Journal of the Formosan Medical Association (2020) 119, 282e289

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journal homepage: www.jfma-online.com

Original Article

Perceived pain for orthodontic patients with

conventional brackets or self-ligating
brackets over 1 month period: A single-
center, randomized controlled clinical trial
Tai-Ting Lai a,b,c,d, Jeng-Yuan Chiou e, Tai-Cheng Lai f,
Ted Chen g, Huey-Yuan Wang a, Chung-Hsing Li c,
Min-Huey Chen h,i,*

a
Division of Orthodontics, Dental Department, Mackay Memorial Hospital, Taipei, Taiwan
b
Mackay Medicine, Nursing and Management College, Taipei, Taiwan
c
Orthodontics and Detofacial Orthopedics Division, Dental Department, Tri-Service General Hospital,
Taipei, Taiwan
d
School of Dentistry, College of Oral Medicine, Taipei Medical University, Taiwan
e
School of Health Policy and Management, Chung Shan Medical University, Taiwan
f
Department of Public Health, Kaohsiung Medical University, Kaohsiung, Taiwan
g
School of Public Health & Tropical Medicine, Tulane University, New Orleans, USA
h
Graduate Institute of Clinical Dentistry, School of Dentistry, National Taiwan University, Taiwan
i
Dental Department, National Taiwan University Hospital, Taiwan

Received 16 April 2019; received in revised form 8 May 2019; accepted 14 May 2019

KEYWORDS Abstract Background/Purpose: The objective of this 2-arm parallel trial was to test the su-
Conventional periority of self-ligating brackets (SLB) over conventional brackets (CB) in terms of perceived
brackets; pain for orthodontic patients.
Orthodontic pain; Methods: Patients about to undergo treatment were included to fixed appliance placed with
Self-ligating brackets; CB or SLB. Eligibility criteria included malocclusion patients whose age between 12 to 40 years
Visual analog scale and suitable for orthodontic fixed appliance treatment. The main outcome was pain intensity
measured by visual analog scale (VAS) with all patients followed at 4 h, 24 h, 3 days, 1 week
and 1 month. Randomization was accomplished with a computer-generated list of random
numbers. Blinding was applicable for outcome assessment only. Data were analyzed using mul-
ti-level nonlinear mixed effect model, Friedman’s test and Wilcoxon signed rank test with the
Bonferroni correction for multiple tests.
Results: Eight-eight patients were randomized in a 1:1 ratio to either SLB or CB. All patients
completed the study, and none were lost to follow-up. There were no drop-outs after

* Corresponding author. No. 1 Chang Te Street, Taipei, Taiwan. Fax: þ886 2 23831346.
E-mail address: minhueychen@ntu.edu.tw (M.-H. Chen).

https://doi.org/10.1016/j.jfma.2019.05.014
0929-6646/Copyright ª 2019, Formosan Medical Association. Published by Elsevier Taiwan LLC. This is an open access article under the CC
BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Perceived pain from two kinds of bracket 283

randomization. Baseline characteristics were similar between groups. The is no statistical sig-
nificant difference in pain intensity between CB and SLB at 4 h, 24 h, 3 days, 1 week and 1
month. Data were analyzed on an intention-to-treat basis. No serious harm was observed.
Conclusion: The results of this study indicated no evidence that the pain intensity differs be-
tween CB and SLB at 4 h, 24 h, 3 days, 1 week and 1 month.
Copyright ª 2019, Formosan Medical Association. Published by Elsevier Taiwan LLC. This is an
open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-
nc-nd/4.0/).

Introduction
Several researchers have studied the relationship between
pain and initial insertion of archwire. Jones found that most
patients felt pain 4 h after insertion of an initial archwire.1
He further pointed out that the peak of pain intensity
occurred at around 24 h and decreased with the passage of
time. Other studies reached the same conclusion by similar
research, designed to reach different racial and ethnic
populations.2e4 In some investigations, patients’ pain was
perceived for 2e3 days after placement of archwire and
only subsided gradually over 5e6 days.5 This discomfort
experienced in the early stages of archwire placement may
cause poor compliance and treatment discontinuation for
most orthodontic patients.6
It is very hard to assess pain objectively, since pain is
well-known to be influenced by multiple factors such as:
psychological, economical, sociocultural, and environ-
mental considerations. Most investigators assess the
perception of pain indirectly, and the visual analog scale
(VAS) is the most commonly used instrument to assess pain
perception.7,8 A widely used version of the VAS for pain
consists of a 100 mm horizontal line with 2 endpoints
labeled “no pain” and “severe pain”. The patient draws a
mark on the line at a point that corresponds to the level of
pain intensity she currently feels.
There are some reported advantages of self-ligating
brackets: full and secure archwire engagement,9 low fric-
tion between the bracket and the archwire,10 reduced chair
time,11 improved oral hygiene,12 reduced total treatment
time,13,14 and lower levels of patient discomfort.15e17
There are also some reported disadvantages however: the
expensive cost, hard to express closing mechanism, bulky
profile, and hard to express torque.16,17 Few randomized
controlled clinical trials have compared the differences
between the two bracket types with consideration of or-
thodontic pain. Treatment results may be enhanced with
more knowledge about whether self-ligating brackets did
really reduce the perceived pain compared with conven-
tional brackets. Comparisons of pain perception at 4 h,
24 h, 3 days, 1 week and 1 month after the fixed appliances
were placed are examined. Furthermore we investigate
whether gender, age, and arch length discrepancy influence
the course of perceived pain during the orthodontic
treatment.
The objective of this 2-arm parallel randomized trial was
to test the superiority of self-ligating brackets (SLB) over
conventional brackets (CB) in terms of perceived pain
measured by VAS with all patients followed at 4 h, 24 h, 3
days, 1 week and 1 month after the fixed appliances were
placed.
Materials and methods
Trial design and any changes after trial
This was a 2-arm parallel, randomized, active controlled
trial with a 1:1 allocation ratio to test the superiority of
self-ligating brackets (SLB) over conventional brackets (CB)
in terms of perceived pain for orthodontic patients.
Participants, eligibility criteria, and setting
This study is a single-center, prospective randomized
controlled trial of self-ligating brackets (Damon Q) versus
conventional brackets (OPA-K) in malocclusion patients who
seek orthodontic treatment. Eighty eight eligible patients
were identified and recruited at the participating clinical
center, subject to the inclusion and exclusion criteria. In-
clusion criteria were malocclusion patients between 12 and
40 years of age, suitable for orthodontic treatment using
either self-ligating brackets or conventional brackets. Pa-
tients who satisfied any of the following conditions were
excluded: surgery in the previous six months; previous
temporomandibular joint arthrotomies; fewer than 20
teeth total or fewer than 10 teeth in each arch; unstable
residence or travel restrictions; periodontal disease judged
to be severe by the surgeon; pregnancy; previous mandib-
ular surgery; or inability to follow instructions or the study
protocol.
No changes to methods after trial commencement
occurred.
Intervention
Following informed consent, the subjects were randomly
allocated for treatment with either 0.022 inch Damon Q
(Ormco, California, USA) standard prescription self-ligating
brackets or 0.022 inch OPA-K (Tomy, Tokyo, Japan) pre-
adjusted edgewise brackets. Randomization was carried
out using a table of random numbers. The bonding method
was standardized between the two groups, using conven-
tional etching and Enlight (Ormco) bracket adhesive, ac-
cording to the manufacturers’ instructions. After bracket
bonding, Damon 0.014 inch Cu NiTi (Ormco) archwires were
inserted and ligated to all teeth in both maxillary and
mandibular arches. Participants were all at the same stage
284 T.-T. Lai et al.

of treatment i.e. had all just had their appliance fitted. No
other intervention was carried out at this stage of
treatment.
Outcomes
The main outcome was the pain score on the visual analog
scale (VAS). The primary outcome was the pain score at 24 h
after the fixed appliance placement. The secondary out-
comes were pain scores at 4 h, 3 days, 1 week and 1 month
after the fixed appliance placement. Bonferroni adjustment
was calculated to the significance level of 0.01 to account
for the existence of multiple tests. Following archwire
insertion, the subjects were given full instructions and a
prepared discomfort diary to complete over the first month.
The diary records discomfort by means of a 100 mm visual
analog scale (VAS) at 4 h, 24 h, 3 days, 1 week and 1 month,
using the terms ‘very comfortable’ and ‘very uncomfortable’
as peripheral weighting. The VAS score is the distance from
the left end of the line to the point of the subject’s mark,
measured to the nearest millimeter. We kept the diaries in
our clinic and instructed the patients to write down the pain
score on their appointment card at 4 h, 24 h, 3 days and 1
week. One week later when they came back for the follow
up visit, they recorded their pain score from the appoint-
ment card into the VAS diaries we provided.
Sample size calculation
Statistical analysis
Statistical analyses followed the intent-to-treat paradigm,
which meant all patients were analyzed according to the
treatment group to which they were randomized. The re-
sults were expressed as the median, interquartile range
(Median, IQR). A multi-level nonlinear mixed effect model
was used to compare the bracket groups for differences in
perceived pain levels at baseline, 4 h, 24 h, 3 days, 1 week
and 1 month after bracket bonding. Multi-level nonlinear
mixed effect model was conducted according to a two-level
structure (patient, and repeated measures). Time was
treated as a continuous variable to assess random effects at
the different time points in all groups. To control for
possible confounders, we added the following sets of
covariates: sex, age, arch length discrepancy (ALD) and
baseline VAS. This technique allowed for differences in
conditions at the same time intervals, differential devel-
opment across subsequent time periods, and the general
effect of time on perceived pain. The Friedman test was
used to detect differences in treatments across multiple
test attempts. Contrasts were performed post hoc by Wil-
coxon sign rank test to study differences at two subsequent
time points. We performed Bonferroni adjustment to the
significance level of 0.01 to account for the existence of
multiple tests. Data were analyzed using SPSS Statistics 22
(Statistical Software). Statistical significance was pre-
determined at a Z 0.05.

The sample size was determined by using the results from a

study that evaluated pain perception during orthodontic
treatment with fixed appliances.2,15 Since the pain score at
24 h was our primary outcome, we use it for the sample size
calculation. The calculation was based on the number of
patients required for a 2-sample t test to demonstrate a 20-
mm difference in mean maximum pain intensity between
the 2 groups on the visual analog scale (VAS). The sample
size was calculated as 33 patients per group, based on a
significance level of 0.05, a power of 80%, and a standard
deviation of 28.3 mm in both groups on the VAS. Accounting
for 15% missing data, we determined a sample size of 39
patients per group.

Randomization (random number generation,

allocation concealment, implementation)

Block randomization was done with a computer-generated

list of random numbers. Once the patient had consented, a
sequentially numbered, opaque, sealed envelope was given
to the operator; it contained the name of the bracket
system to be used. Baseline information was written on the
outside before opening the envelope. The practice man-
ager was responsible for opening the next envelope in
sequence and implementing the randomization process.

Blinding

Blinding of either patient or operator was impossible; how-

ever, the pain assessment was blind. Since the patients were
assigned to a treatment option by random number, the
outcome assessor did not know which one wore SLB or CB. Figure 1 Consort diagram.
Perceived pain from two kinds of bracket 285

treatment, and the course of pain over time. As summarized

Table 1 Description of sample at baseline.
in Table 2, there were no significant differences for perceived
OPAK Damon Q P-value pain level between males and females in relation to the Visual
(N Z 44) (N Z 44) Analog Scale score (Estimate Z 2.03, SE Z 3.26, 95%
Gender (N, %) 0.67 C.I. Z 8.41e4.35, p Z 0.53), or by age (Estimate Z 0.11,
Female 25, 48.1 27, 51.9 SE Z 0.18, 95% C.I. Z 0.45e0.24, p Z 0.55), or arch length
Male 19, 52.8 17, 47.2 discrepancy (ALD) (Estimate Z 0.03, SE Z 0.27, 95%
Age (M, IQR) 19.5, 11.0 19.0, 8.0 0.69 C.I. Z 0.50e0.57, p Z 0.91). There were also no differ-
ALD (M, IQR) 5.8, 10.1 5.0, 5.6 0.21 ences by treatment group (Damon Q vs. OPA-K) on perceived
VAS (M, IQR) 0.0, 0.0 0.0, 0.0 0.64 pain level (Estimate Z 3.09, SE Z 3.22, 95%
C.I. Z 3.22e9.39, p Z 0.34). However, there were differ-
M Z Median (P50); IQR Z Interquartile range (P75eP25).
ences in pain across time regardless of group membership
ALD Z Arch length discrepancy; VAS Z Visual analog scale.
(p < 0.01) (see Table 2).
The Friedman test was used to detect differences in
Results treatments across multiple test attempts. Significant main
effects for time were followed up using post hoc multiple
Participant flow comparisons across time points by Wilcoxon sign rank test.
We performed Bonferroni adjustment to the significance
One hundred and two patients from the Orthodontic level of 0.01 to account for the existence of multiple tests.
Department of Mackay Memorial Hospital were screened The follow-up analysis of the VAS indicated a significant
from June 2010 to November 2011 as study candidates. difference in pain scale for the following time points:
Eight of them were excluded due to not meeting the in- baseline to 4 h, baseline to 1 day, baseline to 3 days,
clusion and exclusion criteria. Ninety four patients met the baseline to 1 week, baseline to 1 month, 4 h to 1 day, 4 h to
screening criteria. Of these, six did not provide consent for 1 week, 4 h to 1 month, 1 day to 3 days, 1 day to 1 week, 1
the study and were excluded. Eighty eight patients con- day to 1 month, 3 days to 1 week, 3 days to 1 month, and 1
sented and were randomly assigned by random tables, with week to 1 month. And all the p-values were less than 0.01.
an equal number in each arm (n Z 44). All patients There were no significant differences in pain scale for 4 h to
completed the study, and none were lost to follow-up. 3 days (p > 0.99) (see Table 3).
There were no drop-outs after randomization. The CON- Examination of the median difference revealed a sta-
SORT diagram was shown in Fig. 1. tistically significant increase in pain scale from baseline
(M Z 0.00) to 4 h (M Z 19.50), from 4 h to 1 day
Baseline data (M Z 40.00) and begin to decrease to 3 days (M Z 27.50);
then decrease from 3 days to 1 week (M Z 5.50) and
continue to decrease to 1 month (M Z 0.00) (see Fig. 2).
The baseline characteristics for sex, age, arch length
Individual plots of VAS pain scores at baseline, 4 h, 1 day, 3
discrepancy and VAS pain score in both groups were similar.
days, 1 week and 1 month for self-ligating brackets (Damon
There were no statistically significant differences between
Q) and conventional brackets (OPA-K) were shown in Fig. 3.
the OPA-K and Damon Q treatment groups on any de-
mographic or clinical characteristics at baseline. All p-
values were greater than 0.05 (see Table 1). Harms

Comparing changes in perceived pain for patients
treated with self-ligating versus conventional
brackets
Differences in VAS scores at T0, T1, T2, T3, T4 and T5 were
compared for the two treatment groups. A multi-level
nonlinear mixed effect model was used to compare differ-
ences in pain by gender, age, arch length discrepancy,
No serious harm was observed other than gingivitis associ-
ated with plaque accumulation.
Discussion
This study investigated perceived pain between conven-
tional brackets (OPA-K) and self-ligating brackets (Damon
Q) after initial orthodontic treatment. Pain was measured

Table 2 Comparison of between-group differences in VAS at the 1-Month follow-up.

Estimate SE 95% C.I. Z p
Sex (male/female) 2.03 3.26 8.41w4.35 0.62 0.53
Age 0.11 0.18 0.45w0.24 0.60 0.55
ALD 0.03 0.27 0.50w0.57 0.11 0.91
Baseline_VAS_T0 0.46 0.50 0.51w1.44 0.93 0.35
Bracket_type (Q/C) 3.09 3.22 3.22w9.39 0.96 0.34
time 13.84 3.13 7.69w19.98 4.41 <0.01*
time2 3.61 0.51 4.62w2.61 7.05 <0.01*
ALD Z Arch length discrepancy; VAS Z Visual analog scale; * means a significant statistical difference (p < 0.05).
286 T.-T. Lai et al.

Table 3 Pairwise comparisons- visual analog scale.

Baseline 4 Hours 1 Day 3 Days 1 Week 1 Month
T0 T1 T2 T3 T4 T5
MD p MD p MD p MD p MD p MD p
Baseline T0
4 Hours T1 19.50 <0.01*
1 Day T2 40.00 <0.01* 20.50 <0.01*
3 Days T3 27.50 <0.01* 8.00 >0.99 12.50 <0.01*
1 Week T4 5.50 <0.01* 14.00 <0.01* 34.50 <0.01* 22.00 <0.01*
1 Month T5 0.00 <0.01* 19.50 <0.01* 40.00 <0.01* 27.50 <0.01* 5.50 <0.01*
MD Z Median difference; Friedman’s test p < 0.01; post hoc test by Wilcoxon sign rank test; Bonferroni 0.05/5 Z 0.01. * means a
significant statistical difference (p < 0.05).

Figure 2 Box plot of VAS Pain Scores at baseline, 4 h, 1 day, 3
days, 1 week and 1 month for Self-ligating brackets (Damon Q)
and Conventional brackets (OPA-K).
using a VAS (Visual Analog Scale), which is one of the most
popular used instruments to measure the subjective
perceived pain during fixed orthodontic therapy.18 The re-
turn rate for the VAS diaries was quite high compared to
previous similar studies, since we kept the diaries in our
clinic and instructed the patients to write down the pain
score at their appointment card at 4 h, 24 h, 3 days and 7
days. One week later when the patients came back for the
follow up visit, they rewrote the pain score from the
appointment card into the VAS diaries we provided. In this
way, we effectively improved the return rate for the VAS
diaries.
In this study, there were no significant differences in
perceived pain level between males and females as
expressed in the Visual Analog Scale score. This is in
accordance with previous investigations, which have
revealed that gender does not influence perceived
discomfort during initial orthodontic therapy.1,3,5,15,19,20
But this study’s findings were in contrast with some
studies which have shown that females reported a higher
perceived pain than males.21,22 In addition, girls tended to
report more oral ulceration than the boys with fixed or-
thodontic appliance.22 Therefore, the gender difference
was ruled out and all the male and female data were
analyzed together.
There were also no statistically significant differences by
age between OPA-K and Damon Q groups on perceived pain
level. Our findings were in agreement with a study which
concluded that age does not affect perceived pain between
Damon 3 self-ligating and Synthesis conventional ligating
preadjusted brackets systems.15,20 Ngan et al. also reached
a similar result of no age-related differences in pain
perception during fixed orthodontic therapy.3 But our
finding was in contrast to that of several previous re-
searchers. Some research revealed that younger adoles-
cents experienced higher levels of pain than older
patients.23 Some studies found that patients over 16 years
had higher perceived pain; others stated that patients
under 13 years have lower pain scores.1,21
Furthermore, there were no statistically significant dif-
ferences by arch length discrepancy (ALD) between OPA-K
and Damon Q groups on perceived pain level. In the past,
people assumed that the more severely crowded the teeth,
the more perceived pain the patient would feel during the
fixed orthodontic therapy.15 This study found no statistical
significant difference between the degree of crowding and
perceived pain level during the fixed orthodontic appliance
treatment.5,15,24,25
There was no statistically significant difference between
the perceived pain for the Damon Q or OPA-K bracket sys-
tems at any time interval (4 h, 24 h, 3 days, 1 week and 1
month). The manufacturers argued that the self-ligating
bracket design would produce less friction between
brackets and archwire, more free play of the archwire in
the slot, require lighter forces to move the teeth and hence
would result in less pain sensation to the malocclusion pa-
tients who were treated during the fixed orthodontic
therapy (http://www.damonbraces.com). However,
Burrow found that friction was not the major component
of resistance to sliding in laboratory studies. Clinical
studies supported the concept that resistance to sliding
had little to do with friction and, instead, is largely a
binding-and-release phenomenon that was about the
same with conventional brackets and self-ligating
brackets.26 Our results confirmed the findings of most
recent RCTs and meta-analysis studies that there was no
significant difference on subjective pain experience
between self-ligating and conventional
brackets.15,16,20,25,27,28
Perceived pain from two kinds of bracket
Figure 3 Individual plots of VAS pain scores at baseline, 4 h, 1 day, 3 days, 1 week and 1 month for self-ligating brackets (Damon
Q) and conventional brackets (OPA-K).
The variations in perceived pain at certain time points
were not small, since pain is a complex sensation that
varies among different individuals. It has been shown to be
associated with an individual’s past experiences, education
level, social-economic class, cultural background and
sometimes psychological status.3 Although our study
showed no difference in perceived pain by treatment
group, the median pain score for each time point (4 h, 1 day
and 3 days) is much lower than those of other
studies.15,17,20,25 The difference in pain levels may be
explained by differences by ethnic and cultural back-
ground. Caucasians tends to encourage the open expression
of perceived pain and expect to get more attention and
sympathy. On the other hand, Asians tend to restrain their
open expressions of pain and expect to get less attention
and hide in the crowd.29
The perceived pain score increased from baseline to 4 h
and continued to reach its peak at 24 h. Pain then started to
decrease during the 3 days and 1 week intervals. By one
month, pain levels were similar to those at baseline. These
findings diverge from those of a study in which the peak of
perceived pain was experienced between 4 and 24 h post
treatment.20,25 They also differ from the findings of other
studies in which the peak of discomfort was found 2e3 days
after the archwire insertion.3,18 Our results were similar to
studies that showed that perceived pain after placement of
287
fixed orthodontic appliances was reduced to negligible
levels around 1 week.22 The pain course could be accounted
for by the loss of proprioceptive ability around 4 days after
placement of archwire.30 But these results are in general
accordance with previous studies. Wilson et al. found that
the perceived discomfort level after initial archwire inser-
tion into the slot would reach the peak around 24 h and
come back to a baseline level at around 1 week post
insertion.5,18,21,31
Above all, these findings of our study indicate the Damon
Q brackets system demonstrates no extra advantage over
the conventional brackets system (OPA-K) regarding patient
perceived pain at 4 h, 24 h, 3 days, 1 week and 1 month
intervals after initial archwire insertion for orthodontic
fixed appliance treatment.
In this study, we kept the VAS diaries in the clinic and
patients self-reported pain scores recorded on their
appointment card. In this way, we improved the return rate
for the VAS diaries and reduced the missing data; however,
we could not guarantee that they had not filled in all the
values at the same time. It might lead to some potential
recall bias. The use of a smartphone app reminder would be
useful in future study.
Another limitation of this trial was the very wide age
range of participants that were included (12e40 years).
Some studies found young people to be much more tolerant
288
of and adaptable to orthodontic pain than adults. Although
Table 1 suggested that the median age was similar in the
two groups, this difference may not represent the whole
story. A third limitation is that when a result was statisti-
cally non-significant then there might be an alternative
reason other than that there was no actual difference. The
problem might be that the study was not designed to detect
a difference in arch length discrepancy, gender etc, only to
detect a difference between pain level experienced with
two appliances. It may be helpful to stratify the randomi-
zation by age and analyze young people and adults sepa-
rately, as well as increasing the sample size during future
study.
The generalizability of these results might be limited
because this research was undertaken in a single medical
center by one clinician experienced in both conventional
brackets (OPA-K) and self-ligating brackets (Damon Q).
In conclusion, the study actually supported the null hy-
pothesis of this investigation. Self-ligating brackets (Damon
Q) is not shown to be statistically superior to conventional
brackets (OPA-K) in reducing perceived pain in participants
with malocclusion during initial orthodontic treatment. In
addition, our findings revealed that age, gender, and arch
length discrepancy (ALD) do not affect the level of pain
sensation experienced by malocclusion patients undergoing
initial orthodontic therapy. The results showed that peak
orthodontic pain sensation perceived by malocclusion pa-
tients occurs at 24 h after initial fixed appliance bonding
and placement. The pain level is decreased around 3 days
and almost reaches pretreatment levels around 1 month
after initial treatment.
Conflicts of interest
The authors have no conflicts of interest relevant to this
article.
Acknowledgments
This study was performed in the Mackay Memorial Hospital.
The authors wish to acknowledge the support and encour-
agement of their colleagues in the Orthodontic Division of
Dental Department. The authors are indebted to Professor
Ellen J. MacKenzie and Professor Leiyu Shi for the thesis
advice. The authors also appreciate Professor Marie Diener-
West, Miss Fang-Ju Sun and Mr. Jing-Yang Huang for their
statistical advice.
Appendix A. Supplementary data
Supplementary data to this article can be found online at
https://doi.org/10.1016/j.jfma.2019.05.014.
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