Coverage Policy Manual
Policy #: 1998039
Category: Medicine
Initiated: February 1998
Last Review: June 2018
  Temporomandibular Joint Dysfunction

Description:
Temporomandibular joint (TMJ) disorders refer to a group of disorders characterized by pain in the TMJ and surrounding tissues. Initial conservative therapy is generally recommended; there are also a variety of non-surgical and surgical treatment possibilities for patients whose symptoms persist.
 
Temporomandibular joint (TMJ) dysfunction (also known as TMJ disorders) refers to a cluster of problems associated with the temporomandibular joint and musculoskeletal structures. The etiology of TMJ disorders remains unclear and is believed to be multifactorial. TMJ disorders are often divided into two main categories: articular disorders (e.g., ankylosis, congenital or developmental disorders, disk derangement disorders, fractures, inflammatory disorders, osteoarthritis and joint dislocation) and masticatory muscle disorders (e.g., myofacial pain, myofibrotic contracture, myospasm and neoplasia).
 
There are no generally accepted criteria for diagnosing TMJ disorders. It is often a diagnosis of exclusion, and involves physical examination, patient interview, and dental record review. Diagnostic testing and radiologic imaging is generally only recommended for patients with severe and chronic symptoms.
 
Symptoms attributed to TMJ dysfunction are varied and include but are not limited to clicking sounds in the jaw; headaches; closing or locking of the jaw due to muscle spasms (trismus) or displaced disc; pain in the ears, neck, arms, and spine; tinnitus; and bruxism (clenching or grinding of the teeth).
 
For many patients, symptoms of TMJ dysfunction are short-term and self-limiting. Conservative treatments such as eating soft foods, rest, heat, ice, and avoiding extreme jaw movements, and anti-inflammatory medication, are recommended prior to consideration of more invasive and/or permanent therapies such as surgery.
 

Policy/
Coverage:
Effective, July 2011
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
The following diagnostic procedures meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the diagnosis of TMJ dysfunction:
        • Diagnostic X-ray, tomograms, and arthrograms;
        • CT scan or MRI (generally CT scans and MRI's are reserved for pre-surgical evaluations);
        • Cephalograms (X-rays of jaws and skull);
        • Pantograms (X-rays of maxilla and mandible).
  Cephalograms and pantograms should be reviewed on an individual basis.
 
The following non-surgical treatments meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the treatment of TMJ dysfunction:
        • intraoral reversible prosthetic devices/appliances (encompassing fabrication, insertion, and adjustment);
        • Pharmacological treatment (such as anti-inflammatory, muscle relaxing, and analgesic medications).
 
The following surgical treatments meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the treatment of TMJ dysfunction:
        • Arthrocentesis;
        • Manipulation for reduction of fracture or dislocation of the TMJ;
        • Arthroscopic surgery in patients with objectively demonstrated (by physical examination or imaging) internal derangements (displaced discs) or degenerative joint disease who have failed conservative treatment;
        • Open surgical procedures including, but not limited to, arthroplasties; condylectomies; meniscus or disc plication and disc removal when TMJ dysfunction is the result of congenital anomalies, trauma, or disease in patients who have failed conservative treatment.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
  
The following diagnostic procedures do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the diagnosis of TMJ dysfunction:
        • Electromyography (EMG), including surface EMG;
        • Kinesiography;
        • Thermography;
        • Neuromuscular junction testing;
        • Somatosensory testing;
        • Transcranial or lateral skull X-rays;
        • Ultrasound imaging/Sonogram (ultrasonic Doppler auscultation);
        • intraoral tracing or gothic arch tracing (intended to demonstrate deviations in the positioning of the jaws that are associated with TMJ dysfunction);
        • Muscle testing;
        • Standard dental radiographic procedures;
        • Range of motion measurements;
        • Computerized mandibular scan (this measures and records muscle activity related to movement and positioning of the mandible and is intended to detect deviations in occlusion and muscle spasms related to TMJ dysfunction);  
        • Arthroscopy of the TMJ for purely diagnostic purposes.
        • Joint vibration analysis (Effective April 2014)
 
The following non-surgical treatments do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the treatment of TMJ dysfunction:
        • Electrogalvanic stimulation;
        • Iontophoresis;
        • Biofeedback;
        • Ultrasound;
        • Devices promoted to maintain joint range of motion and to develop muscles involved in jaw function;
        • Orthodontic services;
        • Dental restorations/prostheses;
        • TENS (Transcutaneous electrical nerve stimulation);
        • PENS (percutaneous electrical nerve stimulation);
        • Physical therapy, including diathermy, infrared, and heat and cold treatment, and manipulation;
        • Acupuncture
        • Hyaluronic acid (Effective April 2014)
 
The surgical repositioning of segments of the maxilla or mandible containing one to several teeth, or the bodily repositioning of entire jaws, whether to reduce a dislocation of temporomandibular joint or for any other purpose is an exclusion in the member benefit certificate of coverage.
 
For contracts without primary coverage criteria, the services above that do not meet member benefit certificate primary coverage criteria, are considered investigational. Investigational services are exclusions in most member benefit certificates of coverage.
 
Effective, June 2010 through June 2011
The following diagnostic procedures meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the diagnosis of TMJ dysfunction:
    • Diagnostic X-ray, tomograms, and arthrograms;
    • CT scan or MRI (generally CT scans and MRI's are reserved for pre-surgical evaluations);
    • Cephalograms (X-rays of jaws and skull);
    • Pantograms (X-rays of maxilla and mandible).
  Cephalograms and pantograms should be reviewed on an individual basis.
 
The following non-surgical treatments meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the treatment of TMJ dysfunction:
    • intraoral reversible prosthetic devices/appliances (encompassing fabrication, insertion, and adjustment);
    • Pharmacological treatment (such as anti-inflammatory, muscle relaxing, and analgesic medications).
 
The following surgical treatments meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the treatment of TMJ dysfunction:
    • Arthrocentesis;
    • Manipulation for reduction of fracture or dislocation of the TMJ;
    • Arthroscopic surgery in patients with objectively demonstrated (by physical examination or imaging) internal derangements (displaced discs) or degenerative joint disease who have failed conservative treatment;
    • Open surgical procedures including, but not limited to, arthroplasties; condylectomies; meniscus or disc plication and disc removal when TMJ dysfunction is the result of congenital anomalies, trauma, or disease in patients who have failed conservative treatment.
 
The following diagnostic procedures do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the diagnosis of TMJ dysfunction:
    • Electromyography (EMG), including surface EMG;
    • Kinesiography;
    • Thermography;
    • Neuromuscular junction testing;
    • Somatosensory testing;
    • Transcranial or lateral skull X-rays;
    • Sonogram (ultrasonic Doppler auscultation);
    • intraoral tracing or gothic arch tracing (intended to demonstrate deviations in the positioning of the jaws that are associated with TMJ dysfunction);
    • Muscle testing;
    • Standard dental radiographic procedures;
    • Range of motion measurements;
    • Computerized mandibular scan (this measures and records muscle activity related to movement and positioning of the mandible and is intended to detect deviations in occlusion and muscle spasms related to TMJ dysfunction).  
 
The following non-surgical treatments do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the treatment of TMJ dysfunction:
    • Electrogalvanic stimulation;
    • Iontophoresis;
    • Biofeedback;
    • Ultrasound;
    • Devices promoted to maintain joint range of motion and to develop muscles involved in jaw function;
    • Orthodontic services;
    • Dental restorations/prostheses;
    • TENS (Transcutaneous electrical nerve stimulation);
    • PENS (percutaneous electrical nerve stimulation);
    • Physical therapy, including diathermy, infrared, and heat and cold treatment, and manipulation.
    • Acupuncture
 
Arthroscopy of the TMJ for purely diagnostic purposes does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
The surgical repositioning of segments of the maxilla or mandible containing one to several teeth, or the bodily repositioning of entire jaws, whether to reduce a dislocation of temporomandibular joint or for any other purpose is an exclusion in the member certificate of coverage.
 
For contracts without primary coverage criteria, the services above that do not meet member benefit certificate primary coverage criteria, are considered investigational. Investigational services are an exclusion in the member certificate of coverage.
 
Effective, February 1998 – May 2010
 
The following diagnostic procedures are considered medically necessary in the diagnosis of TMJ dysfunction:
    • Diagnostic X-ray, tomograms, and arthrograms;
    • CT scan or MRI (generally CT scans and MRI's are reserved for pre-surgical evaluations);
    • Cephalograms (X-rays of jaws and skull);
    • Pantograms (X-rays of maxilla and mandible).
 
Cephalograms and pantograms should be reviewed on an individual basis.
 
The following non-surgical treatments are considered medically necessary in the treatment of TMJ dysfunction:
    • intraoral reversible prosthetic devices/appliances (encompassing fabrication, insertion, and adjustment);
    • Pharmacological treatment (such as anti-inflammatory, muscle relaxing, and analgesic medications).
 
The following surgical treatments are considered medically necessary in the treatment of TMJ dysfunction:
    • Arthrocentesis;
    • Manipulation for reduction of fracture or dislocation of the TMJ;
    • Arthroscopic surgery in patients with objectively demonstrated (by physical examination or imaging) internal derangements (displaced discs) or degenerative joint disease who have failed conservative treatment;
    • Open surgical procedures including, but not limited to, arthroplasties; condylectomies; meniscus or disc plication and disc removal when TMJ dysfunction is the result of congenital anomalies, trauma, or disease in patients who have failed conservative treatment.
 
The  following diagnostic procedures are considered investigational and are not covered in the diagnosis of TMJ dysfunction:
Electromyography (EMG), including surface EMG;
    • Kinesiography;
    • Thermography;
    • Neuromuscular junction testing;
    • Somatosensory testing;
    • Transcranial or lateral skull X-rays;
    • Sonogram (ultrasonic Doppler auscultation);
    • intraoral tracing or gothic arch tracing (intended to demonstrate deviations in the positioning of the jaws that are associated with TMJ dysfunction);
    • Muscle testing;
    • Standard dental radiographic procedures;
    • Range of motion measurements;
    • Computerized mandibular scan (this measures and records muscle activity related to movement and positioning of the mandible and is intended to detect deviations in occlusion and muscle spasms related to TMJ dysfunction).  
 
The following non-surgical treatments are considered investigational and are not covered in the treatment of TMJ dysfunction:
    • Electrogalvanic stimulation;
    • Iontophoresis;
    • Biofeedback;
    • Ultrasound;
    • Devices promoted to maintain joint range of motion and to develop muscles involved in jaw function;
    • Orthodontic services;
    • Dental restorations/prostheses;
    • TENS (Transcutaneous electrical nerve stimulation);
    • PENS (percutaneous electrical nerve stimulation);
    • Physical therapy, including diathermy, infrared, and heat and cold treatment, and manipulation.
 
Arthroscopy of the TMJ for purely diagnostic purposes is considered investigational and is not covered.
 
The surgical repositioning of segments of the maxilla or mandible containing one to several teeth, or the bodily repositioning of entire jaws, whether to reduce a dislocation of temporomandibular joint or for any other purpose is an exclusion in the member certificate of coverage.
 
Investigational services are an exclusion in the member certificate of coverage.

Rationale:
This policy was originally created in February 1998.  It was later archived in 2001 and is now being reactivated in June 2010.  A literature search was performed through April 2010.  This literature review concentrated on identifying systematic reviews and meta-analyses. For treatment of TMJ disorders, the focus was on studies that compared novel treatments to conservative interventions and/or placebo controls (rather than no treatment control groups) and that reported pain reduction and/or functional outcomes, e.g., jaw movement.
 
Diagnosis of temporomandibular dysfunction
Systematic reviews were identified on magnetic resonance imaging (MRI) and surface electromyography to diagnose TMJ dysfunction. The most recent systematic review on MRI was published in 2009 by Koh and colleagues and included 23 studies (Koh, 2009). Eight of the 23 studies found a relationship between a clinical and MRI diagnosis. The authors found substantial variability in study design, methods of clinical examination and diagnostic criteria and therefore could not pool study findings. The Koh review concluded that there is no clear evidence of a relationship between clinical and MRI diagnosis and findings, and additional studies using improved methodologies.
 
The authors of a systematic review on surface electromyography found a lack of literature on the accuracy of this method of diagnosis compared to a gold standard (i.e., comprehensive clinical examination and history-taking) (Klasser, 2006). They concluded that there is insufficient evidence that electromyography can accurately separate individuals with facial pain from those without pain, but that the technique may be useful in a research setting.
 
Treatment of temporomandibular dysfunction
A 2010 article by List and colleagues was a review of systematic reviews on treatments for TMJ dysfunction published between January 1 1987 and September 8 2009 (List, 2010). The authors identified 30 reviews; there were 23 qualitative systematic reviews and 7 meta-analyses. Eighteen of the systematic reviews included only randomized controlled trials (RCT), 3 included case-control studies and 9 included a mixture of RCTs and case series. There was inconsistency in how TMJ disorders were defined in the primary studies and systematic reviews, and several of the reviews addressed the related diagnoses of bruxism, disc replacements and myofascial pain. Twenty-nine of the systematic reviews had pain intensity or pain reduction as the primary outcome measure and 25 reported clinical outcome measures such as jaw movement or jaw tenderness on palpation. The authors divided the treatments into 5 categories (some studies were included in more than 1 category). These categories and the main findings are as follows:
1) Occlusal appliances, occlusal adjustment and orthodontic treatment (10 articles): six systematic reviews did not find significant benefit compared to other treatments, 4 found no benefit compared to a placebo device, and 3 found that occlusal therapy was better than no treatment.
2) Physical therapy including acupuncture, TENS, exercise and mobilization (8 articles): four reviews found no significant benefit of acupuncture over other treatments, 1 found no difference between acupuncture and placebo treatment, and 3 found that acupuncture was better than no treatment.
3) Pharmacologic treatment (7 articles): treatments found to be superior to placebo were analgesics (2 reviews), clonazepam or diazepam (3 reviews), antidepressants (4 reviews) and hyaluronate (1 review). The last review also found hyaluronate and glucosteroids to have a similar effect.
4) Maxillofacial surgery (4 articles): three reviews evaluated surgery for patients with disc displacements and the fourth addressed orthognathic surgery in patients with TMJ disorder. Reviews of surgical treatments generally included lower level evidence, e.g., case series, and did not always compare surgery to a control condition. One systematic review found a similar effect of arthocentesis, arthroscopy and physical therapy.
5) Behavioral therapy and multimodal treatments (6 articles): two reviews found biofeedback to be better than active control or no treatment, 1 review found a combination of biofeedback and cognitive-behavioral therapy to be better than no treatment and 2 found a combination of biofeedback and relaxation to be better than no treatment. One review found that the effects of biofeedback and relaxation were similar.
 
Overall, the authors concluded that there is insufficient evidence that electrophysical modalities and surgery are effective for treating TMJ dysfunction. They found some evidence that occlusal appliances, acupuncture, behavioral therapy, jaw exercise, postural training and some medications can be effective in reducing pain for patients with TMJ disorders. However, the authors note that most of the systematic reviews they examined included primary studies with considerable variation in methodological quality and thus, it is not possible to make definitive conclusions about the effectiveness of any of the treatments.
 
Key relevant studies were also examined. Three systematic reviews by the Cochrane Collaboration that evaluated treatments for TMJ disorders were identified.
 
A Cochrane review by Guo et al, last updated in 2009, identified 2 RCTs (total N=81 patients) that compared the effectiveness of arthrocentesis and lavage for the treatment of TMJD to arthroscopy (Guo, 2009). Data were pooled only for the outcome of maximum incisal opening. A meta-analysis of the 2 trials found a statistically significant difference between the interventions for this outcome, with a WMD of -5.28 (95% CI, -7.10 to -3.46) in favor of arthroscopy. The Cochrane review was withdrawn in 2015 for being out of date and not meeting current Cochrane methodologic standards (Guo, 2015); a new Cochrane review on surgical interventions for managing TMJDs is planned. Another Cochrane review reporting on arthroscopy for TMJD, originally published in 2010, was also withdrawn from Cochrane from 2015 for being out of date and not meeting current Cochrane methodologic standards (Rigon, 2015).
 
Koh and Robinson identified 3 trials evaluating treatment of TMJ disorders with occlusal adjustment; a total of 193 patients completed the trials (KOH, 2003). Due to differences in outcomes and reporting scales, findings were not pooled. Individual trials did not find significant differences between symptom reduction with occlusal adjustment and control groups. The authors concluded that there is insufficient evidence on occlusal adjustment as a treatment for TMJ.
 
Al-Ani and colleagues identified 12 randomized controlled trials comparing stabilization splint therapy for TMJ dysfuction to a control intervention (Al-Ani, 2004). There was wide variability in the comparison interventions and no standardization of outcomes; thus, results of studies were not pooled. The authors stated that they found little evidence of a difference in the effectiveness of stabilization splint therapy for patients with pain associated with TMJ dysfunction. They further stated that there is some evidence that stabilization splint therapy may be more beneficial for reducing pain severity than no treatment.
 
In addition to the Cochrane reviews, two other relevant systematic reviews were identified; both addressed acupuncture as a treatment for TMJ. The more recent review, published in 2006, identified 6 randomized controlled trials; one study was from the United States and the remainder were conducted in Sweden (Fink, 2006). The U.S.-based study, by Goddard and colleagues, was the only one to use a sham comparison. However, that study included only 18 patients, involved a single treatment session, and assessed efficacy immediately after treatment, not longer-term. There was no significant difference in pain reduction between groups; pain was significantly lower in both the active and sham acupuncture groups after treatment compared to before (70% vs. 50% respectively experienced a significant reduction in pain). The Swedish studies tended to find similar effectiveness of acupuncture and occlusal splints, and both of these interventions were more effective than no treatment. The authors concluded that acupuncture was similar in effectiveness to occlusal splints but that, due to the methodological limitations e.g., lack of blinding in most studies, further studies are needed to rigorously evaluate acupuncture as a treatment for TMJ dysfunction.
 
A randomized controlled trial was identified that directly compared four treatments for TMJ (Schiffman, 2007).  A total of 106 patients were randomized; 29 to a medical management group (non-steroidal anti-inflammatory drugs for 3-6 weeks plus muscle relaxants and over-the-counter analgesics as needed), 26 to a rehabilitation group (medical management along with a intra-oral orthotic, physical therapy and cognitive-behavioral therapy), 27 to an arthroscopy group, and 26 to an arthroplasty group. Ten patients withdrew before receiving treatment. An intention-to-treat analysis was performed at five years and 8 of 10 withdrawals were included in their assigned group. The study was single-blind (blinded outcome assessment). The two primary outcome measures were the craniomandibular index of pain, and function on the symptom severity index; both range from 0 to 1, with 0 being the lowest value. There was not a significant difference among groups in either of the 2 primary outcomes at any follow-up visit, including the 6-month, 1-, 2- and 5-year visits. For example, mean scores on the symptom severity index at 1 year were 0.28 in the medical management group, 0.31 in the rehabilitation group, 0.30 in the arthroscopy group and 0.20 in the arthroplasty group (p=0.37). Corresponding scores on the craniomandibular index at 1 year were 0.20, 0.20, 0.21 and 0.23, respectively (p=0.86).
 
Summary
Other than on acupuncture, the literature search did not identify any studies that would lead to changes in the policy statements as written at the time of the last policy update. The primary conclusion from the systematic review of studies on acupuncture for TMJ dysfunction is that evidence on efficacy is insufficient due to a lack of rigorous trials.
 
Technology Assessments, Guidelines and Position Statements
American Society of Temporomandibular Joint Surgeons: Consensus clinical guidelines, published in 2001, focus on TMJ associated with internal derangement and osteoarthritis.  For diagnosis of this type of temporomandibular joint dysfunction, a detailed history and, when indicated, general physical examination are recommended. Imaging of the TMJ and associated structures is also recommended. Options for basic radiography to provide information on temporal bone and condylar morphology include use of plain films, panoramic films and tomograms. Also recommended is imaging of the disc and associated soft tissue with MRI or arthrography. Other diagnostic procedures that may be indicated include computed tomography, MRI, arthrography (for selected cases) and isotope bone scans.
 
Non-surgical treatment should be considered first for all symptomatic patients with this condition. Recommended treatment options include change in diet, non-steroidal anti-inflammatory drugs, maxillomandibular appliances, physical therapy, injections of corticosteroids or botox, and behavior modification. If adequate symptom relief does not occur within 2-3 weeks, surgical consultation is advised. The guideline states that the following surgical procedures are considered to be accepted and effective for patients with TMJ associated with internal derangement/osteoarthritis:
    • Arthrocentesis
    • Arthroscopy
    • Condylotomy
    • Arthrotomy (prosthetic joint replacement may be indicated in selected patients who have severe joint degeneration, destruction or ankylosis)
    • Coronoidotomy/coronoidectomy
    • Styloidectomy
 
American Dental Association: Selected statements from their dental practice parameters for TMJ, revised in 1997
    • The key element in the design of this set of parameters for temporomandibular (TM) disorders is the professional judgment of the attending dentist, for a specific patient, at a specific time
    • Initially the dentist should select the least invasive and most reversible therapy that may ameliorate the patient’s pain and/or functional impairment.
    • Any treatment performed should be with the concurrence of the patient and the dentist.
    • The dentist should evaluate the effectiveness of initial therapy prior to considering more invasive and/or irreversible therapy.
    • The dentist should counsel the patient that TM disorders are often managed, rather than resolved, and that symptoms of TM disorders may persist, change, or recur intermittently.
    • The patient should be informed that the success of treatment is often dependent upon patient compliance with prescribed treatment and recommendations for behavioral modifications. Lack of compliance should be recorded.
    • When articular derangement and/or condylar dislocation has been determined to be the etiology of the patient’s pain and/or functional impairment, manual manipulation of the mandible may be performed by the dentist.
    • Oral orthotics (guards/splints) may be used by the dentist to enhance diagnosis, facilitate treatment or reduce symptoms.
    • The dentist should periodically evaluate oral orthotics (guards/splints) for their effectiveness, appropriateness and possible risks associated with continued use.
    • Before restorative and/or occlusal therapy is performed, the dentist should attempt to reduce, through the use of reversible modalities, the neuromuscular, myofascial and temporomandibular joint symptoms.
    • The dentist may replace teeth, alter tooth morphology and/or position by modifying occluding, articulating, adjacent or approximating surfaces, and by placing or replacing restorations (prostheses) to facilitate treatment.
    • Transitional or provisional restorations (prostheses) may be utilized by the dentist to facilitate treatment.
    • Intracapsular and/or intramuscular injection, and/or arthrocentesis may be performed for diagnostic and/or therapeutic purposes.
    • Orthodontic therapy may be utilized to facilitate treatment.
    • Orthognathic surgery may be performed to facilitate treatment.
    • When internal derangement or pathosis has been determined to be the cause of the patient’s pain and/or functional impairment, arthroscopic or open resective or reconstructive surgical procedures may be performed by the dentist.
 
2011 Update
A search of the MEDLINE database was conducted through May 2011.  The following is a summary of the relevant literature that was identified.
 
A 2009 systematic review identified 20 studies evaluating ultrasound for diagnosing TMJ disorders; all studies evaluated disc displacement and several additionally considered osteoarthrosis and/or joint effusion (Manfredini, 2009). The reported sensitivity of ultrasound to detect disc displacement, compared to the reference standard (MRI in the majority of studies), ranged from 31-100%, and the specificity ranged from 30-100%. The investigators stated that, even when changes in ultrasound technology over time were taken into consideration, study findings were contradictory. They noted unexplained differences between studies conducted by the same group of researchers. The authors concluded that additional progress needs to be made in standardizing ultrasound assessment of the TMJ joint before this can be considered an accurate tool for diagnosing TMJ disorders.
 
A 2011 meta-analysis identified 7 sham-controlled RCTs on acupuncture for treating TMJ disorders (Jung, 2011). The studies included a total of 141 patients. Sample sizes of individual studies ranged from 7 to 28. Four studies used a single acupuncture session, and the other 3 used 6-12 sessions. All 7 studies reported change in pain intensity as assessed by a visual analogue scale (VAS). In 6 of the studies, pain intensity was measured immediately after treatment, the 7th measured pain after 16 weeks. A pooled analysis of findings from 5 studies (n=107) found a statistically significant improvement in pain intensity, as measured by a VAS. The pooled weighted mean difference (WMD) in pain intensity was -13.63 (95% confidence interval [CI]: -21.16 to -6.10, p=0.0004). In a sub-group analysis, a pooled analysis of 4 studies (n=89) found acupuncture to be superior to a non-penetrating sham acupuncture, WMD: -13.73, 95% CI:-21.78 to -5.67, p=0.0008. A pooled analysis of 2 studies (n=18) did not find a significant difference in efficacy between acupuncture and a penetrating sham acupuncture, WMD: -12.95, 95% CI:-34.05 to 8.15, p=0.23. The latter analysis may have been underpowered. The authors noted that previous studies have found that a 24.2 mm change in pain assessed by a 100 mm VAS represents a clinically significant difference and that only 2 of the included studies had a change of 24.2 mm or more. The evidence on acupuncture is limited by the small number of studies, small sample sizes, and, in most studies, assessment of effectiveness only immediately post-treatment.
 
A 2010 systematic review searched for RCTs on intraoral treatment of TMJ disorders and identified 47 publications on 44 trials (Fricton, 2010). Intraoral appliances included soft and hard stabilization appliances, anterior positioning appliances, anterior bite appliances, and soft resilient appliances. Studies compared 2 types of devices or compared one device to a different treatment, e.g., acupuncture or biofeedback None of the studies evaluated use of one device during the day and a different device during the night. The primary outcome of the meta-analysis was pain. Pain was measured differently in the studies, and the authors defined a successful outcome as at least a 50% reduction in pain on a self-report scale or at least an “improved” status when pain was measured by subjective report of status. Ten RCTs were included in a meta-analysis; the others were excluded because they did not measure pain, there were not at least 2 studies using similar devices or control groups, or data were not usable in a pooled analysis. A pooled analysis of 7 RCTs with 385 patients evaluating hard stabilization appliances and using palatal non-occluding appliances as a control found a significantly greater reduction in pain with hard appliances (odds ratio [OR]: 2.45, 95% CI: 1.56 to 3.86, p=0.0001). A pooled analysis of 3 studies with 216 patients did not find a significant effect of hard appliances compared to a no-treatment control group, OR: 2.14 (95% CI: 0.80 to 5.75, p=0.12), p=0.86.
 
A 2010 Cochrane review by Luther and colleagues did not identify any RCTs evaluating orthodontic treatment for treating TMJ disorders and thus concluded that there is insufficient evidence on the efficacy of orthodontics (Luther, 2010). They defined orthodontic treatment as appliances that would induce stable tooth movement for a sufficient period of time to bring about permanent change in tooth position. The 2010 Cochrane review was withdrawn in 2016 for being out of date and not meeting current Cochrane methodologic standards (Luther, 2016); a new Cochrane review on occlusal interventions for managing TMJDs is planned.
 
 
In summary a recent systematic review suggests that there is insufficient evidence that ultrasound is sufficiently accurate and reliable for use in diagnosing TMJ disorders. Other recent systematic reviews and meta-analyses do not suggest changes to the policy statements on treatment of TMJ.
 
2012 Update
A search of the MEDLINE database was conducted through June 2012.  The search focused on identifying recent systematic reviews and meta-analyses as well controlled studies evaluating hyaluronic acid as a treatment for TMJ dysfunction.
 
The identified literature is summarized below.
 
In 2011, the Cochrane collaboration published a systematic review of psychosocial interventions for managing chronic orofacial pain (Aggarwal, 2011). The review included 15 RCTs on TMJ disorders. However, only 9 of the trials had data that were suitable for pooling; the others were excluded due to study design and/or because they only reported data graphically. The 9 studies had a high degree of heterogeneity e.g., used different interventions, reported different outcomes or outcomes over different time periods. The interventions addressed in the studies included cognitive-behavioral therapy (CBT) alone (4 studies), biofeedback alone (2 studies), combination of CBT and biofeedback (2 studies), and physical self-regulation (1 study). Short-term follow-up was defined as 3 months or less, and long-term as more than 3 months. Due to heterogeneity among studies, an overall pooled analysis of data from the 7 studies on short-term pain could not be performed. The investigators were able to pool data from the 2 studies on combined CBT and biofeedback compared to usual care; the analysis found a statistically significant difference favoring usual care (standardized mean difference [SMD]: 0.46, 95% confidence interval (CI): 0.02 to 0.90). A pooled analysis of the 2 studies on biofeedback alone did not find a significant benefit of the intervention (SMD: -0.41; 95% CI: -1.06 to 0.25). In a pooled analysis of data from the 7 studies on long-term change in pain, there was a statistically significant difference in favor of psychosocial interventions compared to control interventions (SMD: -0.34; 95% CI: -0.50 to -0.18). Pooled analyses of 4 studies on CBT alone and 3 studies on CBT plus biofeedback also significantly favored the group receiving the psychosocial intervention. Only one study each reported long-term pain with biofeedback alone and with physical self-regulation.
 
A meta-analysis of RCTs on low-level laser therapy for treating TMJ disorders was published in 2011 (Petrucci, 2011). The investigators identified 6 randomized placebo-controlled trials. A pooled analysis of data from the 6 trials did not find a statistically significant difference in the primary outcome of interest, change in pain from baseline to endpoint. The pooled difference in pain, measured on a visual analogue scale (VAS), was a mean difference of 7.77 mm (95% CI: -2.49 to 18.02), p=0.14. All studies had small sample sizes (ranging from a total of 14 to 52 participants), and the confidence interval in the pooled analysis was wide.
 
Hyaluronic Acid
Literature on hyaluronic acid was added to the policy in 2012. There are several systematic reviews of studies on hyaluronic acid for treating TMJ disorders (Manfredini, 2010; Machado, 2013; Shi, 2003; Goiato, 2016). Only one of the systematic reviews limited its inclusion criteria to randomized controlled trials and pooled study findings- the 2013 Cochrane review by Shi et al.. This was a Cochrane review by Shi and colleagues, published in 2003 (Shi, 2003). The Shi review included RCTs comparing the effect of at least one hyaluronic acid injection alone or in combination with other active treatments to placebo or glucocorticoid injections alone or in combination with the same active treatment group. A total of 7 studies met inclusion criteria; 3 studies compared hyaluronic acid and placebo, 3 studies compared hyaluronic acid and glucocorticoids and 2 studies compared hyaluronic acid plus arthroscopy or arthrocentesis to arthroscopy or arthrocentesis alone. (One study included 3 arms and was included in the first 2 comparisons). Five of the 7 studies included fewer than 50 participants.
 
Outcomes were categorized as symptoms which reflected subjective feeling and the judgment of the patients and clinical signs which reflected objective judgment of the observer. A meta-analysis of 2 trials did not find a statistically significant difference between hyaluronic acid and placebo on short-term (less than 3 months) improvement in symptoms (risk ratio [RR]: 1.24; 95% CI: 0.72 to 2.14). Similarly, a pooled analysis of 3 trials did not find a significant difference between hyaluronic acid and placebo on short-term improvement of clinical signs (RR:1.69; 95% CI: 0.80 to 3.57). However, a pooled analysis of 2 studies found a statistically significant between-group difference in long-term effect on clinical signs (RR: 1.71; 95% CI: 1.05 to 2.77) (long-term was defined as 3 months or longer). For the comparison between hyaluronic acid and glucocorticoids, only short-term data were available for pooling. There were no significant differences between groups on short-term improvement in symptoms (2 studies, RR: 0.99; 95% CI: 0.84-1.17) or short-term improvement in clinical signs (3 studies, RR: 0.91; 95% CI: 0.66 to 1.25). Data were not pooled for studies on combination treatment (hyaluronic acid plus arthroscopy or arthrocentesis). The investigators concluded that there is insufficient consistent evidence to draw conclusions on the use of hyaluronate for treating patients with TMJ disorders.
Most of the published RCTs evaluating hyaluronic acid for treating TMJ disorders had small sample sizes, short follow-up times, and/or lack of blinding. Representative RCTs published through May 2012 are described below. RCTs with larger sample sizes and stronger methodology were selected for description. The Cochrane review was withdrawn in 2013 for being out of date and not meeting contemporary Cochrane methodology standards (Shi, 2013).
 
A 2012 study by Manfredini and colleagues in Italy randomized 72 patients with TMJ dysfunction to one of 6 treatment groups: 1) single-session arthrocentesis alone; 2) single-session arthrocentesis plus corticosteroid; 3) single-session arthrocentesis plus low-molecular weight hyaluronic acid; 4) single-session arthrocentesis plus high-molecular weight hyaluronic acid; 5) 5 weekly 2-needle arthrocenteses plus low-molecular weight hyaluronic acid; or 6) 5 weekly single-needle arthrocenteses plus low-molecular weight hyaluronic acid (Manfredini, 2012). A total of 60 out of 72 (83%) participants completed the study, between 9 and 12 patients per treatment group. In a per protocol analysis, there were no significant differences among groups on any of the outcome variables at the 3-month follow-up. For example, the percentage change in pain at rest ranged from -29.1% (standard deviation [SD]: 62.9%) in the group receiving 5 weekly single-needle arthrocenteses plus low-molecular weight hyaluronic acid to -38.4% (SD: 56.5%) in the group receiving a single-session of arthrocentesis alone. Limitations of the study include the small number of patients in each treatment group and the substantial number of dropouts in absence of an intention-to-treat analysis.
 
A 2007 study by Bjorland and colleagues in Norway published a double-blind RCT that included 40 patients with osteoarthritis of the TMJ (Bjornland, 2007). Patients received 2 injections, 14 days apart, of either sodium hyaluronate or corticosteroids. Pain was assessed using a visual analogue scale (VAS) from 0 to 100. Patients were followed for 6 months (assessed at 14 days, 1 month and 6 months). There was a statistically significant reduction in pain within each group at all of the follow-up points. At the 6 month follow-up, pain intensity (mean VAS score) was 14 (SD: 16) in the hyaluronic acid group and 31 (SD: 32) in the corticosteroid group; the difference was statistically significant (p=0.0012). The number of patients who were pain-free at 6 months was 7 of 20 (35%) in the hyaluronic acid group and 6 of 20 (30%) in the corticosteroid group (p value not reported).
 
Bertolami and colleagues published a double-blind placebo-controlled trial in 1993 which included 121 TMJ patients (Bertolami, 1993). Patients needed to have a confirmed diagnosis of degenerative joint disease (DJD), reducing displaced disc (DDR) or non-reducing displaced disc (DDN), to have failed other non-surgical treatments, and to have severe dysfunction. Patients received a single injection of sodium hyaluronate or saline and were followed for 6 months. A total of 80 patients were randomized to the hyaluronate group and 41 to the placebo group. This included a total of 57 patients in the DJD group, 50 patients in the DDR group, and 14 patients in the DDN group. Fourteen of 121 patients (12%) were excluded from the analysis because they were found not to meet eligibility criteria. No significant differences in outcomes were seen for the DJD group. In the DDN group, there were significant between-group differences through 1 month, favoring the hyaluronic acid group. The number of patients in the DDN group who completed follow-up after 1 month was insufficient to draw meaningful conclusions about efficacy. In the DDR group, there were no statistically significant differences between groups in any outcome at 1 or 2 months. At 3 and 6 months, 2 out of 7 reported outcomes were significantly better in the hyaluronic acid compared to the placebo group. At 5 months, 5 out of 7 reported outcomes were significantly better in the hyaluronic acid group. The 7 outcomes included 3 measures of dysfunction, 2 measures of patient perception of improvement, 2 measures of change in noise. The most consistent between-group differences in the DDR group were for the 2 measures of patient perception of improvement and one of the noise variables. There were fewer between-group differences on dysfunction measures.
 
Summary
The evidence on diagnosis of TMJ dysfunction supports the use of several diagnostic modalities, as listed in the policy statement. The evidence on treatment of TMJ dysfunction includes a large number of RCTs evaluating different treatment modalities, and systematic reviews of these RCTs.
 
Hyaluronic acid and low-level laser therapy were added to the policy as non-covered indications.. A new systematic review did not find that low-level laser therapy improves health outcomes in patients with TMJ disorder. The evidence on hyaluronic acid is mixed, with some studies reporting benefits in pain but some that do not. Overall, there is a lack of consistent evidence from RCTs that hyaluronic acid improves outcomes compared to placebo or an alternative treatment, and results of systematic reviews do not support a benefit.
 
2014 Update
This policy is being updated with a literature search through March 2014. The following is a summary of the key identified literature.
 
Joint vibration analysis
In 2013, Sharma and colleagues published a systematic review of literature on joint vibration analysis for diagnosis of TMJ disorders (Sharma, 2013). The authors identified 15 studies that evaluated the reliability and/or diagnostic accuracy of joint vibration analysis compared to a reference standard. Methodological limitations were identified in all the studies. These limitations included the absence of well-defined diagnostic criteria, use of a non-validated system for classifying disease progression, variability within studies in the reference standard, and lack of blinding. In the 14 studies reporting on diagnostic accuracy, there was a wide range of reported values, with sensitivity ranging from 50-100% and specificity ranging from 59-100%.
 
Stabilization splints
In 2012, Ebrahim and colleagues identified 11 RCTs comparing splint therapy for TMJ to minimal or no therapy (Ebrahim, 2012).  Nine of the 11 studies used stabilization splints, 1 used soft splints and 1 used an anterior repositioning appliance. The authors used the GRADE system to rate study quality. Nine studies did not report whether allocation was concealed, and 6 studies did not report masking of outcome assessors. Length of follow-up in the studies ranged from 6 to 52 weeks. A pooled analysis of study findings found that splint therapy was significantly associated with a reduction in reported pain compared to minimal or no intervention (standardized mean difference [SMD]: -0.93, 95% CI: -1.33 to -0.53). Using a visual analogue scale to measure pain, splint therapy was associated with an 11.5 mm lower mean VAS score (95% CI: -16.5 mm to -6.6 mm). There were not statistically significant differences between groups in quality of life or depression scores. An earlier meta-analysis by Al-Ani and colleagues, published in 2004, identified 12 RCTs that compared stabilization splint therapy for TMJ dysfunction to a control intervention (Al-Ani, 2004). (The control group was not limited to minimal or no intervention as in the Ebrahim review, described above). There was wide variability in the comparison interventions and no standardization of outcomes; thus, results of the studies were not pooled.  
 
This Cochrane review was withdrawn in 2016 for being out of date and not meeting current Cochrane methodologic standards (Al-Ani, 2016); a new Cochrane review on occlusal interventions for managing TMJDs is planned.
 
Surgery
In a 2013 systematic review, Vos and colleagues identified 3 RCTs with a total of 222 patients comparing the efficacy of lavage of the TMJ (i.e., arthrocentesis or arthroscopy) to non-surgical TMJ treatment (Vos, 2013).  Although they assessed the quality of the studies to be adequate, only 1 study stated that allocation to treatment group was concealed, and 2 studies did not explicitly state that an intention-to-treat analysis was used. The 2 primary outcomes considered were change in pain and maximal mouth opening (MMO) at 6 months compared to baseline. Pain was measured by a visual analogue scale (VAS). Pooled analysis of data from the 3 trials found a statistically significant reduction in pain at 6 months with lavage versus non-surgical therapy (SMD: -1.07, 95% CI: -1.38 to -0.76). There was not a statistically significant difference in the efficacy of the 2 treatments for the other outcome variable, MMO (SMD: -0.05, 95% CI;-0.33 to 0.23).
 
2016 Update
A literature search conducted through February 2016 did not reveal any new randomized controlled trials or any new information that would prompt a change in the coverage statement.     
 
2017 Update
A literature search conducted using the MEDLINE database through February 2017 did not reveal any new information that would prompt a change in the coverage statement. The following are summaries of key identified literature.
 
In 2016, Randhawa et al published a systematic review of noninvasive interventions for TMJDs, which included RCTs with at least 30 individuals per treatment arm, cohort studies with at least 100 patients per exposed group, and case control interventions (Randhawa, 2016). Reviewers identified 31 studies for appraisal, of which 7 RCTs described in 8 publications had a low risk of bias and were assessed further. Most RCTs evaluated interventions outside the scope of our review, including cognitive-behavioral therapy and self-care management. Three RCTs evaluated occlusal devices for TMJDs of variable duration, and generally reported no significant improvements with occlusal devices in terms of pain, mouth opening, or other outcomes.
 
Intraoral Devices or Appliances
In 2016, Ivorra-Carbonell et al reported on a systematic review of functional advancement devices for TMJD, which included systematic reviews, meta-analyses, RCTs, case-control studies, and cohort studies (Ivorra-Carbonell, 2016). Reviewers included 21 articles evaluating some kind of advancement device, considered of medium or high quality by CONSORT criteria. Results were summarized descriptively; reviewers concluded that after treatment with mandibular advancement the condyle was in “more advanced position.”
 
Stabilization Splints
In another systematic review published in 2016, Zhang et al identified 13 publications from 11 studies (n=538 patients) evaluating splint therapy for TMJDs (Zhang, 2016). Risk of bias was high for 2 or more domains for all of the studies. Splint therapy group patients had greater improvement in pain control than control patients (mean difference [MD], 2.02; 95% CI, 1.55 to 2.49; I2=0.558).
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Häggman-Henrikson et al published a systematic review that included 41 RCTs assessing various pharmacologic regimens for pain from TMJDs or burning mouth syndrome; of these, 13 were selected for a network meta-analysis Haggman-Henrikson, 2017). Nine studies evaluated temporomandibular muscular pain, which appeared to decrease more with cyclobenzaprine than with placebo, although no specific statistics were reported. Pain reduction was also favorable for botulinum toxin and Ping-On ointment in the meta-analysis; other descriptive analyses showed a reduction of pain with nonsteroidal anti-inflammatory drugs and melatonin tablets when compared with placebo.
 
 
Liu et al conducted a systematic review and meta-analysis of RCTs or cohort studies that compared temporomandibular osteoarthritis outcomes in patients treated with intra-articular corticosteroid, hyaluronate, or placebo injection (Liu, 2017). All 8 selected studies were RCTs; of these, three contained data on hyaluronate injection. Compared with placebo, corticosteroid injections prompted a significant decrease in long-term (ie, ≥6 months postprocedure) pain (3 studies; mean difference, -0.74; 95% CI, -1.34 to -0.13; p=0.02; I2=0%). However, in a pooled analysis of 2 studies (both of which included pretreatment arthrocentesis), long-term maximal mouth opening was increased for placebo more than for corticosteroid injection (mean difference, -2.06; 95% CI, -2.76 to -1.36; p<0.001; I2=28%). Only 2 studies were available for comparing corticosteroid with hyaluronate injections, which precluded strong analysis. Short-term pain and mouth opening measures did not significantly differ between any of the injection groups, nor did the incidence of adverse events. The meta-analysis was limited by the small sample sizes of included trials, as well as by the variety of corticosteroid types used. Reviewers concluded that corticosteroid injection following arthrocentesis may be effective for relief of long-term joint pain, but may be less effective for improving mouth opening.
 
 
Most published RCTs evaluating hyaluronic acid for treating TMJDs have had small sample sizes, short follow-up times, and/or lacked blinding. Representative RCTs with larger sample sizes and stronger methodology are described next.
 
Gorrela et al reported on the efficacy of injecting sodium hyaluronate in patients with TMJDs (Gorrela, 2017). The trial comprised 62 individuals with the disorder; some members (n=31) of the trial were treated with arthrocentesis, and some members (n=31) were treated by a combination of arthrocentesis and an injection of sodium hyaluronate. Follow-up was observed at 1 week, 2 weeks, 1 month, 3 months, and at 6 months. Using a VAS, patients were asked to measure pain from 1 to 10. Pain decreased significantly for patients in both treatment groups (p<0.001) at the 1 week and the 6-month follow-up; however, patients who were injected with sodium hyaluronate reported a significantly stronger decrease in pain at the 6-month follow-up (p<0.001). Preoperative mean VAS pain scores for patients who received injection started at 6.0; by the 6-month follow-up, the mean VAS pain score was 0.23. Preoperative mean pain scores for patients who received arthrocentesis alone started at 6.77; by the 6-month follow-up, the mean pain score was 1.71. While not an overwhelmingly significant difference, the trialists concluded that adding an injection of sodium hyaluronate to arthrocentesis treatment can significantly decrease the pain felt by patients who suffer from TMJD.

CPT/HCPCS:
20605Arthrocentesis, aspiration and/or injection, intermediate joint or bursa (eg, temporomandibular, acromioclavicular, wrist, elbow or ankle, olecranon bursa); without ultrasound guidance
20606Arthrocentesis, aspiration and/or injection, intermediate joint or bursa (eg, temporomandibular, acromioclavicular, wrist, elbow or ankle, olecranon bursa); with ultrasound guidance, with permanent recording and reporting
21010Arthrotomy, temporomandibular joint
21050Condylectomy, temporomandibular joint (separate procedure)
21060Meniscectomy, partial or complete, temporomandibular joint (separate procedure)
21073Manipulation of temporomandibular joint(s) (TMJ), therapeutic, requiring an anesthesia service (ie, general or monitored anesthesia care)
21116Injection procedure for temporomandibular joint arthrography
21240Arthroplasty, temporomandibular joint, with or without autograft (includes obtaining graft)
21242Arthroplasty, temporomandibular joint, with allograft
21243Arthroplasty, temporomandibular joint, with prosthetic joint replacement
29800Arthroscopy, temporomandibular joint, diagnostic, with or without synovial biopsy (separate procedure)
29804Arthroscopy, temporomandibular joint, surgical
70330Radiologic examination, temporomandibular joint, open and closed mouth; bilateral
70332Temporomandibular joint arthrography, radiological supervision and interpretation
70336Magnetic resonance (eg, proton) imaging, temporomandibular joint(s)
70350Cephalogram, orthodontic
70355Orthopantogram (eg, panoramic x-ray)
97010Application of a modality to 1 or more areas; hot or cold packs
97024Application of a modality to 1 or more areas; diathermy (eg, microwave)
97026Application of a modality to 1 or more areas; infrared
97033Application of a modality to 1 or more areas; iontophoresis, each 15 minutes
J7320Hyaluronan or derivitive, genvisc 850, for intra-articular injection, 1 mg
J7321Hyaluronan or derivative, Hyalgan or Supartz, for intra-articular injection, per dose
J7322Hyaluronan or derivative, hymovis, for intra-articular injection, 1 mg
J7323Hyaluronan or derivative, Euflexxa, for intra-articular injection, per dose
J7324Hyaluronan or derivative, Orthovisc, for intra-articular injection, per dose
J7325Hyaluronan or derivative, Synvisc or Synvisc-One, for intra-articular injection, 1 mg
J7326Hyaluronan or derivative, Gel-One, for intra-articular injection, per dose
J7327Hyaluronan or derivative, Monovisc, for intra-articular injection, per dose
J7328Hyaluronan or derivative, gel-syn, for intra-articular injection, 0.1 mg

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