Article type : Original Article

A multicenter, prospective, randomized trial of pain and discomfort

during maxillary expansion: Leaf expander versus Hyrax expander

Runnig title: Pain and discomfort during maxillary expansion

Accepted Article
Ugolini Alessandro1

Cossellu Gianguido2

Farronato Marco3

Silvestrini-Biavati Armando4

Lanteri Valentina5

1
DDS, PhD. Assistant Professor. Department of Orthodontics, University of Genova, Genoa, Italy

2
DDS, PhD. Research Fellow. Department of Biomedical Surgical and Dental Sciences, University
of Milan, Milan, Italy

3
DDS, PhD. Research Fellow. Department of Biomedical Surgical and Dental Sciences, University
of Milan, Milan, Italy

4
MD, DDS. Professor. Department of Orthodontics, University of Genova, Genoa, Italy

5
DDS, PhD. Research Fellow. Department of Biomedical Surgical and Dental Sciences, University
of Milan, Milan, Italy

Author contributions: A.U. contributed to the design of the study, analysis and interpretation of data and drafted the
manuscript; C.G. contributed to acquisition and interpretation of data and critically revised the manuscript; F.M.
contributed to interpretation of data; V.L. contributed to acquisition and interpretation of data; S.B.A. contributed to
conception and design of the study and critically revised the manuscript.

This article has been accepted for publication and undergone full peer review but has not been
through the copyediting, typesetting, pagination and proofreading process, which may lead to
differences between this version and the Version of Record. Please cite this article as doi:
10.1111/IPD.12612
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Accepted Article
Conflict of interest: Ugolini Alessandro, Cossellu Gianguido, Farronato Marco, Silvestrini-Biavati Armando,
Lanteri Valentina declare that have no conflict of interest.

Corresponding Author:

Alessandro Ugolini

Department of Orthodontics, University of Genoa, Italy

Largo Rosanna Benzi 10, Pad. IV - 16132 Genova

tel +39 010 3538404 fax +39 010 3537584

[email protected]
Accepted Article

Abstract

BACKGROUND: Pain suffered by the young patient is the most frequent symptom during
orthodontic treatment and is the one that most frightens children and causes worry in their
families.

AIM: to investigate pain perception and function impairment during the first week of activation
of two palatal expansion screws.

DESIGN: 101 subjects were randomly divided into two groups: RME group included patients
treated with the standard hyrax expansion screw and LEAF group included patients treated with
Leaf Expander appliance. Pain intensity was assessed via the Wong-Baker scale. A questionnaire
on oral function impairments was also compiled by the patients.

RESULTS: The pain Scale analysis showed that patients in the RME group suffered from a
significantly higher level of pain than those in the LEAF group (88.6% vs 25%, p<0.01). RME
group showed highest pain indexes from day 1 to day 4 (51,4% RME vs 9,7% LEAF suffered at
least once from strong pain in the first four days, p<0.01). Furthermore, oral functions were
similarly affected in both groups.

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Accepted Article
CONCLUSIONS: Pain reported during maxillary arch expansion is influenced by clinical
activation protocol and by the screw type. Patients treated with Leaf Expander reported
significantly lower pain level in the first 7 days of treatment.

KEYWORDS
maxillary expansion, pain, palatal expansion, leaf expander

Introduction

Maxillary arch expansion through a fixed appliance is a well-known and consolidated practice in
clinical orthodontics but current findings of “evidence-based dentistry” have not yet identified an
ideal clinical expansion protocol. Recent systematic reviews1,2 have shown that both rapid and
slow expansion protocols are clinically effective on the primary outcome (i.e. the resolution of
the crossbite with a significant increase of skeletal transversal dimension in the maxillary
transverse deficiency subjects). So, the choice of appliance type solely based on its ability to
solve maxillary constriction issues is no longer the main selection criteria and the relevant choice
of the orthodontist should, therefore, be based on timing3,4 and on a "patient-oriented" device,
that can minimize the various possible side effects, such as appliance breakages, functional
impairments, injuries to the periodontal tissues and, of course, pain.5-12

In orthodontic daily practice, pain suffered by the young patient is the most frequent symptom
during treatment and is the one that most frightens children and causes worry in their families.13
Available literature shows that rapid maxillary arch expansion is, among the early orthodontic
therapies, the one with the highest incidences of pain (up to 98%) as an adverse symptom
reported by patients.5-9 Pain could be related to the rapid expansion protocol, during which, for
each activation of the screw (0.2 or 0.25 mm) the force expressed can reach up to 10 pounds. 14-18

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Accepted Article
In the relevant literature, prevention and management of pain during palate expansion is a poorly
analyzed topic, despite being a daily occurring problem in orthodontic clinical practice; 5,6,19-21

thus the present study aims at investigating and analyzing the perception of pain and function
impairment during the first week of activation with two palatal expansion screws to identify the
effect of different maxillary arch expansion protocol on the pain perception and discomfort in
young patients.

Material and Methods

The present multicentric randomized study was conducted at the Departments of Orthodontics of
the Universities of Milan and Genoa (Italy). The trial was first approved by the Institutional
Ethical Review Board (Fondazione IRCSS Ca’ Granda n° 936-1666/13) and published on
ClinicalTrials.gov (ClinicalTrials.gov Identifier: NCT03757468,
https://clinicaltrials.gov/ct2/show/NCT03757468). CONSORT documents, including a checklist
and a flow-chart have been used to report the findings.
One-hundred and sixteen consecutive subjects with transversal maxillary deficiency (intermolar
width <30 mm, with or without crossbite) were randomly assigned to RME group (treated with
the standard hyrax expansion screw) or LEAF Group (treated with Leaf Expander appliance).
The treating clinician was blinded from the randomization procedure, but because of clear
differences in appliance design, blinding was not possible during the treatment period itself. The
data examiner was also blinded from the treatment protocol. Both appliances were anchored on
the second deciduous molars. All subjects had a Class I or Class II dental malocclusion with uni-
or bilateral crossbite and/or constricted maxilla and were selected before the puberal peak
(cervical vertebral maturation stage 1–3).
Patients with previous orthodontic treatment, hypodontia in any quadrant excluding third molars,
inadequate oral hygiene, craniofacial syndromes, or cleft lip or palate were considered ineligible
for the study and thus duly excluded from it.

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Accepted Article
One hundred and one patients completed the study: 48 subjects were included in the RME group
(23 males and 26 females, mean age 9.4 years, range 6-13 years) and 53 subjects in the LEAF
group (25 males and 28 females, mean age 9.1 years, range 6-13 years) (Table 1).
The RME Group was treated with the standard hyrax expansion screw anchored on second
deciduous molars (figure 1a). When the appliance was in situ, the screw was initially turned 2
times at chairside and then patients started the screw activation (Lancer Orthodontics, Vista,
California, USA) of two-quarter turns a day, one in the morning and one in the evening (0.40
mm/day) until overcorrection was achieved. Then the RME remained in place for approximately
9 months.
The LEAF Group was treated with Leaf Expander appliance (figure 1b) anchored on the second
22-23
deciduous molars. A detailed appliance description was reported elsewhere; Briefly, design
of the Leaf Expander is similar to that of a conventional rapid palatal expander with a double
nickel-titanium leaf spring instead of a midline jackscrew. The screws deliver a maximum
expansion of 6 or 10mm, by activating (compressing) the leaf spring, which generates a constant
force of 450g. The screw was pre-activated in the laboratory to deliver the first 3 mm expansion,
then re-activation was performed in the office by 10 quarter turns of the screw per month until
expansion has been completed. One-quarter turn corresponds to 0.1 mm of activation (10
activations of the screw generate 1 mm of activation). The Leaf expander was activated by the
clinician only and require no compliance from the patients and their parents. Active expansion
and overcorrection generally take about five to six months after which the Leaf Expander should
be maintained passively in place for three months and then removed (after a total time of 9
months).
A questionnaire regarding oral/masticatory function and a Wong-Baker Faces Pain Scale with a
complementary numeric rating scale from 0 to 10 was compiled by each subject. Pain intensity
was assessed using the Wong-Baker scale24 from the first to the seventh day of the screw
activation, reporting a double registration per day (in the morning and evening). The Wong-
Baker scale is a tool for self-assessment of pain intensity and is used in children from three years
of age. The emojis range from the most smiling, corresponding to "no pain perceived", up to the
crying emoji, corresponding to "worst pain imaginable”.9 Each emoji is also paired with a
number, from 0 to 10, which coincides with the intensity of the pain. Verbal instructions were
given to the parent and child about how to correctly assess pain. The child’s pain response was

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 measured 5 minutes after each turn.5 Questionnaires also asked the patients about eventual
Accepted Article
difficulties in swallowing and speaking, hypersalivation, analgesic consumption and pain
localization (anterior teeth, anchored/posterior teeth, palatal vault and head) (Table 2).

Statistical Analysis
Shapiro-Wilk’s test showed that pain intensity data were normally distributed, parametric
statistics were thus applied. Descriptive statistics, median value, standard deviation and
confidence interval (95% CI) were calculated. Differences between groups in pain intensity were
tested with parametric T student test and Risk Ratio (RR) analysis was performed to assess the
questionnaire data. Probabilities of less than 0.05 were accepted as significant in all statistical
analyses.
The sample size was calculated 'a priori' to obtain a statistical power of the study greater than
0.85 at an alpha of 0.05, using the mean values and standard deviations of pain intensity during
maxillary arch expansion therapy found by Baldini and co-authors (“overall pain”: mean
0.80±1.22 and 1.88 ±2.15)9 and resulted in a minimum of 47 subjects for each group. Moreover,
a drop out of 20% was considered and the final sample size comprised a minimum of 58 subjects
for each group. The effect size (ES) coefficient (d)25 was also calculated. An ES of .2 to .3 might
be a ‘‘small’’ effect and thus a small clinically significant difference, about .5 a ‘‘medium’’
effect, and 0.8 to infinity a ‘‘large’’ effect.

Results

Three patients in the LEAF group and two patients in the RME group did not complete the
questionnaire, eight subjects, all in the RME group, did not follow the prescribed activation
protocol at home. Two subjects in the LEAF group missed the appointment and did not receive
the allocation. Fifteen subjects were thus excluded from the study and the final sample
comprised 101 subjects. Crossbites and traversal maxillary discrepancy were entirely corrected
in 100% of the subjects at the end of the expansion active phase.
The Wong-Baker Faces Pain Scale analysis showed that patients in the RME group suffered
from a significant generalised sensation of pain during the first week of screw activation

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Accepted Article
compared to those in the LEAF group (88.6% vs 25%, p<0.01), moreover in the RME group
25.2% of the patients reported analgesic consumption (Table 3). Table 4 reported the pain
perceived in the first 7 days of activation from both groups: patients treated with the rapid
maxillary expander reported a statistically significant higher amount of pain in the first four days
of treatment (Table 4). In detail, RME group reported higher pain indexes recorded on the
Wong-Baker scale from day 1 to day 4 with a 51.4% of the patients indicated they suffered at
least once from a strong pain in the first four days. Patients treated with the Leaf Expander have
instead a statistically lower pain where only 9.7% of the subjects of the LEAF group suffered
from a level of pain indicated as strong and in any case limited to the first two days after
cementation and activation of the device, while the remaining 90% of the subjects report that
they did not perceive any pain in the first two days of therapy. From the fifth to the seventh day,
the amount of pain reported was small and did not differ significantly between the two groups
(Table 4). There were also no differences between the two centers in the analyzed variables.
Overall high scores of discomfort values in different oral functions were reported (more than
80% of the sample reported hypersalivation and difficulty in swallowing and speaking) but did
not differ between the groups (Table 3). Subjects treated with RME have a significantly higher
risk of suffering pain from posterior teeth (RR=2.54, 95% IC:1.51-4.28, p<0.001), incisors
(RR=3.3, 95% IC:1.14-9.58, p=0,02) and taking pain medications (RR=11.14, 95% IC:1.62-
90.60, p<0,01).

Discussion

From a clinical point of view correction of crossbites and traversal maxillary discrepancy were
achieved in all patients with both appliances. The jackscrew and the shape memory leaf spring
expander have different methods of activation: the jackscrew or expansion screw (eg. hyrax) is a
telescoping appliance that requires several patient activations to achieve the maxillary arch
expansion. The memory leaf springs instead, due to their superelastic nature, required only a few
activations or no activation at all because of its reliance upon elastic restoration forces to achieve
the desired expansion. In the jackscrew, to a given amount of screw turn corresponds a
determined amount of expansion (from 0.20 to 0.25 mm), so this allows clinicians to calculate
the number of activations required to achieve the desired expansion. But it also suffers from

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Accepted Article
several disadvantages because with each subsequent jackscrew activation the maxilla is
subjected to a rapid increase in forces and this is not only uncomfortable for the patient, but it
has also been suggested that high magnitude forces (up to 10 pounds) may result in a less
pronounced physiologic expansion of the suture.26 Another disadvantage for this type of screw
activation method is that it requires the patient (and parents) compliance to achieve the
expansion: In the present study we had to exclude 14% (8 out 58) of the subject of the RME
initial sample because they did not follow the recommended activation protocol in the first
week.27 Other complications during treatment (besides those reported in the questionnaire)
included mainly appliance breakage and decementation. All the complications reported were
lower in the Leaf group.
The main advantage with the shape memory leaf spring is the continuous force application,
similar to those of superelastic NiTi wires. In fact, superelasticity is “the transformation from
austenitic to martensitic that occurs by stress application within a temperature range and is
manifested by a flat or nearly flat plateau in a force-deflection curve”.28 This superelastic
behaviour minimizes the number of rapid force increments exerted on the tissue (and their
magnitude as well) which may lead to a more physiologic expansion and to an increased feeling
of comfort for the patients, as reviewed by Romanyk and Co-authors.26 One disadvantage of the
leaf-type activation method is that longer time is required to achieve the expansion (up to six
months) but the total time amount (9 months, active expansion plus retention period) is equal to
that with rapid maxillary arch expansion.
The results of the present study on the pain perceived during the maxillary arch expansion
reflected the differences between appliances in their biomechanical work and in the release of the
forces; in fact, overall pain during the first week of the screw activation was significantly higher
in the RME group compared to the LEAF group (88.6% vs 25%, p=0.01). In detail, the subjects
treated with the Leaf Expander reported low pain level in the first 7 days of activation (the
appliance was pre-activated to deliver the first 3 mm expansion) and 9.7% of the subjects
suffered from a pain indicated as strong at least once for the first two days only after activation
(the remaining 90.3% of subjects reported that they did not experience pain in the first two days
of therapy). Instead, the patient in the RME (the screw activation was about 3mm in a week)
reported high pain level in the first 4 days with a 51.4% (maximum peak in the second day) of

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Accepted Article
the subjects that indicated they suffered from severe pain at least once in the first four days;
moreover 25.2% of the patients in the RME group reported analgesic consumption.
5,8,9,20,21
The results reported in the RME group were in accord with those found in the literature
that found that rapid maxillary expander was generally well tolerated with a peak of pain
perceived during the first four days of the screw activation with a complementary analgesic
consumption (usually paracetamol or ibuprofen). 21
To our knowledge no other study investigated the pain intensity and discomfort during maxillary
arch expansion with a memory leaf spring and based on the present results it can be postulated
that statistically significant differences in the perception of pain found during the active phase of
expansion between RME and LEAF group were due to the different biomechanical work carried
out by the screws, which release the force generated by activation with different patterns, as
reviewed by Romanyk et al.26
The LEAF screw is designed to compress a double nickel-titanium leaf spring that recovers its
original shape during deactivation, resulting in a calibrated expansion of the upper arch. 21,22 This
slow and continuous activation significantly reduces the mechanical forces transmitted to the
bone and sutural complex, consequently decreasing the inflammatory response and maintaining
tissue integrity during repositioning and remodeling of the midpalatal suture, as postulated by
Arndt. 29
It has been observed that the forces generated by the jackscrews, which can reach up to 10
pounds per turn,13-14 produced a series of reactions characterized by tissue displacement,
deformation and development of cellular stress in the palatine suture area with the formation of
exudates, fibroblasts death, collagen fibers disruption and acute inflammation.30 Human and
animal studies have shown that following a rapid expansion of the palatal suture, a disorganized
and highly vascularized connective inflammatory tissue is created, which acts as the main
14,15,17
receptor of the pain perceived during the expansion. The transmission of the slow and
continuous force generated by the nickel-titanium screw inhibits the establishment of these
inflammatory processes with the clinical effect of a limited and negligible perception of pain
during appliance activation, unlike the level of pain reported with the traditional screw expander.
To corroborate this hypothesis, a significantly higher risk of suffering from pain and tension in
the anterior and in the anchored/posterior teeth was found in the RME group only. The main
limitation of the present study is that the skeletal effects of the Leaf expander on the midpalatal

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Accepted Article
suture have not yet been clarified, even if some promising results were recently published as
reported by Manzella et al. 31
which found a mild sutural disruption after Leaf expander
treatment. Anyway, our analysis didn’t evaluate the skeletal effects of the appliances and further
carefully designed studies taking into account the sutural opening are necessary to support this
hypothesis. So, based on our results, we can conclude the leaf expander is an effective pain-free
and compliance-free alternative treatment for patients with maxillary arch constriction.

Conclusion

Pain suffered during maxillary arch expansion is influenced by the choice of screw and
activation protocol and the use of continuous force through the nickel-titanium spring allows
avoiding the worst levels of pain in the first days of activation. Leaf expander proved itself an
effective and efficient expansion appliance in the prevention of pain.

Why this paper is important to paediatric dentists

 Pain is the most frequent symptom during maxillary arch expansion treatment and is the
one that most frightens children and causes worry in their families.

 More than 50% of patients treated with the rapid maxillary expander reported strong pain
at least once in the first four days of treatment while in the Leaf Expander group less than
10% of the subjects suffered at least once from a level of pain indicated as strong and the
first two days only.

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 
Accepted Article Pain suffered during maxillary arch expansion is influenced by the choice of screw and
activation protocol and Leaf Expander proved itself as an effective and efficient
expansion appliance in the prevention of pain.

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Accepted Article
Table 1. Flow of participants.

Enrollment Assessed for eligibility (n=116 )

Excluded (n=0)
 Other reasons (n=0 )

Randomized (n=114)

Allocation
Allocated to intervention (LEAF) (n=58) Allocated to intervention (RME) (n=58)
 Received allocated intervention (n=56)  Received allocated intervention (n=58)
 Did not receive allocated intervention (n=2,  Did not receive allocated intervention (give
missed appointment) reasons) (n=0 )

Follow-Up
Lost to follow-up Lost to follow-up
Not complete the questionnaire (n=3)  Not complete the questionnaire (n=2)
 Not follow the prescribed activation protocol) (n=8)

Analysis
Analysed (n=53) Analysed (n=48)
 Excluded from analysis (give reasons) (n=0)  Excluded from analysis (give reasons) (n=0)
 Table 2. Self-Reported Questions Concerning Pain and Discomfort, Analgesic Consumption in the first
Accepted Article
week of treatment (modified from Feldman and Bazagani23)

1 - Pain intensity
- Do you now have pain? And for how many days?
- Do you have pain from the molars?
- Do you have pain from the incisors?
- Do you have pain from the upper jaw?
- Do you have pain from the palate?
- Do you have pain from head?
- Do you have pain during appliance activation?
2 - Analgesic consumption
Have you used analgesics for pain from your jaws, teeth, or face?
If yes, what kind of analgesic and dosage did you use?
3 - Jaw function impairment
If you have pain or discomfort in your teeth and jaws, how
much does that affect
- Speaking
- Salivation (hypersalivation)
- Swallowing
 Table 3. Discomfort and analgesic consumption in the first week of therapy; * P = .05; ** P = .01.,
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*** P =.001

RME (%) LEAF (%) Relative Risk Ratio 95% CI Significance level
Difficulty in Swallowing 79.2 84.9 0.93 0.77 - 1.12 0.74
Hyersalivation 81.3 79.2 1.02 0.84 - 1.24 0.8
Difficulty in Speaking 87.5 92.5 0.94 0.82 - 1.07 0.41
Pain - Posterior teeth 62.5 24.5 2.54 1.51 - 4.28 <0.001***
Pain - Incisors 25.0 5.7 3.31 1.14 - 9.58 0.02*
Pain - Palatal vault 12.5 3.8 3.12 0.70 - 15.63 0.13
Pain - Head 8.3 0.0 4.43 0.51 - 38.15 0.17
Analgesic consumption 25.2 0.0 11.14 1.62 - 90.60 0.01**
 Table 4. Pain intensity reported on the Wong-Baker Faces Pain Scale; Student’s t-test for independent samples. M=
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morning questionnaire registration E= evening questionnaire registration. Cohen Effect size: S indicates small clinical
significance; M, medium clinical significance, L, large clinical significance. * P = .05; ** P = .01., *** P =.001

Day 1 M Day 1 E Day 2 M Day 2 E Day 3 M Day 3 E Day 4 M Day 4 E Day 5 M Day 5 Day 6 M Day 6 E Day 7 M Day 7 E
RME
Mean 1.9 2.1 2.7 2.9 2.4 2.2 1.6 1.5 0.9 1.0 0.9 0.7 0.7 0,9
group
SD 1.0 1.1 1.2 1.1 1.0 1.0 1.0 1.1 1.2 0.9 0.9 0.8 0.5 0,6
CI 0.2 1.8 2.3 2.6 2.1 1.9 1.3 1.1 0.6 0.7 0.6 0.5 0.5 0,8
95% 0.3 2.4 3.1 3.2 2.7 2.5 1.8 1.8 1.3 1.3 1.1 0.9 0.9 1,1

LEAF
Mean 0.8 1.3 1.2 1.2 0.8 0.8 0.7 0.7 0.6 0.7 0.6 0.6 0.6 0,7
group
SD 0.9 0.8 0.8 0.7 0.6 0.6 0.5 0.6 0.9 0.8 0.7 0.9 0.6 0,5
IC 0.6 1.1 1.0 1.0 0.6 0.6 0.7 0.5 0.4 0.5 0.4 0.3 0.4 0,2
95% 1.1 1.5 1.4 1.4 0.9 0.9 0.5 0.8 0.9 0.9 0.8 0.9 0.8 0,7
Test T
RME vs LEAF 0,001*** 0.020** 0.000*** 0.000*** 0.000*** 0.000*** 0.000*** 0.000*** 0.15 0.08 0.07 0.55 0.36 0.08

Cohen Effect Size 1,7 L 0.8 L 1.4 L 1.8 L 1.9 L 1.7 L 1.1 L 0.9 L - - - - - -

Figures Legend

Figure1. (a) Hyrax expansion appliance; (b) Leaf Expander appliance.

Accepted Article

ipd_12612_f1a.tif

This article is protected by copyright. All rights reserved

Accepted Article
ipd_12612_f1b.tif

This article is protected by copyright. All rights reserved