prior authorization review panel mco policy …...page 5 of 63 tmj surgery may be considered...

Prior Authorization Review PanelMCO Policy Submission

A separate copy of this form must accompany each policy submitted for review.Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health Submission Date:04/01/2019

Policy Number:0028 Effective Date: Revision Date: 03/18/2019

Policy Name: Temporomandibular Disorders

Type of Submission – Check all that apply: New Policy Revised Policy* Annual Review – No Revisions

*All revisions to the policy must be highlighted using track changes throughout the document. Please provide any clarifying information for the policy

below: CPB 0028 Temporomandibular Disorders

This CPB has been revised to state that ultrasonography is considered medically necessary for diagnosis of internal derangements of the temporomandibular joints. This CPB is revised to state that intra-articular injection of analgesics is considered experimental and investigational for the treatment of TMDs.

Update History since the last PARP Submission:

01/29/2019 This CPB has been updated with additional coding.

Name of Authorized Individual (Please type or print):

Dr. Bernard Lewin, M.D.

Signature of Authorized Individual:

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http://www.aetna.com/cpb/medical/data/1_99/0028.html 03/28/2019

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Temporomandibular Disorders

Clinical Policy Bulletins Medical Clinical Policy Bulletins

Policy History

Last Re

view

03/18/2019

Effective: 08/01/1995

Next

Review: 01/09/2020

Review

Histor

y

Definitions

Additional Informat ion

Number: 0028

Policy

*Please see amendment for Pennsylvania Medicaid at the end of this CPB.

Notes: Some Aetna HMO plans exclude coverage for treatment of

temporomandibular disorders (TMD) and temporomandibular joint (TMJ)

dysfunction and may also exclude coverage for other services described in this

bulletin (e.g., non-surgical management) The plan determines the scope of

coverage. Please check benefit plan descriptions for details.

For plans that cover treatment of TMD and TMJ dysfunction, requests for TMJ

surgery require review by Aetna's Oral and Maxillofacial Surgery patient

management unit. Reviews must include submission of a problem-specific history

(i.e., Aetna Temporomandibular Disorder Questionnaire) and physical examination,

TMJ radiographs/diagnostic imaging reports, patient records reflecting a complete

history of 3 to 6 months of non-surgical management (describing the nature of the

non-surgical treatment, the results, and the specific findings associated with that

treatment), and the proposed treatment plan. The provider will be notified of the

coverage decision after review of all pertinent data.

I. Diagnostic Testing

Aetna considers the following medically necessary for diagnostic testing for

TMJ/TMD using the following modalities:

http://www.aetna.com/cpb/medical/data/1_99/0028.html

https://www.aetna.com/

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A. Examination including a history, physical examination, muscle testing,

range of motion measurements and psychological evaluation as

necessary; and

B. Diagnostic X-rays - a single panoramic X-ray of the jaws is considered

medically necessary for the initial evaluation of TMJ disorders. The

current scientific literature does not show that additional x-rays will

result in better, reproducible outcomes during the initial screening or

when fabricating of a TMJD oral splint. Additional X-rays are considered

medically necessary if surgery is contemplated; and

C. Ultrasonography for detection of internal derangements of the

temporomandibular joint; and

D. Computed tomography (CT) or magnetic resonance imaging (MRI) only

when used in conjunction with anticipated surgical management.

II. Non-Surgical Management

Comprehensive non-surgical management of TMJ/TMD includes all of the

following, unless contraindicated:

A. Reversible Intra-Oral Appliances: (i.e., removable occlusal orthopedic

appliances-orthotics, stabilization appliances, occlusal splints, bite

appliances/planes/splints, mandibular occlusal repositioning appliances

[MORAs])

Reversible intra-oral appliances may be considered medically necessary

in selected cases only when there is evidence of clinically significant

masticatory impairment with documented pain and/or loss of function.

Prolonged (greater than 6 months) application of TMD/J intra-oral

appliances is not considered medically necessary unless, upon individual

case review, documentation is provided that supports prolonged intra-

oral appliance use. Note: Appliances for bruxism are typically excluded

under Aetna medical plans (please check benefit plan descriptions) but

may be covered under dental plans. Only 1 oral splint or appliance is

considered medically necessary for TMD/TMJ therapy.

For plans that cover intra-oral appliances, adjustments of intra-oral

appliances performed within 6 months of initial appliance therapy are

considered medically necessary; while adjustments performed after 6


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months are subject to review to determine necessity and

appropriateness. More than 4 adjustments or adjustments that are

done more than 1 year after placement of the initial appliance are

subject to review. Note: Replacement of a lost, missing or stolen intra-

oral appliance is not covered; while replacement (for other reasons) or

repair is subject to review to determine necessity and appropriateness.

Note: Intra-oral appliances for the treatment of headaches or trigeminal

neuralgia are considered experimental and investigational, as there is

insufficient data on the effectiveness of this therapy. See CPB 0688 - Intra

oral Appliances for Headaches and Trigeminal

Neuralgia (../600_699/0688.html).

B. Physical Therapy:

Aetna considers physical therapy to be a medically necessary

conservative method of TMD/TMJ treatment. Therapy may include

repetitive active or passive jaw exercises, thermal modalities (e.g., hot or

cold packs), manipulation, vapor coolant spray-and-stretch technique,

and electro-galvanic stimulation. See CPB 0325 - Physical

Therapy (../300_399/0325.html) for medical necessity criteria and

documentation requirements for physical therapy. For manipulation

under anesthesia for TMD/TMJ, see CPB 0204 - Manipulation Under

General Anesthesia (../200_299/0204.html).

C. Pharmacological Management:

Non-opiate analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) are

considered medically necessary for mild-to-moderate inflammatory conditions and

pain. Low-dosage tricyclic antidepressants (e.g., amitriptyline) are considered

medically necessary for treatment of chronic pain, sleep disturbance and nocturnal

bruxism. Adjuvant pharmacologic therapies, including anticonvulsants, membrane

stabilizers, and sympatholytic agents, are considered medically necessary for

unremitting TMJ pain. Opiate analgesics, corticosteroids, anxiolytics, and muscle

relaxants are considered medically necessary in refractory pain.

D. Relaxation Therapy and Cognitive Behavioral Therapy (CBT):


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Aetna considers relaxation therapy, electromyographic biofeedback and cognitive

behavioral therapy medically necessary for treatment of TMJ/TMD.

Relaxation therapy, electromyographic biofeedback, and cognitive

behavioral therapy are considered medically necessary in chronic

headaches and insomnia, which are frequently associated with TMD/TMJ

conditions. The above therapies may be considered medically necessary

in treating these conditions as well. Treatment in multi-disciplinary pain

centers may be considered medically necessary in those few individuals

who have been unresponsive to less comprehensive interventions.

See CPB 0237 - Chronic Pain Programs (../200_299/0237.html).

E. Acupuncture and Trigger Point Injections:

(Note: some plans limit coverage of acupuncture only when used in lieu

of surgical anesthesia. Please check plan benefit descriptions for details.

See CPB 0135 - Acupuncture (../100_199/0135.html)). Aetna considers

acupuncture and trigger point injections medically necessary for persons

with temporomandibular pain. For acute pain, generally 2 visits per week

for 2 weeks are considered medically necessary. Additional treatment is

considered medically necessary when pain persists, and further

improvement is expected.

F. Manipulation for reduction of fracture or dislocation of the TMJ is

considered medically necessary.

III. Surgical Procedures

Surgical procedures include therapeutic arthroscopy, arthrocentesis,

condylotomy/eminectomy, modified condylotomy, arthroplasty, and joint

reconstruction using autogenous or alloplastic materials. In general, the

least invasive appropriate surgical treatments should be attempted prior to

progression to more complicated surgeries. Note: All TMJ surgical

precertification requests or claims are reviewed by Aetna's Oral and

Maxillofacial Surgery (OMS) Patient Management Unit.


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TMJ surgery may be considered medically necessary in cases where there is conclusive

evidence that severe pain or functional disability is produced by an intra-capsular

condition, confirmed by magnetic resonance imaging (MRI), computed

tomography or other imaging, that has not responded to nonsurgical management, and

surgery is considered to be the only remaining option. Nonsurgical management include

three or more months of t he following, where appropriate: professional physical

therapy, pharmacological therapy, behavioral therapy (such as cognitive behavioral

therapy or relaxation therapy), manipulation (for reduction of dislocation or fracture of

the TMJ) and reversible intra-oral appliances (unless the member is unable to open

mouth wide enough). In certain cases (e.g., bony ankylosis and failed TMJ total joint

prosthetic i mplants) that require immediate surgical intervention, surgery may be

considered medically necessary without prior non-surgical management. Note: All

requests for surgery must include documentation that all medically appropriate non-

surgical therapies noted above have been exhausted. Patients with chronic head and

neck pain may be candidates for chronic pain assessment.

A. Arthrocentesis with insufflation, lysis, and lavage is considered medically

necessary when imaging and clinical examination reveal anchored disc

phenomenon, anterior disc displacement without reduction and without

effusion, osteoarthritis without fibrosis or loose bone particles, open

lock, or hemarthrosis. Note: For purposes of this policy, arthrocentesis for

TMJ internal derangement is defined as the insertion of two separate

single- needle portals or a single double- needle portal for input and

output of fluids. The process includes insufflation of the joint space,

lavage, manipulation of the mandible for the purpose of lysis of

adhesions, and the elective infusion of steroids.

B. Therapeutic arthroscopy is considered medically necessary when MRI or

other imaging confirms the presence of adhesions, fibrosis, degenerative

joint disease, or internal derangement of the disc that requires internal

modification.

C. Open surgical procedures including, but not limited to meniscus or disc

repositioning or plication, disc repair, and disc removal with or

without replacement are considered medically necessary when TMJ

dysfunction is the result of congenital anomalies, trauma, or disease in

patients who have failed nonsurgical management.

D. Arthroplasty or arthrotomy includes a) disk repair procedures;

b) diskectomy with or without replacement; and c) articular surface

recontouring (condylectomy and eminectomy or eminoplasty).


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Arthroplasty or arthrotomy is considered medically necessary when MRI

or other imaging confirms the presence of any of the following:

1. Osteoarthritis or osteoarthrosis; or

2. Severe disc displacement associated with degenerative changes or

perforation; or

3. Scarring that is severe and often the result of old injury or prior

procedure

E. Aetna considers joint replacement with an FDA-approved prosthesis

(including the TMJ Concepts prosthesis, the Christensen TMJ Fossa-

Eminence Prosthesis System (partial TMJ prosthesis), the Christensen

TMJ Fossa-Eminence/Condylar Prosthesis System (Christensen total joint

prosthesis), or the W. Lorenz TMJ prosthesis) medically necessary when

used as a “salvage device” for treatment of end-stage TMJ disease, when

conservative management and other surgical treatment has been

unsuccessful, and MRI or other imaging documents one or more of the

following:

1. Temporal bone that no longer provides a smooth articular fossa; or

2. Damaged condyles that are no longer ball-shaped; or

3. Persistent, stable inflammatory arthritis that is not responsive to

other modalities of treatment; or

4. Recurrent fibrous or bony ankylosis that is not responsive to other

modalities of treatment; or

5. Loss of mandibular condylar height and/or occlusal relationship due

to trauma, resorption, pathological lesion or congenital anomaly; or

6. Failed autologous bone graft or alloplastic reconstruction effort.

F. Autogenous grafts (e.g., costochondral, cartilage, dermal, fat, fascial and

other autogenous graft materials) may be considered medically necessary

upon individual case review. Autologous costochondral grafts are

considered medically necessary when criteria for joint replacement

(II.D.) are met or when there is congenital absence or deformity of the

joint or for surgical reconstruction post head and neck tumor

resection.


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IV. Aetna considers the following experimental and investigational for

diagnosis and treatment of TMJ disorders

A. Diagnostic Procedures

1. Cephalometric or lateral skull x-rays

2. Computerized mandibular

scan/kinesiography/electrogathograph/jaw tracking

3. Diagnostic study models

4. Electromyography (EMG), surface EMG (see CPB 0112 - Surface

Scanning and Macro Electromyography (../100_199/0112.html))

5. Electronic registration (Myomonitor)

6. Genetic testing

7. Joint vibration analysis

8. Measurements of circulating omentin-1 levels

9. Muscle testing/range of motion measurements (incidental to

examination)

10. Neuromuscular junction testing

11. Salivary stress biomarkers (e.g., alpha-amylase and cortisol levels)

12. Somatosensory testing

13. Sonogram (ultrasonic Doppler auscultation)

14. Standard dental radiographic procedures

15. Thermography (see CPB 0029 - Thermography (0029.html)).

B. Non-Surgical Treatments

1. Bio-oxidative ozone therapy

2. Botulinum toxin (type A or type B) (however, botulinum toxin type A

is considered medically necessary for jaw-closing oromandibular

dystonia -- see CPB 0113 - Botulinum Toxin (../100_199/0113.html))

3. Continuous passive motion (see CPB 0010 - Continuous Passive

Motion (CPM) Machines (0010.html))

4. Cranial (craniosacral) manipulation (see CPB 0388 - Complementary

and Alternative Medicine (../300_399/0388.html))

5. Dental restorations/prostheses (see CPB 0082 - Dental Services and

Oral and Maxillofacial Surgery: Coverage Under Medical Plans

(0082.html))


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6. Diathermy, infrared, and ultrasound treatments

7. Dry needling

8. Hydrotherapy (immersion therapy, whirlpool baths)

9. Hypnosis/relaxation therapy

10. Injection of plasma rich in growth factors

11. Iontophoresis (see CPB 0229 - Iontophoresis (../200_299/0229.html))

12. Intra-articular injection of analgesics

13. Intra-articular injection of hyaluronic acid (viscosupplementation)

14. Intra-articular injection of platelet-rich plasma

15. Intra-articular injections of rituximab

16. Intraoral appliances for headache or trigeminal neuralgia (see CPB

0688 - Intra-oral Appliances for Headache and Trigeminal Neuralgia

(../600_699/0688.html))

17. Irreversible occlusion therapy aimed at modification of the occlusion

itself through alteration of the tooth structure or jaw position

18. Ketamine (local/intra-articular administration)

19. Magnetic neurostimulator

20. Manual therapy

21. MIRO therapy

22. Myofunctional therapy

23. Myomonitor treatment (J-4, BNS-40, Bio-TENS)

24. Neuromuscular re-education

25. Orthodontic/bite adjustment services and orthodontic fixed

appliances (see CPB 0095 - Orthognathic Surgery (0095.html); and

CPB 0082 - Dental Services and Oral and Maxillofacial Surgery:

Coverage Under Medical Plans (0082.html))

26. Permanent mandibular repositioning (e.g., equilibration,

orthodontics)

27. Phototherapy (e.g., low-level (cold) laser therapy (LLLT) and light-

emitting diode (LED) therapy) see CPB 0363 - Cold Laser and High-

Power Laser Therapies (../300_399/0363.html))

28. Prophylactic management of TMJ disorder, including occlusal

adjustment

29. Radiofrequency generator thermolysis (see also CPB 0400 - Ernest or

Eagle's Syndrome (Stylomandibular Ligament Pain): Treatment

with Radiofrequency Thermoneurolysis (../400_499/0400.html))

30. Stem cell therapy


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31. Therabite Jaw Motion Rehabilitation System (see CPB 0412 -

Therabite Jaw Motion Rehabilitation System (../400_499/0412.html))

32. Transcranial direct current stimulation

33. Transcutaneous electrical nerve stimulation (TENS) (see CPB 0011

Electrical Stimulation for Pain (0011.html))

C. Surgical Treatments

1. Orthognathic surgery (see CPB 0095 - Orthognathic Surgery

(0095.html))

2. Permanent mandibular repositioning (e.g., full-mouth reconstruction)

3. Treatment of alveolar cavitational osteopathosis (see CPB 0642

Neuralgia Inducing Cavitational Osteonecrosis (NICO) and

Ultrasonograph Bone Densitometer to Detect NICO

(../600_699/0642.html))

Background

Although the precise etiology of temporomandibular joint (TMJ) syndrome and

temporomandibular joint disorder (TMD) has not yet been identified, these

conditions are believed to be the result of either "macro" or "micro" trauma affecting

the joint and/or the associated facial musculature. Macro-trauma is usually

historically obvious (e.g., acute joint overload), and there is generally a documented

history of direct trauma to the TMJ. Micro-trauma is a chronic and insidious

process, multi-factorial in presentation, and commonly associated with para-

functional habits, stress and anxiety, sleep disorders, dysfunctional occlusion, and

various myofascial conditions (e.g., fibromyalgia).

The etiology of temporomandibular disorders are intracapsular or extracapsular.

Intracapsular abnormalities consist of internal derangements, including anterior disc

displacement with or without reduction, disc perforation or fragmentation leading to

degenerative joint disease, rheumatoid arthritis, synovitis, and neoplasia.

Extracapsular abnormalities consist of myalgia or myospasm which may be related

to trauma or parafunctional habits such as bruxism, tooth pain, or postural

abnormalities.


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The diagnosis of TMD is largely based upon the symptoms of pain and signs of

TMD (e.g., joint sounds, variations from ideal disc position, clicking). These signs

may also be found in large segments of the general population without evidence of

impairment or dysfunction. According to available literature, specialized radiological

studies (e.g., cephalometric x-rays, tomograms, submental vertex radiographs) are

not medically necessary in evaluating persons with TMD unless surgery is being

considered.

The extent of internal derangements is often determined by magnetic resonance

imaging (MRI). MRI is a useful for assessing disc morphology, disc fragmentation,

and the disc-condylar relationship, especially where the patient is in a closed lock

with a limited oral opening. Limchaichana et al (2006) assessed the evidence for

the effectiveness of MRI in the diagnosis of disk position and configuration, disk

perforation, joint effusion, and osseous and bone marrow changes in the TMJ. Two

reviewers evaluated the level of evidence of relevant publications as high,

moderate, or low. Based on this, the evidence grade for diagnostic efficacy was

rated as strong, moderately strong, limited, or insufficient. The literature search

yielded 494 titles, of which 22 were relevant. No publication had a high level of

evidence, and 12 had moderate and 10 low levels of evidence. The evidence

grades for diagnostic efficacy expressed as sensitivity, specificity, and predictive

values was insufficient. The authors concluded that evidence for the effectiveness

of MRI is insufficient; and it emphasizes the need for high-quality studies on the

diagnostic efficacy of MRI, incorporating accepted methodological criteria.

Therapy of TMD varies considerably according to the particular training, discipline

and experience of the clinician. This variation in clinical practice is due, in part, to a

paucity of evidence-based outcome research and lack of consensus on the

appropriate management of TMD. Scientifically valid clinical trials are lacking for

the vast majority of therapies that are currently employed. There are also no

objective, generally accepted, diagnostic standards to correctly identify when a

TMD is present.

The appropriate diagnosis and treatment of TMD is complicated by a high incidence

of TMD/TMJ signs and symptoms that are associated with systemic disorders.

These usually represent local or regional manifestations of chronic, global,

musculoskeletal pain conditions, such as fibromyalgia, systemic myofascial pain

and chronic fatigue syndrome. While an association with headaches has been


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identified, a causal relationship between TMD/TMJ and headaches has not been

established. These conditions occur coincidentally and may be produced by

etiologic factors that are common to both.

The National Institutes of Health emphasizes the importance of 2 key words in

therapy: CONSERVATIVE and REVERSIBLE. A growing body of literature

supports non-surgical intervention for this condition. Similar to other

musculoskeletal/joint conditions, treatment is directed towards unloading the

affected structures and managing the attendant discomfort. Non-surgical therapy

customarily includes occlusal appliance therapy, physical therapy, medical

management, and relaxation/cognitive-behavioral therapy. Prudence usually

dictates that non-surgical therapy first be exhausted prior to any invasive therapies.

Patients with a long history of head and neck pain may be candidates for a chronic

pain assessment.

The American Academy of Oral and Maxillofacial Surgeons Parameters of Care

(2012) states: "Surgical intervention for internal derangement is indicated only when

nonsurgical therapy has been ineffective, and pain and/or dysfunction are moderate

to severe. Surgery is not indicated for asymptomatic or minimally symptomatic

patients. Surgery also is not indicated for preventive reasons in patients without

pain and with satisfactory function. Pretreatment therapeutic goals are determined

individually for each patient."

Appliance (splint) therapy has been shown to be beneficial for TMD. These devices

represent the most common and effective TMD/TMJ therapy that is routinely

provided by dentists, even though the physiologic mechanism of the treatment

response is not completely understood. Splint design and usage are different

depending upon whether the etiology is intracapsular or extracapsular. For

extracapsular problems, a night guard or bite plain appliance worn at night may

help. For intracapsular problems, the appliance needs to be worn through the entire

day and night, except at meal times for a trial period of at least 2 to 3

months. Appliance therapy would not be indicated for patients who are unable to

open their mouth wide enough to obtain the impressions of dental arches that are

necessary for making a dental model for a custom-made appliance.

Physical therapy is an established conservative method of TMD/TMJ treatment. As

is the case with physical therapy for most other medical conditions, scientific

evidence of therapeutic benefit from physical therapy in TMJ/TMD is limited.


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Therapy may include repetitive active or passive jaw exercises, thermal modalities,

manipulation, vapor coolant spray-and-stretch technique, and electro-galvanic

stimulation.

Initial medical management of TMD/TMJ conditions may include pharmaceutical

therapy, similar to other acute and chronic orthopedic and musculoskeletal

conditions. Non-opiate analgesics and non-steroidal anti-inflammatory drugs

(NSAIDs) have been shown to be effective for mild-to-moderate inflammatory

conditions and pain. Low-dosage tricyclic anti-depressants (e.g., amitriptyline) are

have been used successfully in the treatment of chronic pain, sleep disturbance and

nocturnal bruxism. Adjuvant pharmacologic therapies, including anticonvulsants,

membrane stabilizers, and sympatholytic agents, may be useful for unremitting TMJ

pain. Opiate analgesics, corticosteroids, anxiolytics, and muscle relaxants are also

used in refractory pain.

There is strong evidence of effectiveness for the relaxation class of techniques in

reducing chronic pain associated with a variety of medical conditions. See CPB

132 - Biofeedback. The effectiveness of electromyography (EMG) biofeedback in

the treatment of TMD has been evaluated in a meta-analysis of 13 studies.

Approximately 70 % of patients required no further treatment, were symptom free,

or were substantially improved following EMG biofeedback therapy, compared with

approximately 35 % of patients who received placebo treatments. A synergistic

response has been demonstrated when intra-oral appliance therapy is combined

with biofeedback and stress management. These results demonstrate the

importance of using both dental and psychological treatments for successful

intervention. Cognitive-behavioral therapy (CBT) also has been demonstrated to

improve long-term outcomes for TMD patients, as has been the case with other

chronic pain disorders. Behavior modification interventions and relaxation

techniques are frequently included as a behavioral component of CBT.

Acupuncture and trigger-point injections may be used for TMD pain. A systematic

review found substantial evidence of the effectiveness of acupuncture for treatment

of TMD pain. While relatively fewer controlled studies on trigger-point injection have

been conducted, trigger-point injection and dry needling of trigger points have

become widely accepted. While dry needling and trigger point injections of

anesthetic appear to be equally effective, post-injection soreness from dry needling

has been found to be more intense and of longer duration than experienced by

patients injected with local anesthetic.


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In cases involving chronic intractable pain and/or prior (including multiple) TMJ

surgical procedures, caution is recommended due to the significant morbidity that

may be experienced with TMJ surgical interventions. The long-term prognosis of

this therapy for intractable pain may be unfavorable, due to the neurophysiology of

chronic pain disorders. There is also evidence that the prognosis for success

decreases with each additional (repeat) TMJ surgical intervention. In such cases,

the literature indicates that the most promising treatment may be admission into a

multidisciplinary chronic pain treatment program.

In a review on TMD, Laudenbach and Stoopler (2003) noted that when patients do

not respond to non-invasive TMD therapy, surgical procedures are considered.

Initial closed-approach, surgical options include arthrocentesis and arthroscopy of

the TMJs. These are the simplest and least invasive of all the surgical techniques.

More advanced, open-approach TMJ surgeries include disk re-positioning,

diskectomy, and modified condylotomy. Indeed, guidelines for the diagnosis and

management of disorders involving the TMJ and related musculoskeletal structures

that are approved by the American Society of Temporomandibular Joint Surgeons

(2001) listed condylotomy (including modified condylotomy) as one of the surgical

options.

In a prospective, controlled study, Hall et al (2005) compared the outcomes of 4

operations (arthroscopy, condylotomy, discectomy, and disc repositioning) used for

the treatment of painful TMJ with an internal derangement. Studies were

conducted at 3 sites, and all sites used the same inclusion and exclusion criteria.

Trained, independent examiners assessed pain, diet, and range of motion before

operation and 1 month and 1 year after operation. There were statistically

significant reductions in the amount of pain (p < 0.001) and daily time in pain (p <

0.001) that were similar for all 4 operations 1 month and 1 year after the

procedures. The degrees of change after each of the 4 procedures were not

statistically different from each other (amount: p = 0.453 and time: p = 0.416).

Ability to chew, as measured by diet visual analog scale, was substantially

improved 1 year after operation (p < 0 .001). The degrees of change for diet at 1

year also were not different from each other (p = 0.314). There were, however,

statistically significant differences (p < 0.05) in range of motion that varied with

procedure. The authors concluded that all 4 operations were followed by marked

improvements in pain and diet. The amounts of improvement varied slightly by

operation, but these differences were not statistically significant. There were small

but statistically significant differences between procedures for range of motion.


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McKenna (2006) stated that the therapeutic objective of modified condylotomy is to

increase joint space, providing immediate joint load reduction and reducing if not

abolishing condylar interference. The technical aspects of modified condylotomy are

simple and familiar to surgeons comfortable with intraoral vertical ramus osteotomy.

Satisfactory pain relief following modified condylotomy for non-reducing disc

displacement (NRDD) demonstrate that disc reduction is not a pre-requisite.

However, when disc reduction is possible, as it often is in reducing disc

displacement joints or joints that have recently progressed to NRDD, the odds of

pain relief, especially moderate to severe pain, are improved and lower the risk for

re-operation. Furthermore, modified condylotomy seems to favorably change the

natural course of internal derangement/osteoarthrosis.

A partial TMJ prosthesis consists of a meniscectomy and placement of a metallic

glenoid fossa metal prosthesis (Christensen fossa-eminence prosthesis, TMJ, Inc.,

Golden, CO) in place of the meniscus, such that a natural condyle articulates with a

metal fossa prosthesis. The U.S. Food and Drug Administration (FDA) Dental

Products Advisory Panel reviewed clinical studies of the Christensen fossa

prosthesis, and advised the FDA to approve the total prosthesis, but to not approve

the partial joint prosthesis because of a lack of clinical data on its safety and

effectiveness. The information originally submitted to the FDA on the safety and

effectiveness of the partial TMJ prosthesis was limited and had not been published

in a peer-reviewed journal. In an editorial, Laskin (2001), former editor-in-chief of

the Journal of Oral and Maxillofacial Surgery, the official journal of the American

Association of Oral and Maxillofacial Surgeons, commented on the data on the

partial TMJ prosthesis presented to the FDA Dental Products Advisory Panel: “At

that meeting [of the FDA Dental Products Advisory Panel where the partial TMJ

prosthesis was considered] the FDA staff presentation expressed concern

regarding the lack of data on the effect of the natural condyle articulating against a

metal fossa, the limited number of patients with long-term follow-up, and the broad

diagnosis of internal derangement as an indication for its use. The panel

expressed similar concerns about these issues, as well as the fact that the registry

data provided in support of the product did not include all the patients treated and

the sample size was insufficient for each of the individual indications. They

recommended clarification of the patient inclusion criteria in the clinical study,

evaluation of failures and additional patient follow-up, more clearly defined

indications for use of the device, and that a power analysis of the clinical data be

done to place the pre-market approval in an approvable form. However, despite


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these criticisms, and the panel’s opinion that adequate safety and effectiveness

data for the given surgical indications were lacking, the device was approved by the

FDA for distribution in February 2001”.

Laskin (2001) concluded that “there are insufficient data” to answer questions about

the safety and effectiveness of the partial TMJ prosthesis. “For example, how

reliable are clinical data based on a registry that did not include all patients treated

with the device, in which there was a very small number of total patients with serial

data and even smaller numbers in each diagnostic subcategory, and where in 1

group of 97 patients with a diagnosis of internal derangement and/or inflammatory

arthritis, only 30 % (12 subjects) had a follow-up of 3 or more years and 70 % were

either lost to follow-up, withdrawn, or potentially lost to follow-up. How can one

make an informed decision with such information?”

The manufacturer subsequently submitted a post-approval study to the FDA on the

long-term follow-up of patients with a variety of TMJ conditions treated with the partial

TMJ prosthesis (Christensen, 2008). A total of 145 subjects (228 joints) were

evaluated immediately before surgery and at regular intervals after surgery for up to 3

years. Success was measured as improvement of function and decrease in pain as

measured on a visual analog scale (VAS), as well as improved incisor opening as

measured with a Therabite Scale. Subjects showed a 4.9-cm reduction of pain on a

10-cm VAS scale and a 5.0-cm reduction in diet restriction at 36 months. Subjects

who were admitted with an inter-incisal opening of less than or equal to 15 mm

showed a 19.4 mm average improvement at 18 months and 17.4 mm average

improvement at 36 months. The manufacturer reported that 4.1 % (6 subjects) of

partial joint replacement subjects experienced device-related events, a percentage

that was not significantly different than the percentage of device-related events

reported with total joint replacement subjects (11.5 %). Limitations of the post-

approval study were similar to those of the initial study submitted for FDA approval. In

particular, less than half (44 %) of the 145 subjects enrolled in the study had pain,

diet restriction, and incisal opening data through three years (36 months).

The manufacturer also submitted a post-approval study to the FDA on the long-

term followup of patients with a variety of TMJ conditions who were treated with the

total TMJ prosthesis (Christensen, 2008). A total of 78 subjects (127 joints) were

evaluated immediately before surgery and at regular intervals after surgery for up to

3 years. Subjects showed a 4.9 cm reduction of pain and a 5.9 cm diet restriction


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at 36 months. Subjects who were admitted with an interincisal opening of less than

or equal to 15 mm showed a 16.8 mm average improvement at 18 months and 18.0

mm average improvement at 36 months. Nine subjects (11.5 %) of total joint

replacement subjects experienced device-related events. Follow-up was

incomplete, as just over half (54 %) of subjects had pain data and diet restriction

data (54 % and 57 %, respectively) at 36 months, and half (50 %) of subjects with

reduced inter-incisal openings had incisal opening data at 36 months.

An evaluation study has reported better post-surgical outcomes with the TMJ

Concepts total joint prosthesis than the Christensen total joint prosthesis. Wolford

et al (2003) reported the results of a study comparing the Christensen total joint

prosthesis (TMJ Inc., Golden, CO) with the TMJ Concepts total joint prosthesis (TMJ

Concepts Inc, Camarillo, CA) in 45 patients, 23 of whom were treated with the

Christensen prosthesis, and 22 of whom were treated with the TMJ Concepts

Prosthesis. The investigators reported that, although subjects treated with either

total joint prosthesis showed good skeletal and occlusal stability, the subjects

treated with the TMJ Concepts Prosthesis had statistically significant improved

outcomes compared to subjects treated with the Christensen prosthesis with

respect to post-surgical incisal opening (37.3 mm versus 30.1 mm, p = 0.008), pain

(decrease of 3.1 versus 1.8 on 10 point VAS score, p = 0.042), jaw function

(improvement of 3.0 versus 1.2 on a 10 point scale, p = 0.008), and diet (2.0 versus

1.8 on a 10-point scale, p = 0.021). The investigators concluded “[a]s a result of

our study, it appears that [TMJ Concepts Prosthesis] provides a more biologically

accepted and functional prosthesis than the [Christensen prosthesis] for the

complex TMJ patient.”

In a study that examined factors to consider in joint prosthesis systems, Wolford

(2006) stated that metal-on-ultra-high-molecular-weight polyethylene (UMWPE) has

shown negligible wear debris histologically in the TMJ, whereas the Christensen

prosthesis often demonstrates visible and histological evidence of metallosis from

wear debris. Furthermore, the author stated that to appropriately evaluate the

success of the Christensen products, independent researchers (not affiliated with

TMJ Implants Inc.) must perform prospective studies, because the research data

provided by the company are highly suspect.

The W. Lorenz total TMJ replacement system (Walter Lorenz Surgical, Inc.,

Jacksonville, FL) was approved by the FDA on September 21, 2005 the FDA for the

functional reconstruction of diseased and/or damaged jaw joints. Its 2 components


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(mandibular condyle and glenoid fossa) are available in multiple sizes as left- and

right-side specific designs. Approved indications for the W. Lorenz TMJ

replacement system include arthritic conditions such as osteoarthritis, traumatic

arthritis, or rheumatoid arthritis; ankylosis including but not limited to recurrent

ankylosis with excessive heterotopic bone formation; and revision procedures in

which other treatments have failed (e.g., alloplastic reconstruction, autogenous

grafts). The approval was based on data from a 6-year case series study of 224

patients (329 joints), showing that patients receiving the implant reported reduced

pain, improved function, an increase in maximal incisal opening, as well as

satisfaction with the outcome.

The device is not intended for partial TMJ reconstruction or for use in patients

susceptible to infection or having active/chronic infection, insufficient bone to

support the device, an immature skeleton, or hyper-functional habits such as

clenching/grinding of teeth. An evaluation of the W. Lorenz total TMJ replacement

system by the Australian Department of Health and Aging (2006) stated that the

only available study on this prosthesis was the case series included in the FDA

safety and effectiveness summary. The Australian Department of Health and Aging

recommended monitoring of the continual development of this technology.

Certain other total joint prostheses, such as the Vitek-Kent total joint prosthesis

(Vitek Inc, Houston, TX) and silastic implants, are not considered medically

necessary as they have been removed from the market due to poor

biocompatibility, increased wear, fragmentation, and foreign body giant cell

reaction.

For persons who already have had implant or other invasive surgery, additional

surgical interventions (with the possible exception of implant removal) should be

considered only with great caution, since the evidence indicates that the probability

of success decreases with each additional surgical intervention. For these persons,

available evidence indicates that the most promising immediately available

treatment may be a patient-centered, multidisciplinary, palliative approach.

In a pilot study, Adiels and colleagues (2005) assessed if fibromyalgia syndrome

(FMS) patients with signs and symptoms of TMD refractory to conservative TMD

treatment would respond positively to tactile stimulation in respect of local and/or

general symptoms. A total of 10 female patients fulfilling the inclusion criteria

received such treatment once-weekly during a 10-week period. At the end of


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treatment, a positive effect on both clinical signs and subjective symptoms of TMD,

as well as on general body pain, was registered. Eight out of 10 patients also

perceived an improved quality of their sleep. At follow-ups after 3 and 6 months,

some relapse of both signs and symptoms could be seen, but there was still an

improvement compared to the initial degree of local and general complaints. At the 6-

month follow-up, half of the patients also reported a lasting improvement of their

sleep quality. One hypothetical explanation to the positive treatment effect

experienced by the tactile stimulation might be the resulting improvement of the

patients' quality of sleep leading to increased serotonin levels. The authors

concluded that "the results of the present pilot study are so encouraging that they

warrant an extended, controlled study".

There is insufficient evidence in the literature to support the hypothesis that

orthognathic surgical correction for TMJ abnormalities such as condylar

hypertrophy, status post condylar fracture, ankylosis, etc., will predictably prevent

or improve a temporomandibular dysfunction. There is no body of evidence in the

peer reviewed literature to suggest that orthognathic surgery is a curative modality

for internal joint derangements of the temporomandibular joints.

A systemic review on malocclusions and orthodontic treatment by the Swedish

Council on Technology Assessment in Health Care (SBU, 2005) concluded that the

appearance of the teeth is the patients' most important reason for seeking

orthodontic treatment. In addition, scientific evidence is insufficient for conclusions

on patient satisfaction in the log-term (at least 5 years) after the conclusion of

orthodontic treatment. Furthermore, the assessment stated that scientific evidence

is insufficient for conclusions on a correlation between specific untreated

malocclusions and symptomatic TMJ disorders.

In a Cochrane review on orthodontics for treating TMD, Luther et al (2010)

examined the effectiveness of orthodontic intervention in reducing symptoms in

patients with TMD (compared with any control group receiving no treatment,

placebo treatment or reassurance) and whether active orthodontic intervention

leads to TMD. The Cochrane Oral Health Group's Trials Register, CENTRAL,

MEDLINE and EMBASE were searched. Hand-searching of orthodontic journals

and other related journals was undertaken in keeping with the Cochrane

Collaboration hand-searching program. No language restrictions were applied.

Authors of any studies were identified, as were experts offering legal advice, and

contacted to identify unpublished trials. Most recent search was April 13, 2010. All


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randomized controlled trials (RCTs) including quasi-randomized trials assessing

orthodontic treatment for TMD were included. Studies with adults aged equal to or

above 18 years old with clinically diagnosed TMD were included. There were no

age restrictions for prevention trials provided the follow-up period extended into

adulthood. The inclusion criteria required reports to state their diagnostic criteria for

TMD at the start of treatment and for participants to exhibit 2 or more of the signs

and/or symptoms. The treatment group included treatment with appliances that

could induce stable orthodontic tooth movement. Patients receiving splints for 8 to

12 weeks and studies involving surgical intervention (direct exploration/surgery of

the joint and/or orthognathic surgery to correct an abnormality of the underlying

skeletal pattern) were excluded. Main outcome measures were how well the

symptoms were reduced, adverse effects on oral health and quality of life.

Screening of eligible studies, assessment of the methodological quality of the trials

and data extraction were conducted in triplicate and independently by 3 review

authors. As no 2 studies compared the same treatment strategies (interventions) it

was not possible to combine the results of any studies. The searches identified 284

records from all databases. Initial screening of the abstracts and titles by all review

authors identified 55 articles that related to orthodontic treatment and TMD. The

full articles were then retrieved and of these articles only 4 demonstrated any data

that might be of value with respect to TMD and orthodontics. After further analysis

of the full texts of the 4 studies identified, none of the retrieved studies met the

inclusion criteria and all were excluded from this review. The authors concluded

that there are insufficient research data on which to base their clinical practice on

the relationship of active orthodontic intervention and TMD. There is an urgent

need for high quality RCTs in this area of orthodontic practice. When considering

consent for patients it is essential to reflect the seemingly random

development/alleviation of TMD signs and symptoms.

da Cunha et al (2008) assessed the effectiveness of low-level laser therapy (LLLT) in

patients presenting with TMD. A total of 40 patients were randomized into an

experimental group (G1) or a placebo group (G2). The treatment was carried out with

an infrared laser (830 nm, 500 mW, 20s, 4J/point) at the painful points, once- weekly

for 4 consecutive weeks. Patients were evaluated before and after the treatment

through a VAS and the cranio-mandibular index (CMI). The baseline and post-

therapy values of VAS and CMI were compared by the paired t-test, separately for

the placebo and laser groups. A significant difference was observed between initial

and final values (p < 0.05) in both groups. Baseline and post- therapy values of

pain and CMI were compared in the therapy groups by the


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2-sample t-test, yet no significant differences were observed regarding VAS and

CMI (p > 0.05). The authors concluded that after either placebo or laser therapy,

pain and temporomandibular symptoms were significantly lower, although there was

no significant difference between groups. The LLLT was ineffective for the treatment

of TMD, when compared to the placebo. This is in agreement with the findings of

Emshoff et al (2008) who reported that LLLT is not better than placebo in reducing

TMJ pain during function (n = 52).

In a randomized, double-blinded, placebo-controlled study, Castrillon et al (2008)

examined the effect of peripheral N-methyl-D-aspartate (NMDA) receptor blockade

with ketamine on chronic myofascial pain in patients with TMD. A total of 14

patients (10 women and 4 men) were recruited. The subjects completed 2

sessions in a double-blinded randomized and placebo-controlled trial. They

received a single injection of 0.2 ml ketamine or placebo (buffered isotonic saline,

155 mmol/l) into the most painful part of the masseter muscle. The primary

outcome parameters were spontaneous pain assessed on an electronic VAS and

numeric rating scale. In addition, numeric rating scale of unpleasantness, numeric

rating scale of pain relief, pressure pain threshold (PPT), pressure pain tolerance,

completion of a McGill Pain Questionnaire and pain drawing areas, maximum

voluntary bite force and maximum voluntary jaw opening were obtained. Paired

t-tests and analysis of variance were performed to compare the data. There were no

main effects of the treatment on the outcome parameters except for a significant

effect of time for maximum voluntary bite force (analysis of variance [ANOVA]; p =

0.030) and effects of treatment, time, and interactions between treatment and time

for maximum voluntary jaw opening (ANOVA; p < 0.047).The authors concluded

that these findings suggest that peripheral NMDA receptors do not play a major role

in the pathophysiology of chronic myofascial TMD pain. Although there was a

minor effect of ketamine on maximum voluntary jaw opening, local administration

may not be promising treatment for these patients.

Al-Saleh et al (2012) noted that although electromyography (EMG) has been used

extensively in dentistry to assess masticatory muscle impairments in several

conditions, especially TMD, many investigators have questioned its psychometric

properties and accuracy in diagnosing TMD. These investigators performed a

systematic review to analyze the literature critically and determine the accuracy of

EMG in diagnosing TMDs. They conducted an electronic search of Medline,

Embase, all Evidence-Based Medicine Reviews, Allied and Complementary

Medicine, Ovid HealthSTAR and SciVerse Scopus. They selected abstracts that


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fulfilled the inclusion criteria, retrieved the original articles, verified the inclusion

criteria and hand searched the articles' references. They used a methodological

tool (Quality Assessment of Diagnostic Accuracy Studies [QUADAS]) to evaluate

the quality of the selected articles. The electronic database search resulted in a

total of 130 articles. The authors selected 8 articles as potentially meeting eligibility

for the review. Of these 8 articles, only 2 fulfilled the study inclusion criteria, and

the authors analyzed them. Investigators in both studies reported low sensitivity

(values ranged from 0.15 to 0.40 in 1 study and a mean of 0.69 in the second

study). In addition, investigators in the 2 studies reported contradictory levels of

specificity (values ranged from 0.95 to 0.98 in 1 study, and the mean value in the

2nd study was 0.67). The likelihood ratios and predictive values were not helpful in

diagnosing TMD by means of EMG. The quality of the 2 studies was poor on the

basis of the QUADAS checklist. The authors concluded that this systematic review

found no evidence to support the use of EMG for the diagnosis of TMD.

Sharma et al (2013) conducted a systematic review of papers reporting the

reliability and diagnostic validity of the joint vibration analysis (JVA) for diagnosis of

TMD. A search of PubMed identified English-language publications of the reliability

and diagnostic validity of the JVA. Guidelines were adapted from applied

STAndards for the Reporting of Diagnostic accuracy studies (STARD) to evaluate

the publications. A total of 15 publications were included in this review, each of

which presented methodological limitations. The authors concluded that this

literature review was unable to provide evidence to support the reliability and

diagnostic validity of the JVA for diagnosis of TMD.

Hypnosis/Relaxation Therapy

In a systematic review and meta-analysis, Zhang et al (2015) evaluated the

effectiveness of hypnosis/relaxation therapy compared to no/minimal treatment in

patients with TMD. Studies reviewed included RCTs where investigators

randomized patients with TMD or an equivalent condition to an intervention arm

receiving hypnosis, relaxation training, or hypo-relaxation therapy, and a control

group receiving no/minimal treatment. The systematic search was conducted

without language restrictions, in Medline, EMBASE, CENTRAL, and PsycINFO,

from inception to June 30, 2014. Studies were pooled using weighted mean

differences and pooled risk ratios (RRs) for continuous outcomes and dichotomous

outcomes, respectively, and their associated 95 % confidence intervals (CI). Of

3,098 identified citations, 3 studies including 159 patients proved eligible, although


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none of these described their method of randomization. The results suggested limited

or no benefit of hypnosis/relaxation therapy on pain (risk difference in important pain -

0.06; 95 % CI: -0.18 to 0.05; p = 0.28), or on PPTs on the skin surface over the TMJ

and masticatory muscles. Low-quality evidence suggested some benefit of

hypnosis/relaxation therapy on maximal pain (mean difference on 100-mm scale = -

28.33; 95 % CI: -44.67 to -11.99; p = 0.007) and active maximal mouth opening

(mean difference on 100-mm scale = -2.63 mm; 95 % CI: -3.30 mm to -1.96 mm; p <

0.001) compared to no/minimal treatment. The authors concluded that 3 RCTs were

eligible for the systematic review, but they were with high risk of bias and provided

low-quality evidence, suggesting that hypnosis/relaxation therapy may have a

beneficial effect on maximal pain and active maximal mouth opening but not on

pain and PPT. They stated that larger RCTs with low risk of bias are needed to

confirm or refute these findings and to inform other important patient outcomes.

Manual Therapy

Calixtre et al (2015) stated that there is a lack of knowledge about the effectiveness

of manual therapy (MT) on subjects with TMD. These investigators synthetized

evidence regarding the isolated effect of MT in improving maximum mouth opening

(MMO) and pain in subjects with signs and symptoms of TMD. MEDLINE, Cochrane,

Web of Science, SciELO and EMBASE electronic databases were consulted,

searching for RCTs applying MT for TMD compared to other intervention, no

intervention or placebo. Two authors independently extracted data, PEDro scale was

used to assess risk of bias, and GRADE (Grading of Recommendations Assessment,

Development and Evaluation) was applied to synthetize overall quality of the body of

evidence. Treatment effect size was calculated for pain, MMO and PPT. A total of 8

trials were included, 7 of high methodological quality. Myofascial release and

massage techniques applied on the masticatory muscles are more effective than

control (low-to-moderate evidence) but as effective as toxin botulinum injections

(moderate evidence). Upper cervical spine thrust manipulation or mobilization

techniques are more effective than control (low-to-high evidence), while thoracic

manipulations are not. There is moderate-to- high evidence that MT techniques

protocols are effective. The methodological heterogeneity across trials protocols

frequently contributed to decreased quality of evidence. The authors concluded that

there is widely varying evidence that MT


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improves pain, MMO and PPT in subjects with TMD signs and symptoms,

depending on the technique. They stated that further studies should consider using

standardized evaluations and better study designs to strengthen clinical relevance.

Armijo-Olivo and colleagues (2016) summarized evidence from and evaluated the

methodological quality of RCTs that examined the effectiveness of MT and

therapeutic exercise interventions when compared with other active interventions or

standard care for treatment of TMD. Electronic data searches were performed

including 6 databases in addition to manual search; RCTs involving adults with

TMD, comparing any type of MT intervention (e.g., mobilization, manipulation) or

exercise therapy compared to a placebo intervention, controlled comparison

intervention, or standard care were included. The main outcomes of this systematic

review were pain, range of motion (ROM) and oral function. A total of 48 studies

met the inclusion criteria and were analyzed. Data were extracted in duplicate on

specific study characteristics. The overall evidence for this systematic review was

considered low. The trials included in this review had unclear or high risk of bias.

Thus, the evidence was generally down-graded based on risk of bias

assessments. Most of the effect sizes were low-to-moderate with no clear

indication of superiority of exercises versus other conservative treatments to treat

TMD. However, MT alone or in combination with exercises at the jaw or cervical

level showed promising effects. The authors concluded that no high-quality

evidence was found, indicating that there is great uncertainty about the

effectiveness of exercise and manual therapy for TMD.

Permanent Mandibular Repositioning

Greene and Obrez (2015) reviewed the rationale and history of mandibular

repositioning procedures in relation to TMDs as these procedures have evolved

over time. A large body of clinical research evidence showed that most TMDs can

and should be managed with conservative treatment protocols that do not include

any mandibular repositioning procedures. Although this provided a strong clinical

argument for avoiding such procedures, very few reports have discussed the

biologic reasons for either accepting or rejecting them. This scientific information

could provide a basis for determining whether mandibular repositioning procedures

can be defended as being medically necessary. This position paper introduced the

biologic concept of homeostasis as it applies to this topic. The continuing

adaptability of teeth, muscles, and temporomandibular joints throughout life is

described in terms of homeostasis, which leads to the conclusion that each


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person's current temporomandibular joint position is biologically "correct".

Therefore, that position does not need to be changed as part of a TMD treatment

protocol. This means that irreversible TMD treatment procedures, such as

equilibration, orthodontics, full-mouth reconstruction, and orthognathic surgery,

cannot be defended as being medically necessary.

Phototherapy

Herpich et al (2014) stated that according to the International Association for the

Study of Pain (IASP), the term TMD regards a subgroup of orofacial pain, the

symptoms of which include pain or discomfort in the temporomandibular joint, ears,

masticatory muscles and neck on one or both sides, as well as joint sounds, limited

mandibular movements or mandibular deviation and difficulties chewing.

Phototherapy, such as low-level laser therapy (LLLT) and light-emitting diode (LED)

therapy, is one of the resources used to treatment muscle pain. Thus, there is a need

to investigate therapeutic resources that combine different wavelengths as well as

different light sources (LLLT and LED) in the same apparatus. The aim of the

proposed study is to evaluate the effects of 4 different doses of phototherapy on pain,

activity of the masticatory muscles (masseter and bilateral anterior temporal) and joint

mobility in individuals with TMD. A further aim is to determine the cumulative effect 24

and 48 hours after a single session. A placebo-controlled, double-blind, randomized,

clinical trial will be carried out involving 72 women between 18 and 40 years of age

with a diagnosis of myogenous TMD. The participants will then be randomly allocated

to 4 groups totaling 18 individuals per group; 3 groups will be submitted to a single

session of phototherapy with different light sources, and 1 group will receive placebo

therapy: Group A (2.62 Joules); Group B (5.24 Joules); Group C (7.86 Joules); and

Group D (0 Joules). The following assessment tools will be administered on 4

separate occasions (baseline and immediately after, 24 hours after and 48 hours after

phototherapy). Pain intensity will be assessed using the VAS for pain, while pain

thresholds will be determined using algometer, and EMG analysis on the masseter

and anterior temporal muscles. The study will contribute to the practice of the

evidence-based use of phototherapy in individuals with a myogenous TMD. Data will

be published after the study is completed. This study is registered with the Brazilian

Registry of Clinical Trials, NCT02018770, date of registration: December 7, 2013.

Stem Cell Therapy


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Zhang et al (2015) noted that in the past decade, progress made in the development

of stem cell-based therapies and tissue engineering have provided alternative

methods to attenuate the disease symptoms and even replace the diseased tissue in

the treatment of TMJ disorders. Resident mesenchymal stem cells (MSCs) have

been isolated from the synovia of TMJ, suggesting an important role in the repair

and regeneration of TMJ. The seminal discovery of pluripotent stem cells including

embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs) have

provided promising cell sources for drug discovery, transplantation as well as for

tissue engineering of TMJ condylar cartilage and disc. The authors discussed the

most recent advances in development of stem cell-based treatments for TMJ

disorders through innovative approaches of cell- based therapeutics, tissue

engineering and drug discovery. The effectiveness of stem cell therapy for the

treatment of TMD has yet to be determined.

Transcranial Direct Current Stimulation

Oliveira et al (2015) evaluated the effect of adding transcranial direct current

stimulation (tDCS) to exercises for chronic pain, dysfunction and quality of life in

subjects with TMD. Participants were selected based on the Research Diagnostic

Criteria (RDC)/TMD criteria and assessed for pain intensity, PPT over

temporomandibular joint and cervical muscles and quality of life. After initial

assessment, all individuals underwent a 4-week protocol of exercises and MT,

together with active or sham primary motor cortex tDCS. Stimulation was delivered

through sponge electrodes, with 2 mA amplitude, for 20 mins daily, over the first 5

days of the trial. A total of 32 subjects (mean age of 24.7 ± 6.8 years) participated

in the evaluations and treatment protocol. Mean pain intensity pre-treatment was

5.5 ± 1.4 for active tDCS group, and 6.3 ± 1.2 for sham tDCS. Both groups showed

a decrease in pain intensity scores during the trial period (time factor - F4.5, 137.5

= 28.7, p < 0·001; group factor - F1.0, 30.0 = 7.7, p < 0.05). However, there were

no differences between the groups regarding change in pain intensity (time*group

interaction - F4.5, 137.5 = 1.5, p = 0.137). This result remained the same after 5

months (t-test t = 0.29, p > 0.05). Pressure pain thresholds decrease and

improvement in quality of life were also noticeable in both groups, but again without

significant differences between them. Absolute benefit increase was 37.5 % (CI 95

%: -15.9 % to 90.9 %), and number needed to treat was 2.66. The authors

concluded that the findings of this study suggested that there is no additional

benefit in adding tDCS to exercises for the treatment of chronic TMD in young

adults.


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Brandao Filho et al (2015) examine if cathodal tDCS over the dorsolateral prefrontal

cortex has an analgesic effect on chronic TMD pain. The investigators will run a

randomized, controlled, cross-over, double-blind study with 15 chronic muscular

TMD subjects. Each subject will undergo active (1 mA and 2 mA) and sham tDCS.

Inclusion criteria will be determined by the RDC for TMD questionnaire, with

subjects who have a pain VAS score of greater than 4/10 and whose pain has been

present for the previous 6 months, and with a State-Trait Anxiety Inventory score of

more than 42. The influence of tDCS will be assessed through a VAS, quantitative

sensory testing, quantitative electroencephalogram, and the State-Trait Anxiety

Inventory score. Some studies have demonstrated a strong association between

anxiety/depression and chronic pain, where one may be the cause of the other.

This is especially true in chronic TMD, and breaking this cycle may have an effect

over the symptoms and associated dysfunction. The authors believe that by

inhibiting activity of the dorsolateral prefrontal cortex though cathodal tDCS, there

may be a change in both anxiety/depression and pain level. They state that tDCS

may emerge as a new tool to be considered for managing these patients. These

investigators envision that the information obtained from this study will provide a

better understanding of the management of chronic TMD. This trial was registered

at clinicaltrials.gov on May 24, 2014 (Identifier: NCT02152267).

Somatosensory Testing

In a cross-over, double-blinded, placebo-controlled manner, Ayesh and associates

(2008) studied the effect of intra-articular ketamine on TMJ pain and

somatosensory function. Spontaneous pain and pain on jaw function was scored

by patients on 0 to 10 cm VAS for up to 24 hours. Quantitative sensory tests:

tactile, pin-prick, PPT and pressure pain tolerance were used for assessment of

somatosensory function at baseline and up to 15 mins after injections. There were

no significant effects of intra-articular ketamine over time on spontaneous VAS pain

measures (ANOVA: p = 0.532), pain on jaw opening (ANOVA: p = 0.384), or any of

the somatosensory measures (ANOVA: p > 0.188). The poor effect of ketamine

could be due to involvement of non-NMDA receptors in the pain mechanism and/or

ongoing pain and central sensitization independent of peripheral nociceptive input.

The authors concluded that there appears to be no rationale to use intra-articular

ketamine injections in TMJ arthralgia patients, and peripheral NMDA receptors may

play a minor role in the pathophysiology of this disorder.


http://clinicaltrials.gov

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Kothari and colleagues (2015) noted that the pathophysiology and underlying pain

mechanisms of TMD are poorly understood. These researchers evaluated

somatosensory function at the TMJs (TMJs) and examined if conditioned pain

modulation (CPM) differs between TMD pain patients (n = 34) and healthy controls

(n = 34). Quantitative sensory testing was used to assess the somatosensory

function. Z-scores were calculated for patients based on reference data.

Conditioned pain modulation was tested by comparing pressure pain thresholds

(PPTs) before, during, and after the application of painful and non-painful cold

stimuli. Pressure pain thresholds were measured at the most painful TMJ and

thenar muscle (control). Data were analyzed with analyses of variance. Most (85.3

%) of the patients exhibited at least 1 or more somatosensory abnormalities at the

most painful TMJ with somatosensory gain with regard to PPT and punctate

mechanical pain stimuli, and somatosensory loss with regard to mechanical

detection and vibration detection stimuli as the most frequent abnormalities. There

was a significant CPM effect (increased PPT) at both test sites during painful cold

application in healthy controls and patients (p < 0.001). There was no significant

difference in the relative CPM effect during painful cold application between groups

(p = 0.227). The authors concluded that somatosensory abnormalities were

commonly detected in TMD pain patients and CPM effects were similar in TMD

pain patients and healthy controls.

Genetic Testing

Sangani and associates (2015) stated that the TMJ is a bilateral synovial joint

between the mandible and the temporal bone of the skull and TMDs are a set of

complicated and poorly understood clinical conditions, in which TMDs are

associated with a number of symptoms including pain and limited jaw movement.

The increasing scientific evidence suggests that genetic factors play a significant

role in the pathology of TMDs. However, the underlying mechanism of TMDs

remains largely unknown. These researchers determined the associated genes to

TMDs in humans and animals. The literature search was conducted through

databases including Medline (Ovid), Embase (Ovid), and PubMed (NLM) by using

scientific terms for TMDs and genetics in March 2015. Additional studies were

identified by searching bibliographies of highly relevant articles and Scopus

(Elsevier). Systematic analyses identified 31 articles through literature searches,

and a total of 112 genes were identified to be significantly and specifically


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associated with TMDs. The authors concluded that this systematic review provided a

list of accurate genes associated with TMDs and suggested a genetic contribution to

the pathology of TMDs.

Hattori and colleagues (2015) noted that synovial fibroblasts contribute to the

inflammatory TMJ under pathogenic stimuli. Synovial fibroblasts and T cells

participate in the perpetuation of joint inflammation in a mutual activation feedback,

via secretion of cytokines and chemokines that stimulate each other. IL-17 is an

inflammatory cytokine produced primarily by Th17 cells that plays critical role in the

pathogenesis of numerous autoimmune and inflammatory diseases. These

researchers investigated the roles of IL-17A in TMD using genome-wide analysis of

synovial fibroblasts isolated from patients with TMD. IL-17 receptors were

expressed in synovial fibroblasts as assessed using real-time polymerase chain

reaction (PCR). Microarray analysis indicated that IL-17A treatment of synovial

fibroblasts up-regulated the expression of IL-6 and chemokines. Real-time PCR

analysis showed that the gene expression of IL-6, CXCL1, IL-8, and CCL20 was

significantly higher in IL-17A-treated synovial fibroblasts compared to non-treated

controls. IL-6 protein production was increased by IL-17A in a time- and a dose-

dependent manner. Additionally, IL-17A simulated IL-6 protein production in

synovial fibroblasts samples isolated from 3 patients. Furthermore, signal inhibitor

experiments indicated that IL-17-mediated induction of IL-6 was transduced via

activation of NFκB and phosphatidylinositol 3-kinase/Akt. The authors concluded

these results suggested that IL-17A is associated with the inflammatory progression

of TMD.

Nicot and co-workers (2016) stated that dento-facial deformities are dysmorpho-

functional disorders involving the TMJ. Many investigators have reported a TMJ

improvement in dysfunctional subjects with malocclusion after orthodontic or

combined orthodontic and surgical treatment particularly for the relief of pain. In

particular, few studies have highlighted the demographic and clinical predictors of

response to surgical treatment. To-date, no genetic factor has yet been identified as

a predictor of response to surgical treatment. These researchers identified single-

nucleotide polymorphisms (SNPs) associated with post-operative TMD or with TMJ

symptoms after orthognathic surgery. They found the AA genotype of SNP

rs1643821 (ESR1 gene) as a risk factor for dysfunctional worsening after

orthognathic surgery. In addition, they have identified TT genotype of SNP

rs858339 (ENPP1 gene) as a protective factor against TMD in a population of

patients with dento-facial deformities. Conversely, the heterozygous genotype AT


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was identified as a risk factor of TMD with respect to the rest of the population. All

these elements are particularly important to bring new screening strategies and

tailor future treatment. The authors concluded that the findings of this study helped

to identify sub-populations at high risk of developing post-operative

temporomandibular disorders after orthognathic surgery procedures. Moreover,

they stated that many other genes of interest could be potential factors influencing

the dysfunctional response to orthognathic surgery, particularly genes of the Opera

cohort.

Yilmaz and colleagues (2016) noted that TMJ internal derangement (TMJ ID) is a

multi-factorial complex disease characterized by articular disc degeneration.

Matrilin-3 is a cartilage and bone-specific adaptor protein, and amino-acid

substitutions in the protein are associated with skeletal diseases and joint disorders.

These investigators examined the variants of Matrilin-3 gene (MATN3) in a TMJ ID

case-control group and investigated the risk association of the detected variants

with TMJ ID. A case control study was conducted consisting of 57 unrelated TMJ

ID patients (32.7 ± 8.2) and 96 unrelated healthy controls (26.63 ± 3.05) without TMJ

ID to look for associations with variants of the MATN3 gene.

DNA from individual subjects was extracted and each of the 8 exons was amplified

by PCR and analyzed by single-strand conformation polymorphism (SSCP)

analysis. SSCP variants were subjected to DNA sequence analysis, which yielded

band pattern variations in exon 2 of the gene. These researchers further analyzed

exon 2 by DNA sequencing to determine the sequence of these variants. They

identified SSCP band patterns variants in exon 2 of the MATN3 gene, which upon

sequencing revealed a single C to T transition mutation (rs28598872) c.447 C>T

(g.11608 C>T). This polymorphism is predicted to result in a synonymous mutation

(pAla149 =). The TT and CT genotypes were more prevalent than the CC genotype

in TMJ ID patients compared to the control group with a risk factor of 2.12 (CI: 0.88

to 5.08) and 2.0 (CI: 0.726 to 5.508). In addition, TMJ ID patients were divided into

2 groups as anterior disc displacement with reduction (ADDWR) and anterior disc

displacement without reduction (ADDWOR) and compared with the controls. The TT

and CT genotypes were more prevalent than the CC genotype in ADDWR patients

compared to the control group with a risk factor of 3.85 (CI: 0.927 to 16.048) and

3.75 (1.02 to 13.786), respectively. These investigators found that, among ADDWR

patients, the T allele is a risk factor both in homozygous and heterozygous carriers

(p < 0.052, p < 0.036). The authors concluded that the findings of this study

indicated a potential role for the MATN3 rs28598872 polymorphism in the

pathogenesis of TMJ ID.


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Melis and Di Giosia (2016) performed a review of the literature of published articles

assessing the role of genetic factors in the etiology of TMDs. A PubMed search

was carried out by looking for all controlled clinical trials related to the topic and

limiting the search to English language and humans. The references from the

studies included and those from review articles were also examined for further

relevant papers. A total of 1,999 articles were first identified, 24 of which were

considered relevant to the topic; 2 other papers were found while searching the

references. While TMD signs and symptoms' co-occurrence was not found in

subjects within the same family, many gene polymorphisms were shown to be

associated with a higher or lower risk of TMD. Such genes were mainly related to

serotonin activity and metabolism, T-cell receptor pathway, catecholamine activity

and metabolism, estrogen activity, folate metabolism, glutathione activity, ANKH

gene, major histocompatibility complex, extracellular matrix metabolism, genes

studied in the orofacial pain prospective evaluation risk and assessment (OPPERA)

study and related to cytokines activity and metabolism. The authors concluded

that this new understanding of the pathophysiology of TMD can lead to a different

treatment approach by identifying the subjects at higher risk for this pathology, and

possibly by creating new drugs targeted at interfering with the expression of the

genes that enhance such risk.

Furthermore, an UpToDate review on “Temporomandibular disorders in

adults” (Scrivani and Mehta, 2016) does not mention genetic testing as a

management tool.

Measurement of Circulating Omentin-1

In a case-control study, Harmon and colleagues (2016) examined the relationship

between omentin-1 levels and painful TMD. Chronic painful TMD cases (n = 90)

and TMD-free controls (n = 54) were selected from participants in the multi-site

OPPERA study. Painful TMD case status was determined by examination using

established Research Diagnostic Criteria for TMD (RDC/TMD). Levels of omentin-1

in stored blood plasma samples were measured by using an enzyme linked

immune-sorbent assay (ELISA). Binary logistic regression was used to calculate

the odds ratios (ORs) and 95 % CIs for the association between omentin-1 and

painful TMD. Models were adjusted for study site, age, sex, and body mass index

(BMI). The unadjusted association between omentin-1 and chronic painful TMD

was statistically non-significant (p = 0.072). Following adjustment for covariates,

odds of TMD pain decreased 36 % per standard


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deviation increase in circulating omentin-1 (adjusted OR = 0.64; 95 % CI: 0.43 to

0.96; p = 0.031). The authors concluded that circulating levels of omentin-1 were

significantly lower in painful TMD cases than controls, suggesting that TMD pain is

mediated by inflammatory pathways.

Botulinum Toxin

In a systematic review, Chen and associates (2015) evaluated the effectiveness of

botulinum toxin therapy (BTX) for TMDs. A comprehensive search of major

databases through PubMed, Embase, and Cochrane CENTRAL was conducted to

locate all relevant articles published from inception to October 2014. Eligible studies

were selected based on inclusion criteria and included English language, peer-

reviewed publications of RCTs comparing BTX versus any alternative intervention or

placebo. Quality assessment and data extraction were done according to the

Cochrane risk of bias tool and recommendations. The entire systematic search and

selection process was done independently by 2 reviewers. A total of 5 relevant study

trials were identified, involving 117 participants; 2 trials revealed a significant

between-group difference in myofascial pain reduction, another trial that compared

BTX with fascial manipulation showed equal effectiveness of pain relief on TMDs,

while the remaining 2 trials showed no significant difference between the BTX and

placebo groups. Because of considerable variations in study methods and

evaluation of results, a meta-analysis could not be performed. The authors

concluded that based on this review, no consensus could be reached on the

therapeutic benefits of BTX on TMDs; a more rigorous design of trials should be

performed in future studies.

Keenan (2015) evaluated the evidence on the use of BTX for TMD pain. The author

performed a comprehensive search on major databases such as PubMed, Embase

and Cochrane CENTRAL. Reference lists of the included studies were explored

along with journals likely to contain studies relevant to the topic. The search was

restricted to the English language. The inclusion criteria included RCTs and quasi-

RCTs including parallel or cross-over studies comparing BTX versus any alternative

intervention or placebo. Quality assessment and data extraction were done

following the Cochrane risk of bias tool and recommendations. All of the steps in the

review, including the search and selection process, were done independently by 2

reviewers. Disagreements were discussed with one another until consensus was

reached. A total of 5 relevant studies were included in the review, which consisted

of 117 participants; 2 trials revealed a significant inter-


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group difference in myofascial pain reduction. Another trial that compared BTX with

fascial manipulation showed no significant difference in pain relief for TMDs, while

the remaining 2 trials showed no significant difference between the BTX and

placebo groups. Meta-analysis was not performed due to the considerable variation

in study methods and evaluation of the results. All 5 studies were targeted primarily

on the masseter and temporalis muscles and most of them administered injections

at bilateral muscle sites. The methods used to find the muscles to target were all

based on physical examination, with 3 studies using EMG as guidance.

The dose of BTX ranged from 70 U to 300 U, the majority used to be 100 to 150

U. All studies gave a single session of BTX and re-evaluated participants at least 1

month following the injection. The authors concluded that no consensus could be

reached on the therapeutic benefit of BTX on TMDs.

Injection of Plasma Rich in Growth Factors

In a randomized, prospective clinical study, Fernandez Sanroman and colleagues

(2016) evaluated the effectiveness of injection of plasma rich in growth factors

(PRGF) after TMJ arthroscopy in patients with Wilkes stage IV internal

derangement. A total of 92 patients were randomized to 2 experimental groups:

group A (42 joints) received injections of PRGF, and group B (50 joints) received

saline injections. Pain intensity on a VAS and MMO (mm) were measured before

and after surgery and compared by analysis of variance (ANOVA). The mean age

of patients was 35.8 years (range of 17 to 67 years); 86 were female. Significant

reductions in pain were noted in both groups after surgery: VAS 7.9 pre-operative

and 1.4 at 24 months post-operative. Significantly better clinical results were

achieved in group A than in group B only at 6- and 12-months post-operative; no

significant difference was noted at 18 or 24 months after the surgical intervention;

MMO increased after surgery in both groups: 26.2 mm pre-operative and 36.8 mm

at 24 months post-operative. No significant differences in MMO were found when

the 2 groups of patients were compared. The authors concluded that the injection

of PRGF did not add any significant improvement to clinical outcomes at 2 years

after surgery in patients with advanced internal derangement of the TMJ.

Intra-Articular Injections of Hyaluronic Acid

In a systematic review, Manfredini and colleagues (2010) examined the clinical

studies on the use of hyaluronic acid (HA) injections to treat TMJ disorders

performed over the last decade. The selected papers were assessed according to


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a structured reading of articles format, which provided that the study design was

methodologically evaluated in relation to 4 main issues: (i) population, (ii)

intervention, (iii) comparison, and (iv) outcome. A total of 19 papers were

selected for inclusion in the review, 12 dealt with the use of HA in TMJ disk

displacements and 7 dealt with inflammatory-degenerative disorders. Only 9

groups of researchers were involved in the studies, and less than 50 % of the

studies (8/19) were randomized and controlled trials. All studies reported a

decrease in pain levels independently by the patients' disorder and by the adopted

injection protocol. Positive outcomes were maintained over the follow-up period,

which ranged between 15 days and 24 months. The superiority of HA injections

was shown only against placebo saline injections, but outcomes are comparable

with those achieved with corticosteroid injections or oral appliances. The available

literature seems to be inconclusive as to the effectiveness of HA injections with

respect to other therapeutic modalities in treating TMJ disorders. The authors

concluded that studies with a better methodological design are needed to gain

better insight into this issue and to draw clinically useful information on the most

suitable protocols for each different TMJ disorder.

Goiato and colleagues (2016) examined if intra-articular (IA) injections of HA are

better than other drugs used in TMJ arthrocentesis, for the improvement of TMD

symptoms. Two independent reviewers performed an electronic search of the Medline

and Web of Science databases for relevant studies published in English up to March

2016. The key words used included a combination of “hyaluronic acid”,

“viscosupplementation”, “intra-articular injections”, “corticosteroids”, or “nonsteroidal

anti-inflammatory agents” with “temporomandibular disorder”. Selected studies were

RCTs and prospective or retrospective studies that primarily investigated the

application of HA injections compared to other IA medications for the treatment of

TMD. The initial screening yielded 523 articles. After evaluation of the titles and

abstracts, 8 were selected. Full texts of these articles were accessed, and all fulfilled

the inclusion criteria. These researchers found that IA injections of HA were beneficial

in improving the pain and/or functional symptoms of TMDs. However, other drug

therapies (e.g., corticosteroid and NSAID injections), can be used with satisfactory

results. The authors concluded that well-designed clinical studies are needed to

identify an adequate protocol, the number of sessions needed, and the appropriate

molecular weight of HA for use.


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Ferreira and colleagues (2018) performed a systematic review of the

viscosupplementation effectiveness with HA in the management of articular TMDs.

Electronic searches were performed in the following databases: Medline (via

PubMed), Scopus, Web of Science, Cochrane Library, Embase, LILACS, BBO,

SIGLE (System for Information on Grey Literature in Europe), ClinicalTrials.gov, and

the Brazilian Clinical Trials Registry (ReBec). Only randomized clinical trials that

evaluated the intra-articular administration of HA or its derivatives in osteoarthritis

and/or anterior displacement of the TMJ disc were included. The primary outcomes

evaluated were patients' self-report of pain and/or discomfort in the TMJ. Each

study was assessed for the risk of bias, using the Cochrane collaboration's risk of

bias tool. A total of 640 studies were obtained in the electronic search. After the

application of the eligibility criteria, manual search, and duplicate removal, 21

articles were included; 5 articles classified their volunteers with internal

derangements of the TMJ, in 4 articles the treatment was directed to participants

with disc displacement with reduction and the other articles evaluated HA therapy in

osteoarthritis. The protocols presented heterogeneity, varying in the form of

application, associated or not with arthrocentesis, number of applications, molecular

weight, dose and concentration; and 9 studies presented high risk of bias. The

authors concluded that due to the heterogeneity and methodological inconsistencies

of the studies evaluated, it was not possible to establish the efficacy of HA for the

treatment of articular TMDs.

Fonseca and associates (2018) noted that viscosupplementation is a minimally

invasive technique that replaces synovial fluid by intra-articular injection of HA.

Although effective in some joints, there is not conclusive evidence regarding TMDs.

In a case-series study, these investigators described the efficacy of a

viscosupplementation protocol in intra-articular TMDs. A total of 10 patients with a

diagnosis of disc displacement and/or osteoarthritis by Research Diagnostic Criteria

for Temporomandibular Disorders (RDC/TMD) were submitted to 4 monthly injections

of low or medium molecular weight HA. Pain, mandibular function, image analysis by

CT and MRI, and quality of life (QOL) were assessed at baseline and follow-ups (1

and 6 months). Pain, jaw ROM, mandibular function, and QOL improved at follow-up

evaluations. Osteoarthritis changes decreased, and 20 % of patients improved

mandibular head excursion after treatment. Resolution of effusion and improvement

in disc morphology were observed for most patients.

The authors concluded that this viscosupplementation protocol reduced pain and

symptoms associated with internal derangement of TMJ, improved QOL, and


http://clinicaltrials.gov

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showed benefits from both low and medium molecular weight HA in alternate

cycles. Moreover, they stated that randomized clinical trials of this treatment

protocol should deserve attention in future researches.

The authors stated that although this trial showed promising results regarding the

described protocol of viscosupplementation for TMJ, they were aware of the

limitations of this work. These researchers believed its greater contribution may be

the description of a new perspective to be tested in a well-controlled clinical trial in

future research studies. The small number of patients (n = 10) and the study

design as an open-label non-controlled trial did not allow inference of

viscosupplementation positive effects to all TMD patients.

Intra-Articular Injections of Rituximab

In a retrospective study, Stoll and colleagues (2015) evaluated the involvement of

IA infliximab (IFX) in the management of TMJ arthritis associated with juvenile

idiopathic arthritis (JIA) that is refractory to systemic treatment and IA corticosteroid

therapy. Subjects were children with JIA who received IA IFX into the TMJ. The

effectiveness of treatment on the progression of acute and chronic changes was

assessed by a quantitative MRI scoring system. Median acute and chronic scores

worsened by 0.25 and 0.75, respectively. In multi-variate analysis, worsening acute

scores and passage of time predicted worsening of the chronic scores. The

authors concluded that IA IFX allowed for progression of refractory TMJ arthritis in

most but not all children with JIA.

Platelet-Rich Plasma

Pihut et al (2014) evaluated the regression of temporo-mandibular pain as a result

of intra-articular injections of platelet-rich plasma (PRP) to patients with TMJ

dysfunction previously subjected to prosthetic treatment. The baseline study

material consisted of 10 patients, aged 28 to 53 years, previously treated due to

painful TMJ dysfunction using occlusal splints. All patients underwent a specialist

functional assessment of the dysfunction using the Polish version of the RDC/TMD

questionnaire axis I and II. The injection sites were determined by the method used

during arthroscopic surgical procedures. Following aspiration, 0.5 ml of PRP was

injected into each TMJ. The comparison of the intensity of pain during all

examinations suggested a beneficial effect of the procedure being performed as the

mean VAS score was 6.5 at examination I, 2.8 at examination II, and 0.6 at


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examination III. The authors concluded that the application of the intra-articular

injections of PRP into the TMJs has a positive impact on the reduction of the

intensity of pain experienced by patients treated for TMJ dysfunction. These

preliminary findings need to be validated by well-designed studies.

In a systematic review, Bousnaki and Koidis (2018) examined if intra-articular

injections of PRP are beneficial for the treatment of degenerative TMDs, such as

TMJ osteoarthritis (TMJ-OA) and disc displacement with osteoarthritic lesions,

when compared to other treatments, such as injections of HA or saline. These

researchers carried out an electronic search of the Medline and Scopus databases

using combinations of the terms "temporomandibular" and "platelet rich plasma", to

identify studies reported in English and published up until May 2017. A hand-

search of relevant journals and the reference lists of selected articles was also

performed. The initial screening identified 153 records, of which only 6 fulfilled the

inclusion criteria and were included in this review. Of these studies, 3 compared

PRP with HA, while 3 compared PRP with Ringer’s lactate or saline; 4 of the

studies found PRP injections to be superior in terms of improvements in mandibular

ROM and pain intensity up to 12 months after treatment, while the remaining 2

studies found similar results for the different treatments. The authors concluded

that there is slight evidence for the potential benefits of intra-articular injections of

PRP in patients with TMJ-OA. However, they stated that a standardized protocol

for PRP preparation and application needs to be established.

Salivary Stress Biomarkers

Kobayashi and colleagues (2017) noted that the etiology of TMD remains a

controversial issue in clinical dentistry. These researchers examined if salivary alpha-

amylase (sAA), cortisol levels, and anxiety symptoms differ between children with

and without TMD. Initially, 316 young subjects were screened in public schools (non-

referred sample); 76 subjects aged 7 to 14 years were selected and comprised the

TMD and control groups with 38 subjects each matched by sex, age, and the

presence/absence of sleep bruxism. Four saliva samples were collected: upon

waking, 30 mins and 1 hour after awakening (fasting), and at night (at 8 PM) on 2

alternate days to examine the diurnal profiles of cortisol and sAA. Anxiety symptoms

were screened using the Multidimensional Anxiety Scale for Children (MASC-

Brazilian version). Shapiro-Wilk test, Student's t-test/Mann-Whitney U test, and

correlation tests were used for data analysis. No significant differences were

observed in the salivary cortisol area under the curve (AUCG mean ± SD = 90.22 ±


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63.36 × 94.21 ± 63.13 µg/dL/min) and sAA AUCG (mean ± SD = 2,544.52 ±

2,142.00 × 2,054.03 ± 1,046.89 U/mL/min) between the TMD and control groups,

respectively (p > 0.05); however, the clinical groups differed in social anxiety

domain (t = 3.759; CI: 2.609 to 8.496), separation/panic (t = 2.243; CI: 0.309 to

5.217), physical symptoms (U = 433.500), and MASC total score (t = -3.527; CI:

-23.062 to -6.412), with a power of the test greater than 80 % and large effect size

(d = 0.80), with no significant correlation between the MASC total score, cortisol,

and sAA levels. The authors concluded that although children with TMD scored

higher in anxiety symptoms, no difference was observed in the salivary stress

biomarkers between children with and without TMD.

Bio-Oxidative Ozone Therapy

In a double-blind, randomized clinical trial, Celakil and colleagues (2017) examined

the effect of bio-oxidative ozone application at the points of greatest pain in patients

with chronic masticatory muscle pain. A total of 40 women (mean age of 31.7) were

selected after the diagnosis of myofacial pain dysfunction syndrome according to

the Research Diagnostic Criteria for TMD (RDC/TMD). Patients were randomly

divided into 2 groups: (i) patients received the ozone therapy at the point of

greatest pain, ozone group (OG; n = 20); and (ii) patients received the sham

ozone therapy at the point of greatest pain, placebo group (PG; n = 20). Ozone

and placebo were applied 3 times/week, for a total of 6 sessions. Mandibular

movements were examined, masticator muscles tenderness was assessed and

PPT values were obtained. Subjective pain levels were evaluated using VAS.

These assessments were performed at baseline, 1 month and 3 months. Ozono

therapy decreased pain intensity and increased PPT values significantly from

baseline to 1 month and 3 months in OG compared with PG; PPTs of the temporal

(OG = 24.85 ± 6.65, PG = 20.65 ± 5.43, p = 0.035) and masseter (OG = 19.03 ±

6.42, PG = 14.23 ± 2.95, p = 0.007) muscles at 3 months of control (T2) were

significantly higher in the OG group. PPT value of the lateral pole was also

significantly higher at T2 in the OG group (OG = 21.25 ± 8.43, PG = 15.35 ± 4.18, P

= 0.012). Mandibular movements did not show significant differences between

treatment groups except right lateral excursion values at T2 (OG = 8.90 ± 1.77, PG

= 6.85 ± 2.41, p = 0.003); however, OG demonstrated significantly better results

over time. Overall improvements in VAS scores from baseline to 3 months were

OG 67.7 %; PG 48.4 %. The authors concluded that although ozone therapy can

be accepted as an alternative treatment modality in the management of masticatory

muscle pain, sham ozone therapy (placebo) showed significant improvements in


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the tested parameters. The main drawbacks of this study were its small sample

size (n = 20 for the ozone group) and short-term follow-up (3 months). These

preliminary findings need to be validated in well-designed studies.

Magnetic Neurostimulator

Florian and colleagues (2017) evaluated application of the magnetic neurostimulator

(Haihua model CD-9), used within the precepts of acupuncture, in treating TMD-

related pain symptoms and limited mouth opening. Analysis and discussion of this

study were based on pain intensity index and range of mouth- opening evaluation

before and after each session. A total of 9 patients diagnosed with muscle TMD,

referred by the surgery sector of Center Dental Specialties (CEO

- I) in Piracicaba-Sao Paulo participated in this research. The authors concluded

that considering the simplicity of the technique and good results obtained, use of

this device is suggested as an additional therapeutic tool for relief of TMD

symptoms. These preliminary findings need to be validated in well-designed

studies.

Roj and colleagues (2018) evaluated the effect of magnetic stimulation on EMG

activity in temporal muscles and masseters in patients with painful TMD using

occlusal splints. Participants consisted of 40 edentulous patients with TMD. They

were evaluated based on Helkimo Index. Next, EMG activity of the temporal

muscle and masseter were examined using 8-channel surface EMG. All patients

received acrylic occlusal splints for 12 weeks. The group qualified for the study

included 20 randomized patients, whose therapy was additionally carried out by

extremely low-frequency magnetic fields for a period of 21 days. Follow-up

examinations were conducted after 3, 6 and 12 weeks with surface EMG recording

of the examined muscles. Patients received occlusal splint corrections using the

T-Scan III system. The clinical evaluation of TMD was analyzed using Helkimo

index and VAS scale before and after the treatment. All the data were analyzed

using Statistica 12.5 PL. Patients with combination therapy had lower asymmetry

of temporal muscle activity. The authors concluded that combination therapy using

magnetic stimulation reduced intensity of pain in patients with TMD and decreased

values of the Helkimo indices. This was a small (n = 20 in the combined treatment

group) study; and its findings were confounded by the combined therapy of

magnetic stimulation and occlusal splint. These preliminary findings need to be

validated by well-designed studies.


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MIRO Therapy

MIRO therapy entails the following:

▪ Transcutaneous neural stimulations (TENS) to relax your muscles, increase

blood flow and remove waste products.

▪ TENS to relieve pain by stimulating the release of endorphins, your body’s

own natural pain killer.

▪ Energex pulsed radio frequency energy to reduce pain and rapidly improve

symptoms. In a recent study by Tufts University School of Dental Medicine,

Energex therapy was found to be highly effective in reducing pain associated

with TMJ arthralgia and improving range of motion in the joint.

▪ Vectra Genisys Ultrasound to reduce joint inflammation, muscle spasms

and adhesions using sound waves that gently pass through your tissue to

accelerate healing and repair.

▪ A clear, almost invisible temporary device worn over your lower teeth to

correct improper alignment of your jaw without altering any of your actual

teeth.

▪ Stabilize and refine your bite with periodic adjustments to the device until

your symptoms are relieved or resolved.

▪ Find the exact position where your muscles and joints are most comfortable

to stop the cycle of pain, pills and dysfunction.

▪ Multi Radiance cold laser to promote tissue healing and repair.

▪ NuCalm neuroscience technology to quickly produce deep relaxation of

your muscles.

There is a lack of evidence regarding the effectiveness of MIRO therapy for the

treatment of TMD/TMJ dysfunctions.

Ultrasonography for the Diagnosis of Temporomandibular Disorders

Gauer and Semidy (2015) noted that ultrasonography is a noninvasive, dynamic,

low-cost technique to diagnose internal derangement of the TMJ when magnetic

resonance imaging is not readily available.

Hechler and associates (2018) performed a systematic review of published articles

on ultrasound (US) and MRI of the TMJ in JIA to answer the question "What is the

sensitivity and specificity of US as compared to MRI in diagnosing acute and


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chronic joint changes in patients with JIA?" The most recent evidence was sought

in published articles via a search of the PubMed, Ovid, and Embase databases.

Article appraisal was carried out by 2 reviewers. A total of 19 articles reporting

prospective or ambispective studies comparing US to MRI in TMJ imaging were

found; 6 of these articles were specific to JIA patients. The heterogeneity of these

articles made comparison difficult. Of the acute and chronic changes assessed

(disk displacement, joint effusion, bony deformity), only joint effusion was

appropriately assessed by multiple authors, with US having a sensitivity of 0 to 72

% and specificity of 70 to 83 % as compared to MRI. There was a paucity of

studies specific to JIA, with many studying adult, non-rheumatic patients. The

authors concluded that this systematic review found that dynamic imaging with

high-resolution US improved sensitivity and specificity compared to static, low-

resolution US. Furthermore, there is evidence to suggest that US imaging following

a baseline MRI could increase US sensitivity and specificity and may have a future

role in disease surveillance.

Klatkiewicz and colleagues (2018) stated that the increased prevalence of TMDs

requires searching for new, easily accessible diagnostic methods. In addition to

routine clinical examination, various methods of imaging TMJs are available, such

as MRI, CT scans, or scintigraphy. These investigators stated that US imaging,

due to short examination time, low cost, and non-invasiveness, should be

recommended as a routine diagnostic procedure. These investigators examined if

US imaging could be used in the diagnosis of TMJDs. Publications during the

period 2006 to March 2017 from the US National Library of Medicine database

were selected for analysis by entering the terms "ultrasonography", "ultrasound",

"USG", "temporomandibular joint", "TMJ", "temporomandibular disorders", and

"TMD". Papers were chosen if they met the required criteria relating to the

sensitivity, specificity, accuracy, positive predictive value (PPV), and negative

predictive value (NPV) of this diagnostic technique with regard to imaging articular

disc displacement, joint effusion, and condylar abnormalities. The search yielded

1,883 publications, of which 8 were selected that met the criteria for inclusion in the

analysis. For articular disc displacement examinations, the following results were

obtained: sensitivity 75.6 %; specificity 69.1 %; accuracy 76.1 %; PPV 72.2 %; and

NPV 65.6 %. When the examinations of joint effusion and condylar abnormalities

were included, the results were respectively 66.9 %; 70.8 %; 69.9 %; 75.8 %; and

62.4 %. The authors concluded that the use of US in the diagnosis of TMDs

requires standardizing the method as well as further research to confirm its

effectiveness.


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Intra-Articular Injection of Analgesics for the Treatment of Temporomandibular Disorders

Gopalakrishnan and associates (2018) evaluated the efficacy of intra-articular

analgesics in improving outcomes after TMJ arthrocentesis. These researchers

carried out an electronic search of PubMed, Scopus, and Google scholar

databases for papers in English published up to December 2017 reporting the use

of intra-articular analgesics after TMJ arthrocentesis; RCTs, controlled clinical trials

(CCTs), comparative studies, retrospective studies, and case series were included

while case reports, technical reports, animal studies, cadaveric studies, and review

papers were excluded. Of the 6 studies included in the review, 3 were RCTs, 2

were randomized comparative studies, and 1 was a retrospective study. Both

opioids and NSAIDs have been used after TMJ arthrocentesis. Morphine,

tramadol, fentanyl, buprenorphine, tenoxicam, and COX-2 inhibitors are the drugs

used to-date. Placebo-controlled studies reported improved outcomes after TMJ

arthrocentesis with morphine and fentanyl; but no such results with buprenorphine

and tenoxicam. Tramadol was found to be better than COX-2 inhibitor. The quality

of literature was not high. The authors concluded that there is inconclusive

evidence in literature on the benefits of using intra-articular analgesics after TMJ

arthrocentesis. They stated that well-designed high-quality RCTs with standard

protocol studying the effects of intra-articular opioids and NSAIDS after TMJ

arthrocentesis would provide stronger evidence on its use.

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

CPT codes covered if selection criteria are met:


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Code Code Description

20605 Arthrocentesis, aspiration and/or injection, intermediate joint or bursa

(eg, temporomandibular, acromioclavicular, wrist, elbow or ankle,

olecranon bursa); without ultrasound guidance [not covered for

viscosupplementation injection] [not covered for intra-articular injections

of rituximab] [not covered for Intra-articular injection of analgesic]

20910 Cartilage graft; costochondral [autologous]

21010 Arthrotomy, tempomandibular joint

21050 Condylectomy, tempomandibular joint (separate procedure)

21060 Meniscectomy, partial or complete, tempomandibular joint (separate

procedure)

21070 Coronoidectomy (separate procedure)

21073 Manipulation of temporomandibular joint(s) (TMJ), therapeutic, requiring

an anesthesia service (ie, general or monitored anesthesia care)

21076 Impression and custom preparation; surgical obturator prosthesis

21079 interim obturator prosthesis

21080 definitive obturator prosthesis

21081 mandibular resection prosthesis

21085 oral surgical splint

21110 Application of interdental fixation device for conditions other than

fracture or dislocation, includes removal

21193 Reconstruction of mandibular rami, horizontal, vertical, C, or L

osteotomy; without bone graft

21198 Osteotomy, mandible, segmental;

21240 Arthroplasty, temporomandibular joint, with or without autograft (includes

obtaining graft)

21242 Arthroplasty, temporomandibular joint, with allograft

21243 Arthroplasty, temporomandibular joint, with prosthetic joint replacement

21255 Reconstruction of zygomatic arch and glenoid fossa with bone and

cartilage (includes obtaining autografts)

21440 Closed treatment of mandibular or maxillary alveolar ridge fracture

(separate procedure)


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21445 Open treatment of mandibular or maxillary alveolar ridge fracture

(separate procedure)

21450 Closed treatment of mandibular fracture; without manipulation

21451 with manipulation

21452 Percutaneous treatment of mandibular fracture; with external fixation

21453 Closed treatment of mandibular fracture with interdental fixation

21454 Open treatment of mandibular fracture with external fixation

21461 Open treatment of mandibular fracture; without interdental fixation

21462 with interdental fixation

21465 Open treatment of mandibular condylar fracture

21470 Open treatment of complicated mandibular fracture by multiple surgical

approaches including internal fixation, interdental fixation, and/or wiring

of dentures or splints

21480 Closed treatment of temporomandibular dislocation; initial or subsequent

21485 complicated (e.g., recurrent requiring intermaxillary fixation or

splinting), initial or subsequent

21490 Open treatment of temporomandibular dislocation

21497 Interdental wiring, for condition other than fracture

29800 Arthroscopy, temporomandibular joint, diagnostic, with or without

synovial biopsy (separate procedure)

29804 Arthroscopy, temporomandibular joint, surgical

70355 Orthopantogram (eg, panoramic x-ray)

76536 Ultrasound, soft tissues of head and neck (eg, thyroid, parathyroid,

parotid), real time with image documentation [ultrasonography of

temporomandibular joints]

90832 - 90840 Psychotherapy

90901 Biofeedback training by any modality

97010 Application of a modality to 1 or more areas; hot or cold packs

97110 Therapeutic procedure, one or more areas, each 15 minutes;

therapeutic exercises to develop strength and endurance, range of

motion and flexibility


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97124 massage, including effleurage, petrissage and/or tapotement

(stroking, compression, percussion)

97140 Manual therapy techniques (e.g., mobilization/manipulation, manual

lymphatic drainage, manual traction), one or more regions, each 15

minutes

97530 Therapeutic activities, direct (one-on-one) patient contact by the provider

(use of dynamic activities to improve functional performance), each 15

minutes

97810 Acupuncture, 1 or more needles; without electrical stimulation, initial 15

minutes of personal one-on-one contact with the patient

+ 97811 without electrical stimulation, each additional 15 minutes of personal

one-on-one contact with the patient, with re-insertion of needle(s) (List

separately in addition to primary procedure)

97813 with electrical stimulation, initial 15 minutes of personal one-on-one

contact with the patient

+ 97814 with electrical stimulation, each additional 15 minutes of personal one-

on-one contact with the patient, with re-insertion of needle(s) (List

separately in addition to primary procedure)

CPT codes not covered for indications listed in the CPB:

Bio-oxidative ozone therapy, Magnetic neurostimulator, MIRO therapy - no specific code:

0232T Injection(s), platelet rich plasma, any site, including image guidance,

harvesting and preparation when performed

0481T Injection(s), autologous white blood cell concentrate (autologous protein

solution), any site, including image guidance,harvesting and

preparation, when performed

21120 - 21123 Genioplasty

21125 - 21127 Augmentation mandibular body or angle

21141 - 21147 Reconstruction midface, Lefort I

21150 - 21151 Reconstruction midface, Lefort II

21154 - 21155 Reconstruction midface, Lefort III (extracranial), any type, requiring bone

grafts (includes obtaining autografts)


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21159 - 21160 Reconstruction midface, Lefort III (extra and intracranial) with forehead

advancement (e.g., mono bloc), requiring bone grafts (includes obtaining

autografts)

21194 Reconstruction of mandibular rami, horizontal, vertical, C, or L

osteotomy; with bone graft (includes obtaining graft)

21195 - 21196 Reconstruction of mandibular rami and/or body, sagittal split

21199 Osteotomy, mandible, segmental; with genioglossus advancement

21206 Osteotomy, maxilla, segmental (e.g., Wassmund or Schuchard)

21208 - 21209 Osteoplasty, facial bones

21247 Reconstruction of mandibular condyle with bone and cartilage autografts

(includes obtaining grafts) (e.g., for hemifacial microsomia)

21248 - 21249 Reconstruction of mandible or maxilla, endosteal implant (e.g., blade,

cylinder)

38205 Blood-derived hematopoietic progenitor cell harvesting for

transplantation, per collection; allogeneic

38206 autologous

38230 Bone marrow harvesting for transplantation; allogenic

38232 autologous

38240 Hematopoietic progenitor cell (HPC); allogeneic transplantation per

donor

38241 autologous transplantation

38242 Allogeneic lymphocyte infusions

70300 Radiologic examination, teeth; single view

70310 partial examination, less than full mouth

70320 complete, full mouth

70487 Computerized tomography, maxillofacial area; with contrast material(s)

70488 without contrast material, followed by contrast material(s) and further

sections

77077 Joint survey, single view, 2 or more joints (specify) [joint vibration

analysis for TMJ]


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90867 Therapeutic repetitive transcranial magnetic stimulation (TMS)

treatment; initial, including cortical mapping, motor threshold

determination, delivery and management

90868 subsequent delivery and management, per session

90869 subsequent motor threshold re-determination with delivery and

management

90880 Hypnotherapy

95867 Needle electromyography; cranial nerve supplied muscle(s), unilateral

95868 cranial nerve supplied muscles, bilateral

95887 Needle electromyography, non-extremity (cranial nerve supplied or

axial) muscle(s) done with nerve conduction, amplitude and

latency/velocity study (List separately in addition to code for primary

procedure)

95937 Neuromuscular junction testing (repetitive stimulation, paired stimuli),

each nerve, any one method

96900 Actinotherapy (ultraviolet light)

96910 Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or

petrolatum and ultraviolet B

96912 Photochemotherapy; psoralens and ultraviolet A (PUVA)

96913 Photochemotherapy (Goeckerman and/or PUVA) for severe

photoresponsive dermatoses requiring at least 4-8 hours of care under

direct supervision of the physician (includes application of medication

and dressings)

97014 Application of a modality to 1 or more areas; electrical stimulation

(unattended)

97024 diathermy (e.g., microwave)

97026 infrared

97028 ultraviolet

97032 Application of a modality to one or more areas; electrical stimulation

(manual), each 15 minutes

97033 iontophoresis, each 15 minutes

97035 ultrasound, each 15 minutes


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97036 Hubbard tank, each 15 minutes

97127 Therapeutic interventions that focus on cognitive function (eg, attention,

memory, reasoning, executive function, problem solving, and/or

pragmatic functioning) and compensatory strategies to manage the

performance of an activity (eg, managing time or schedules, initiating,

organizing and sequencing tasks), direct (one-on-one) patient contact

97750 Physical performance test or measurement (e.g., musculoskeletal,

functional capacity), with written report, each 15minutes

Other CPT codes related to the CPB:

70328 Radiologic examination, temporomandibular joint, open and closed

mouth; unilateral [covered only when used in conjunction with

anticipated surgical management]

70330 bilateral [covered only when used in conjunction with anticipated

surgical management]

70332 Temporomandibular joint arthrography, radiological supervision and

interpretation

70336 Magnetic resonance (e.g., proton) imaging, temporomandibular joint(s)

[covered only when used in conjunction with anticipated surgical

management]

70486 Computerized tomography, maxillofacial area; without contrast material

[covered only when used in conjunction with anticipated surgical

management]

70540 Magnetic resonance (e.g., proton) imaging, orbit, face, and/or neck;

without contrast material(s)

70542 with contrast material(s)

70543 without contrast material(s), followed by contrast material(s) and

further sequences

HCPCS codes covered if selection criteria are met:

D0320 Temporomandibular joint arthrogram, including injection

D0321 Other temporomandibular joint films, by report

D0322 Tomographic survey

D0340 Cephalometric film


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D5931 - D5933,

D5936

Obturator prostheses

D5934 Mandibular resection prosthesis with guide flange

D5982 Surgical stent

D5988 Surgical splint

D7630 Mandible, open reduction (teeth immobilized, if present)

D7640 Mandible, closed reduction (teeth immobilized, if present)

D7730 Mandible, open reduction

D7740 Mandible, closed reduction

D7810 - D7880 Reduction of dislocation and management of other temporomandibular

joint dysfunctions

D9940 Occlusal guards, by report

D9951 - D9952 Occlusal adjustment, limited/complete

E0746 Electromyography (EMG), biofeedback device

HCPCS codes not covered for indications listed in the CPB: A4556

Electrodes (e.g., apnea monitor), per pair

A4557 Lead wires (e.g., apnea monitor), per pair

A4558 Conductive gel or paste, for use with electrical device (e.g., TENS,

NMES), per oz.

A4595 Electrical stimulator supplies, 2 lead, per month, (e.g., TENS, NMES)

D0350 Oral/facial photographic images

D5110 - D5899 Prosthodontics (removable)

D6210 - D6999 Prosthodontics (fixed)

D7899 Unspecified TMD therapy, by report

D7940 Osteoplasty, for orthognathic deformities

D7941 Osteotomy - mandibular rami

D7943 Osteotomy - mandibular rami with bone graft; includes obtaining the

graft

D7944 Osteotomy - segmented or subapical

D7945 Osteotomy, body of mandible


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D7946 Lefort I (maxilla, total)

D7947 Lefort I (maxilla, segmented)

D7948 Lefort II or Lefort III (osteoplasty of facial bones for midfce hypoplasia or

retrusion), without bone graft

D7949 Lefort II or Lefort III, with bone graft

D7950 Osseous, osteoperiosteal, or cartilage graft of the mandible or maxilla,

autogenous or nonautogenous, by report

D7951 Sinus augmentation with bone or bone substitutes

D7953 Bone replacement graft for ridge preservation - per site

D7955 Repair of maxillofacial soft and/or hard tissue defect

E0720 Transcutaneous electrical nerve stimulation (TENS) device, 2 lead,

localized stimulation

E0730 Transcutaneous electrical nerve stimulation (TENS) device, 4 or more

leads, for multiple nerve stimulation

E0745 Neuromuscular stimulator, electronic shock unit

G0515 Development of cognitive skills to improve attention, memory, problem

solving (includes compensatory training), direct (one-on-one) patient

contact, each 15 minutes

J0585 Botulinum toxin type A, per unit [Botox]

J0586 Injection, Abobotulinumtoxina, 5 units [Dysport]

J0587 Injection, rimabotulinumtoxinB, 100 units

J0588 Injection, incobotulinumtoxinA, 1 unit [Xeomin]

J7321 Hyaluronan or derivative, Hyalgan or Supartz, for intra-articular injection,

per dose [knee only - see selection criteria]

J7323 Hyaluronan or derivative, Euflexxa, for intra-articular injection, per dose

[knee only - see selection criteria]

J7324 Hyaluronan or derivative, Orthovisc, for intra-articular injection, per dose

[knee only - see selection criteria]

J7325 Hyaluronan or derivative, Synvisc, or Synvisc-One for intra-articular

injection, per dose [knee only - see selection criteria]

J9312 Injection, rituximab, 10 mg


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ICD-10 codes covered if selection criteria are met:

M26.609

M26.69

S03.02x+

http://www.aetna.com/cpb/medical/data/1_99/0028.html 03/28/2019 Proprietary

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36. Van Loon JP, De Bont L, Boering G. Evaluation of temporomandibular joint

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53. American Society of Temporomandibular Joint Surgeons. Guidelines for

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54. White SC, Heslop EW, Hollender LG, et al. American Academy of Oral and

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55. Dawson PE. Position paper regarding diagnosis, management, and

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Neck and Facial Pain; American Academy of Orofacial Pain; American

Academy of Pain Management; American College of Prosthodontists;

American Equilibration Society and Society of Occlusal Studies; American

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Temporomandibular Joint Surgeons; International College of Cranio

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57. Laskin D. Shifting responsibility for medical decisions. Editorial. J Oral

Maxillofac Surg. 2001; 59:601-602.

58. Forssell H, Kalso E, Koskela P, et al. Occlusal treatments in

temporomandibular disorders: A qualitative systematic review of

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59. Reston JT, Turkelson CM. Meta-analysis of surgical treatments for

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60. Park J, Keller EE, Reid JI. Surgical management of advanced degenerative

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61. Al-Ani MZ, Davies SJ, Gray RJ, et al. Stabilisation splint therapy for

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67. Adiels AM, Helkimo M, Magnusson T. Tactile stimulation as a

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68. American Society of Temporomandibular Joint Surgeons. Guidelines for the

diagnosis and management of disorders involving the temporomandibular

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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan

benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,

general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care

services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in

private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible

for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to

change.

Copyright © 2001-2019 Aetna Inc.

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AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0028 Temporomandibular

Disorders

There following benefit exclusion does not apply to Medicaid:

“Most Aetna HMO plans exclude coverage for treatment of temporomandibular disorders (TMD) and temporomandibular joint (TMJ) dysfunction and may also exclude coverage for other services described in this bulletin (e.g., non‐surgical management) The plan determines the scope of coverage. Please check benefit plan descriptions for details.”

Please contact Member Services for specific details regarding the individual member’s covered benefits under Medicaid. Most services may be covered for adults. There are no benefit limitations for children under age 21 years.

www.aetnabetterhealth.com/pennsylvania revised 03/18/2019 Proprietary

http://www.aetnabetterhealth.com/pennsylvania

prior authorization review panel mco policy …...page 5 of 63 tmj surgery may be considered...

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