodontics, 2023

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Figure 5. Functional jaw impairment and eating difficulties days 1, 4, and 7.

some patients described the pain and discomfort as the Strength and limitation
worst imaginable. Perception of pain intensity is subjective The strengths of this study were that the patients were homo-
and influenced by many factors, such as anxiety levels and genous in age and gender distribution and therefore representa-
motivational attitude (29). tive of the most common age for RME and QH treatments, and
S. Hansson et al. 279

Table 4. Comparing pain and discomfort from mouth, teeth, and jaws and daily activities between boys and girls.

Boys Girls P1
(n = 44) (n = 26)

Pain and discomfort from mouth, teeth and jaws

10. Have you taken any analgesic today? (Day 1) 40.9% (18 of 44) 40.0% (10 of 25) 0.94
10. Have you taken any analgesic today? (Day 4) 13.6% (6 of 44) 19.2% (5 of 26) 0.73
10. Have you taken any analgesic today? (Day 7) 2.3% (1 of 43) 0.0% (0 of 26) >0.99

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Daily activities
14. Have you stayed home from school today due to pain from your appliance? (Day 1) 20.5% (9 of 44) 12.0% (3 of 25) 0.51
14. Have you stayed home from school today due to pain from your appliance? (Day 4) 2.3% (1 of 44) 0.0% (0 of 26) >0.99
14. Have you stayed home from school today due to pain from your appliance? (Day 7) 0.0% (0 of 43) 0.0% (0 of 26) N.A.
15. Have you refrained from leisure activities today because of pain from your appliance? (Day 1) 15.9% (7 of 44) 8.0% (2 of 25) 0.47
15. Have you refrained from leisure activities today because of pain from your appliance? (Day 4) 2.3% (1 of 44) 0.0% (0 of 26) >0.99
15. Have you refrained from leisure activities today because of pain from your appliance? (Day 7) 2.3% (1 of 43) 0.0% (0 of 26) >0.99

Chi-2 test or Fischer exact test if appropriate for binary variables.

1

N.A., not applicable.

that questionnaires with documented good reliability and val-
idity were used. This study also has good generalizability due
to its bi-centre nature. In addition, selection bias was avoided
because consecutive patients were invited and randomized into
two groups in which the treatments were standardized. This
study has some limitations, however. Double blinding was not
possible due to the clinical limitations. Children were allowed
help from their parents to read the questions, although the chil-
dren were requested to answer independently, the influence of
the parents cannot be disregarded.
Generalizability
The result of this RCT can be generalized only in a similar
population aged 9–10 years and in the case that the exclusion
criteria are met.
Harm
No harm or adverse effects were recorded in the present study.
Clinical implications
From the point of view of pain and discomfort, it appears
that the both appliances are tolerated quite well by our pa-
tients. However, the information about perceived discomfort
from the tongue and chafe with the QH appliance, and slight
speech impairment during the first week with both appli-
ances, should be mentioned to our patients following initi-
ation of treatment.
Conclusion
- Patients with QH experienced more chafe and pain from
tongue on the first days than the RME group.
- Speech was more affected in patients with RME on days
4 and 7.
- The levels of pain are to be considered as low to moder-
ate in both groups the first week.
Funding
This study was supported by the Regional Research Council.
The authors’ work was independent of the funders.
Conflict of interest
The authors declare no conflict of interest.
Data availability
The authors confirm that the data supporting the findings of
this study are available within the article or its supplementary
materials.
Supplementary material
Supplementary material is available at European Journal of
Orthodontics online.
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