European Journal of Orthodontics, 2016, 266–271

doi:10.1093/ejo/cjv032
Advance Access publication 11 June 2015

Randomized controlled trial

Self-reported pain after orthodontic treatments:

a randomized controlled study on the effects of
two follow-up procedures
Mauro Cozzani*, Giulia Ragazzini*, Alessia Delucchi*,

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Carlo Barreca*, Daniel J. Rinchuse**, Roberto Servetto***,
Maria Grazia Calevo**** and Vincenzo Piras*****
*School of Dental Medicine, University of Cagliari, Italy, **Center for Orthodontics, Seton Hill University, Greensburg,
PA, USA, Departments of ***Dentistry and ****Epidemiology and Biostatistics, Ist. G. Gaslini, Genova, Italy,
*****School of Dental Medicine, University of Cagliari, Italy

Correspondence to: Giulia Ragazzini, 6/2 Tower Place, Edinburgh EH67BZ, UK. E-mail: giuliaragazzini84@gmail.com

Summary
Objectives: To assess the effects of a follow-up text message and a telephone call after bonding on
participants’ self-reported level of pain.
Materials and methods: Eighty-four participants were randomly assigned to one of three trial
arms. Randomization was performed by the Department of Epidemiology and Biostatistics
of IRCCS G.Gaslini. Participants were enrolled from patients with a permanent dentition
who were beginning fixed no extraction treatment at the Orthodontic Department, Gaslini
Hospital. Participants completed baseline questionnaires to assess their levels of pain prior
to treatment. After the initial appointment, participants were completed a pain questionnaire
at the same time, daily, for 7 days. The first group, served as control, did not receive any
post-procedure communication; the second group received a structured text message; and
the third group received a structured telephone call. Participants were blinded to group
assignment.
Limitations: A larger sample size should have been considered in order to increase the ability to
generalize this study’s results.
Results: Participants in both the telephone call group and the text message group reported lower
level of pain than participants in the control group with a larger and more consistent effect for the
telephone call group. Most participants reported a higher level of pain during the first 48 hours
post-bonding. The analgesic’s consumption significantly correlated with the level of pain during
the previous 24 hours. Female participants appeared to be more sensitive to pain than male
participants.
Conclusions: A telephone follow-up after orthodontic treatment may be an effective procedure to
reduce participants’ level of pain.
Protocol: The research protocol was approved by the Italian Comitato Etico Regionale della
Liguria-sezione 3^ c/o IRCCS- Istituto G.Gaslini 845/2014.
Registration: 182 Reg 2014, 16/09/2014 Comitato Etico Regione Liguria, Sez.3.

© The Author 2015. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved.
266
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M. Cozzani et al.
Introduction
Pain in orthodontics
Orthodontic appliances may be uncomfortable and usually require
a period of physical and psychological adjustment. Studies in the
literature have shown that in many cases, the lack of treatment com-
pletion may be explained by the pain associated with orthodontic
procedures (1, 2). Prospective studies assessing both children and
adults have shown that approximately 94% of participants expe-
rienced pain during orthodontic treatments with a higher intensity
during the first 24 hours, albeit the duration of the pain differed
among participants (2).
Scheurer et al. (3) have demonstrated that the extent of tissue
damage cannot fully explain the degree of perceived pain and that
the correlation between pain stimulus and the individual experience
of pain is usually low. A recent systematic review conducted by Jian
et al. (4) concluded that there is insufficient evidence to determine
whether or not there is a difference between type of arch wires with
regard to speed of alignment or pain. Similarly, other investiga-
tors (5–7) have pointed out the lack of any significant correlation
between the magnitude of perceived pain and the degree of crowd-
ing, measured using the Little index (8) and the vertical displacement
of maxillary canine.
On the other hand, a significant correlation has been demon-
strated between psychological factors and perception of pain. The
Gate Control Theory (9), which integrates sensory aspects of pain
with cognitive, behavioural, and psychological factors, indicates that
both anxiety and stress are directly correlated with the perception of
pain. Post-procedure interventions, which aim at reducing individual
anxiety and stress, may influence the subjective perception of pain and
facilitate health-related lifestyle changes (10–12). A follow-up proce-
dure, which provides encouragement and reassurance after orthodon-
tic treatments, may be helpful in reducing the participants’ feeling of
uncertainty and anxiety. Bartlett et al. (11) and Keith et al. (12) have
recently demonstrated that a telephone call or a text message from
a health care provider during the first hours following orthodontic
treatment significantly decrease post-procedural pain and anxiety.
The aim of this study was to investigate the effects of a structured
telephone call and of a structured text message on the perception
and of pain in a cohort of participants who underwent orthodontic
treatments.
Materials and methods
Guidelines
The study was conducted according to current guidelines CONSORT
2010 (13).
Trial design
Participants were enrolled from patients who were beginning fixed
orthodontic treatment at the Orthodontic Department, Gaslini
Hospital, Genova, between July and October 2014. Ninety-six sub-
jects were examined and 88 patients fulfilled the inclusion and exclu-
sion criteria. Among these 88 patients, 84 patients and their parents
consented to participate in the study and they were randomly allo-
cated to the three groups:
1. fifteen male and fifteen female participants with a mean age of
13.5 ± 1.7 were assigned to the control group (group 1);
2. twelve male and 16 female participants with a mean age of
12.8 ± 1.5 to the text message group (group 2);
267
3. 16 male and 10 female participants with a mean age of 13.6 ± 1.7
to the telephone group (group 3).
Ethical issue
The methods of the present study were detailed in a research proto-
col that was approved by the Italian Comitato Etico Regionale della
Liguria – Sezione 3^ c/o IRCCS - Istituto G. Gaslini (845/2014).
Prior to participation, informed consent was obtained from all par-
ticipants and from the parents of children younger than 18 years old.
Subjects, eligibility criteria and setting
Study setting and eligibility criteria
Inclusion criteria were:
1. participants’ age between 10 and 19 years,
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2. access to a mobile phone,
3. orthodontic treatment with fixed maxillary self-ligating appli-
ances,
4. no extraction treatment,
5. no previous orthodontic treatment,
6. no chronic usage of analgesic medications,
7. no previous pain-related pathology or disease,
8. permanent dentition.
The structure of the message, received by group 2, was consistent
with that reported by Keith et al. (12) and it offered encouragement
and enquiring about participants’ well-being after their initial ortho-
dontic treatment.
The structure of the call, made to group 3, consisted of the fol-
lowing aspects: 1. to thank for participating in the study and for
attending the previous orthodontic appointment; 2. to explain possi-
ble reasons of pain or discomfort; 3. to encourage appropriate dental
hygiene; 4. to recommend adequate use of painkillers/analgesics; and
5. to stress the importance of a positive attitude towards orthodontic
treatment.
The questionnaire, completed by all patients, was previously
validated (11, 12), contained clear instructions for its completion
and consisted of a number of dichotomous questions related to the
socio-demographic characteristics of the participants (e.g. age, gen-
der), to the individual experience of pain and discomfort, including
a 100-mm self-assessment visual analogue scale, and to the use of
analgesics during the previous 24 hours.
Randomization method
Participants were randomly assigned to one of three intervention
trial arms by the Department of Epidemiology and Biostatistics of
IRCCS G.Gaslini.
Treatment protocol and process
Group 1 served as control and participants did not receive any kind
of structured follow-up. Participants in group 2 received a structured
text message. Participants in group 3 received a structured telephone
call after few hours from orthodontic appliance placement. Phone
calls and text message were performed 5–7 hours after the bonding
by the orthodontists.
Following the study protocol proposed by Keith et al. (12), all
patients were bonded with fixed self-ligating maxillary appliances
but, depending on the degree of crowding, some variation of the
initial arch wire may have occurred in certain cases. This was not
accounted for during the randomization process. Before the bond-
ing, a so-called ‘zero time questionnaire’ was completed by the
268
participants to evaluate the perception of pain at baseline, prior to
the beginning of orthodontic treatment. A subsequent questionnaire
was completed by the participants at home approximately 4 hours
after bonding and then daily for the next 7 days. This questionnaire
was categorized as follows: T1 = questionnaire completed 1 day
after bonding, T2 = questionnaire completed 2 days after bonding,
T3 = questionnaire completed 3 days after bonding, T4 = question-
naire completed 4 days after bonding, T5 = questionnaire completed
5 days after bonding, T6 = questionnaire completed 6 days after
bonding, and T7 = questionnaire completed 7 days after bonding.
All completed questionnaires were collected at the next orthodontic
appointment.
The participants and their caregivers in case of youngsters were
informed on the possible consequences of orthodontic treatment,
such as pain, ulcers, difficulty in chewing hard food, and subsequent
changes in the daily diet. They also received instructions on oral
hygiene procedures and remedies that could reduce discomfort.
The degree of perceived pain after orthodontic treatment was
assessed by evaluating the intensity of the pain, the use of painkill-
ers, and the participants’ anticipation regarding potential problems,
which could arise from orthodontic treatment.
Blinding
Participants were blinded to group assignment and were not made
aware that the text message or the telephone call was part of the
study. A blinded examiner performed data collection and analysis.
Statistical analyses
Sample size calculation
A power calculation indicated that for a type I alpha risk of 0.05
and a power of 80%, a sample of 28 participants per group would
be required.
Statistics
For continuous variables, data were expressed as mean and stand-
ard deviation or median and range of variability, while for cat-
egorical variables, data were expressed as absolute and relative
frequencies. The normality of variables distribution was assessed
using the Komogorov–Smirnov test and a non-parametric statis-
tical approach was considered appropriate. Continuous variables
were compared between groups using the Kruskal–Wallis and
Mann–Whitney U-tests. The chi-square test or the Fisher Exact
test was used to assess the association between categorical vari-
ables. The Spearman correlation coefficient was also computed.
All P-values were calculated using a two-tailed test. A P-value less
than 0.05 was considered statistically significant. Statistical anal-
yses were performed using SPSS, version 18, for Windows (SPSS
Inc., Chicago, Illinois, USA). The statistician, who performed all
statistical analyses, was blinded to name of participants and group
assignment.
Harms
There are no harms associated with the protocol of this study.
Results
Participant flow
Eight patients (four in the control group, two in the text message group,
and two in the telephone call group) did not return the questionnaires
and therefore were not included in the statistical analyses (Figure 1).
European Journal of Orthodontics, 2016, Vol. 38, No. 3
Baseline findings
Sample demographic features
There were no statistically significant baseline differences in the
participants’ demographic characteristics between the three study
groups (Table 1).
Participants’ expectation of braces at T0
Overall, about 70% of participants were convinced that orthodontic
treatment could cause pain and discomfort, 58% were concerned
about possible changes in dietary habits and oral hygiene, 31% were
worried that orthodontic appliances could affect normal speech, and
7% were convinced to be taunted.
Primary outcomes
Perception of pain
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The majority of participants (88%) reported pain during the first 24
hours after bonding. The proportion dropped to 50% after 3 days
and continued to decrease gradually after Day 4 (Figure 2).
During the first 3 days after orthodontic treatment, fewer par-
ticipants in both the telephone group and the text message group
reported pain compared with those in the control group, but no sta-
tistical differences were detected between groups.
Degree of pain
For all groups, higher values of pain were recorded in the first 24
hours with peaks of 97/100 mm, which decreased gradually in the
next few days.
At Day 1 and Day 2 after bonding, participants in both the telephone
call group and the text message group reported a lower, but not signifi-
cant different, mean level of pain compared to participants in the con-
trol group. Table 2 shows that participants in the telephone call group
reported a significant reduction of pain compared to those in the control
group at Day 3 (P = 0.02), Day 5 (P = 0.03), and Day 6 (P = 0.006).
A statistically significant difference was also observed between the con-
trol group and the text message group at Day 6 after bonding (P = 0.03)
but not at any other assessment (Table 2 and Figure 3).
Secondary outcomes
Gender difference in response to pain
With regard to the perception of pain, differences were observed
between female and male participants. Female participants tended
to report higher levels of pain compared with male participants even
though these differences were statistically significant only at Day 5
(P = 0.005) and Day 6 (P = 0.04; Figure 4).
Use of analgesics
Overall, the proportion of participants who reported analgesics
usage after orthodontic treatment was 37% at Day 1, 24% at Day
2, 9% between Days 3 and 6, and 1% at Day 7. No statistically sig-
nificant group differences were detected. At T1, there is a significant
correlation between the consumption of analgesic compared with
no analgesic consumption (P = 0.003); this correlation became not
significant after Day 1.
Discussion
We analysed the effects of two structured orthodontic follow-up
procedures, a telephone call and a text message, on pain perception
and oral hygiene compliance during the 7 days after the application
of orthodontic appliance. The questionnaire we used was a validated
instrument (11, 12), with simple and clear instructions, easy to com-
plete even by young patients (14, 15). In order to avoid the influence
M. Cozzani et al. 269

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Figure 1. Patients’ flow diagram.

Table 1. Demographic characteristics of the sample.

Text
Control message Phone call
(n = 30) (n = 28) (n = 26)

Male/female 15/15 12/16 16/10

Age (years), mean ± SD 13.5 ± 1.7 12.8 ± 1.5 13.6 ± 1.7
Median (range) 10.3–18.7 10–16 11–17

of past experiences on pain perception, we enrolled only patients

who did not receive previous treatment with orthodontic appliances.
We found that a telephone call to patients following initial appli-
ance placement resulted in reduced levels of pain. From Day 3, par-
ticipants in the telephone call group reported a significant reduction
of pain compared to those in the control group. These findings are
Figure 2. Percentage of patients who reported pain during the 7 days after
in line with those reported by Bartlett et al. (11) who observed that
the bonding.
a telephone call following an initial orthodontic procedure resulted
in a decreased perception of reported pain. We did not find the same and in communication style. People of Italian or Jewish origin, for
impact for a text message who other investigators have reported in instance, are apt to report pain before people of northern European
the literature. In particular, our results differ from those of Keith descendant and to tolerate less intense levels of laboratory-induced
et al. (12), who observed lower levels of pain among patients who pain before refusing to continue (16, 17). Moreover, French, Italians,
received a text message compared with those who did not. Different and Latin Americans prefer a more empathic and emotional com-
results could be explained by cultural differences in reaction to pain munication like the verbal one. People from America and northern
270 European Journal of Orthodontics, 2016, Vol. 38, No. 3

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Figure 3. Differences between male and female in the perception of pain during the 7 days after the bonding.

Table 2. Different degree of pain perception among the three trial

arms.

Time of pain Groups (1 = control,

measurement 2 = SMS, 3 = call) N Mean ± SD

Baseline 1 30 0.73 ± 1.8

2 28 1.68 ± 5.7
3 26 0.69 ± 2.6
T1 1 26 48.5 ± 23.6
2 26 43 ± 28.4
3 24 36.2 ± 22.9
T2 1 26 38.9 ± 23.1
2 26 34.5 ± 28.4
3 24 28 ± 24.9
T3 1 26 26.3 ± 21.4*
2 26 18.6 ± 20.7
3 24 15.2 ± 21.2
T4 1 26 16.1 ± 16.3
Figure 4. Comparison of the average level of reported pain among the three
2 26 16.5 ± 19.7
groups during the 7 days after the bonding.
3 24 10.1 ± 18.1
T5 1 26 10.1 ± 12.8**
2 26 10.1 ± 17.6 been demonstrated between psychological factors and individual
3 24 7 ± 17 perception of pain. Psychological approaches, such as the cogni-
T6 1 26 9.3 ± 13.1*** tive restructuring method, which provide encouragement and reas-
2 26 4.1 ± 8.1**** surance to reduce patients’ anxiety and feeling of uncertainty, have
3 24 5.8 ± 17 been proposed in the literature (10). It is therefore plausible that a
T7 1 26 5.2 ± 10.1 follow-up intervention, which aims at reducing individual anxiety
2 26 1.3 ± 2.3 and stress, may have a positive impact on the individual perception
3 24 5.5 ± 16 of pain (10–12). In our study, a verbal communication approach (i.e.
spoken words) proved to be more powerful than a written approach.
*Control versus phone call, P = 0.02. The theory of Token Economy (19) maintains that both positive
**Control versus phone call, P = 0.03.
and negative reinforcements are essential to obtain a proper behaviour
***Control versus phone call, P = 0.006.
and to avoid the extinction process described by Skinner (20). The lack
****Control versus SMS, P = 0.03.
of compliance may be explained by the pain associated with ortho-
Europe, in contrast, pay secondary attention to the emotional com- dontic procedures and by the absence of adequate encouragement. We
ponent of the communication style and react positively also to writ- believe that post-procedure interventions may facilitate health-related
ten approach (18). lifestyle changes, reduce the individual perception of pain (negative
A possible explanation for the reduced levels of reported pain we stimulus), and promote correct habits (positive stimulus).
observed could be that usually from Day 3 the periodontal ligament Similar to the findings of other studies in the current literature, in
compression decreases and the association between pain stimulus our study, the majority of participants reported pain during the first
and patient’s pain perception is weaker. Significant correlation has 24 hours after bonding (3–7, 21–23).
M. Cozzani et al.
We observed a statistically significant correlation between the use
of analgesics and pain only at Day 1. As suggested by Jones and
Chan (7) and Feinmann et al. (24), patients often take tablets in
order to reduce their anxiety and stress.
We also found that compared to male participants, female par-
ticipants reported higher levels of pain at Day 5 and Day 6. This
finding is consistent with other reports in the literature, which dem-
onstrate that women are more sensitive to perception of pain (3,
21–24).
Limitations
Even though a certain degree of bias exists in any randomized
clinical trial, we tried to minimize major potential biases. In par-
ticular, all our results were analysed by an independent statisti-
cian who was blinded to the name of participants and groups
assignment.
Further investigations should involve a larger sample to general-
ize the results and should include patients of various cultural and
ethnic groups in order to limit the influence of culture-specific differ-
ences on the results.
Conclusions
Our study demonstrated that from the Day 3 after the bonding, a
post-procedure phone call may reduce the perception of pain. Our
sample of patients showed more sensitivity to a verbal communica-
tion rather than a written approach.
We believe that patient motivation is a crucial factor to reduce
the perception of pain.
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