Side effects of stabilization occlusal splints: a report of three cases and literature review.
Article Type:
Temporomandibular joint disorders (Care and treatment)
Temporomandibular joint disorders (Research)
Bruxism (Care and treatment)
Bruxism (Research)
Splints (Surgery) (Usage)
Splints (Surgery) (Health aspects)
Magdaleno, Fernando
Ginestal, Eduardo
Pub Date:
Name: CRANIO: The Journal of Craniomandibular Practice Publisher: Chroma, Inc. Audience: Academic Format: Magazine/Journal Subject: Science and technology Copyright: COPYRIGHT 2010 Chroma, Inc. ISSN: 0886-9634
Date: April, 2010 Source Volume: 28 Source Issue: 2
Event Code: 310 Science & research
Geographic Scope: Spain Geographic Code: 4EUSP Spain

Accession Number:
Full Text:
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).


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.


Literature Search

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 relation. (67)

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 this paper.

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., D.D.S., Ph.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 unexpectedly.

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.
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