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Myotronics K7 EMG are Safe, Effective for the Diagnosis of TMD patients – No Longer Investigational

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K7 EMG IS NO LONGER INVESTIGATIONAL!

Over the years, the insurance companies have falsely claimed that an FDA clearance of a device is an administrative process and these devices are still “experimental” or “investigational”. In fact, two different FDA Dental Advisory panels, that were convened in 1997 and 1998, concluded, based on their review of a large body of the scientific literature, that the Myotronics K6/K7 are safe and effective for the diagnosis of TMD patients.

An insurance company has no basis—and there are no standards—to render EMG as an “experimental” procedure in the evaluation and diagnosis of TMD patients, in view of the large body of supportive scientific studies and the regulatory scrutiny and classification of the Myotronics EMG System.

Proper diagnosis of any medical/ dental condition is made by the treating doctor and begins with obtaining the patient’s medical history and performing a comprehensive clinical examination of the affected area.  The temporomandibular disorders (TMD) diagnostic process and treatment plan are greatly enhanced using technologies that can scrutinize the anatomic and functional components of the masticatory system, providing reliable and precise objective measurement data.  Surface Electromyography (EMG) is a well-accepted modality that is safe and effective for the evaluation of masticatory muscle function of TMD patients, for providing objective milestones in planning treatment and for documenting patients’ response to treatment.

Myotronics Surface EMG System (K6/K7 Evaluation System) underwent the review processes of the US Food and Drug Administration in 1997 and 19981,2 and has been recognized as a safe and effective aid in the diagnosis and treatment of patients with temporomandibular disorders.  The FDA Dental Panel of Nov. 3, 1998 reviewed a large body of scientific literature in reaching its conclusion regarding the safety and effectiveness of the Myotronics EMG System in the diagnosis of TMD patients.

According to the FDA 510(k) documents K992694 and K003287, one of the Indications for Use of the Myotronics EMG System is for:

“Diagnosis and Management of TMJ/MPD disorders, Orthodontic Patients, Denture Patients, and Reconstruction Patients”

A significant body of the scientific literature published in peer-reviewed journals over the past 60 years has concluded that the TMD patient population has an elevated resting EMG muscle activity and weak or asymmetrical functional EMG muscle activity.3-59

Supportive References:

  1. US Food and Drug Administration. Re-review of Devices for Diagnosis and Management of TMJ/TMD, November 3, 1997.
  2. U.S. Food and Drug Administration: Meeting of the Dental Products Advisory Panel regarding the Classification of Devices for Use in the Diagnosis and/or Treatment of Temporomandibular Joint Dysfunction and Oral-Facial Pain, August 5, 1998.
  3. Jarabak JR: An electromyographic analysis of muscular and temporomandibular joint disturbances due to imbalances in occlusion. Angle Orthod 1956; 26:170-190.
  4. Perry HT: Muscular changes associated with temporomandibular joint dysfunction. Journal of Am Dent Res 1957; 54:644-653.
  5. Lous L, Sheikholeslam A, Moller E: Postural activity in subjects with functional disorders of the chewing apparatus. Scand J Dent Res 1970; 78:404-410.
  6. Moller E, Sheikholeslam A, Lous L: Deliberate relaxation of the temporal and masseter muscles in subjects with functional disorders of the chewing apparatus. Scand J Dent Res 1971; 79:478-482.
  7. Munro RR: Electromyography of the masseter and anterior temporalis muscles in patients with atypical facial pain. Australian Dent J 1972:131-139.
  8. Moss JP, Chalmers CF: An electromyographic investigation of patients with a normal jaw relationship and a class III jaw relationship. Am J Orthod 1974; 665:538-556.
  9. Yemm R: Neurophysiologic studies of temporomandibular joint dysfunction. Oral Science Rev 1976; 7:31-53.
  10. Kotani H, Kawazoe Y, Hamada T, Yamata S: Quantitative electromyographic diagnosis of myofascial pain dysfunction syndrome. J Prosthet Dent 1980; 43:450-456.
  11. Sheikholeslam A, Moller E, Lous L: Pain, tenderness and strength of human mandibular elevators. Scand J Dent Res 1980; 88:60-66.
  12. Sheikholeslam A, Moller E, Lous L: Postural and maximal activity in elevators of mandible before and after treatment of functional disorders. Scand J Dent Res 1982; 90:37-46.
  13. Riise C, Sheikholeslam A: The influence of experimental interfering occlusal contacts on the postural activity of the anterior temporal and masseter muscles in young adults. J Oral Rehabil 1982; 9:419-425.
  14. Sheikholeslam A, Riise C: Influence of experimental interfering occlusal contacts on the activity of the anterior temporal and masseter muscles during submaximal and maximal bite in the intercuspal position. J Oral Rehabil 1983; 10:207-214.
  15. Riise C, Sheikholeslam A: The influence of experimental interfering occlusal contacts on the activity of the anterior temporal and masseter muscles during mastication. J Oral Rehabil 1984; 11:325-333.
  16. Moller E, Sheikholeslam A, Lous L: Response of elevator activity during mastication to treatment of functional disorders. Scand J Dent Res 1984; 90:37-46.
  17. Keefe FJ, Dolan EA: Correlation of pain behavior and muscle activity in patients with myofascial pain-dysfunction syndrome. J Craniomandib Disord Facial Oral Pain1984; 2:181-184.
  18. Sherman RA: Relationships between jaw pain and jaw muscle contraction level: Underlying factors and treatment effectiveness. J Prosthet Dent 1985; 54(1):114-118.
  19. Naeije M, Hansson TL: Electromyographic screening of myogenous and arthrogenous TMJ dysfunction patients. J Oral Rehabil 1986; 13(5):433-441.
  20. Balciunas BA, Staling LM, Parente FL: Quantitative electromyographic response to therapy for myo-oral facial pain: a pilot study. J Prosth Dent 1987; 58(3):366-369.
  21. Burdette BH, Gale EN: The effects of treatment on masticatory muscle activity and mandibular posture in myofascial pain-dysfunction patients. J Dent Res 1988; 67(8):1126-1130.
  22. Cram JR, Klemons TM: EMG: Comparisons in craniofacial muscles following therapy for head and neck pain. Med Electr 1988:106- 110.
  23. Gervais RO, Fitzsimmons GW, Thomas NR: Masseter and temporalis electromyographic activity in asymptomatic, subclinical and temporomandibular joint dysfunction patients. J Craniomandib Pract 1989; 7:52-57.
  24. Chong-Shan S, Hui-Yun W: Postural and maximum activity in elevators during mandible pre- and post-occlusal split treatment of temporomandibular joint disturbance syndrome. J Oral Rehabil 1989; 16:155-161.
  25. Chong-Shan S, Hui-Yun W: Value of EMG analysis of mandibular elevators in openclose- clench cycle to diagnosing TMJ disturbance syndrome. J Oral Rehabil 1989; 16:101-107.
  26. Shi CS. Proportionality of mean voltage of masseter muscle to maximum bite force applied for diagnosing temporomandibular joint disturbance syndrome. J Prosthet Dent 1989; 62(6):682-684.
  27. Harness DM, Donlon WC, Eversole LR: Comparison of clinical characteristics in myogenic, TMJ internal derangement and atypical facial pain patients. Clin J Pain 1990; 6(1):4-17.
  28. Choi J: A study on the effects of maximal voluntary clenching on the tooth contact points and masticatory muscle activities in patients with temporomandibular disorders. J Craniomandib Disord Facial Oral Pain 1992; 6:41-46.
  29. Kroon GW, Naeije M: Electromyographic evidence of local muscle fatigue in a subgroup of patients with myogenous craniomandibuthe postural activity of the anterior temporal and masseter muscles in young adults. J Oral Rehabil 1982; 9:419-425.
  30. Visser A, McCarroll RS, Oosting J, Naeije M: Masticatory electromyographic activity in healthy young adults and myogenous craniomandibular disorder patients. J Oral Rehabil 1994; 21(1):67-76.
  31. Abekura H, Kotani H, Tokuyama H, Hamada T: Asymmetry of masticatory muscle activity during intercuspal maximal clenching in healthy subjects and subjects with stomatognathic dysfunction syndrome. J Oral Rehabil 1995; 22(9):699-704.
  32. Erlandson PM, Poppen R: Electromyographic biofeedback and rest position training of masticatory muscles in myofascial pain-dysfunction patients. J Prosthet Dent 1998; 62:335-338.
  33. Liu ZJ, Yamagata K, Kasahara Y, Ito G: Electromyographic examination of jaw muscles in relation to symptoms and occlusion of patients with temporomandibular joint disorders. J Oral Rehabil 1999; 26(1):33-47.
  34. Pinho JC, Caldas FM, Mora MJ, Santana-Penín U: Electromyographic activity in patients with temporomandibular disorders. J Oral Rehabil 2000; 27(11):985-990.
  35. Alajbeg IZ, Valentic-Peruzovic M, Alajbeg I, Illes D: Influence of occlusal stabilization splint on the asymmetric activity of masticatory muscles in patients with temporomandibular dysfunction. Coll Antropol 2003; 27(1):361-371.
  36. Glaros AG, Burton E: Parafunctional clenching, pain, and effort in temporomandibular disorders. J Behav Med 2004; 27(1):91-100.
  37. Pallegama RW, Ranasinghe AW, Weerasinghe VS, Sitheeque MA: Influence of masticatory muscle pain on electromyographic activities of cervical muscles in patients with myogenous temporomandibular disorders. J Oral Rehabil 2004; 31(5):423-429.
  38. Bodéré C, Téa SH, Giroux-Metges MA, Woda A: Activity of masticatory muscles in subjects with different orofacial pain conditions. Pain 2005; 116(1-2):33-41.
  39. da Silva MA, Issa JP, Vitti M, da Silva AM, Semprini M, Regalo SC: Electromyographical analysis of the masseter muscle in dentulous and partially toothless patients with temporomandibular joint disorders. Electromyogr Clin Neurophysiol 2006; 46(5):263-268.
  40. Tosato Jde P, Caria PH: Electromyographic activity assessment of individuals with and without temporomandibular disorder symptoms. J Appl Oral Sci 2007; 15(2):152-155.
  41. Ries LG, Alves MC, Bérzin F: Asymmetric activation of temporalis, masseter, and sternocleidomastoid muscles in temporomandibular disorder patients. J Craniomandib Pract 2008; 26(1):59-64.
  42. Tartaglia GM, Moreira Rodrigues da Silva MA, Bottini S, Sforza C, Ferrario VF: Masticatory muscle activity during maximum voluntary clench in different research diagnostic criteria for temporomandibular disorders (RDC/TMD) groups. Man Ther 2008; 13(5):434-440.
  43. Bodéré C, Woda A: Effect of a jig on EMG activity in different orofacial pain conditions. Int J Prosthodont 2008; 21(3):253-258.
  44. Tecco S, Tetè S, D’Attilio M, Perillo L, Festa F: Surface electromyographic patterns of masticatory, neck, and trunk muscles in temporomandibular joint dysfunction patients undergoing anterior repositioning splint therapy. Eur J Orthod 2008; 30(6):592-597.
  45. Santana-Mora, U, Cudeiro J, Mora-Bermudez MJ, Rilo-Pousa B, Ferreira-Pinho JC, Otero- Cepeda JL, Santana-Penin U: Changes in EMG activity during clenching in chronic pain patients with unilateral temporomandibular disorders. J Electromyography and Kinesiology 2009; 19(6):e543-549.
  46. Ardizone I, Celemin A, Aneiros F, del Rio J, Sanchez T, Moreno I: Electromyographic study of activity of the masseter and anterior temporalis muscles in patients with temporomandibular joint (TMJ) dysfunction: comparison with the clinical dysfunction index. Med Oral Patol Oral Cir Bucal 2010; 15(1):e14-19.
  47. Botelho AL, Silva BC, Gentil FH, Sforza C, da Silva MA: Immediate effect of the resilient splint evaluated using surface electromyography in patients with TMD. J Craniomandib Pract 2010; 28(4):266-273.
  48. Hermens HJ, Boon KL, and Zilvold G: The clinical use of surface EMG. Medica Physica 1986; 9:119-130.
  49. Goldensohn E: Electromyography. In: Disorders of the temporomandibular joint. Lazlo Schwartz, ed. Philadelphia/London: W.B. Saunders Co., 1966:163-176.
  50. Lloyd AJ: Surface electromyography during sustained isometric contractions. J Applied Physiology 1971; 30(5):713-719.
  51. Burdette BH, Gale EN: Intersession reliability of surface electromyography. Journal of Dental Research, [Abstract No. 1370], Vol 66, 1987.
  52. Christensen LV: Reliability of maximum static work efforts by the human masseter muscle. Am J Orthod Dentofacial Orthop 1989; 95(1):42-45.
  53. Burdette BH, Gale EN: Reliability of surface electromyography of the masseteric and anterior temporal areas. Arch Oral Biol 1990; 35(9):747-751.
  54. Ferrario VF, Sforza C: Coordinating electromyographic activity of the human masseter and temporalis anterior muscles during mastication. Eur J Oral Sci 1996; 104(5-6): 511-517.
  55. Buxbaum J, Mylinski N, Parente FR: Surface EMG reliability using spectral analysis. J Oral Rehabil 1996; 23(11):771-775.
  56. Castroflorio T, Icardi K, Torsello F, Deregibus A, Debernardi C, Bracco P: Reproducibility of surface EMG in the human masseter and anterior temporalis muscle areas. J Craniomandib Pract 2005; 23(2):130-137.
  57. Castroflorio T, Icardi K, Becchino B, Merlo E, Debernardi C, Bracco P,Farina D: Reproducibility of surface EMG variables in isometric sub-maximal contractions of jaw elevator muscles. J Electromyogr Kinesiol 2006;16(5):498-505. Epub 2005 Nov 15.
  58. Castroflorio T, Bracco P, Farina D: Surface electromyography in the assessment of jaw elevator muscles. J Oral Rehabil 2008; 35(8):638-645. Epub 2008 May 9.
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