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This
retrospective observational study aims to assess the effectiveness of direct
bite raiser onlays (DBRO) on pain and dysfunctional symptoms in patients
affected by pain-related temporomandibular disorders (TMD). Furthermore, it
wants to provide descriptive information about the clinical performance of the
treatment.
We
screened the electronic medical records of male and female patients with a
diagnosis of pain-related temporomandibular disorders treated with DBRO. A data
collection was performed from patients routinely gathered clinical records. A
final sample of 43 patients was included in the analysis.
At
the beginning of treatment all patients (100%) referred having pain and 12
patients (27.9%) complained about both pain and functional limitation. At the
end of the treatment, 36 patients (83.7%) were symptom-free. In 5 subjects
(11.6%), pain was still present but reduced in intensity. In 2 subjects (16.6%)
functional limitations were improved but not completely resolved. During the
treatment that lasted on average 8 months a mean of 7 checks have been carried
out; the occlusal changes made on the DBRO had been on average 3. In 23
patients (53.5%) initial discomfort occurred after the beginning of treatment.
The first beneficial effect was obtained on average on the fifth week of
therapy.
The
results of this retrospective observational study should be treated cautiously
because of the limitations of the study design but suggest that patients with a
diagnosis of pain-related temporomandibular disorders who are treated with
direct bite raiser onlays experience a reduction in pain and dysfunctional
symptoms.
Keywords: Temporomandibular disorders,
TMD, Pain-related TMD, Occlusal appliance
INTRODUCTION
The
definition of “temporomandibular disorders” (TMDs) embraces a group of painful
and/or dysfunctional musculoskeletal and neuromuscular conditions that involve
the temporomandibular joints (TMJ), the masticatory muscles and associated head
and neck structures that get together with them into anatomical and functional
relationships. They have been identified as a major cause of non-dental pain in
the orofacial region.
TMDs
represent clusters of related disorders in the masticatory system with many
common symptoms. Patients with TMDs most frequently present with pain, limited
or asymmetric mandibular motion, and TMJ sounds. The pain or discomfort is
often localized to the jaw, TMJ and muscles of mastication. Common associated
symptoms include ear pain and stuffiness, tinnitus, dizziness, neck pain and
headache [1].
TMDs have a considerable prevalence, reported to
be between 3, 7 and 12%, with significant impact on physical and psychosocial
factors [2]. A systematic review reported a prevalence of up to 9.7% for
masticatory muscle pain, up to 11.4% for disc derangement disorders and up to
2.6% for TMJ pain disorders in the general population; while the prevalence of
the different diagnoses in TMDs within patient populations varied widely, the
results of a meta-analysis showed a prevalence of 45.3%, 41.1% and 30.1% for
muscle disorders, disc derangements disorders and joint pain disorders,
respectively [3]. TMDs are primarily a condition of young and middle-ages
adults, rather than of children or the elderly, and are approximately twice
more common in women than in men.
TMDs are often remitting, self-limiting, or fluctuating over time; the
progression to a potentially more serious chronic and disabling disease is
relatively uncommon. Only 3.6% to 7% of individuals with TMDs are estimated to
require treatment; for painful TMDs specifically, the most recent estimate for
first onset was 3.9% [4].
Currently, the reference standards for a correct classification of TMDs
are represented by the Diagnostic Criteria for Temporomandibular Disorders
(DC/TMD) [5] developed by the International RDC/TMD Consortium Network of the
International Association for Dental Research (IADR). The DC/TMD is a dual-axes
taxonomic system that provides both the clinician and the researcher with
evidence-based diagnostic criteria to be used in the evaluation of patients and
populations involved in research projects.
Management goals for patients with TMDs include decrease pain, decrease
adverse loading, restoration of function and resumption of normal daily
activities. Most patients with this type of disorders achieve good symptom
relief with conservative therapy. Long-term follow up of TMD patients shows
that 50% to over 90% of the patients have few or no symptoms after conservative
treatment. Stability is achieved in most cases between 6 and 12 months after
the start of treatment [4].
All therapies required for TMDs can be classified as causal or
symptomatic treatment. The latter is directed to modify patient’s
symptomatology, but usually has no effect on disease etiology. Symptomatic
treatments encompass patient education and self-management, pharmacotherapy,
physical therapy and orthopedic appliance therapy.
Orthopedic appliances, including stabilization splint, anterior
repositioning splint and distraction splint, are routinely used in the
treatment of TMDs. They usually consist in removable acrylic resin appliances
that cover the teeth, traditionally used to alter occlusal relationships and to
redistribute occlusal forces, to prevent wear and mobility of the teeth, to
reduce bruxism and parafunction, to treat masticatory muscle pain and
dysfunction, to treat painful TMJs and to alter structural relationships in the
TMJ. The most recent systematic reviews and meta-analysis did conclude that
there is a moderate effect for reduction of pain with the use of splint therapy
in TMDs.
Over time, stabilization splint has become one of the preferred
therapies for treating patients with TMDs, and also one of the most studied. It
represents the standard orthopedic appliance therapy for pain-related TMD. A
recent systematic review by Pficer et al. [6] concluded that stabilization
splint may have a significant role in treating TMDs in short term, while its
effect is equalized with other therapeutic modalities in long term follow up.
MATERIALS AND METHODS
This retrospective observational study was carried out in the Institute
of Clinical Dentistry of Fondazione Policlinico Universitario A. Gemelli in
Rome.
We searched the Orthodontics Department database from January 1, 2008
to May 31, 2018 to identify our study sample. We screened the electronic
clinical records of male and female patients with a diagnosis of pain-related
temporomandibular disorders - every subtype of myalgia, arthralgia, headache
attributed to TMD, according to the DC/TMD - of any degree of severity, aged
0-65 years; only the ones who had been treated with direct bite raiser onlays
were included in the analysis. Patients who had unsuccessfully undergone splint
therapy or other TMD treatments in the past were not excluded. Patients whose
medical records did not provided all the necessary information for the analysis
were excluded. Patients with a history of facial trauma, systemic disease and
comorbidities were excluded, as well as patients who had denied their consent
to the treatment of clinical data.
A data collection was performed from selected patients’ records:
·
Pain at the beginning and at the end of
treatment;
·
Limitation in mandibular range of motion
at the beginning and at the end of treatment;
·
The maximum mouth opening value at the
beginning and at the end of treatment (only if limitations in mandibular range
of motion were present);
·
Number of repetitive occlusal adjustment
and/or resurfacing in course of treatment;
·
Number of clinical checks carried out
during the treatment;
·
Time frame necessary for treatment;
·
Discomforts at the beginning of
treatment, related to the presence of the direct bite raiser onlays in the oral
cavity;
·
Number of weeks necessary to obtain the
first benefit from the therapy.
We also gathered a range of other clinical and demographic data that
were recorded in the patients’ electronic notes, including sex, age at the
initiation of treatment, diagnosis received (according to the DC/TMD),
parafunctions, previous gnathological treatments attempted for the same
disorder.
RESULTS
Patients selected from the archives were at first 49. After applying
our inclusion criteria a final sample of 43 patients was retained. The main
reason for excluding cases was related to having insufficient data from the
clinical records.
At the end of the treatment, 36 patients (83.7%) were symptom-free. In
5 subjects (11.6%) pain was still present; in 2 subjects (16.6%) functional
limitations were improved but not completely resolved.
The maximum mouth opening values at the end of treatment with direct
bite raiser onlays in patients with functional limitations had increased
compared to the beginning of therapy, with a mean difference of 9.5 ± 4.96 mm.
For 6 patients the treatment period lasted less than 3 months (13.9%),
for 9 patients between 3 and 6 months (20.9%), for 14 patients between 6 and 9
months (32.5%), for 8 patients between 9 and 12 months (18.6%) and for 6
patients more than 12 months (13.9%). During the treatment, that lasted on
average 8.34 months (SD=4.59), a mean of 7.09 checks (SD=2.89) have been
carried out; the occlusal changes made on the DBRO had been on average 3.16
(SD=2.08).
In 23 patients (53.5%) initial discomfort occurred after the beginning
of treatment. The first beneficial effect was obtained on average on the fifth
week of treatment.
DISCUSSION
Direct bite raiser onlays (DBRO) are occlusal wedges realized directly
in composite material bonded to the chewing surface of the teeth. Their
occlusal portion must be flat to allow freedom in protrusive and lateral jaw
movements; furthermore, it must ensure equally distributed inter-arch contacts
to lend occlusal and orthopedic jaw balance. The height of the onlays must be
the minimum to consent the absence of contacts between the teeth during the
closing and eccentric mandibular movements but avoiding increases in the
vertical dimension that do not respect the freeway space (physiologically from
2-5 mm). DBRO must be realized on the upper or lower first and/or second molar
- depending on the occlusal conditions of the individual patient – to ensure
maximum orthopedic jaw balance when the dental arches collide. DBRO therapy is
recommended for the treatment of severe pain-related temporomandibular
disorders for which resolution stabilization splint worn 24 h a day would be
desirable.
The structural features of direct bite raiser onlays and stabilization
splints are conceptually superimposable. The stabilization splint - acting like
an occlusal and articular release – allows, through a smooth contact surface
without forced gear, the suppression of anomalous contact causing nociceptive
information that generate improper muscle work, the occlusal stabilization
preventing unwanted slipping, the relaxation and the suppression of pain due to
the muscular hyperactivity, the restoration of correct joint spaces lost for
occlusal reasons, the control of parafunctional habits.
The principles by which the DBRO function and exert their therapeutic
potential are similar to those of the stabilization splint: the occlusal
release through the mechanical interposition of the onlays between the arches,
which causes an interruption of the neuromuscular engram built around the
previous maximum intercuspation occlusion; the reduction of abnormal activity
of the muscles participating in the masticatory functions, due to the increase
in the vertical dimension generated by the thickness of the onlays; a
mandibular ante-rotation, which results in a minimal articular distraction; the
release of cervical tensions and a certain degree of postural adaptation, due
to the rotation of the skull on the occiput secondary to the mandibular
rotation; a component of non-controlled extrusion of the mesial teeth that
allows an increase in the vertical dimension of occlusion, which is useful to a
certain stabilization of the results over time [7]. The latter feature, which belongs
exclusively to direct bite raiser onlays, means that this type of symptomatic
therapy is more invasive than other therapies classically considered
reversible, whose use is recommended especially in the initial phases of DTM
management - such as self-management, pharmacotherapy, physiotherapy, occlusal
devices. Precisely this aspect, although it connotes this therapy as not really
conservative, means that direct bite raiser onlays are recommended above all in
subjects that have unsuccessfully undergone reversible treatments and in
subjects who do not intend to undergo any phase of stabilization of the results
afterwards to the gnathological therapy.
Because of the current lack of evidence from observational studies on
direct bite raiser onlays it is difficult to compare and contrast our results
with previously published papers.
Treatment outcomes were assessed by observing pain reduction and
functional limitation. In a systematic review of Pficer et al. [6] on
stabilization splints pain reduction was taken as a measure of outcome and was
defined as an improvement or reduction in signs and symptoms at the end of
treatment. In our study, the pain reduction was measured categorically,
considering the symptom as "present" whenever pain of any degree of
intensity was reported and as "absent" only in case of total absence
of any type of algic symptomatology. The functional limitation was also
measured categorically, in relation to the maximum mouth opening (MMO)
expressed in millimeters; an MMO of 40 mm was taken as a critical value,
considering the functional limitation as "present" for values of MMO
lower than 40 mm and as "absent" for values greater than or equal to
40 mm.
Our primary endpoint analysis shows that the treatment with direct bite
raiser onlays in 36 patients with pain-related TMD was associated with the
remission of pain and dysfunctional symptoms. Therefore, in our sample of 43
subjects, the therapy had a good success rate, both with respect to the algic
symptomathology - 38 out of 43 patients (81.4%) denied the presence of pain at
the end of the therapy – and to the functional limitation - 10 out of 12
patients (83.3%) had recovered a maximum mouth opening equal to or greater than
40 mm at the end of treatment. The values of the maximum mouth opening in the
subjects presenting it limited at the beginning of the treatment showed an
improvement of on average 9.5 ± 4.96 mm.
The clinical performance of a Tanner stabilization splint therapy was
evaluated in a study by Zonnenberg and Mulder [10] observing the actual
timeframe necessary for treatment and the need to do repetitive occlusal
adjustments and/or resurfacing of the split in the course of therapy. In our
study we also considered the number of checks performed during treatment.
The data collected showed that the therapy lasted on average 8 months
with a large variability, since only in 14 subjects (32.5%) the treatment
lasted between 6 and 9 months. In total, for 37 patients, the treatment ended
within 12 months (86%). During this time, about on average 7 checks were carried
out, normally on a monthly basis. During these checks, excluding the session of
construction and that of complete removal, the onalys have undergone on average
about 3 adjustments, both in addition and in subtraction way. The latter
outcome may suggest that therapy with direct bite raiser onlays is not very
efficient; it is however necessary to remember that, compared to an occlusal
splint made in the laboratory in an indirect way, the onlays are built directly
in the patient's mouth and this makes it necessary to have more adjustments to
obtain an ideal surface and height.
In 23 patients (53.5%) initial discomfort occurred after the beginning
of treatment. In particular it has been reported difficulties in mastication,
phonation or swallowing, sensitivity to the carrier teeth of the onlays,
fatigue and muscle pain caused by transitory parafunctional activities
triggered by the presence of the onlays themselves. However, generally, these
discomforts disappeared after the first 7-10 days from the realization of the
DBRO.
The first beneficial effect of therapy has been reported to be around
the fifth week from the start of treatment. This figure, however, is probably
affected by the fact that the first check took place roughly 30-35 days after
making the onlays. We can imagine that symptoms relief can occur before five
weeks.
Because of the limitations of the retrospective observational study
design and the relatively small sample size, our results should be treated with
caution, particularly as any changes in pain and dysfunctional symptoms may be
due to numerous possible extraneous influences. We cannot establish with
certainty that direct bite raiser onlays reduce the symptomatology of
pain-related TMDs or are more or less effective than other therapy because this
is a non-controlled study without a comparison group. However, since this study
was expected to collect non-controlled therapy-related observation, all
findings need to be confirmed in future experimental studies, accompanied by
appropriate diagnostic tests. Direct bite raiser onalys appear to be promising
efficient means for the treatment of patients with pain-related TMDs, and their
efficacy makes them eligible to be tested in trials to provide higher levels of
evidence.
CONCLUSION
Because of the limitations of the retrospective observational study,
our results should be treated with caution, particularly as any changes in pain
and dysfunctional symptoms may be due to numerous possible extraneous
influences.
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