UNIVERSIDADE ESTADUAL PAULISTA
“JÚLIO DE MESQUITA FILHO”
Instituto de Ciência e Tecnologia
Campus de São José dos Campos
ORIGINAL ARTICLE DOI: https://doi.org/10.4322/bds.2023.e3669
1
Braz Dent Sci 2023 Jan/Mar;26 (1): e3669
Quality of life assessment in patients with temporomandibular
disorder with stabilization splints and home therapeutic exercises:
a randomized clinical trial
Avaliação da qualidade de vida em pacientes com desordem temporomandibular com uso da placa estabilizadora e
exercícios terapêuticos caseiros: um ensaio clínico randomizado
Simone Saldanha Ignacio de OLIVEIRA
1
, Juliana Ignacio de OLIVEIRA
2
, Maria Luiza Moreira Arantes FRIGERIO
2
,
Dalva Cruz LAGANÁ
2
1 - Centro de DTM e Dor Orofacial, Departamento de Odontotécnica, Faculdade de Odontologia da Universidade Federal Fluminense,
Niterói, RJ, Brazil.
2 - Departamento de Prótese Dentária, Faculdade de Odontologia da Universidade de São Paulo, São Paulo, SP, Brazil.
How to cite: Oliveira SSI, Oliveira JI, Frigerio MLMA, Laganá DC. Quality of life assessment in patients with temporomandibular disorder
with stabilization splint and home therapeutic exercises: a randomized clinical trial. Braz Dent Sci. 2023;26(1):e3669. https://doi.
org/10.4322/bds.2023.e3669
ABSTRACT
Objective: The present study aimed to evaluate the quality of life in TMD patients with the use of Stabilization
Splints (SSs) and Home Therapeutic Exercises (HTEs) guidance. Material and Methods: The study was a
clinical, randomized, controlled, prospective, and interventional trial. The screening included dentate patients
of both genders, diagnosed with TMD through the RDC/TMD questionnaire with no TMJ osteoarthritis and/or
osteoarthrosis. To assess the quality of life, the Short-Form Health Survey (SF-36) questionnaire was applied
to all patients (n=70), randomized into a test group with SS and a control group with HTE. The evaluations of
both questionnaires were performed before and after the intervention of 12 weeks. Results: The comparisons
between pre- and post-intervention intragroups were performed by the non-parametric Wilcoxon test with a 5%
signicance level. There was a frequency distribution of the responses to the 36 items of the SF-36 questionnaire
and comparisons between times. In the test group, 49 patients received a SS and did HTEs. In the control group,
21 patients performed HTEs. In the statistical analysis, among the eight domains, three were identied with
signicant scores: pain, mental health, and vitality. Conclusion: It was found that there was an improvement
in pain and quality of life after the treatment of TMD with a SS and HTE.
KEYWORDS
Clinical trial; Quality of life; Stabilization splint; Temporomandibular disorder; Therapeutic exercises.
RESUMO
Objetivo: O presente estudo teve como objetivo avaliar a qualidade de vida em pacientes com DTM com o uso de
placas de estabilização (SSs) e orientação de exercícios terapêuticos domiciliares (HTEs). Material e Métodos: O
estudo foi um ensaio clínico, randomizado, controlado, prospectivo e intervencionista. A triagem incluiu pacientes
dentados de ambos os sexos, diagnosticados com DTM através do questionário RDC/TMD sem osteoartrite
e/ou osteoartrose da ATM. Para avaliar a qualidade de vida, o questionário Short-Form Health Survey (SF-36)
foi aplicado a todos os pacientes (n=70), randomizados em grupo teste com SS e grupo controle com HTE. As
avaliações de ambos os questionários foram realizadas antes e após a intervenção de 12 semanas. Resultados:
As comparações intragrupos pré e pós-intervenção foram realizadas pelo teste não paramétrico de Wilcoxon com
nível de signicância de 5%. Houve distribuição de frequência das respostas aos 36 itens do questionário SF-36
e comparações entre os tempos. No grupo controle, 21 pacientes realizaram HTEs. Na análise estatística, dentre
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Braz Dent Sci 2023 Jan/Mar;26 (1): e3669
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular disorder with stabilization splint and home therapeutic exercises: a randomized clinical trial
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular
disorder with stabilization splint and home therapeutic
exercises: a randomized clinical trial
INTRODUCTION
Temporomandibular disorders (TMDs) are
a group of clinical conditions that affect the
masticatory muscles, the temporomandibular
joints, and the associated structures [1,2]. The
common signs and symptoms of TMD include
pain, joint sounds, limited mouth opening, and
asymmetric jaw movement [3]. In addition to pain
and dysfunction, TMDs have also been shown to
reduce sleep quality [4,5], increase anxiety and
lower the psychological stability of sufferers [6].
The etiology of TMDs is multifactorial with
biomechanical, neuromuscular, biopsychosocial,
and neurobiological factors contributing to
the development of this disorder [7]. The
‘biopsychosocial model,’ which incorporates
biological, psychological, social, and cultural
aspects, has a role in the onset, maintenance,
and exacerbation of TMDs [8], and it also
supports the high occurrence of psychological
distress and somatization among individuals with
TMDs [9-11].
Previous studies with patient samples have
pointed out that pain, functional limitations,
and muscle tension associated with TMD may
exacerbate physical, psychological, and social
disabilities and lead to a substantial negative
impact on the Oral Health-Related Quality of
Life (OHRQoL) [11-21]. Hence, therapeutic
TMD intervention requires an emphasis on pain
management and maintaining good mental
health [22,23], while targeting the improvement
of quality of life assessments [20,24].
Clinicians and researchers emphasize
the importance of providing conservative
treatment rst before introducing irreversible
methods [24]. Stabilization Splints (SSs) are
the most recommended non-invasive treatment
method for TMD [1,25,26]. They provide an
ideal centric relation occlusion which has been
suggested to reduce abnormal muscle activity
and contribute to the formation of so-called
‘neuromuscular balance’ in the masticatory
system [27]. The systematic review by
Fricton et al. [28], claimed that hard stabilization
appliances when adjusted properly present good
evidence of modest efficacy in the treatment
of TMJ disorder pain when compared to non-
occluding appliances and no treatment, and are,
at least, equally effective in reducing TMJ disorder
pain when compared to physical, behavioral
therapies, and pharmacological treatments.
Therefore, there is insufcient evidence either
for or against the use of stabilization splint
therapy over other active interventions for the
treatment of temporomandibular myofascial
pain [20,25,26,29], especially when analyzing
RCT studies with standardized criteria for TMD
assessment and intervention outcomes. Another
conservative treatment option is exercise therapy,
which is used to improve strength, mobility,
coordination and reduce pain in the joints and
muscles. Previous reviews have already analyzed
the effectiveness of exercise therapy for the
management of TMD due to improvements in
local analgesia, muscle function, and restoration
of local blood ow [30]. And yet, in the literature,
there are inconclusive and controversial results
regarding the effect of exercises and occlusal
splint treatments on the OHRQoL perceived
by the TMD patients [31]. More randomized
controlled trials comparing the effects of each
therapy need to be implemented [30].
For a painful condition such as TMD, the
patient’s point of view of well-being, known as the
quality of life, is positive for the measurement of
effectiveness. It has been shown that the OHRQoL
provides more information regarding the impact
of the oral condition or disease on a patient’s
everyday life and its quality when compared
to clinical measures of disease or mere pain
intensity. The present RCT aimed to evaluate the
impact of SS therapy on the quality of life among
TMD patients compared with Home Therapeutic
Exercises.
MATERIAL AND METHODS
A single-blind, two parallel arms, randomized
controlled clinical trial study was performed.
The present research was approved by the
os oito domínios, três foram identicados com escores signicativos: dor, saúde mental e vitalidade. Conclusão:
Vericou-se que houve melhora da dor e da qualidade de vida após o tratamento da DTM com SS e HTE.
PALAVRAS-CHAVE
Ensaio Clínico; Qualidade de vida; Placa oclusal; Desordem temporomandibular; Exercícios terapêuticos.
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Braz Dent Sci 2023 Jan/Mar;26 (1): e3669
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular disorder with stabilization splint and home therapeutic exercises: a randomized clinical trial
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular
disorder with stabilization splint and home therapeutic
exercises: a randomized clinical trial
FOUSP Ethics Committee (protocol 200/10)
and registered on ClinicalTrials.gov under the
identier NCT02251015 according to the Consort
Extension Checklist for Non-Pharmacologic
Treatments (Yap, Tan, Chua, & Tan, 2002).
Study population
The present study was performed at the
Occlusion and TMJ Clinic and “Envelhecer
Sorrindo” (Aging with a Smile) Program of the
Department of Prosthodontics of the University
of São Paulo Dental School.
Eligibility criteria
To be eligible for the study, patients should
be dentate and have TMD, of both genders, 18
years of age and older. The criteria included TMD
diagnosed through the RDC/TMD (Research
Diagnostic Criteria/Temporomandibular
Disorders) questionnaire, defined as Axis I
diagnoses of myofascial pain, myofascial pain
with limited opening, disk displacement with
reduction, disk displacement without reduction
with limited opening, disk displacement
without reduction without limited opening,
and arthralgia. The patient, to participate in
the research, presented a recent (6 months)
Magnetic Resonance Imaging (MRI) image exam
of the TMJ to verify the type of alteration and
complement the diagnosis of TMD and Orofacial
Pain according to the RDC/TMD questionnaire.
The RDC/TMD questionnaire was applied
by a single trained and calibrated examiner.
Excluded were those patients diagnosed with
osteoarthritis and osteoarthrosis on the RDC/
TMD; patients on continuous use of medications
that could affect balance; patients with visual
impairment (without corrections); neurological
problems; diabetes accompanied by sensory
neuropathies; labyrinthitis; history of TMJ
surgery; and pregnancy.
Procedures
The rst part of the study consisted of the
screening period and anamnesis procedure which
contained questions related to general health and
medical-dental history. All participants brought
their MRI of the TMJ and completed the RDC/
TMD. According to the eligibility criteria, included
patients diagnosed with TMD and Orofacial pain
lled the quality of life questionnaire (SF-36).
Subsequently, patients were randomized into
a splint group and a control group to begin the
intervention stage. The clinical intervention
period involved the confection, fitting, and
subsequent monitoring for adaptation of the
occlusal splint. After 12 weeks, re-evaluation
was performed using the SF-36 and RDC/TMD
questionnaires.
The test group received a stabilizing occlusal
splint and home therapeutic exercise guidelines.
The patients wore the acetate and acrylic resin
stabilizing occlusal splint according to the occlusal
stability criteria. The occlusal appliance was made
using a mixed technique under a 1.5 mm thick
crystal acetate plate (Bioart®), made by vacuum
in a plasticizer (Bioart®), and adapted in the
patient’s mouth after passive insertion of the plate
over the upper arch. Next, the colorless acrylic
resin was added to create a stability criteria in a
physiologic maxillomandibular position of centric
relation, simultaneous and punctiform bilateral
contacts, lateral disocclusion guide by the canine
on both sides and an anterior disocclusion guide
by the anterior teeth. The occlusal splint was used
throughout the night plus 4 hours during the day,
mainly at times of teeth-clenching wakefulness
bruxism [32]. The occlusal splint was adjusted
until the patient felt it adapted, and it was used
for 12 weeks [32-35].
The orientation of the Home Therapeutic
Exercises was to encourage patients to place their
jaw in a resting position for as long as possible
during the day. At this position, the teeth are
unclenched, approximately 2 mm apart, and
the tip of the tongue is placed over the incisor
papilla on the hard palate with the lips sealed.
The patients were also instructed to perform 15
repetitions of opening and closing movements
three times a day for 12 weeks, keeping their
tongue on the instructed location during the
exercises.
Questionnaires
RDC/TDM
The RDC/TMD (Research Diagnostic Criteria
/ Temporomandibular Disorders) questionnaire
consists of a biaxial questionnaire, with Axis
I represented by the clinical examination and
Axis II corresponding to the psychosomatic
evaluation [3,36]. For joint and muscle palpation,
the examiner was calibrated to perform digital
pressure according to the RDC/TMD guidelines
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Braz Dent Sci 2023 Jan/Mar;26 (1): e3669
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular disorder with stabilization splint and home therapeutic exercises: a randomized clinical trial
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular
disorder with stabilization splint and home therapeutic
exercises: a randomized clinical trial
at 12 bilateral sites. The 1.0 kg pressure was
applied to the temporalis muscle (anterior,
medial, and posterior), and the masseter muscle
(origin, body, and insertion) regions. The 0.5 kg
pressure was applied to the submandibular region
(medial pterygoid, suprahyoid, and anterior
digastric region), the posterior mandibular region
(stylohyoid and posterior digastric region), the
TMJ lateral pole region, posterior ligament,
lateral pterygoid muscle, and temporal muscle
tendon.
SF-36
Quality of life was assessed by the Medical
Outcome Study Short-Form 36 Health Survey
(SF-36) [37] validated in Portuguese [38]. This
questionnaire consists of 36 items, stratied into
eight domains: Functional Capacity (10 items),
Physical Aspects (4 items), Pain (2 items),
General Health Status (5 items), Vitality (4
items), Social Aspects (2 items), Emotional
Aspects (3 items) and Mental Health (5 items).
The quantitative measures obtained according
to the items generated the domain scores [39],
which were calculated according to the functions
proposed by the author of the questionnaire.
The values vary from 0 to 100 and the higher
the score, the better the quality of life indicator.
Sample calculation and statistical method
The sample size was based on a difference
between groups of 0.5 for the primary outcome,
with an estimated standard deviation of 0.7,
power of 80%, and alpha of 5%. Considering
these estimates, 25 subjects per group would
be needed (total: 50 subjects). Considering the
losses to follow-up, the inclusion of 70 subjects
was planned.
Comparisons between pre- and post-
intervention intra-groups were performed
using the Wilcoxon’s non-parametric test with a
signicance level of 5%. There was a distribution
of frequencies of responses to the 36 items
of the SF-36 questionnaire and comparisons
between times. Categorical data were described
by absolute (n) and relative (%) frequencies and
continuous data by statistics of mean, standard
deviation (SD), median, minimum (min), and
maximum (max) values. The SPSS software
(IBM SPSS Statistics for Windows, release 19.0.
Armonk, NY: IBM Group), was used for the
analyses.
RESULTS
The study began in July 2011, and the
primary completion date was December 2011.
A total of 70 patients diagnosed with TMD met
the inclusion criteria of the present research. The
nal analysis of the SF-36 questionnaire, after
the intervention, was performed for a total of 70
patients. Of this number, 49 were from the test
group and 21 from the control group. The total
number of patients who completed the survey had
a female prevalence, with 77% of women and a
mean age of 42.5 years.
The 36 items of the quality of life questionnaire
led to the construction of 8 domain scores, which
included: functional capacity, physical aspects,
pain, general health status, vitality, social
aspects, emotional aspects, and mental health.
For the test group, among the eight domains,
three of them (pain, vitality, and mental health
domains), indicated improvement in quality of
life after treatment, with a signicant increase
in their values. Table I describes the statistically
signicant measures of the quality of life domain
scores and comparisons between the times,
and Table II presents the results of frequency
distribution for the statistically significant
responses on the SF-36 and comparisons between
times. Table II table shows the
p-value
for the
comparisons before and after the intervention.
The items of the quality of life instrument
that showed signicant differences after treatment
and contributed to the increase in the scores of
the domains were: QV4 (Does your health now
limit you in these activities? Moderate activities
such as moving a table, pushing a vacuum
cleaner, bowling, or playing golf. If so, how
much?), QV21 (How much bodily pain have you
had during the past 4 weeks?), QV22 (During the
past 4 weeks, how much did pain interfere with
your normal work (including both work outside
the home and housework?), QV23 (How much
of the time during the past 4 weeks did you feel
energized?), and QV26 (How much of the time
during the past 4 weeks have you felt calm and
peaceful?). It was observed that the differences
in items QV4, QV21, QV23, and QV26 occurred
only in the test group. Meanwhile, item QV22 was
observed in the total number of patients.
Table III showed that there was a signicant
difference between the times that indicated
improvement after treatment according to the
RDC/TMD diagnosis. A statistically signicant
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Braz Dent Sci 2023 Jan/Mar;26 (1): e3669
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular disorder with stabilization splint and home therapeutic exercises: a randomized clinical trial
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular
disorder with stabilization splint and home therapeutic
exercises: a randomized clinical trial
difference was shown for myofascial pain in
both groups and only for the test group in the
diagnoses of disc displacement and arthralgia.
There was an improvement in the test
group in relation to the opening pattern and
the Range Of Movement (ROM), regarding the
values in “mm” during the opening. There was
an improvement in muscle and joint pain in
maximum opening with and without assistance
(Table IV).
DISCUSSION
In the literature, there is a consensus that
temporomandibular disorder is a condition that
compromises quality of life. Former analyses
with patient samples have pointed out the
negative impact of TMD on the quality of life
(QoL) [13, 14,16, 17, 40, 41]. A recent study has
claimed that the presence of TMJ pain appeared
to impair the OHRQoL more than the severity
of TMJ DJD (Degenerative Joint Disease) [18].
This is best explained by the biopsychosocial
model of etiopathogenesis, whether TMD risk
factors include alterations of mood, anxiety,
depression, somatization, emotional stress, or
catastrophizing, which go along with a genetic
character (i.e., serotonin and dopamine receptors
and monoamine oxidase expression), social
functions (affective and cognitive equilibrium,
sleep, and physical activities), and environmental
aspects (everyday stress, lifestyle, cultural beliefs,
and demographics). These may manifest with the
OHRQoL in multiple ways.
It is noted that for the management of
TMD, conservative methods are preferred since
success rates from invasive treatment are not
better [19,42]. An invasive approach - TMJ
surgeries - varying from arthrocentesis to
complex total joint replacements is considered
only if patients fail to respond to conservative
therapy [18]. In 2010, a systematic review [43]
concluded that conservative treatment including
exercise therapy, postural training, and occlusal
appliances could effectively relieve TMD pain
and increase jaw opening. Yet, there is a lack
of agreement in studies regarding the efcacy
of stabilization splint therapy and therapeutic
exercises. Previous studies have provided
inconclusive and controversial results. [41,44]
These findings corroborate with two recent
reviews [30,45], which proposed an analysis
of the effectiveness of exercise therapy versus
occlusal splint therapy for the treatment of painful
temporomandibular disorders. It’s been settled
that there is a small number of reproducible and
clear protocols in well-designed RCT studies, with
overall standardized and validated measurements
of clinical outcomes and high-quality evidence.
In the present study, the Stabilization Splint
(SS) combined with Home Therapeutic Exercises
(HTEs) guidance has been appointed as a
signicant therapeutic option for the improvement
of life quality in TMD patients. The reection on
the quality of life (QoL) is a great measurement
of assessing how a condition or disease affects
the patient`s everyday life [46, 47], especially
considering a scenario of chronic pain and with
a fluctuant condition such as TMD, this is a
Table I - Descriptive statistics of scores and p-values of tests for comparison before (pre) and after (post) treatment of QOL scores
Total Control Group Test Group
M SD Mdn Q1 Q3 Min Max M SD Mdn Q1 Q3 Min Max M Mdn Q1 Q3 Min Max
V. Pre I. (%) 58.6 18.5 60 50 75 10 90 56.4 17.3 50 50 70 30 90 59.6 60 47.5 75 10 90
V. Post I(%) 62.7 19.2 65 50 76.3 20 100 59 15.4 60 50 67.5 35 95 64.3 70 47.5 80 20 100
p-value
(between times):
0.006 0.176 0.018
MH Pre I. (%) 66 17.9 68 55 81 16 100 65.9 17.7 68 48 80 36 92 66 64 56 82 16 100
MH Post I.(%) 69.3 17.9 72 60 84 20 100 68 15.8 68 56 80 36 96 69.8 72 62 86 20 100
p-value
(between times):
0.017 0.258 0.034
P. Pre I. (%) 62.8 24.3 61.5 41 84 10 100 64.1 25.1 72 46 84 22 100 62.2 61 41 84 10 100
P. Post I. (%) 69.4 24.7 72 51 100 22 100 66 20.8 72 51 79 31 100 70.9 74 46 100 22 100
p-value
(between times):
0.006 0.959 0.004
V: Vitality; MH: Mental Health; P: Pain; M: Mean; SD: Standard Deviation; Med: Median; Q1: 25th percentile; Q3: 75th percentile;
Pre-I.: Pre-Intervention; Post I.: Post-Intervention; p-value (between times): Wilcoxon test.
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Braz Dent Sci 2023 Jan/Mar;26 (1): e3669
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular disorder with stabilization splint and home therapeutic exercises: a randomized clinical trial
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular
disorder with stabilization splint and home therapeutic
exercises: a randomized clinical trial
Table II - Frequency distribution of significant statistical responses on SF-36 items and comparisons between times
Total (n=70) Control Group (n=21) Test Group (n=49)
Pre I. Post I. Pre I. Post I. Pre I. Post I.
n % n % p- value* n % n % p- value* n % n % p value*
QV4 0.02 0.317 0.033
Yes, limited a lot 6 8.6 2 2.9 2 9.5 2 9.5 4 8.2 0 0.0
Yes, limited a little 18 25.7 17 243 6 28.6 5 23.8 12 24.5 12 24.5
No, not limited at all 46 65.7 51 72.9 13 61.9 14 66.7 33 67.3 37 75.5
QV21 <0.001 0.942 < 0.001
None 12 17.1 22 31.4 4 19 4 19 8 16.3 18 36.7
Very mild 12 17.1 15 21.4 4 19 4 19 8 16.3 11 22.4
Mild 15 21.4 12 17.1 6 28.6 6 28.6 9 18.4 6 12.2
Moderate 23 32.9 19 271 5 23.8 7 33.3 18 36.7 12 24.5
Severe 7 10 2 2.9 2 9.5 0 0.0 5 10.2 2 4.1
Vere severe 1 1.4 0 0 0 0.0 0 0.0 1 2 0 0,0
QV22 0.032 0.068 0.162
Not at all 30 42.9 36 52.2 9 42.9 10 47.6 21 42.9 26 54.2
A little bit 16 22.9 18 26.1 4 19 7 33.3 12 24.5 11 22,9
Moderately 18 25.7 10 14.5 5 23.8 3 14.3 13 26.5 7 14.6
Extremely 6 8.6 5 7.2 3 14.3 1 4.8 3 6.1 4 8.3
QV23 0.004 1 0.002
All of the time 3 4.3 8 11.4 1 4.8 2 9.5 2 4.1 6 12.2
Most of the time 23 32.9 24 34.3 9 42.9 7 33.3 14 28.6 17 34.7
A good bit of the time 17 24.3 19 27.1 3 14.3 5 23.8 14 28.6 14 28.6
Some of the time 17 24,3 12 17.1 6 28.6 4 19 11 22.4 8 16.3
A little of the time 9 12.9 6 8.6 2 9.5 3 14.3 7 14.3 3 6.1
None of the time 1 1.4 1 1.4 0 0.0 0 0.0 1 2 1 2
QV26 0.002 0.129 0.005
All of the time 4 5.7 9 12.9 2 9.5 2 9.5 2 4.1 7 14.3
Most of the time 17 24.3 19 27.1 4 19 4 19 13 26.5 15 30.6
A good bit of the time 18 25.7 20 28.6 4 19 7 33.3 14 28.6 13 26.5
Some of the time 16 22.9 15 21.4 9 42.9 8 38.1 7 14.3 7 14.3
A little of the time 12 17.1 6 8.6 2 9.5 0 0.0 10 20.4 6 12.2
None of the time 3 4.3 1 1.4 0 0.0 0 0.0 3 6.1 1 2
Pre I.: Pre-Intervention; Post I.: Post-Intervention; p-value* (between times): Wilcoxon test.
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Braz Dent Sci 2023 Jan/Mar;26 (1): e3669
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular disorder with stabilization splint and home therapeutic exercises: a randomized clinical trial
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular
disorder with stabilization splint and home therapeutic
exercises: a randomized clinical trial
Table III - P-values for between-time and between-group comparisons of TMD diagnostic measures
Between times (W) Between groups (MN)
Total Control Test Pre I. Post I.
Myofacial pain <0.001 0.046 <0.001 0.147 <0.001
Right Side Disc Displacement 0.445 0.257 0.007 0.539 0.004
Left Side Disc Displacement 0.403 0.564 0.058 0.296 0.423
Right Side Arthralgia 0.002 1 0.002 0.992 0.005
Left Side Arthralgia 0.004 0.317 <0.001 0.243 0.025
W: Wilcoxon test; MN: Mann-Whitney test; Pre I.: Pre-Intervention; Post I.: Post-Intervention.
Table IV - P-values for between-time and between-group comparisons of TMD sign and symptom measures
Between times (W) Between groups (MN)
Total Control Test Pre I. Post I.
Opening pattern <0.001 0.063 <0.001 0.568 0.002
Pain Free Opening (mm) <0.001 0.095 <0.001 0.764 <0.001
Maximum Unassisted Opening <0.001 0.082 <0.001 0.099 0.,036
Muscle Pain <0.001 0.109 0.002 0.616 0.001
Joint Pain 0.039 0.066 0.002 0.155 <0.001
Maximum Assisted Opening (mm) <0.001 0.106 <0.001 0.266 0.009
Muscular Pain <0.001 0.317 0.001 0.986 0.004
Articular Pain 0.003 0.655 0.003 0.141 0.269
W: Wilcoxon test; MN: Mann-Whitney test; Pre I.: Pre-Intervention; Post I.: Post-Intervention.
relevant clinical measure to conclude the efcacy
of SS+HTE intervention.
A similar RCT study was conducted by
Kokkola et al. [31], and the results showed that
SS+HTE treatment compared to HTE alone,
was not more benecial to self-perceived oral
health-related quality of life among TMD patients
over a 1-year follow-up. It is hypothesized that
the result differences were mainly due to the SS
time usage orientation. In the test group, patients
were instructed to use the SS only during the
night. In contrast to the present study, usage was
orientated during nighttime and daytime (2 hours
in the morning and 2 hours in the afternoon),
according to Oliveira et al. [32]. It is believed that
the instructional use of the SS therapy during the
day is associated with changes in oral behaviors of
teeth clenching in patients with waking bruxism,
for example, in stressful situations or during
physical activity. The stabilization splint provides
benets not only in protecting teeth clenching but
it reproduces a position of neuromuscular balance
and reorganization of motor unit recruitment.
Furthermore, a sample controlled study [48]
showed reduction of sleep bruxism by the use
of a stabilizing plate in a short period, revealing
that peripheral oral sensory input temporarily
reduces sleep bruxism associated with cortical
plasticity by adaptation of the oral condition in a
short term. It is important to highlight the need
for periodical adjustments of the appliance during
the period of adaptation of the individual for a
new splint because the intensity of contraction
of the masseter muscle differs for everyone.
Attention should also be paid to the period of
re-evaluation of the use of the plate by patients
in relation to the pre-established criteria [49].
It’s recognized that while sleep bruxism is
centrally mediated with a complex interaction
of autonomic system function during sleep,
awake bruxism is mainly related to psychosocial
factors [50]. Another difference between
both studies was the means of assessment of
the Oral Health Impact Profile-14 (OHIP-14)
questionnaire. According to a systematic review
(Bitiniene et al. [40]), the two most utilized
methods of assessment of the quality of life in TMD
patients were the SF-36 and OHIP-14, which are
short-form questionnaires, which are, therefore,
very comfortable to use in everyday practice.
The time evaluation period was successful in the
Kokkola et al. [31] study. In assessing a complex
context such as the quality of life, longer follow-up
analyses would provide a more accurate measure
8
Braz Dent Sci 2023 Jan/Mar;26 (1): e3669
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular disorder with stabilization splint and home therapeutic exercises: a randomized clinical trial
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular
disorder with stabilization splint and home therapeutic
exercises: a randomized clinical trial
of how the intervention affects the patient’s life.
However, it’s worth noticing that, over a longer
period, more variables could interfere with the
patient treatment context. Few long-term studies
in the literature conducted the efcacy of a SS
and, to our knowledge, just one of them analyze
the quality of life outcome.
A strength of the present study was the
standardization protocol confection of the
stabilization splint parameters. In our perspective,
the absence of well-designed stabilization splints,
according to the ideal occlusal criteria, is the
main reason for failures in splint intervention
patients. This idea agrees with other authors’
statements [25,29]. Likewise, other researchers
have discussed the need for an appliance that
provides a centric relation position (or as close
as it can get, depending on the patient TMD
stage), which has been suggested to reduce
abnormal muscle activity and contribute to the
formation of so-called ‘neuromuscular balance’
in the stomatognathic system [26,51]. Other
potential factors that have been suggested are the
increase of cognitive awareness or a peripheral
input to the central nervous system [20]. In
the present study, the splints were made by an
experienced professional through the mixed
technique, under a 1.5 mm thick crystal acetate
plate frame. A transparent acrylic resin was added
to create the stability criteria of a physiologic
maxillomandibular position in centric relation,
simultaneous bilateral and punctiform contacts,
canine disocclusion guide on both sides, and
anterior disocclusion guide by the anterior
teeth. A key element of the present research
was that the occlusal appliance needed to
be adjusted until the patient felt it adapted.
This could occur over several visits as the
masticatory muscles relaxed into a consistent jaw
relationship [28]. In the present study, starting
from this maxillomandibular position, the patient
was oriented to use the appliance for 12 weeks.
Well designed and adjusted splints are the bottom
line of clinical outcome success.
In the present research, the isolated Home
Therapeutic Exercise (HTE) intervention did
not show any improvement in the quality of
life domains. However, the HTE therapy alone
showed signicant improvement on the diagnosis
of myofascial pain by RDC/TMD. Previous
reviews have investigated the effectiveness of
exercise therapy for the treatment of TMD and
emphasized the lack of high-quality evidence
due to the divergence of nomenclature and
well-established exercises protocols [44,45,52].
Herein, HTE aimed to make patients aware of
the need to position their jaws rested for as
long as possible during the day. In this position,
the teeth are unclenched, approximately 2 mm
apart, and the tip of the tongue should be placed
over the incisor papilla with the lips sealed. In
addition, patients were instructed to perform
15 repetitions three times a day for 12 weeks of
repeated opening and closing movements, while
keeping the tongue in the position instructed
during the exercises. It is hypothesized that
exercise programs are designed to improve
muscular coordination, relax tense muscles, and
increase Range of Motion (ROM), and muscular
strength. In addition, it reduces the mechanical
stress on the TMJ and the contraction of the facial
muscles. When considering a highly complex and
connected device such as the Stomatognathic
System, when something is out of range, the
system tries to adapt and, sometimes, the
muscles are over-required. For this reason,
especially when a collapse situation on the TMJ
complex is evident, techniques for re-education
and rehabilitation of the masticatory muscles
are useful. Clinical and study-based outcomes
have conrmed the effectiveness of therapeutic
exercise modalities for the management of TMD
due to improvements in local analgesia, muscle
function, and restoration of local blood ow [53].
McNeely et al. [54] have pointed out that passive
and active stretching of muscles or range-of-
motion exercises are performed to increase oral
opening and decrease pain. In addition, postural
exercises are also recommended to restore or
optimize the alignment of the craniomandibular
system. Following the same path, Armijo-
Olivo et al
.
[44], realized that manual therapy
has been used to restore normal ROM, reduce
local ischemia, stimulate proprioception, break
fibrous adhesions, stimulate synovial fluid
production, and reduce pain. In the present study,
statistically signicant difference was shown only
when the Home Therapeutic Exercise Therapy
was associated with the Stabilization Splint.
Whereas an improvement in ROM measures was
demonstrated: “mm” during opening, opening
pattern, muscle, and joint pain in maximum
opening with and without assistance.
For the TMD diagnosis, the RDC/TMD
questionnaires were applied. In TMD studies, RDC/
TMD and DC/TMD are the most contemporary
9
Braz Dent Sci 2023 Jan/Mar;26 (1): e3669
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular disorder with stabilization splint and home therapeutic exercises: a randomized clinical trial
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular
disorder with stabilization splint and home therapeutic
exercises: a randomized clinical trial
gold-standard instruments of evaluation. By the
time the present study was projected, the DC/TMD
wasn’t available in Brazilian Portuguese, which
excluded the possibility of using the most recent
diagnostic criteria tool available in the present
research. The usage of contemporary diagnostic
criteria tools is fundamental in research to allow
classification, taxonomy, and nomenclature,
especially for further validation by analysis
reviews. [2,14]. Likewise, to assess the quality of
life, the validated Brazilian Portuguese translated
SF-36 questionnaire was applied. For the present
study, the authors have chosen the non-disease-
specic SF-36 due to the mental and psychological
health approach [16] on a pain perspective due
to the importance of the biopsychosocial model
on TMD etiopathogenesis. TMD is a painful
condition that can be acute or chronic. The
association with related comorbidities can further
disturb the biopsychosocial aspect. Intervention
reection on the quality of life is an important
measure of the treatment evolution process.
Therefore, the use of these two validated tools
(SF-36 and RDC/TMD), were strengths for the
present research.
A possible limitation in most of the TMD
intervention RCT studies observed in the literature
is probably due to the lack of multidisciplinary
treatment, excluding the biopsychosocial
character of TMD [8-11]. Since the psychological
domains were featured prominently in the TMD
etiopathogeneses, a careful psychosocial approach
would be necessary for the management of
patients with TMD. This could include supportive
psychotherapy, cognitive behavioral therapy,
interpersonal therapy, counseling, and wellness
programs. Psychosocial interventions have been
shown to reduce both psychological and physical
symptoms, increase coping, enhance the quality
of life and improve function [18]. Likewise, in
the present study, associated comorbidities were
not identified. Temporomandibular disorder,
when in a chronic condition, is often embedded
in a bigger scenario of central sensitization.
Thus, there is a high chance of the existence of
associated comorbidities, and if not well treated
and identied, could potentially worsen the TMD
condition. This knowledge substantiates recent
ndings [52], which noted that the presence of
widespread pain, before treatment initiation in
TMD patients was related to a worse response to
conventional TMD treatment.
A suggestion for future studies, in the absence
of a multimodal treatment approach, is at least
tracking the possible associated comorbidities.
CONCLUSION
It was concluded that there was an
improvement in pain and quality of life after
treatment of temporomandibular disorder with a
stabilization splint and home therapeutic exercises.
Author’s Contributions
SSIO: Investigation and writing and reading.
JIO: Writing and reading. MLMAF: Research
advisor and methodology. DCL: Research advisor
and methodology.
Conict of Interest
The authors declare that there is no afliation
or any other conict of interest. Implementation of
the present study happened without any nancial
industrial support. There were no financial
relationships between any of the authors and the
manufacturers of products involved in the study.
Funding
The authors would like to thank the IDREF
(Implant Dentistry Research & Education
Figure 1 - CONSORT flow diagram.
10
Braz Dent Sci 2023 Jan/Mar;26 (1): e3669
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular disorder with stabilization splint and home therapeutic exercises: a randomized clinical trial
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular
disorder with stabilization splint and home therapeutic
exercises: a randomized clinical trial
Foundation) for the Research Grant awarded
in March 2016, by Simone Saldanha Ignacio
de Oliveira, University of São Paulo (Effects
of Occlusal Splint Over Implants in Oral
Rehabilitation).
Regulatory Statement
The manuscript was prepared according
to the Consort Extension Checklist for Non-
Pharmacologic Treatments. This research was
approved by the ethics committee of FOUSP
(protocol 200/10) and registered at ClinicalTrials.
gov under identier NCT2251015.
Clinical Trials
The present study is available at https://
clinicaltrials.gov/, registered under ClinicalTrials.
gov Identifier NCT 02251015. CONSORT
transparent reporting of trials by CONSORT ow
diagram in Figure 1.
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Quality of life assessment in patients with temporomandibular
disorder with stabilization splint and home therapeutic
exercises: a randomized clinical trial
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular disorder with stabilization splint and home therapeutic exercises: a randomized clinical trial
Oliveira SSI et al.
Quality of life assessment in patients with temporomandibular
disorder with stabilization splint and home therapeutic
exercises: a randomized clinical trial
Date submitted: 2022 Oct 23
Accept submission: 2023 Jan 11
Simone Saldanha Ignacio de Oliveira
(Corresponding address)
Centro de DTM e Dor Orofacial, Departamento de Odontotécnica, Faculdade de
Odontologia da Universidade Federal Fluminense, Niterói, RJ, Brazil.
Email: ssioliveira@id.uff.br
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