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J Am Dent Assoc, Vol 137, No 8, 1108-1114.
© 2006 American Dental Association | ![]() |
COVER STORY |
A randomized clinical trial
| ABSTRACT |
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Methods. The authors randomly assigned 57 people with signs of disk displacement and TMJ pain into three groups according to the type of splint: bilateral balanced, canine guidance and nonoccluding. The authors followed the groups for six months using analysis of a visual analog scale (VAS), palpation of the TMJ and masticatory muscles, mandibular movements and joint sounds. They used repeated analysis of variance and a
2 test to test the hypothesis.
Results. The type of guidance used did not influence the pain reduction, yet both occlusal splints were superior to the nonoccluding splint, on the basis of the VAS. Despite similar outcomes in relation to opening, left lateral and protrusive movements, TMJ and muscle pain on palpation, subjects who used the occlusal splints had improved clinical outcomes. The frequency of joint noises decreased over time, with no significant differences among groups. Subjects in the groups using the occlusal splints reported more comfort.
Conclusion. The type of lateral guidance did not influence the subjects improvement. All of the subjects had a general improvement on the VAS, though subjects in the occlusal splint groups had better results that did subjects in the nonoccluding splint group.
Key Words: Temporomandibular disorders; occlusion; occlusal splints
Temporomandibular disorders (TMDs) have signs and symptoms that affect the masticatory muscles, temporomandibular joint (TMJ) or both. These signs and symptoms include complaints of facial and TMJ pain, tenderness to palpation on the face and TMJ, uncoordinated mandibular movement and the presence of joint sounds.
The full-coverage occlusal splint is one of the therapies most frequently used in the treatment of these problems. A recent systematic review concluded that stabilization splints are beneficial for reducing pain when compared with no treatment.1 The authors, however, suggested the need for well-conducted randomized clinical trial (RCT).
Despite reports of high rates of clinical success of full-coverage occlusal splints on the reduction of TMD signs and symptoms, little is known about their efficacy, especially concerning the effects of lateral and protrusive guidance.
Researchers have proposed several mechanisms of action to explain the reported effectiveness of this therapy, including increasing the vertical dimension of occlusion, incorporating the "ideal" occlusion pattern, muscle relaxation, cognitive awareness and use of a placebo.2
Many studies have shown that the presence of canine guidance is crucial for the success of both natural occlusion and splints.314 DAmico4 stated that "when the canines are in contact, there is an immediate interruption on the tension of the temporal and masseter muscles, therefore reducing the magnitude of force."
On the other hand, some researchers believe that occlusal contacts on the nonworking side might provide an advantage for the treatment of painful TMJs.1518 For example, Kahan16 observed that symptomatic subjects with and without disk displacement had significantly smaller amounts of nonworking side contacts compared with asymptomatic subjects. In 1990, Minagi and colleagues18 evaluated 430 dental students and observed a highly significant correlation between the absence of contacts on the nonworking side and the increase of joint sounds with age. Moreover, other studies19,20 indicate that nonworking side contacts may protect the TMJ at the same side.
When considering the occlusal design of splints, Fitins and Sheikholeslam5 found that incorporating the canine-protection scheme seemed to cause a significant decrease in the electromyographic activity of elevator masticatory muscles. Other investigators have also used mutually protected occlusion21 and extreme canine-protected occlusion with limited lateral movement22 designs in the treatment of patients with TMD. Gray and colleagues23 did not find significant differences when they compared stabilization splints and splints with a localized occlusal interference in patients with TMJ pain. They concluded that the success of the splint therapy is independent of its occlusal design.
We conducted a double-blind, controlled RCT to evaluate the efficacy of stabilization splints with bilateral balanced guidance in the treatment of painful TMJ clicking compared with a traditional splint with canine guidance and a nonoccluding splint.
We obtained informed consent from all of the subjects. The universitys ethics committee approved the study.
Experimental procedure.
An experienced dentist (C.R.P.A.) examined all of the subjects according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).24 We included in the study subjects who met the diagnosis criteria for Group II (disk displacement) and Group IIIa (arthralgia). We then randomly assigned the 55 female and five male subjects to three groups described below (which we matched for aging) using a stratification method; that is, we placed the subjects into different groups according to the severity of the initial pain that was measured using a visual analog scale (VAS) and the tenderness of the TMJ on palpation. We used a table generated by a computer to perform the randomization.
A second experienced dental practitioner (C.N.S.) inserted the splints, without mentioning the type of splint and its expected mechanism to the subject. The dentist instructed the subjects to wear their splints only at night, while sleeping.
We treated the subjects in group I (mean age 28.9 years) with a modified acrylic stabilization (balanced) splint on the maxillary arch. With this design, the mandibular buccal cusps and incisal edges contacted a flat surface, even contacts on posterior and anterior regions, allowing for simultaneous contact of the mandibular teeth in all segments of the splint during excursive movements (right lateral, left lateral and protrusion excursions) (Figure 1
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SUBJECTS, MATERIALS AND METHODS
TOP
ABSTRACT
SUBJECTS, MATERIALS AND METHODS
RESULTS
DISCUSSION
CONCLUSIONS
REFERENCES
Population sample.
We selected 60 subjects (mean age 29.9 years) from a pool of patients attending the Orofacial Pain Center, Prosthodontics Department, Bauru Dental School, University of São Paulo, Brazil, who met the inclusion criteria and entered them into the study. The inclusion criteria were the presence of TMJ reciprocal clicking, subjects report of TMJ pain for at least three months and joint tenderness on palpation on at least one side. We excluded people with systemic conditions, arthritis, or a history of TMJ surgery or TMD treatment. We also excluded people who had a dental prosthesis or who had more than two posterior missing teeth (except for third molars and teeth extracted for orthodontic reasons).
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We monitored and evaluated all subjects at 15 days, one month, three months and six months after the insertion of the splints. A third examiner (P.C.R.C.), who was blinded for group distribution, performed these follow-up examinations. To compare the groups, we used the subjects pain reports from the VAS, TMJ and muscle palpation (temporal and masseter),25,26 analysis of the active mandibular range of motion and TMJ manual inspection for joint sounds. We also evaluated the subjects self-reports as to the progression of joint sounds, changes in occlusion and comfort levels.
Statistical analysis.
We conducted statistical analyses using repeated measurements analysis of variance, a Friedman test and a
2 test. We considered probability levels of 5 percent (P
.05) to be significant.
| RESULTS |
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As for mandibular movement, we observed a significant difference only for the right lateral movement between groups I and III (P < .05). The results were similar among the three groups for the amount of left lateral and protrusive movement.
We observed a reduction in frequency of joint sounds for the entire sample (P < .05) (Table 2
). Although the reduction was more pronounced for group II, we found no significant differences among the groups.
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Reduction in muscle tenderness on palpation was similar for the whole sample. We found significant differences in anterior temporalis muscles and the body of masseter muscles among groups (P < .05), with better results from the occlusal splint groups (Table 3
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| DISCUSSION |
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In our study, the bilateral balanced splint design used in group I did not seem to influence the improvement in subjects pain reports as measured by the VAS when compared with the canine guidance splint design used in group II. Indeed, despite the absence of a difference between groups I and III (P = .064), we found that the change in the group I subjects pain reports to be much more significant, since 14 of the 19 subjects in group I reported some discomfort and pain judged as "0" (absence of pain) on the VAS, whereas just five of the 18 subjects in group III marked "0." The rate of improvement was 83.4 percent for group I and 56.6 percent for group III.
Regarding the presence of joint sounds, we found no significant difference among the groups over time. The percentages, however, suggest a mild reduction in the number of subjects with joint sounds in all groups; the reduction was slightly higher in subjects in group II (Table 1
). We also observed a reduction in muscle tenderness for most of the muscle spots we evaluated, which could reflect a decreased co-contraction after the improvement of the TMJ pain, which was the chief complaint,38 and one of the inclusion criteria for the study.
Joint loading depends on the splint design.25,3943 Several studies have concluded that part of the occlusal force applied on the teeth is transmitted to the TMJ14,35,4450; yet the more anterior the tooth contact on the splint is, the higher the load that is transferred to joint.14,35,4450 It also has been reported that the TMJ is submitted to tension forces (compression and distraction) during unilateral clenching,19,20,42 and that the force applied to the contralateral joint side is reduced highly when simultaneous contacts are established at both working and non-working sides.17,19,20
On the basis of the assumption that people with disk displacement may have a reduced capacity to absorb occlusal loading,51 we believe that the use of balanced splints could help them protect the joint.
Studies have found that the load transmitted to the TMJ at the contralateral side is higher owing to the leverage action caused by the canine guidance on the working side.17,20 Therefore, a contact on the nonworking side would provide more stability to the joints, especially during tooth clenching on the canine edge-to-edge position, which would decrease joint loading. This decreased joint loading could improve and enhance the healing process and, consequently, result in faster healing in people with signs and symptoms of TMJ pain.
The role of the canine guidance in splints to decrease muscle activity and pain has to be considered. Other studies have found that mechanoreceptors in the periodontal ligaments of canine teeth could produce a measurable reduction in the contraction of elevator muscles.7,9,25 This observed reduction in muscle contraction, if caused by these receptors, could be responsible for the decreased intra-articular pressure in patients using bilateral balanced splints to levels similar to what the mechanical configuration of the canine guidance splints could produce.
Our discussion is about the role of canine guidance in splints to treat TMJ pain. The function of this feature in the natural dentition to protect posterior teeth from lateral forces is important and should be considered when establishing occlusal patterns for orthodontic treatment or full-mouth rehabilitation.
Clinicians should consider mechanisms other than splints. A natural and progressive adaptation of TMJ structures to loading may explain the general improvement for most of the subjects in our study, regardless if they used the occlusal splints. It is suggested that the formation of a retrodiskal fibrosis and the establishment of a pseudodisk seem to be the natural progression of TMJ with displaced disks and pain.52,53
People with joint pain and clicking with no treatment had a significant recovery after the six-month follow-up in a one-year controlled study when compared with people who received stabilization and repositioning splints.54 There is a regression to the mean for most people, which characterizes the benign aspect of these conditions.
The acceptable outcome in patients using nonoccluding splints in our study also can be explained by the fact that the patients belief that the treatment will be effective plays a vital role in placebo response.2,51 The patients personal relationship with the professional and his or her feeling of being "under treatment" are important influences on the final outcomes of most pain management therapies. The presence of the splint as a foreign object in the mouth would change the oral tactile stimuli and make the patient aware of the potentially harmful use of the jaw.2
When considering the presence of joint clicking, we found a general improvement. Although it is considered to be one of the goals of TMD treatment, the resolution of TMJ clicking no longer is the primary objective of using oral splints. In a one-year controlled study with a sample comparable to that used in our study, Conti and colleagues54 found similar outcomes for improvement of joint noises between subjects wearing oral splints and subjects in a no-treatment group.
As the goal of the splints used in our study was not to re-establish a "normal" disk-condyle relationship, the improvement observed for the presence of clicking probably is due to morphological alterations and remodeling in the joint structures over time (disk, ligaments and retrodiskal tissues), diminishing the physical obstruction for the condyle translation and, consequently, decreasing the sound. To substantiate this statement, however, the use of more sophisticated diagnostic tools, set as the gold standard, would be necessary (for example, magnetic resonance imaging, which we did not use in our study). This overall reduction on joint clicking did not influence the overall result (that is, decrease in pain and dysfunction).
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| FOOTNOTES |
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