Intraoral Appliances for Headaches (027)

Number: 027 
(Update)

Subject: Intraoral Appliances for Headaches

Date: August 12, 2013

Important note

This Clinical Policy Bulletin expresses our determination of whether certain services or supplies are medically necessary. We have reached these conclusions based on a review of currently available clinical information including:

• Clinical outcome studies in the peer-reviewed published medical and dental literature
• Regulatory status of the technology
• Evidence-based guidelines of public health and health research agencies
• Evidence-based guidelines and positions of leading national health professional organizations
• Views of physicians and dentists practicing in relevant clinical areas
• Other relevant factors

We expressly reserve the right to revise these conclusions as clinical information changes, and welcome further relevant information.

Each benefits plan defines which services are covered, which are excluded and which are subject to dollar caps or other limits. Members and their dentists will need to consult the member's benefits plan to determine if any exclusions or other benefits limitations apply to this service or supply. The conclusion that a particular service or supply is medically necessary does not guarantee that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the federal government or CMS for Medicare and Medicaid members.

Policy

Aetna considers intraoral appliances (for example, the Nociceptive Trigeminal Inhibition-Tension Suppression System) experimental and investigational for the treatment of headaches because their effectiveness for this indication has not been established.

For policy on intraoral appliances for TMJ syndrome, see CPB 0028 - Temporomandibular Disorders.

See also CPB 0113 - Botulinum Toxin;  CPB 0132 - Biofeedback;  CPB 0135 - Acupuncture;  CPB 0172 - Hyperbaric Oxygen Therapy (HBOT);  CPB 0462 - Migraine and Cluster Headache:Nonsurgical Management;  CPB 0469 - Transcranial Magnetic Stimulation and Cranial Electrical Stimulation;  CPB 0647 - Histamine Desensitization Therapy for Intractable Headaches; CPB 0707 - Headaches: Invasive Procedures . 
Background

Headache is a common medical complaint and is generally categorized by one of three syndromes:

• migraine headache
• tension-type headache
• cluster headache

Migraine is characterized by attacks of headache, nausea, vomiting, photophobia, phonophobia and malaise. Tension-type headache is mild to moderate in intensity, bilateral, and non-throbbing without other associated features. Cluster headache is strictly unilateral, begins quickly without warning, and reaches maximal intensity within a few minutes. It is usually deep, excruciating, continuous, and explosive in quality, although occasionally it may be pulsatile and throbbing.

Other headache syndromes may include sinus headache, post-traumatic headache, medication over-use and temporomandibular joint (TMJ) dysfunction. The typical headache associated with TMJ presents as unilateral ear or pre-auricular pain that radiates to the jaw, temple or neck. The pain is deep, dull, continuous and usually worse in the morning. It is typically associated with a limitation of jaw motion and deviation of the jaw upon opening. Physical examination may reveal tenderness of the muscles of mastication and less commonly, clicking of the joint. Many cases are difficult to distinguish from tension-type headaches (Bajwa and Sabahat, 2008).

Pharmacological treatment of headaches is aimed at reversing, aborting, or reducing pain and the accompanying symptoms of an attack as well as optimizing the patient's ability to function normally.

Most attacks of mild migraine can be effectively treated by anti-emetics followed by analgesics such as aspirin, acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs). Moderate to severe attacks are successfully treated using combinations of ergotamine tartrate, dihydroergotamine and triptans with anti-emetics, simple analgesics, NSAIDs and/or opiates.

For severe migraine headaches, alternative medications include intravenous administration of neuroleptics such as chlorpromazine (Thorazine) and prochlorperazine (Compazine); occasionally corticosteroids such as prednisone, hydrocortisone, dexamethasone and methylprednisone, and lastly parenteral narcotic analgesics such as meperidine and the nasal spray butorphanol tartrate (Stadol NS).

The acute or abortive therapy of tension-type headache (TTH) ranges from non-pharmacologic therapies to analgesic medications. The treatment of headache due to TMJ primarily involves therapy of the joint disorder itself. Most cases can be treated with local heat, physical therapy, dental hygiene, NSAIDs and dietary measures (Bajwa and Sabahat, 2008).

Complementary and alternative therapies for headaches include acupuncture, aromatherapy, biofeedback, Bowen technique (remedial therapy tool to manage pain), chiropractic, cranial electrical stimulation, hyperbaric oxygen therapy, hypnotherapy, massage, nutrition, reflexology, Reiki, spinal/osteopathic manipulation, transcranial magnetic stimulation and yoga, although the effectiveness of many of these approaches has not been established. Recently, it has been suggested that intraoral dental appliances used to reduce the intensity and the amount of jaw muscle activity may be beneficial in preventing headaches. 

Advocates of intraoral appliances for preventing headaches believe that stimulation of the trigeminal nerve through increased cervical as well as mandibular muscle activities (for example, clenching or grinding the teeth), which can occur when the patient is awake or asleep, may trigger headaches. Intraoral appliances are thought to aid in controlling clenching and grinding of the teeth, thus decreasing the possibility of over-stimulating the trigeminal nerve system. These intraoral dental appliances are prefabricated in different configurations covering all or some of the upper or lower dentition.

An example of an intra-oral device for the prevention of headaches is the Nociceptive Trigeminal Inhibition - tension suppression system (NTI-tss, NTI-TSS, Inc., Mishawaka, IN). It was developed and patented by James P. Boyd, DDS. While the Standard NTI-tss device can be worn indefinitely (while sleeping), the NTI-tss Daytime device is recommended for patients with migraine (in addition to the use of the Standard device) for 4 to 8 weeks during waking hours. The inch-wide device is made of clear plastic and fits over 2 front teeth -- usually but not always the top teeth. It keeps the back teeth from coming together preventing clenching. The NTI-tss is sold in a kit form, and dentists can mold and custom-fit the device to patients’ teeth in approximately 1 hour.

TThe NTI-tss was cleared by the Food and Drug Administration (FDA) through 510(k) premarket notification in June 2001 for the prevention of medically diagnosed migraine headaches as well as migraine associated with tension-type headaches, and for the prevention of bruxism and TMJ. Thus, the manufacturer was not required to submit to the FDA the evidence of efficacy that is necessary to support a premarket approval application (PMA).

Lamey, et al. (1996) studied the relationship between the nocturnal wearing of an acrylic appliance of 2 mm thickness covering all occlusal surfaces of the teeth (2 appliance designs) and the frequency of migraine attacks in 19 patients who had migraine with or without aura.

One design covered the maxillary occlusal surfaces of the dentition while the other design contacted the palatal mucosa only and was free of the occlusion. Treatment outcome was expressed as the number of migraine attacks per week per patient.

The occlusal cover appliance reduced the number of attacks on average to about 40% of those normally experienced. The improvement was most marked in those who had frequent migraine attacks (that is, 2 attacks per week on a regular basis). The authors concluded that acrylic appliance therapy is of value in migraine sufferers who have attacks on waking but the appliance design has to involve covering of the occlusal surfaces of all of the teeth (note: the NTI-tss only covers the front 2 teeth). The drawbacks of this study were that it was a non-randomized study with a small sample size and no long-term follow-up.

Two studies comparing the NTI-tss splint with a standard stabilization splint in the treatment of TMJ have been published (Magnusson, et al., 2004; Jokstad, et al., 2005). Results obtained by Magnusson favored the use of a stabilization splint over the NTI splint. In addition, one subject treated with the NTI-tss splint exhibited an impaired occlusion at the 6-month follow-up. Jokstad found no differences between a standard stabilization splint versus the NTI splint regarding TMJ treatment efficacy over a 3-month period. Both comparative studies were small and neither focused on migraine as an outcome measure. Further studies are needed to determine the effects of the NTI-tss splint on the treatment of headaches, including migraine, as well as possible long-term side effects. 

There is insufficient data on the effectiveness of oral appliances in the treatment of headaches. Randomized controlled studies are needed to determine the effectiveness of oral appliances in the treatment of headache.

The above policy is based on the following references:

1. Lamey PJ, Steele JG, Aitchison T. Migraine: The effect of acrylic appliance design on clinical response. Br Dent J. 1996;180(4):137-140.
2. Horne M. Treating headaches. A conceptual framework. Aust Fam Physician. 1998;27(7):579-586.
3. Long L, Huntley A, Ernst E. Which complementary and alternative therapies benefit which conditions? A survey of the opinions of 223 professional organizations. Complement Ther Med. 2001;9(3):178-185.
4. Mauskop A. Alternative therapies in headache. Is there a role? Med Clin North Am. 2001;85(4):1077-1084.
5. The NTI-Tension Suppression System for migraine. The most effective FDA- approved method of migraine prevention. Available at: http://nti-tss.com/. Accessed June 27, 2011.
6. Shankland WE. Nociceptive trigeminal inhibition--tension suppression system: A method of preventing migraine and tension headaches. Compend Contin Educ Dent. 2002;23(2):105-108, 110, 112-113.
7. Milanov I, Bogdanova D. Trigemino-cervical reflex in patients with headache. Cephalalgia. 2003;23(1):35-38.
8. Bajwa ZH, Sabahat A. Approach to the patient with headache syndromes other than migraine. Waltham, MA: UpToDate [online serial]; 2008.
9. Turp JC, Komine F, Hugger A. Efficacy of stabilization splints for the management of patients with masticatory muscle pain: A qualitative systematic review. Clin Oral Investig 2004;8:179.
10. Magnusson T, Adiels AM, Nilsson HL, et al. Treatment effect on signs and symptoms of temporomandibular disorders--comparison between stabilisation splint and a new type of splint (NTI). A pilot study. Swed Dent J. 2004;28(1):11-20.
11. Baad-Hansen L, Jadidi F, Castrillon E, et al. Effect of a nociceptive trigeminal inhibitory splint on electromyographic activity in jaw closing muscles during sleep. J Oral Rehabil. 2007;34(2):105-111.
12. Jokstad A, Mo A, Krogstad BS. Clinical comparison between two different splint designs for temporomandibular disorder therapy. Acta Odontol Scand. 2005;63(4):218-226.
13. Wright EF, Jundt JS. The NTI appliance for TMD and headache therapy. Tex Dent J. 2006;123(12):1118-24.
14. Blumenfeld A. The NTI appliance for TMD and headache therapy. Tex Dent J. 2007;124(4):356.
15. Bender SD. The NTI appliance for TMD and headache therapy. Tex Dent J. 2007;124(4):357-358.
16. King M. The discussion about the NTI. Tex Dent J. 2007;124(6):566.

Revision Dates

Original policy: November 4, 2004
Updated: September 25, 2006; August 26, 2008; June 27, 2011; July 12, 2012; August 12, 2013 
Revised: November 16, 2009

Medical Clinical Policy Bulletin 0068: Intraoral Appliances for Headaches and Trigeminal Neuralgia.Updated with additional background information and references 10/31/2013.

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.

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