International Dental Journal

SCIENTIFIC RESEARCH REPORT

doi: 10.1111/idj.12546

Conservative therapies to treat pain and anxiety associated

with temporomandibular disorders: a randomized clinical trial
Rafaela Albuquerque Melo , Camila Maria Bastos Machado de Resende , C
assia Renata de
Figueir^edo R^ego , Andressa de Sousa Leite Bispo , Gustavo Augusto Seabra Barbosa and
Erika Oliveira de Almeida
Department of Dentistry, Universidade Federal, do Rio Grande do Norte (UFRN), Natal, Brazil.

Introduction: Temporomandibular dysfunction (TMD) is a condition that affects the stomatognathic system. Objective:
To determine the effect of treatment with an occlusal splint (OS), manual therapy (MT), counselling (CS) and the combi-
nation of an occlusal splint and counselling (OSCS) on pain and anxiety in patients with TMD. Materials and methods:
A randomised clinical trial was conducted with 89 patients diagnosed with TMD through RDC/TMD (Research Diag-
nostic Criteria for Temporomandibular Disorders) and divided into four groups of treatment: OSCS (n = 25); OS
(n = 24); MT (n = 21); and CS (n = 19). Participants were assessed before and after 1 month of therapy for pain, anxi-
ety and TMD diagnosis. Pain was measured by a visual analogue scale. To assess anxiety, Hospital Anxiety and Depres-
sion Scale (HADS), Beck Anxiety Inventory (BAI) and the State-Trait Anxiety Inventory (STAI-S and T) were used. The
data were analysed using SPSS (Statistical Package for Social Science) 22.0. Results: The four groups obtained a signifi-
cant reduction (P < 0.001) in the pain after 1 month of treatment. Treatment in all groups promoted a significant reduc-
tion in anxiety symptoms 1 month after completion, HADS (P < 0.001), BAI (P < 0.001), STAI-T (P = 0.006). Thus, no
group was superior to the other in reducing the studied variables. Conclusion: The therapies used were effective in reduc-
ing pain and anxiety in patients diagnosed with TMD. However, no treatment was superior to the other in reducing the
studied variables.

Key words: Temporomandibular joint dysfunction syndrome, anxiety, pain, therapy

of the pain are: physical factors such as trauma,

INTRODUCTION
Temporomandibular dysfunction (TMD) is a generic
term that consists of a set of painful and/or dysfunc-
tional conditions that affect the stomatognathic system,
mainly involving the masticatory muscles, temporo-
mandibular joint (TMJ) and associated structures.1
It is represented by episodes of musculoskeletal pain
also involving other signs and symptoms, such as:
headache, otological manifestations (tinnitus, atrial
fullness and vertigo), muscle and TMJ sensitivity to
palpation, changes in mandibular movements and
joint noises (clicks and crepitations). It is estimated
that the prevalence of TMD in the world population
is between 5% and 12%, although only about 2%
require some intervention or treatment.2
The aetiology of TMDs is complex and multifacto-
rial.3 Among the factors that increase the risk of the
disease, starting or even accentuating the progression
© 2020 FDI World Dental Federation
sources of deep pain, parafunctional habits, occlusal
condition, postural characteristics, muscular hyperac-
tivity; neuromuscular factors; and psychosocial fac-
tors, such as socioeconomic conditions, sleep
disturbances, anxiety and depression.4
According to some studies, patients with temporo-
mandibular disorders, especially those with chronic
pain, may present secondary psychiatric disorders
such as anxiety, depression, social phobia, reduced
capacity to work, as well as isolation, and suffering
from loss of concentration and self-confidence.5
Depression and anxiety are important factors that
influence the perception of pain and can explain why
some patients with TMD do not respond to conven-
tional treatments.6 Thus, the biopsychosocial model
has been proposed, broadening the discussion about
the influence of emotional factors in the development
of TMD, being that stress and anxiety are factors that
1
Albuquerque Melo et al.
can cause development of parafunctional habits and
muscular hypertrophy.7
Consequently, due to the multiplicity of factors
associated with TMD, many treatment options have
been proposed. It is widely agreed to prioritise the
most conservative and reversible interventions, aimed
at pain relief, restoration of normal function, and the
patient’s physical and mental well-being.4
The occlusal splint (OS) has been widely used to
restore neuromuscular balance through the return of
balanced occlusal contacts, repositioning of the con-
dyle and muscle relaxation.8 This consists of a remov-
able device made of thermo-polymerisable acrylic
resin that can be used during the day or at night
depending on the clinical situation.9
Manual therapy (MT) is another conservative thera-
peutic option that has been associated with good
results in the management of patients with TMD.10 It
has been used to restore normal range of motion,
reduce local ischaemia, stimulate proprioception,
break fibrous adhesions, stimulate synovial fluid pro-
duction, and reduce pain.1
In addition, it is a consensus in the literature that
treatment focused on patient education through tar-
geted and individualised counselling (CS) should be
considered a central component of TMD manage-
ment.11 Several authors report that this biopsychoso-
cial approach has demonstrated significant
improvement in pain reduction.12
Although these therapies are considered to be effec-
tive, non-invasive treatments, little is known about
their effect in relation to psychological factors such as
anxiety.13 The literature indicates that the studies per-
formed have conflicting results due to the heterogene-
ity of the samples included, lack of strict criteria such
as the diagnosis of TMD through Research Diagnostic
Criteria (RDC), and different periods of follow-up.14
The objective of the present study was to evaluate
the effectiveness of treatments with OS, MT, CS, and
the association of OS with CS (OSCS) within the pain
and anxiety variables in TMD patients after 1 month
of treatment. The expected hypotheses were that, irre-
spective of the treated group, there would be a reduc-
tion in pain and anxiety with 1 month of treatment,
and that patients treated with CS associated with OS
would present less pain and anxiety when compared
with patients who received single therapies.
MATERIALS AND METHODS
The study was submitted for approval to the research
ethics committee of the Federal University of Rio
Grande do Norte (CEP-UFRN), under the number
1,442,401, it was developed according to the norms
and requirements contained in resolution 466/2012 on
human research (BRAZIL, 2013) and has been
2 © 2020 FDI World Dental Federation
conducted in accordance with the World Medical
Association Declaration of Helsinki. Before entering
the study, all participants signed an Informed Consent
Form which contained all of the information about
the research. The study was also registered in the
REBEC Platform (Brazilian Registry of Clinical Tri-
als).
A blinded randomised clinical trial was conducted
in which the evaluating investigator was not aware of
the therapy to which the patient was submitted. The
study was conducted at CIADE (Integrated Center for
Attention to Patients with Stomatognathic Apparatus
Dysfunction), an extension project developed by the
TMD and Occlusion sector of the Department of
Dentistry (DOD) of the Federal University of Rio
Grande do Norte (UFRN) Natal/RN from March
2016 to July 2017.
Initially, 300 patients were screened, but 188
patients were excluded because they did not have the
inclusion criteria necessary for the present study and
23 patients withdrew. Thus, the convenience sample
consisted of 89 patients diagnosed with TMD. Thus,
after some sample losses and non-completion of the
questionnaires by all patients, 89 patients were evalu-
ated by RDC, 85 patients by VAS, 83 patients by
Hospital Anxiety and Depression Scale (HADS), 88
patients by Beck Anxiety Inventory (BAI), and 87 and
89 by STAI-trait and state, respectively.
The sample was divided into four groups: OS; MT;
OSCS; and CS, as described in Figure 1. The ran-
domised trial was performed in blocks, each block
had four treatment options, a draw allocated a type
of therapy to four patients until all the patients were
assigned.
The present study aimed to understand the effects
of the therapies in the short term; therefore, an evalu-
ation was completed after 1 month of treatment. No
evaluated group was left untreated, in agreement with
the research ethics committee.
Individuals who abandoned the selected treatment
or did not follow guidelines and recommendations,
such as inadequate use of OS, absence of the MT
sessions or even having taken any measurement that
could influence therapy outcomes were excluded
from the study and continued to be followed at
CIADE.
Patients who did not improve and were unable to
remain in the initial group went through a waiting
period of 3 months without receiving treatment, fol-
lowed by a change to a new therapy.
The study included patients with a diagnosis of
TMD according to the RDC/TMD axis I,15 who had
not received any treatment for TMD in the last
3 months, had a report of pain in the orofacial region
in the last 3 months, and who were between 18 and
65 years of age.

OS
(n = 28)
n=4 n=7
OS
(n = 24)
Legend: OS (Occlusal splint); MT (Manual Therapy); CS (Counseling); OSCS (Occlusal splint
and Counseling)
Figure 1. Number of patients screened, excluded and allocated in the groups. CS, counselling; MT, manual therapy; OS, occlusal splint; OSCS, associa-
tion of occlusal splint + counselling.
Patients who were identified with some impairment
of cognitive ability were excluded, as they were
unable to understand the questions in the question-
naires; a history of head trauma that is related to the
aetiology of orofacial pain; patients with intracranial
disorders or headache; use of medications in the last
3 months that could interfere with the effect of tested
therapies, such as muscle relaxants, anti-inflammatory
medication, anticonvulsants, antidepressants and anxi-
olytics; use of medication to treat TMD or muscle
pain during the research period; other causes of orofa-
cial pain such as caries, periodontal diseases, or neu-
ropathies and fibromyalgia.
The OS were made by two calibrated researchers,
following the technique described by Okeson
(2013).16 The splints were also manufactured by the
same laboratory technician previously calibrated,
using thermo-polymerisable acrylic resin (Classic Den-
tal Articles LTDA).
At the appointment to deliver the splint, the adapta-
tion, stability, vertical dimension with the splint and
phonetic aspects with the splint in use were observed.
Subsequently, the necessary occlusal adjustments were
made with the aid of carbon paper and a straight
handpiece, obtaining a uniform contact and the
approximate intensity for all teeth. The patient was
instructed about the nocturnal and/or diurnal use of
the splint according to the symptomatology described.
The first return occurred 15 days after the installa-
tion, for verification of the adaptation of the splint,
adjustments and reinforcement of the advice, for the
association group (OSCS). After 30 days of installa-
tion, the splints were readjusted, if necessary. At this
evaluation, the RDC and the questionnaires were
administered.
The MT applied in this study was based on the use
of thermal agents (heat and cryotherapy) and thera-
peutic exercises that were performed clinically by a
trained researcher. The therapeutic regimen consisted
© 2020 FDI World Dental Federation
Therapy and temporomandibular disorders
Screened
Patients (n = 300)
188 patients were excluded because they did
not meet the research criteria
MT CS OSCS
(n = 28) (n = 28) (n = 28)
n=9 n=3 23 withdrawals
MT CS OSCS
(n = 21) (n = 19) (n = 25)
of 40-min sessions, performed twice a week for
4 weeks. Patients were also instructed to repeat at
home, on a daily basis, all the procedures that were
applied during the sessions, as noted below.
All treated patients, regardless of their diagnoses,
were instructed to apply a gel packet at temperatures
between 40 °C and 50 °C for 20 min, three times a
day during the 4 weeks of treatment. The compresses
were applied in the masseter, temporal and TMJ
regions.
The therapeutic exercises used were masseter and
temporal massage and stretching exercises for the jaw
muscles.
For CS, an investigation was made into habits and
other factors that might be responsible for the aetiol-
ogy of the patient’s dysfunction, and then a series of
orientated guidelines for each case were developed that
individualize treatment according to personal needs.
In addition, general characteristics about the disease
were clarified, so that patients understood their condi-
tion and felt able to manage it themselves. At the end
of the consultation, the patient received a written
booklet with dietary guidelines, physical exercises,
deleterious habits, instructions on correct mandibular
function, posture and sleep hygiene. After 15 days, a
new appointment was arranged for reinforcement of
the CS.
The instruments used to measure the variables were
RDC/TMD, visual analogue pain scale (VAS), HADS,
BAI and State-Trait Anxiety Inventory (STAI). Those
instruments were administered at baseline and after
1 month of treatment.
The VAS consisted of a graded visual scale from 0
to 10, where 0 means no pain at the moment and 10
is the worst pain imaginable.
The HADS consisted of 14 questions about how the
patient felt in the last week. Of these, seven include
characteristics focused on anxiety symptoms and
seven assess symptoms of depression. For each
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Albuquerque Melo et al.
question there are four possible answers, which have
a score from 0 to 3, totalling a maximum score of 21
points for each component of the questionnaire. Scor-
ing classifies anxiety as normal (0 7) or mild to sev-
ere (8 21).
The BAI consists of 21 items and has questions that
can be answered on a scale of 0 to 3 (absolutely not;
lightly; moderately and severely). The score is given
by the sum of the items and classifies anxiety into the
following: minimum anxiety (0 7); mild to severe
anxiety (8 63).
The STAI consists of two self-administered ques-
tionnaires that separately evaluate trait anxiety, which
is considered a personality trait of the individual; and
state anxiety, which occurs momentarily in the face of
some specific stimulus. The results of the question-
naire responses are classified as mild anxiety (20 30),
moderate anxiety (31 49), and severe anxiety
(50 80).
Prior to the study, sample size was calculated and
then the power of the estimated minimum difference
detectable of the final sample was calculated.
The sample size calculation was determined from
an initial pilot study. The strategy used was the com-
parison of mean with quantitative (dependent: pain
and anxiety) and categorical (independent: therapies)
variables. Mean, standard deviation and mean differ-
ence of the comparison groups regarding the variables
with a power of 80% and a two-sided significance
level of 5% were used.
At the end of the study, the sample had a power to
detect an estimated minimum difference between
treatment groups of 1.65 (VAS), 1.95 (HADS), 4.25
(BAI), 4.6 (STAI-T) and 5.2 (STAI-S).
The collected data were used in a database created
in the Statistical Package for Social Science program
(SPSS) 22.0 and analysed descriptively in absolute val-
ues, frequency distribution and measures of central
tendency and variability. The ANOVA Split Plot test
was used to observe the difference between the groups
over time and within the group, with a 95% confi-
dence level for analysis between groups and between
evaluations.
Table 1 Diagnosis of TMD (RDC/TMD)
Time TMD diagnostic by RDC/TMD
GI G II G III G I and II
Baseline n=5 n=3 n=2 n = 10
5.61% 3.37% 2.24% 11.23%
30 days n=7 n = 15 n=6 n = 11
8.0% 17.2% 6.9% 12.6%
TMD, temporomandibular dysfunction; RDC/TMD, Research Diagnostic Criteria for Temporomandibular Disorders; G I, patients diagnosed
only by group I of the RDC/TMD; G II, patients diagnosed only by group II of the RDC/TMD; G III, patients diagnosed only by group III of
the RDC/TMD; G I and II, patients diagnosed simultaneously by groups I and II of the RDC/TMD; G I and III, patients diagnosed simultane-
ously by groups I and III of the RDC/TMD; G II and III, patients diagnosed simultaneously by groups II and III of the RDC/TMD; No diagno-
sis: patients without diagnosis for any group of the RDC/TMD.
4 © 2020 FDI World Dental Federation
Thus, the statistical analysis was performed, com-
paring the results observed before starting treatment
(baseline) with the results observed 1 month after
treatment for all groups individually in order to have
a comparative analysis between baseline and 1 month
after treatment. In addition, the results of the different
treatment groups were compared in order to analyse
whether there was a statistically significant difference
between the different therapies.
RESULTS
Diagnosis of TMD
In regard to the study participants, 5.61% had muscu-
lar TMD, diagnosed only by group I of the RDC/
TMD, while 6.73% patients had joint TMD diag-
nosed in groups II and III of RDC/TMD alone or
together, and 87.62% had mixed TMD diagnosed in
groups I associated with group II or III (Table 1).
In relation to the diagnosis of TMD by the RDC/
TMD at the 30-day evaluation, three patients from
the OS group, three from MT and three from OSCS
were diagnosed without TMD, whereas only one
patient from the CS group reached this result. In addi-
tion, from the 43 patients diagnosed with the worst
prognosis (mixed TMD group I, II and III associa-
tion), only 18 remained with this condition. (Table 1).
Pain scale
There was a reduction in the pain variable, measured
by the VAS, for all groups after 1 month of treatment.
Thus, there was a statistically significant reduction in
the indicative values of pain with 1 month of therapy
compared with the baseline in the four groups
(P < 0.001), 27.7% of which was attributed to the
treatment (eta = 0.277; Table 2).
Therefore, the reduction of symptoms among the
different treatment groups was not significant. When
comparing the different groups there was no signifi-
cant difference between treatments in regard to
Total
G I and III G II and III G I, II and III No diagnosis
n = 25 n=1 n = 43 n=0 n = 89
28.08% 1.12% 48.31% 0% 100%
n = 11 n=9 n = 18 n = 10 n = 87
12.6% 10.3% 20.7% 11.5% 100%
 Therapy and temporomandibular disorders

reduction of pain. Thus, no group was better than
another group in improving pain (P = 0.260; Table
2).
Level of anxiety according to HADS
The evaluation of anxiety using the HADS question-
naire showed that there was a reduction in anxiety
symptoms for all groups, but no statistical difference
was observed between them (P = 0.260). However,
over time, all treatments resulted in a significant
reduction of anxiety (P < 0.001). In addition, the
magnitude of the therapeutic effect over time was
considered large, with about 24% of the variation
between the groups being due to the time between vis-
its (eta = 0.240; Table 3).
Thus, there was a statistically significant reduction in
the indicative values of anxiety, measured by the HADS,
with 1 month of therapy compared with the baseline
time in the four groups (P < 0.001), 24% of which was
attributed to the treatment (eta = 0.240; Table 3).
When comparing the different groups in the two
periods analysed, it was seen that there was no signifi-
cant difference between the different treatment groups
in the improvement of anxiety. Thus, no group was
better than another group in improving anxiety
(P = 0.260; Table 3).
Level of anxiety according to BAI
The BAI questionnaire assessing anxiety showed that
all four treatment groups achieved a significant reduc-
tion in anxiety symptoms over time (P < 0.001), com-
paring baseline time with 1 month of treatment,
21.1% of which was attributed to the treatment
(eta = 0.211; Table 4).
In addition, all groups presented similar therapeu-
tic results in BAI-measured anxiety; therefore, there
was no significant statistical difference between the
four therapies groups (P = 0.532). Thus, no group
was better than another group in improving anxiety
(Table 4).

Table 2 Relationship between TMD (RDC/TMD) and pain (VAS)

Time Treatment group n Mean Standard deviation Over time Between groups

P Partial eta squared P Partial eta squared

Baseline OSCS 25 4.6800 2.96816

OS 22 3.5000 3.11295
MT 21 3.4286 2.18109
CS 17 5.0000 2.59808
Total 85 4.1294 2.79791 <0.001 0.277 0.260 0.048
30 days OSCS 25 2.5200 2.61598
OS 22 1.8182 1.65145
MT 21 1.7619 2.18872
CS 17 4.4118 3.08340
Total 85 2.5294 2.56621

SPANOVA.
Over time: P: statistical result of the baseline comparison with 1 month of treatment.
Between groups: P: statistical result of the comparison of the different therapies.
CS, counselling; MT, manual therapy; OS, occlusal splint; OSCS, occlusal splint with counselling; P, P-value.

Table 3 Relationship between TMD (RDC/TMD) and anxiety level according to HADS - Anxiety
Time Treatment group n Mean Standard deviation Over time Between groups

P Partial eta squared P Partial eta squared

Baseline OSCS 25 6.28 3.577

OS 21 6.76 4.242
MT 20 8.10 2.972
CS 17 6.94 3.716
Total 83 6.98 3.653 <0.001 0.240 0.260 0.229
30 days OSCS 25 5.4400 2.64701
OS 21 4.9048 3.83282
MT 20 5.3500 1.81442
CS 17 5.5294 3.24264
Total 83 5.3012 2.91646

SPANOVA.
Over time: P: statistical result of the baseline comparison with 1 month of treatment.
Between groups: P: statistical result of the comparison of the different therapies.
CS, counselling; MT, manual therapy; OSCS, occlusal splint with counselling; OS, occlusal splint; P, P-value.

© 2020 FDI World Dental Federation 5

Albuquerque Melo et al.

Level of anxiety trait and state second STAI DISCUSSION

In the evaluation of the state-trait anxiety measured
by the STAI, there was a reduction in scores for all
treatment groups; however, no significant statistical
difference was found between the different groups
(P = 0.546). Thus, there was a statistically significant
reduction following 1 month of therapy compared
with the baseline for the four groups, but no group
was better than another group in improving these val-
ues. Over time, it was observed that the reduction
was significant in all treatment groups (P = 0.006).
The magnitude of the therapeutic effect was consid-
ered average, with 8.6% of the variation between the
groups (eta = 0.08; Table 5).
The anxiety state, also measured by STAI, was
reduced for all treatment groups, but without a sta-
tistically significant difference between the groups
(P = 0.760) or over time (P = 0.068). The size of
the therapeutic effect was considered small, with
only 3.9% of the variation over time (eta = 0.039;
Table 6).
The present study evaluated pain and anxiety in
patients diagnosed with TMD and provided with four
different treatment strategies: OSCS; OS; MT; and
CS. The sample consisted of 89 participants, was pre-
dominantly female (82, 1%, n = 72), and the mean
age was 28 years (SD = 9.34), confirming that
women and young adults are most frequently
affected.17 This distinction between genders can be
explained by some factors, such as differences in pain
threshold and perception, women’s increased demand
for health services, and the existence of an association
between orofacial pain and the menstrual period.18
As to the occupation of the study participants, the
majority were students (31.5%, n = 28), employees
(30.3%, n = 27), or met both criteria (students and
employees, 15.7%; n = 14). Although the association
between the professional situation and TMD is still
not clearly established in the literature, a possible
explanation can be attributed to the increasing eco-
nomic and scientific productivity, which implies

Table 4 Relationship between TMD (RDC/TMD) and anxiety level according to BAI
Time Treatment group n Mean Standard deviation Over time Between groups

P Partial eta squared P Partial eta squared

Baseline OSCS 24 9.67 8.223

OS 24 12.17 7.922
MT 21 11.14 7.532
CS 19 11.53 7.770
Total 88 11.10 7.805 <0.001 0.211 0.532 0.026
30 days OSCS 24 7.5833 5.72498
OS 24 8.0000 8.16142
MT 21 6.5238 4.17874
CS 19 8.8947 5.98048
Total 88 7.7273 6.19367

SPANOVA.
Over time: P: statistical result of the baseline comparison with 1 month of treatment.
Between groups: P: statistical result of the comparison of the different therapies.
CS, counselling; MT, manual therapy; OS, occlusal splint; OSCS, occlusal splint with counselling; P, P-value.

Table 5 Relationship between TMD (RDC/TMD) and anxiety trait level according to STAI-trait
Time Treatment group n Mean Standard deviation Over time Between groups

P Partial eta squared P Partial eta squared

Baseline OSCS 25 41.28 8.965

OS 22 43.64 9.220
MT 21 44.43 7.820
CS 19 41.58 10.720
Total 87 42.70 9.126 0.006 0.086 0.546 0.025
30 days OSCS 25 40.5200 10.0213
OS 22 41.0455 10.1300
MT 21 40.9048 6.25224
CS 19 40.1579 8.77030
Total 87 40.6667 8.85368

SPANOVA.
Over time: P: statistical result of the baseline comparison with 1 month of treatment.
Between groups: P: statistical result of the comparison of the different therapies.
CS, counselling; MT, manual therapy; OS, occlusal splint; OSCS, occlusal splint with counselling; P, P-value.

6 © 2020 FDI World Dental Federation

 Therapy and temporomandibular disorders

Table 6 Relationship between TMD (RDC/TMD) and anxiety state level according to STAI-state
Time Treatment group n Mean Standard deviation Over time Between groups

P Partial eta squared P Partial eta squared

Baseline OSCS 25 42.28 6.439

OS 24 40.42 10.882
MT 21 42.71 5.255
CS 19 41.42 10.653
Total 89 41.70 8.518 0.068 0.039 0.760 0.014
30 days OSCS 25 40.0400 7.71622
OS 24 40.3750 10.7250
MT 21 40.4762 8.34038
CS 19 39.4211 8.09194
Total 89 40.1011 8.69828

SPANOVA.
Over time: P: statistical result of the baseline comparison with 1 month of treatment.
Between groups: P: statistical result of the comparison of the different therapies.
CS, counselling; MT, manual therapy; OS, occlusal splint; OSCS, occlusal splint with counselling; P, P-value.

increasingly hostile and competitive work and study
environments, resulting in increased tension, anxiety
and a high level of stress that may be the aetiology of
the dysfunction. This trend was also observed in the
study by Reiter et al.19 who evaluated the co-morbid-
ity between depression and anxiety in 207 TMD
patients, of which 63.4% were employed and only
8% were unemployed.
The diagnosis of TMD was made through the
RDC/TMD, as it is a complete and effective tool, with
international acceptance. It is therefore widely recom-
mended as an objective evaluation of TMD for clini-
cal research purposes.20 After 1 month of treatment, a
new diagnosis was made, and from the 43 patients
diagnosed with the worst prognosis (mixed TMD
association of groups I, II and III) only 18 remained
with this condition. Therefore, most of the physically
debilitated patients were reclassified into another clas-
sification of lesser severity.
The results of this study confirm the H1 hypothesis
that patients receiving any of the therapies would
show improvement in relation to the pain variables,
with statistical significant differences between the
baseline and 1 month evaluation for all treatments.
Therefore, the null hypothesis was rejected.
In the evaluation of pain, performed by the VAS,
there was a significant reduction (P < 0.001) in the
self-report symptoms over time, for all groups, with-
out statistical differences (P = 0.260) between them.
A similar result was obtained by Qvintus et al.21 in
which the reduction of pain symptoms measured by
VAS, after 1 year of follow-up of patients treated with
OS, MT and CS, did not differ between treatments.
From another perspective, the study by Van Grootel
et al.22 who compared patients treated with OS and
MT, the final levels of pain measured by VAS were
also similar among groups. However, the MT group
required a shorter treatment time to achieve this
result, suggesting that MT may be preferred as a ini-
tial therapy in the management of painful symptoms.
When analysing the results of this study with the
evaluation of anxiety with three different instruments,
a significant reduction (HADS/P < 0.001, BAI/
P < 0.001; STAI-T/P = 0.006) was observed in all
groups over time, without significant differences
between them. Therefore, in regard to the reduction
of anxiety symptoms, there was no difference between
the individual being treated with one therapy versus
another.
These findings endorse the role of emotion in the
genesis and course of TMD, already widely debated
in the literature, and point out that treatment strate-
gies aimed at pain control and management are able
to positively influence anxiety-related symptoms.
Moreover, although this association is well estab-
lished, there are still few well-designed randomised
clinical trials that evaluate the effect of the most com-
monly used treatments on anxiety symptoms, making
it difficult to compare the data obtained in this study
with the published literature.
For the evaluation of anxiety by the STAI-S, no sig-
nificant reduction was found between the groups
(P = 0.068) or over time (P = 0.760). One possible
explanation is that there is no significant correlation
between TMD and the state of anxiety, as observed in
the study by Monteiro et al.23 In addition, because
the STAI-S affects how the patient feels "now, at this
moment" and their application, in this research, was
performed during clinical care, it is likely that the par-
ticipants were less anxious due to the active participa-
tion by professionals.
Reiter et al.19 used the GAD-7 (Generalised Anxiety
Disorder Questionnaire) in the evaluation of 207
TMD patients, and found no statistically significant
differences in terms of anxiety, suggesting that this
would play a minor role in patients with chronic

© 2020 FDI World Dental Federation 7

Albuquerque Melo et al.
TMD when compared with factors such as depression
and somatisation. However, it should be emphasised
that these reported differences between studies can be
attributed to the use of different instruments with dif-
ferent sensitivity and specificity. Moreover, a priori,
all the instruments to measure anxiety used in this
research have adequate metric properties, and were
translated and validated into Portuguese.24
In addition, based on the results obtained in this
study, it can be concluded that the expected hypothe-
sis that the group treated with a splint and counselling
(OSCS) would present superior results in relation to
the others was rejected, considering that none of the
variables were significantly different between the
treatment groups (VAS/P = 0.260, HADS/P = 0.260,
BAI/P = 0.532, STAI-T/P = 0.546, STAI-S/P = 0.760).
Corroborating with the findings of Conti et al.25
who, when evaluating three treatment groups with
one of them being the OSCS group, observed that all
treatments resulted in significant improvement in pain,
and the OSCS group showed improvement in 2 weeks.
It is noteworthy that patients treated in the OSCS
group showed significant improvements more rapidly
when compared with those who received only CS.
However, these data are in contrast to the results
obtained by Costa et al.13, in which patients treated
with a splint and counselling were improved versus
those who received only counselling. After 5 months
of follow-up, it was observed that the reduction in
anxiety measured by HADS was significant only for
the group that received the associated therapies. This
suggests that, in the long term, treatments may pre-
sent different results than those achieved in this study.
Temporomandibular dysfunction is a disorder with
multifaceted symptoms, which include physical symp-
toms pain being the main motivation for the search for
treatment, and emotional changes (as, for example, anxi-
ety). Therefore, an early bio-behavioural intervention
should be adopted. The treatment modalities used here
are viable options in the management of these patients
and demonstrated good results in the short term.
This study is methodologically sound because it is a
randomised controlled clinical trial, with well-defined
exclusion criteria and use of RDC/TMD for diagnosis
of TMD. However, there is a limitation to its external
validity due to the short follow-up period and the
small samples size. Therefore, additional studies
should be performed, with a similar research design,
but with a longer follow-up period.
Acknowledgements
This research was supported by the SOCIAL
DEMAND Grant Number 00.889.834/0001-08 of the
Coordenacß~ao de Aperfeicßoamento de Pessoal de N
ıvel
Superior (CAPES).
8 © 2020 FDI World Dental Federation
Conflict of interests
This study has no conflict of interest.
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Correspondence to:
Erika Oliveira de Almeida,
Department of Dentistry,
Universidade Federal,
Av. Salgado Filho, 1787; CEP: 59056-000- Lagoa
Nova,
Natal-RN, Brazil.
Email: erika.almeida.protese@gmail.com
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