Dental Policy Bulletins

Number: 023
(Updated)

Subject: TheraBite® Jaw Motion Rehabilitation System

Date: September 23, 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, excluded and 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 we consider 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

Note : Some plans exclude coverage of jaw stretch devices as equipment available over the counter without a prescription. Please check benefit plan descriptions.

  1. Aetna considers the TheraBite® Jaw Motion Rehabilitation System medically necessary to treat mandibular hypomobility caused by radiation in persons with head and neck cancers.
  2. Aetna considers the Therabite System experimental and investigational for all other indications, including any of the following conditions:
    1. Closed lock treatment
    2. Facial burns
    3. Mandibular coronoid hyperplasia
    4. Non-surgical temporomandibular joint (TMJ) dysfunction
    5. Oral burns
    6. Orofacial pain
    7. Post-surgical TMJ rehabilitation
    8. Rehabilitation following facial trauma
    9. Stroke
    10. Treacher-Collins syndrome
    11. Trismus


See also CPB 0405 - Mechanical Stretching Devices for Contracture and Joint Stiffness on the use of dynamic splinting for the treatment of trimus.

Background

Most head and neck cancers are treated with surgery, radiation, or a combination of the two modalities. The choice of treatment depends primarily on the anatomic site, extent and histologic grading of the tumor, and the presence of infection. Modern reconstructive techniques permit cancer patients, especially those with head and neck malignancies, to undergo more immediate reconstruction and thereby achieve better functional outcomes while still progressing through multimodality treatment in a timely manner. However, the more aggressive the cancer therapy, the more it places patients at risk for oral complications related to treatment.

One of the major complications from therapeutic administration of ionizing radiation to the head and neck is mandibular hypomobility -- a reduction in mandibular range of motion caused by radiation-induced scarring and contraction of soft tissues surrounding the jaw. Clinically, the severity of mandibular hypomobility is related to the radiation dose, volume of tissue treated, and age of the patient.

Mandibular hypomobility is treated by stretching the scar tissue. Methods commonly used to stretch the scar tissue and increase mandibular range of motion include:
(i) Oral opening exercises
(ii) Stacking tongue blades between the molars
(iii) Continuous passive motion of the jaw
(iv) Stretching the jaw using custom-made mechanical devices.

One such custom-made device is the TheraBite, a threaded screw-type instrument that is placed between the teeth and turned to gradually open the jaw, much like a car jack. Preliminary evidence indicates that the TheraBite is more effective than other modalities in maintaining and/or improving mandibular range of motion in irradiated patients. There are, however, inadequate outcomes data comparing the TheraBite to more conventional methods to support the use of TheraBite for any other condition.Orabite is another brand of jaw stretch device that is no longer on the market.

Melchers and associates (2009) examined the factors that may influence Therabite exercise adherence, how these interrelate and provided aims for interventions to increase adherence. These researchers performed a multi-center, formal-evaluative qualitative retrospective study. A total of 21 patients treated for head-neck cancer were interviewed in semi-structured, in-depth interviews. Internal motivation to exercise, the perceived effect, self-discipline and having a clear exercise goal influenced Therabite exercise adherence positively. Perceiving no effect, limitation in Therabite opening range and reaching the exercise goal or a plateau in mouth opening were negative influences. Pain, anxiety and physiotherapists could influence adherence both positively and negatively. Based on the results, a model for Therabite exercise adherence was proposed. It is important to signal and evaluate the factors that negatively influencing Therabite adherence, especially before there is a perceived effect. The authors stated that research is needed to examine why some patients do not achieve results despite high exercise adherence, to identify effective exercise regimens and to assess proposed interventions aimed to increase Therabite exercise adherence.

Shulman et al (2008) retrospectively evaluated the effect of the Dynasplint Trismus System (DTS; Dynasplint Systems Inc., Severna Park, MD) for patients who were recently diagnosed with trismus following radiation therapy, dental treatment, oral surgery, or following a neural pathology such as a stroke. These researchers reviewed 48 patient histories (treated in 2006 to 2007), and divided into 4 cohort groups (radiation therapy for head/neck cancer, dental treatment, oral surgery, or stroke), to measure the efficacy of this treatment's modality. Patients were prescribed the DTS after diagnosis of trismus based on examination that showed less than 40 mm maximal interincisal (opening) distance (MID). The DTS uses low-load, prolonged-duration stretch with replicable, dynamic tension to achieve longer time at end range (of motion). Each patient used this device for 20 to 30 mins, 3 times per day. This cohort case series showed that there was a statistically significant difference within all patient groups (p < 0.0001; t = 10.3289), but there was not a significant difference between groups (p = 0.374). The biomechanical modality of DTS with a low-load, prolonged-duration stretch was attributed to the success in reducing contracture in this study. This improved range of motion, allowing patients to regain the eating, hygiene and speaking patterns they had before developing trismus. The main drawbacks of this study were the lack of a control group and small sample size. The authors stated that "future studies should include a randomized, controlled, crossover study of this unit to compare the efficacy of treating trismus, and a case/control study could evaluate prevention of trimus with the DTS".

In a case report, Shulman et al (2009) described the use of dynamic splinting to reduce trismus that occurred in a patient following multiple dental procedures. A 26-year old man was referred for severe trismus and pain following 3 dental procedures on the lower right molars. The patient presented with MID of only 5-mm and mastication muscle spasticity. Following physical therapy (i.e., massage, moist heat, neuromuscular electrical stimulation, and ultrasound) 3 times per week for 2 months and additional treatment of dynamic splinting for 4 weeks (TID), the patient increased his MID to 52 mm and returned to normal eating and speaking. The main drawbacks of this study were (i) it was a single-case report, and (ii) lack of follow-up

In a retrospective, cohort study, Stubblefield et al (2010) examined the effectiveness of a dynamic jaw opening device as part of a multi-modal treatment strategy for trismus in patients with head and neck cancer (n = 20). All patients underwent assessment by a board-certified physiatrist and were referred to physical therapy for delivery of the DTS and instructed to progress use of the DTS to 30 mins 3 times a day. Additional modalities for the treatment of trismus including pain medications and botulinum toxin injections were prescribed as clinically indicated. Main outcome measures included change in MID as documented in the medical record. The use of the DTS as part of multi-modal therapy including physical therapy, pain medications, and botulinum toxin injections as deemed clinically appropriate resulted in an overall improvement of the MID from 16.5 mm to 23.5 mm (p < 0.001). Patients who could comply with the treatment recommendations for DTS treatment did better than those who could not, with an improvement of the MID from 16 mm to 27 mm (p < 0.001) versus 17 mm to 22 mm (p = 0.88). The authors concluded that the DTS is a safe and effective component of a multi-modal strategy for improving trismus associated with head and neck cancer and its treatment. Moreover, they stated that further investigation is needed to determine the relative effectiveness of the treatment modalities available for trismus including physical therapy and other jaw stretching devices. This was a retrospective pilot study with a small sample size (n = 20); and its finding were confounded by the use of other modalities. Furthermore, the authors stated that "a large randomized prospective trial that directly compares DTS with TheraBite and each to physical therapy and a non-treatment group for both acute and chronic trimus patients would be potentially illuminating".

CPT Codes / HCPCS Codes / ICD-9 Codes*
Other CPT codes related to the CPB:
95851 Range-of-motion measurements and report (separate procedure); each extremity, (excluding hand) or each trunk section (spine)
97110 Therapeutic procedure, one or more areas, each 15 minutes; therapeutic exercises to develop strength and endurance, range of motion and flexibility
97530 Therapeutic activities, direct (one-on-one) patient contact by the provider (use of dynamic activities to improve functional performance), each 15 minutes
97535 Self care/home management training (for example, activities of daily living [ADL] and compensatory training, meal preparation, safety procedures, and instructions in use of assistive technology devices/adaptive equipment) direct one-on-one contact by provider, each 15 minutes
HCPCS codes covered if selection criteria are met:
E1700 Jaw motion rehabilitation system
E1701 Replacement cushions for jaw motion rehabilitation system, package of six
E1702 Replacement measuring scales for jaw motion rehabilitation system, package of 200
ICD-9 codes covered if selection criteria are met:
909.2 Late effect of radiation
990 Effects of radiation, unspecified
ICD-9 codes not covered for indications listed in the CPB: (not all-inclusive):
430 - 438.9 Cerebrovascular disease
524.02 Mandibular hyperplasia [coronoid]
524.60 - 524.69 Temporomandibular joint disorders
756.0 Anomalies of skull and face bones [Treacher Collins Syndrome]
781.0 Abnormal involuntary movements
800.00 - 804.99 Fractures of skull
830.0 - 830.1 Dislocation of jaw
848.0 - 848.1 Sprain and strain of septal cartilage of nose and jaw
850.0 - 854.19 Intracranial injury, excluding those with skull fractures
870.0 - 873.9 Open wounds of head
900.89 Other specified blood vessels of head
906.5 Late effect of burn of eye, face, head and neck
910.0 - 910.9 Superficial injury of face, neck and scalp except eye
918.0 - 918.9 Superficial injury of eye and adnexa
920 - 921.9 Contusions of face, scalp, neck, eyes and adnexa
925.1 Crushing injury of face, scalp and neck
941.00 - 941.5 Burn of head, face and neck
950.0 - 951.9 Injury to optic nerve and pathways and other cranial nerves
959.01 - 959.09 Other and unspecified injury to head, face and neck
Other ICD-9 codes related to the CPB:
140.0 -149.9 Malignant neoplasm of lip, oral cavity and pharynx
150.0 - 150.9 Malignant neoplasm of esophagus
160.0 - 162.0 Malignant neoplasm of nasal cavities, middle ear, and accessory sinuses, larynx and trachea
170.0 Malignant neoplasm of bones of skull and face, except mandible
170.1 Malignant neoplasm of mandible
528.9 Other and unspecified diseases of the oral soft tissues
784.0 Headache
784.9 Other symptoms involving head and neck
784.92 Jaw pain
V15.3 Personal history of irradiation
V10.01 - V10.03 Personal history of malignant neoplasm of tongue, other and unspecified oral cavity and pharynx, or esophagus
V10.12 Personal history of malignant neoplasm of trachea
V10.21 Personal history of malignant neoplasm of larynx
V10.22 Personal history of malignant neoplasm of nasal cavities, middle ear and accessory sinuses
V45.89 Other postprocedural status


The above policy is based on the following references:

  1. Kouyoumdjian JH, Chalian VA, Hutton C. An intraoral positive-pressure device for treatment of trismus. Oral Surg. 1986;61(5):456-458.
  2. Buchbinder D, Currivan RB, Kaplan AJ, et al. Mobilization regimens for the prevention of jaw hypomobility in the radiated patient: A comparison of three techniques. J Oral Maxillofac Surg. 1993;51(8):863-867.
  3. Friedman MH. Closed lock. A survey of 400 cases. Oral Surg Oral Med Oral Pathol. 1993;75(4):422-427.
  4. King GE, Toth BB, Fleming TJ. Oral dental care of the cancer patient. Tex Dent J. 1988;105:10-11.
  5. No authors listed. National Institutes of Health Consensus Development Conference Statement: Oral complications of cancer therapies: Diagnosis, prevention, and treatment. J Am Dent Assoc. 1989;119(1):179-183.
  6. Toth BB, Martin JW, Fleming TJ. Oral and dental care associated with cancer therapy. Cancer Bull. 1991;43:397-402.
  7. Toth BB, Frame RT. Dental oncology: The management of disease and treatment-related oral/dental complications associated with chemotherapy. Curr Probl Cancer. 1983;7:7-35.
  8. Toth BB, Martin JW, Fleming TJ. Oral complications associated with cancer therapy: An M.D. Anderson Cancer Center experience. J Clin Periodontol. 1990;17:508-515.
  9. Schweiger JW. Oral complications following radiation therapy: A five-year retrospective report. J Prosthet Dent. 1987;58:78-82.
  10. Fleming TJ. Oral tissue changes of radiation-oncology and their management. Dent Clin North Am. 1990;34:233-237.
  11. Barrett VJ, Martin JW, Jacob RF, et al. Physical therapy techniques in the treatment of the head and neck patient. J Prosthet Dent. 1988;59:343-346.
  12. Rocabardo M, Johnston BE, Blakney MG. Physical therapy and dentistry: An overview. J Craniomand Pract. 1983;1:46-49.
  13. Therabite Corporation. TheraBite Jaw Motion Rehabilitation System. West Chester, PA: TheraBite; 2002.  Available at: http://www.therabite.com. Accessed December 9, 2002.
  14. Gaziano JE. Evaluation and management of oropharyngeal dysphagia in head and neck cancer. Cancer Control. 2002;9(5):400-409.
  15. Maloney GE, Mehta N, Forgione AG, et al. Effect of a passive jaw motion device on pain and range of motion in TMD patients not responding to flat plane intraoral appliances. Cranio. 2002; 20(1):55-66.
  16. Nicalaou N. Prevention and management of radiation toxicity. In: Cancer Management: A Multidisciplinary Approach. 7th ed. R Pazdur, LR Coia, WJ Hoskins, LD Wagman, eds. Melville, NY: PRR; 2003; Ch. 46: 909-939.
  17. Dijkstra PU, Kalk WW, Roodenburg JL. Trismus in head and neck oncology: A systematic review. Oral Oncol. 2004;40(9):879-889.
  18. Cohen EG, Deschler DG, Walsh K, Hayden RE. Early use of a mechanical stretching device to improve mandibular mobility after composite resection: A pilot study. Arch Phys Med Rehabil. 2005;86(7):1416-1419.
  19. McNeely Ml, Olivo SA, Magee DJ. A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. Phys Ther. 2006;86(5):710-725.
  20. Gibbons AJ, Abulhoul S. Use of a TheraBite appliance in the management of bilateral mandibular coronoid hyperplasia. Br J Oral Maxillofac Surg. 2007;45(6):505-506.
  21. Wenghoefer M, Martini M, Anwander T, et al. Hyperplasia of the coronoid process: Diagnosis and treatment. Mund Kiefer Gesichtschir. 2006;10(6):409-414.
  22. Fernández Ferro M, Fernández Sanromán J, Sandoval Gutierrez J, et al. Treatment of bilateral hyperplasia of the coronoid process of the mandible. Presentation of a case and review of the literature. Med Oral Patol Oral Cir Bucal. 2008;13(9):E595-E598.
  23. Melchers LJ, Van Weert E, Beurskens CH, et al. Exercise adherence in patients with trismus due to head and neck oncology: a qualitative study into the use of the TheraBite((R)). Int J Oral Maxillofac Surg. 2009 May Available at: http://www.ijoms.com/article/S0901-5027(09)00860-1/abstract.  Accessed May 25, 2011.
  24. Shulman DH, Shipman B, Willis FB. Treating trismus with dynamic splinting: A cohort, case series. Adv Ther. 2008;25(1):9-16.
  25. Shulman DH, Shipman B, Willis FB. Treating trismus with dynamic splinting: A case report. J Oral Sci. 2009;51(1):141-144.
  26. Stubblefield MD, Manfield L, Riedel ER. A preliminary report on the efficacy of a dynamic jaw opening device (dynasplint trismus system) as part of the multimodal treatment of trismus in patients with head and neck cancer. Arch Phys Med Rehabil. 2010;91(8):1278-1282.

Revision Dates

Original policy: November 4, 2004
Updated: September 25, 2006; June 5, 2012; September 23, 2013
Revised: January 20, 2011
Medical Bulletin #0412: July 19, 2013

This CPB has been updated to note that some plans exclude coverage of jaw stretch devices as equipment available over the counter without a prescription.



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. .

*Current Procedural Terminology(CPT®) 2010 copyright
2010 American Medical Association. All Rights Reserved.

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