ABSTRACT: Stabilization splints are frequently used for the
treatment of temporomandibular disorders (TMD) and bruxism, despite the
fact that little is known about their mechanism of action or the precise
conditions under which they can be recommended. Moreover, information
about their possible adverse effects, which in the majority of cases
include occlusal modifications of little clinical relevance, is scarce.
On occasions, these splints can provoke severe occlusal alterations and
other complications, which are rarely alluded to in the literature.
(1-6) Here presented in this paper are three case reports in which
part-time stabilization splints led to irreversible occlusal alterations
anda discussion of the relevant clinical implications. Such splints are
reported to negatively affect the condyle-disk relation in patients who
exhibit disk displacement with reduction and to modify breathing
features in patients with obstructive sleep apnea, although further
studies are required to unequivocally demonstrate these findings.
Finally, the splint seems to modify peripheral information at the level
of the Central Nervous System, leading to modifications in corporal
postural tone. The clinical repercussions of such alterations are
currently poorly understood. It is our hope that future research will
throw fresh light on these important topics.
Stabilization splints are the method of choice for the management
of temporomandibular disorders (TMD) and bruxism. (1,2) However, their
mechanism of action and the precise conditions under which they can be
recommended have remained quite controversial. (3) Thus, in recent
years, a variety of systematic reviews have been published in an attempt
to clarify their real clinical value. Despite this, the debate continues
between those who consider that their efficacy has not been demonstrated
with respect to alternative therapies, including placebo treatments,
(4-6) and those who defend their clinical use. (7-11)
It should be pointed out that none of the latter reviews concludes
that stabilization splints are not useful for TMD management; at most,
they mention that their clinical efficacy has not been demonstrated and
that more randomized controlled trials are required. However, as
mentioned by Clark (12) in his critical commentary on the paper by
Forssell and Kalso, (5) one must distinguish between the use of splints
as a cure for TMD on the one hand and asa reasonable method of help and
protection for some patients with TMD problems on the other. In this
latter sense, noone has denied their clinical usefulness and even the
European Academy of Craniomandibular Disorders (EACD) recommends their
use for the management of TMD and orofacial pain. (13)
Despite the abundance of literature about these devices, there is a
noticeable lack of reference to the possible undesirable side effects of
stabilization splints, in contrast to other types of oral appliances,
such as anterior repositioning splints, nociceptive trigeminal
inhibition tension suppression systems (NTI-tss) or splints for sleep
apnea, for which a number of systematic reviews have been published.
(14-16) Overall, it appears that complications derived from the use of
stabilization splints are associated with their full-time use, (17)
whereas the risk of undesired effects is considered to be small when
they are used part-time. (18)
The objective of the present work is to review the available
information on the possible adverse effects of stabilization splints in
their different clinical applications, as well as to present three cases
in which the use of a stabilization splint was associated with
irreversible occlusal changes.
Three clinical cases were selected for this study, which involved
occlusal alterations following the use of a parttime stabilization
splint. Case 1 came to the TMD and Orofacial Pain Service of the Dental
Clinic of the University of the Basque Country in 2008, after noting a
substantial change in occlusion. Case 3 was referred to us in that same
year, presenting with orofacial pain following surgical and orthodontic
treatment. In the light of these two patients with occlusal alterations
after splint use, it was decided to carry out a retrospective search
among the clinic's patients over the last five years, using a
simple selection criterion; the presence of irreversible occlusal
modifications subsequent to the use of a parttime stabilization splint.
In accordance with the Clinic's protocol, the splints are made with
hard acrylic resin and cover all of the teeth. As a result of this
search, only one case was found among the 482 revised cases, which we
refer to as Case 2.
Case 1 (Figure 1)
A 19 year-old male, who came on his own initiative to the clinic,
complaining of occlusal changes, without any other signs or symptoms of
TMD, of of alterations of other articulations. He had been wearing a
stabilization splint at night for six months, in accordance with the
recommendation of his orthodontist (Figure 1A). He did not know why his
dentist had recommended this and could not obtain further information
about the therapeutic position in which it was made. Articular paper
revealed contact between all the antagonist teeth, although this was
more intense for the posterior teeth. Upon removing the splint, the
patient exhibited unstable occlusion with dental contacts exclusively at
the level of the wisdom teeth (Figure 1B). Panoramic radiography
revealed no sign of condyle alteration.
Analysis of articulated casts revealed that dental migration had
not occurred, since the casts occluded correctly (Figure 1C). The
removal of the third molars increased the number of dental contacts, but
did not manage to achieve the anterior tooth relation of the manually
articulated models (Figure 1D). The patient was informed that the only
way to stabilize his occlusion was via orthodontic treatment, and he was
referred to his orthodontist.
Case 2 (not shown)
A 23 year-old female student presented with dull and diffuse facial
pain, which she had been experiencing over the past three months,
predominantly during the morning and on the left side, with moderate
intensity and without other accompanying symptoms. Clinical examination
revealed stable occlusion in Angle class I, with bilateral anterior
guidance. The patient exhibited tenderness of the chewing musculature
without trigger points. She did not present signs of internal
derangement, and her mandibular opening capacity was 51 mm, without
deviations. She reported that she tended to clench her teeth. No
unexpected data were revealed by the orthopantomography. The suspected
diagnosis was local myalgia, (19) with para-function as the most
probable etiological factor. She was fitted for night use with an upper
stabilization splint in the intercuspal position and was asked to return
for her first check-up a week later.
This patient returned for the first time nine months later. She
reported that pain had eased at the beginning of the treatment, but that
during recent months, it had reappeared, although with less intensity.
Anterior open bite was observed with characteristics similar to those of
Case 1. In the anamnesis, she reported that she used the splint during
the night and during some day hours, particularly during exam periods.
The splint showed signs of contact only between posterior teeth. After
readjusting the splint, the patient experienced no more facial pain.
Currently, the patient is undergoing orthodontic treatment.
Case 3 (Figure 2)
Case 3 was a 26 year-old female, who had finished treatment
involving orthodontics and bimaxillary orthognathic surgery two years
ago. She complained of intense pain at the level of the left
temporomandibular joint (TMJ), on the left side of the face and in the
lateral region of the neck on the same side, which had worsened over the
last nine months and had not responded to conventional analgesics. Pain
was constant, with moments of heightened intensity, and it became more
acute with mandibular movement and occlusion. There was evidence of
central sensitization, with hyperalgesia and allodynia. Muscular
palpation revealed trigger points at the chewing and neck muscles. Her
mandibular opening capacity was 27 mm, with deviation to the left and
any movement involving mandibular mobilization was very painful. She
exhibited unstable occlusion (Figure 2A) and the absence of anterior
guidance in lateral movements. The orthopantomography revealed bilateral
condylar hypoplasia (Figure 2B). Magnetic resonance imaging verified
disk displacement without reduction, with moderate osteoarthritic
changes and edema in her left TMJ. Our first approach involved
infiltrating the left temporomandibular joint with betamethasone acetate
(two ml; Celestone Cronodose, Bayer Schering, Germany), mixed with
lidocaine. The patient was instructed to take amitriptyline
hydrochloride (25 mg/night; Tryptizol, Neurogard, Spain), and a
stabilization splint was fitted for part-time use, not necessarily
limited to nocturnal use (Figure 2C).
[FIGURE 1 OMITTED]
During the treatment, we increased the dose of amitriptyline to 50
mg/night, in combination with pregabalin (Lyrica, Pfizer, USA) in
increasing doses up to 300 mg/day and tramadol-acetaminophen (Zaldiar,
Grunenthal, Germany) 225-1950 mg/day. Physical therapy treatment was
recommended and the trigger points were infiltrated with lidocaine.
Since the TMJ pain continued, it was decided to carry out an
arthrocentesis of her left TMJ, with lysis and lavage. Five months
later, the doses of the pharmacological treatment were gradually reduced
and the patient only experienced occasional pain, but now exhibited an
anterior open bite, which had occurred gradually (Figure 2D). Her
mandibular opening capacity was 38 mm, with a slight left deviation. In
the clinical and radiographic controls carried out three, six, and nine
months later, there were no observed significant modifications in the
intermaxillary relation or in condylar morphology. Currently, the
patient periodically attends a physiotherapist and uses the splint
during the night and sometimes for a few hours during the day (she does
not want to be without the splint). She occasionally uses nonsteroidal
anti-inflammatory drugs. She decided not to have additional surgery to
improve her occlusal situation.
[FIGURE 2 OMITTED]
In order to evaluate the information available in research
literature related to the adverse effects of stabilization splints, an
initial search was performed in November 2008, using the Medline
database with the terms (side effect or adverse effect or iatrogenic
effect) and (stabilization splint, or oral appliance, or bite splint),
with the only limit being that the language of the publication was one
of the official languages of the European Community. The number of
publications found varied between 0 (iatrogenic effect + stabilization
splint) and 443 (side effect + oral appliance). Eighteen (18) papers
included in their titles the four search terms of equivalent, of which
11 were about splints for sleep apnea, three for repositioning splints,
three for stabilization splints, and one for soft splints. There were no
systematic reviews found about the adverse effects of this type of
orthopedics. The oldest article dated back to 1974.
In the light of this scarce bibliography, a second search was done
using the terms temporomandibular and splint and review, returning 129
results. Of these, 38 papers were selected whose abstracts referred to
any of the aspects relevant to the present study and some of the cited
papers, considered to be the most relevant, were consulted. This search
was also performed in the Cochrane Library database. Finally, chapters
of interest were examined in various books about temporomandibular and
orofacial pain disorders.
The three case reports presented here are representative of the
typical clinical situations in which stabilization splints are
recommended. (20) Case 1 is an example of the use of the splint asa
diagnostic method in orthodontics, applied with a view to establishing a
centric relation. (21) Case 2 represents a simple case of TMD in a
patient with oral parafunction, in which the splint is the first choice
of treatment, and often the only available treatment. Case 3 is a
complex case of chronic orofacial pain in which the splint only played a
coadjuvant role, since the case required multidisciplinary treatment.
Thus, reported here ate three common conditions, which are distinct but
nevertheless have the same outcome: anterior open bite.
Due to the very nature of the methodology employed in this work,
the incidence of this type of alteration cannot estimated, since one of
the three cases was referred to our clinic due to the presence of
occlusal alterations (Case 1) and another (Case 3) was a patient who
presented important orthopedic instability after surgical-orthodontic
treatment. In any event, it seems that the risk of this type of
complication is low.
Occlusal changes in response to the use of stabilization splints
have already been reported, (17, 22-25) but few works specify the type
of alterations produced. It appears to be difficult to foresee these
modifications, since they vary as a function of the type of pathology
and of the coadjuvant factors associated with each case. (26,27)
Nevertheless, these modifications in general do not cause much
discomfort, and on many occasions are not even perceived by patients.
(11) For this reason, it is only rarely necessary to have to consider
applying irreversible treatments after the orthopedic phase. (28,29)
In order to avoid possible side effects of stabilization splints,
it is recommended that the splints cover the entire occlusal surface,
that they are not used around the clock (24 hours a day), and that there
is routine follow-up by the dentist. (13,17-30)
The cases presented here illustrate the potential capacity of these
splints to lead to anterior open bite, as reported occasionally in the
literature. (31, 32) Brayer and Erlich (22) commented on the possibility
of molar intrusion, with accompanying posterior open bite, in full time
users of stabilization splints. Partially covering splints have also
been reported to be able to provoke occlusal modifications, including
anterior open bite. (15,33) However, the patients in the current study
wore splints which covered all the occlusal surface and these were worn
only parttime. Moreover, Case 1 demonstrates that occlusal alterations
need not necessarily be due to tooth movement, since the mounted casts
occluded correctly (Figure 1C). Thus, these alterations are more likely
due to positional changes in the mandible, (34) asa possible consequence
of either changes in masticatory muscle activity, (3) the different
distribution of occlusal load, or modifications in the vertical
dimension. (35) The fact that norte of the three cases could voluntarily
attain occlusion similar to that achieved prior to the splint, suggests
that adaptive changes and articular remodeling had taken place, as
reported in the literature for humans and other animal species. (36-39)
The alterations in Cases 1 and 2 could be attributed to the lack of
regular revision and adjustment of the splint by the dentist. However,
in Case 3, a progressive anterior open bite also developed despite
correct periodic follow-up with regular adjustments.
It is currently not possible to establish which risk factors are
associated with the development of severe occlusal alterations in
response to wearing stabilization splints. Some authors recommend
informing the patient of the possibility of irreversible occlusal
changes when there is a discrepancy (<3 mm) between the retrusive
centric relation and maximal intercuspal position. (40) It has also been
suggested that prior to the placement of any intraoral orthopedic
appliance, a detailed study of centric relation casts should be
performed. (31) However, this is not always possible due to muscular
contraction (41) of to pain upon manipulation, as occurred in Case 3. In
addition, quite a number of studies have provided evidence that centric
relation is not the preferred therapeutic position in patients with disk
displacement. (40,42) These circumstances impede the elaboration of
informed consent and should be examined further in future research.
Finally, dependence on the splint by patients in whom symptoms
recur or by bruxers can also represent a problem. (43) Even
psychological dependence (22,23) and long-term use can represent
important risk factors. (13,17,30) However, in the cases presented here,
the occlusal changes occurred during the first months of use of the
splint. Long-term studies of patients who were treated with
stabilization splints have revealed high percentages of clinical
improvement, but they do not specify if the patients continued to use
the splints. (24,44) Thus, future research should clarify the possible
effects of stabilization splints when employed for periods which are
longer than that needed to revert the clinical symptomatology.
Other Possible Collateral Effects
Stabilization splints are often recommended for the treatment of
anteromedial disk displacement with reduction (ADD), although some
authors recommend in these cases the placing of anterior repositioning
splints, (7,44) which also have potential adverse effects.H Among the
general population, (45) of among patients treated with a splint, (44)
anteromedial disk displacement rarely evolves towards locking. However,
in a study of 68 patients with internal derangement, who were treated
with part-time stabilization splints, four (i.e., 6%) were found to
develop ADD without reduction during the first weeks of treatment. This
percentage rose to 21% when only patients with antecedents of
intermittent closed locking were considered. (46) Of these, three
patients recovered their diskcondyle relation by means of mandibular
maneuvers, (47) after which a repositioning splint was placed; the
fourth patient remained with closed locking. The scientific value of
this finding is limited, since it was reported within the context of a
descriptive study, which included no control group. In a retrospective
study, Kurita, et al., (48) found a similar percentage among patients
with ADD who developed clinical closed locking following use of a
full-time stabilization splint; unfortunately, they did not specify if
there was a prior history of intermittent locking among this sample.
This evolution could be due to the redistribution of the intra-articular
contact surfaces in response to modification of the condyle-fossa
relations, which is produced following insertion of an occlusal splint.
(49) Until further research provides more evidence in this regard, it
would be advisable to exercise caution in recommending stabilization
splints for patients with antecedents of intermittent locking. The
possibility of part-time use of an anterior repositioning splint should
be considered in these cases (for more information in this regard, see
Yoda, et al. (50)).
Another area, which requires further research, is that of the
possible collateral effects of stabilization splints in patients with
obstructive sleep apnea (OSA). In a pilot study of a sample of 10
patients diagnosed with OSA, Gagnon, et al., (51) found that half of the
cases experienced a worsening of AHI (Apnea-Hypopnea Index, or total
number of apneic and hypopnea episodes per hour of sleep) and of the RDI
(Respiratory Disturbance Index) after being fitted with a maxillary
stabilization splint, althOugh the results were not statistically
significant. The authors suggested that this type of oral device might
alter airway patency by posterior mandibular displacement, which in
turn, would modify relations between the tongue, hyoids, and palate.
However, some of the members of the same research team subsequently
reported, using another similar sample, the absence of modifications in
respiratory variables following placement of stabilization splints, or
palatal splints which did not cover the occlusal surface. One of the
reasons for this paradox might be that the latter group was composed of
young bruxers, who are different to the prototypical OSA patient. (52)
Some authors have called attention to the responsibility of
dentists for upper airway sleep disorders, (53) which affect
approximately 4% and 2% of the middle-aged male and female population,
respectively, although infants may also be affected. (54,55) Patient
questionnaires are available, which allow an identification of the
degree of severity of apnea. (53,56)
Finally, the use of stabilization splints also has implications for
posture. It is evident from the literature that the proprioceptive
information provided by dental occlusion and mandibular position has
repercussions on craniocervical musculature (57,58) and on corporal
position, (59,60) due to the connections which the trigeminal nerve
establishes with other brainstem structures, in particular with the
vestibular system and the labyrinth. (61-63) Asa consequence, it is
reasonable to suppose that modifications in the occlusal load and in the
vertical dimension which accompany an intraoral device can modify the
information provided by periodontal mechanoreceptors. In this regard, it
has been reported that the placing of an intermaxillary splint can alter
cervical postural tone at rest (64) and during swallowing, (65) which in
turn is influenced by body position (66) and the craniocervical
Although these connections remain controversial, since they have
been verified principally on the basis of surface electromyography,
functional evidence indicates that the wearing of a stabilization splint
can modify peripheral information at the level of the Central Nervous
System. (68) Nevertheless, prudence is advised when establishing
clinical expectations regarding therapeutic effects which are distal to
the masticatory system. (69) Urbanowicz (70) pointed out the risk of
cervical compression after placing an intraoral orthotic in patients who
had lost the capacity to adapt to cervico-facial functional changes. On
the other hand, the majority of dentists are not specialists in
vertebral pathology or in posture, which means that these implications,
either positive or negative, will often go unnoticed.
In summary, it was concluded that stabilization splints representa
safe therapeutic alternative, providing there is a regular follow-up on
behalf of the dentist, especially during the first months of use. The
most serious known risk, which occurs infrequently, is the appearance of
irreversible occlusal changes, which can also develop with part-time
splint usage. It is difficult to foresee when these complications might
arise, thus justifying their more indepth study in the future. Other
priority areas of research include large sample population studies to
clarify the potential risk of negatively modifying the disk-condyle
relation, the airway permeability/patency in patients with obstructive
sleep apnea, and the implications of stabilization splints for the
maintenance of global postural tone.
The authors would like to express their thanks to Dr. David J.
Fogarty for participating in the translation and scientific revision of
Manuscript received June 2, 2009; revised manuscript received
November 16, 2009; accepted December 7, 2009
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Fernando Magdaleno, M.D., D.D.S., Ph.D.; Eduardo Ginestal, M.D.,
Address for correspondence:
Dr. E. Ginestal
Universidad del Pais Vasco
Facultad de Medicina y Odontologia
Departamento de Estomatologia
Barrio Sarriena s/n, E-48940 Leioa, Vizcaya Spain
Dr. Fernando Magdaleno * received his M.D. from the University of
the Basque Country in 1981, as well as his specialist degree in
stomatology in 1984 and his Ph.D. degree in 1990. Most recently, he was
a lecturer in the Stomatognathic Department of the Faculty of Medicine
and Odontology of the University of the Basque Country. He was the
co-founder of. the Spanish Society of Craniomandibular Disorders and
Orofacial Pain (SEDCYDO).
* This article is dedicated to the memory of Dr. Fernando
Magdaleno, a colleague and friend, who recently passed away
Dr. Eduardo Ginestal received his M.D. from the University of the
Basque Country (1980), as well as his specialist degree in stomatology
in 1984 and his Ph.D. h2 1990. Currently, he is a lecturer in the
Stomatognathic Department of the Faculty of Medicine and Odontology of
the University of the Basque Country.