Clinical and Scientific Substantiation of the J5 Dental TENS

The J5 Dental TENS has been marketed and used in dental practices since September 2003. The base Neuromuscular TENS methodology was established by Dr. Bernard Jankelson with the J3, J4, and BNS-40 predicate devices and consists of published, peer reviewed scientific literature spanning more than 50 years.

The J5 Dental TENS is a battery-operated, Ultra-low Frequency Electrical Muscle Stimulator. It is capable of stimulating either two or four muscle groups at once. The device is based on the previous Model J4 Myo-monitor with next-generation improvements. The major improvement was the addition of 2 stimulation channels that permitted the treatment of four muscle sites simultaneously as opposed to the two muscle group’s treatment with the Model J4.

Description of Function

The J5 Dental TENS is intended to be used to relieve symptoms associated with muscle spasms, to treat temporomandibular joint (TMJ) dysfunction and associated pain. It is designed to relax muscles and establish physiologic occlusion in order to take occlusal registrations, to take denture impressions, to increase local blood circulation and to increase or maintain mandibular range of motion.

Methodology of Clinical and Scientific Evaluation

Those involved in the Clinical Evaluation have been determined by Myotronics management to have sufficient experience in research methodology, information management, clinical understanding of the device, technology and its application sufficient to provide a consistent thorough appraisal and analysis of the articles.

Articles are gathered via routine search using PubMed and Google Scholar search engines, as well as from articles provided to Myotronics directly. Search terms are based upon the proprietary name of the device, function, technology and company name.
-J5, Myomonitor, Ultra Low-Frequency TENS, Dental TENS, Myotronics

All incoming articles were then reviewed using appended MOOSE proposal guidelines, with articles excluded from incorporation due to lacking sound methodology, scientific validity, off-label techniques or uses which are not relevant to the stated indications for use or claims of the device.

The remaining articles were then reviewed with articles deemed most pertinent and complete regarding claims or indications for use being included. Articles are weighted based upon methodology, comprehensiveness of the study. Articles are then discussed via quorum with other reviewers for further concerns or modification in weighing. See Clinical Evaluation Article Review WI (QA-924)

Measures for risk avoidance and risk mitigation

The J5 Dental TENS is fully compliant with ISO 14971:2007. See J5 – 62366 Att.4 RM Plan_Final.

Usability for Users and Instructions for use

The J5 Dental TENS is fully compliant with IEC 62366. See J5- 62366 Final

Comparison to predicate and similar marketed devices

For demonstrated equivalence of the J5 Dental TENS to the predicate device, the J4 Myomonitor.

Comparison to the currently accepted State of the Art

The current State of the Art for use of Ultra-Low Frequency TENS is established in the following literature review article, citing the J5 Dental TENS itself.

1. Chipaila, N, Sgolastra, F, Spadaro, A, Pietropaoli, D, Msci, C, Cattaneo, R, Monaco, A.The Effects of ULF-TENS Simulation on gnathology: the state of the art. Cranio: The journal of Craniomandibular & Sleep Practice, 2014.

Clinical Efficacy (performance and benefits)

The claims, defined as the indications for use of the J5 Dental TENS are:

  1. To treat Temporomandibular Joint (TMJ) dysfunction and associated pain
  2. To relieve symptoms associated with muscle spasm
  3. To relax muscles and establish a physiologic occlusion
  4. To take occlusal registrations
  5. To take denture impressions
  6. To increase local blood circulation
  7. To maintain or increase mandibular range of motion.

Claim 1. To treat Temporomandibular Joint (TMJ) dysfunction and associated pain

​1. Wessberg, G, Carroll, W, Dinham, R Wolford G. Transcutaneous electrical stimulation as an adjunct in the management of myofascial pain-dysfunciton syndrome. The Journal of Prosthetic Dentistry, 1981

Abstract

Twenty-one patients, 14 women and seven men, presenting with symptoms of the MPD syndrome, were treated with a regimen based on a neuromuscular theory of occlusion involving TES. Evaluation of treatment results shows 95% success immediately after therapy and an 86% success 1 year after therapy. No effort was made to establish a personality profile on the patients nor to incorporate active psychotherapy in treatment.

​2. Cooper, B, Kleinberg, I. Establishment of Temporomandibular Physiological State with Neuromuscular Orthosis Treatment Affects Reduction of TMD Systems in 313 Patients. Journal of Cranio Mandibular Practice, 2008

Abstract

The objective of this investigation was to test the hypothesis that alteration of the occlusions of patients suffering from temporomandibular disorders (TMD) to one that is neuromuscularly, rather than anatomically based, would result in reduction or resolution of symptoms that characterize the TMD condition. This hypothesis was proven correct in the present study, where 313 patients with TMD symptoms were examined for neuromuscular dysfunction, using several electronic instruments before and after treatment intervention. Such instrumentation enabled electromyographic (EMG) measurement of the activities of the masticatory muscles during rest and in function, tracking and assessment of various movements of the mandible, and listening for noises made by the TMJ during movement of the mandible. Ultra low frequency and low amplitude, transcutaneous electrical neural stimulation (TENS) of the mandibular division of the trigeminal nerve (V) was used to relax the masticatory muscles and to facilitate location of a physiological rest position for the mandible. TENS also made it possible to select positions of the mandible that were most relaxed above and anterior to the rest position when the mandible was moved in an arc that began at rest position. Once identified, the neuromuscular occlusal position was recorded in the form of a bite registration, which was subsequently used to fabricate a removable mandibular orthotic appliance that could be worn continuously by the patient. Such a device facilitated retention and stabilization of the mandible in its new-found physiological position, which was confirmed by follow up testing. Three months of full-time appliance usage showed that the new therapeutic positions achieved remained intact and were associated with improved resting and functioning activities of the masticatory muscles. Patients reported overwhelming symptom relief, including reduction of headaches and other pain symptoms. Experts consider relief of symptoms as the gold standard for assessment of effectiveness of TMD treatment. It is evident that this outcome has been achieved in this study and that taking patients from a less to a more physiological state is an effective means for reducing or eliminating TMD symptoms, especially those related to pain, most notably, headaches.

​3. Cooper, BC The Role of bioleectronic instrumentation in the documentation and management of temporomandibular disorders. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Jam; 83(1):91-100

Abstract

Temporomandibular disorders (TMDs) can affect the form and function of the temporomandibular joint, masticatory muscles, and dental apparatus. Electronic measurement of mandibular movement and masticatory muscle function provides objective data that are defined by commonly accepted parameters in patients with TMDs; these data can then be used to design and monitor therapy and enhance treatment therapy. In this study, data on 3681 patients with TMD are presented, including electronic test data on 1182 treated patients with TMDs. Electronic jaw tracking was used to record mandibular movement and to compare the presenting and therapeutic dental occlusal positions. Electromyography was used to analyze the resting status of masticatory muscles and occlusal function at presentation and after therapeutic intervention. Transcutaneous electrical nerve stimulation therapy relaxed masticatory muscles and aided in the determination of a therapeutic occlusal position. The data show a positive correlation between the clinical symptoms of TMD and the presenting occlusion, accompanied by muscle activity. A strong positive correlation also appears to exist between a therapeutic change in the dental occlusion to a neuromuscularly healthy position with use of a precision orthotic appliance and the significant relief of symptoms within 1 month and at 3 months.

4. Chipaila, N, Sgolastra, F, Spadaro, A, Pietropaoli, D, Msci, C, Cattaneo, R, Monaco, A. The Effects of ULF-TENS stimulatin on gnathology: the state of the art. Cranio: the Journal of Craniomandibular & Sleep Practice, 2014

​Abstract

AIMS:

The aim of this study was to evaluate the state of the art in the current literature regarding the effect of ultra-low frequency-transcutaneous electrical nerve stimulation (ULF-TENS) on patients with temporomandibular disorders (TMD).

​METHODOLOGY:

The authors reviewed the literature through a thorough manual and electronic research on PubMed database (using the Medical Subject Headings thesaurus) and subsequent analysis of all the found papers regarding the effect of TENS on TMD patients. No randomized controlled trials on the investigated topic were found. Only eight papers regarding controlled clinical trials (CCT) were selected according to the search strategy selection criteria.

​RESULTS:

According to the available literature and the authors’ experience, ULF-TENS seems to be a valid support in the management of TMD patients, but also a ‘provocative’ tool, so its application should always be monitored by electromyographic and electrognathographic analysis (before and after TENS).

​CONCLUSIONS:

Further clinical studies (mainly randomized controlled trials) on ULF-TENS application in neuromuscular gnathology are needed.

​5. Jankelson, B, Sparks, S, Crane, P Radke, J. Neural Conduction of the Myo-Monitor Stimulus: A Quantitative Analysis. Journal of Prosthetic Dentistry, 1975

Abstract

With the introduction of the Myo-Monitor to dentistry, the question has arisen whether the stimulus is neurally mediated or results from direct depolarization of only the fibers of the masseter muscle. Intensity-duration curves recorded for 10 subjects quantified the relationship between stimulus intensity and the duration of the stimulus required to elicit a consistent contraction response to transcutaneous stimulation via the Myo-Monitor. Individual chronaxies ranged from 0.125 to 0.180 msec., with a mean calculated at 0.158 msec. Stimulating the muscle fibers directly, without transmission of the signal across the neuromuscular junction, would have produced chronaxy values at least 50 to 100 times greater. The distinction is clear-cut. The chronaxy values unequivocally establish transmission of the stimulus across the neuromuscular junction. In all 10 subjects, contraction of muscles remote from the site of stimulation was evident by inspection and palpation. These data lend support to the conclusion of Choi and Mitani that the Myo-Monitor stimulates the fifth and seventh cranial nerves. The data derived here correlate with those of other investigations and clearly establish that the transmission of the Myo-Monitor stimulus is accomplished by transcutaneous neural stimulation.

​6. Vesanen, E, Vesanen R. The Jankelson Myo-Monitor and its Clinical Use. Finnish Dental Society, 1973

​Abstract

The Myo Monitor is an electronic instrument that gives programmed impulses to the motor nerves of the mandible and produces involuntary contraction of the corresponding muscles. The instrument and its clinical use are briefly described with two case reports: A patient with Eustachian tube and inner ear disturbances; a joint problem. The instrument offers new possibilities not only in practice but also in research.

​7. Jach. E. Relief of Myo-facial Pain: Treatment of 5 Patients. Dental Survey 1975

​8. Ferreira AP, Costa DR, Oliveira AL, Carvalho, EA, Conti PC, Costa YM, Bonjardim, LR. Short-term transcutaneous electrical nerve stimlation reduces pain and improves the masticatory muscle activity in temporomandibular disorder patients: a randomized controlled trial .J Appl Oral Sci. 2017, Mar-Apr, 25(2):112-120

​Abstract

Objective:

To investigate the short-term effect of transcutaneous electrical nerve stimulation (TENS) by examining pain intensity, pressure pain threshold (PPT) and electromyography (EMG) activity in patients with temporomandibular disorder (TMD).

​Material and Methods:

Forty patients with myofascial TMD were enrolled in this randomized placebo-controlled trial and were divided into two groups: active (n=20) and placebo (n=20) TENS. Outcome variables assessed at baseline (T0), immediately after (T2) and 48 hours after treatment (T1) were: pain intensity with the aid of a visual analogue scale (VAS); PPT of masticatory and cervical structures; EMG activity during mandibular rest position (MR), maximal voluntary contraction (MVC) and habitual chewing (HC). Two-way ANOVA for repeated measures was applied to the data and the significance level was set at 5%.

​Results:

There was a decrease in the VAS values at T1 and T2 when compared with T0 values in the active TENS group (p<0.050). The PPT between-group differences were significant at T1 assessment of the anterior temporalis and sternocleidomastoid (SCM) and T2 for the masseter and the SCM (p<0.050). A significant EMG activity reduction of the masseter and anterior temporalis was presented in the active TENS during MR at T1 assessment when compared with T0 (p<0.050). The EMG activity of the anterior temporalis was significantly higher in the active TENS during MVC at T1 and T2 when compared with placebo (p<0.050). The EMG activity of the masseter and anterior temporalis muscle was significantly higher in the active TENS during HC at T1 when compared with placebo (p<0.050).

​Conclusions:

The short-term therapeutic effects of TENS are superior to those of the placebo, because of reported facial pain, deep pain sensitivity and masticatory muscle EMG activity improvement.

​9. Escalassan, R, Rumerio, A, Monsarrat, P, Combadazou JC, Champion J, Destruhaut, F, Ghrenassia, C. Optimal duration of ultra-low frequency-transcutaneous electrical nerve stimulation (ULF-TENS) therapy for muscular relaxation in neuromuscular occlusion: A preliminary clinical study. Cranio. 2017 May;35(3):175-179.

Abstract

OBJECTIVES:

The primary aim of this work was to determine the duration of ultra-low-frequency transcutaneous electrical nerve stimulation (ULF-TENS) application necessary to achieve sufficient relaxation of the masticatory muscles. A secondary aim was to analyze the influence of stimulation on muscle relaxation in pathological subjects and determine whether ULF-TENS has a noteworthy impact on muscle relaxation.

​METHODS:

Sixteen adult subjects with temporomandibular disorders (TMD) and muscle pain and a group of four control subjects were included in this study. ULF-TENS was applied, and muscular activities of the masseter, temporal, and sternocleidomastoid muscles (SCM) were recorded for 60 min.

​RESULTS:

Significant relaxation was achieved in the TMD group from 20, 40, and 60 min for the temporal, masseter, and SCM muscles (p < 0.05), respectively. Maximum relaxation was achieved in 12.5% of the subjects after 20 min, in a further 12.5% after 40 min, and in the remaining 75% after 60 min. Significant relaxation was achieved in the control group from 20 to 40 min for the masseter and temporal muscles, respectively (p < 0.05).

​DISCUSSION:

Taken together, the results suggest that an ideal ULF-TENS application would last 40 min to obtain sufficient muscle relaxation both in patients with masticatory system disorders and healthy subjects, a time constraint that is consistent with everyday clinical practice.

10. Weiselmann-Penkner, K, Janda, M, Lorenzoni, M Polansky R. A comparison of the muscle relation effect on TENS and EMG-biofeedback in patients with bruxism .J Oral Rehabil, 2001 Sep; 28(9): 849:53

Abstract

This study investigated effects of electromyographic (EMG) biofeedback (BFB) and transcutaneous electrical neuromuscular stimulation (TENS) on the EMG activity of the masticatory muscles and skin conductance level (SCL) of patients, suffering from myofacial pain syndrome. In the course of the investigation, EMG activity, as well as the SCL, was measured after a 20 min BFB or, respectively, after a myomonitor session in 20 patients and pre-and post-treatment values were compared. Results showed tendencies of decreased mean-EMG levels for both groups after the treatment sessions, with higher EMG values for the myomonitor group. There was no indication of a significant decrease in mean EMG levels over the sessions. Furthermore, an increase of the SCL during the period of treatment was observed for both groups in sessions I and II, while session III produced nearly stable values. No existing correlations for changes in SCL and EMG-activity could be established.

​11. Shanavas, M, Chatra, L, Shenai, P, Rao, PK, Jagathish V, Kumar, SP, Naduvakkattu, B. Transcutaneous electrical nerve stimulation therapy: An adjutvant pain controlling modality in TMD patients- A clinical study. Dent Res, J (Ishfahan). 2014 Nov; 11(6):676-9

​Abstract

BACKGROUND:

The use of transcutaneous electrical nerve stimulation (TENS) in dentistry was first described in 1967, by Shane and Kessler, but it has yet to gain widespread acceptance in dentistry. A study was undertaken to evaluate the effectiveness of TENS therapy as an adjuvant modality and to compare it with the conventional medication in controlling pain in temporomandibular disorder (TMD) patients.

​MATERIALS AND METHODS:

The study was carried out in the Department of Oral Medicine and Radiology, Yenepoya Dental College and Hospital, Mangalore. A total of 40 patients with the clinical symptom of pain associated with TMDs were randomly divided into two groups. Group A (control) patients were treated with medication (analgesics and muscle relaxants) alone, while group B patients were treated with TENS therapy in combination with medication. The intensity of the pain was assessed using the Visual Analog Scale (VAS). The results were analyzed with the student’s ‘t’ test. A P-value < 0.05 was considered as significant.

​RESULTS:

A significant improvement was observed in both the TENS and the control group in terms of pain control. On comparative analysis, adjuvant TENS therapy was found to be more effective than medication alone, in controlling pain. (P value = 0.019).

​CONCLUSION:

The observed data suggest that TENS therapy can be used as an adjuvant modality in the management of pain associated with TMDs. This study justifies the use of TENS therapy in the management of TMD.

​12. Mahony, D. Re-establishing Physiologic Vertical Dimension for an Overclosed Patient Orthodontic Journal of Nepal, Vol 4, No1 June 2014

Abstract

Overclosure is a common condition among patients seeking restorative and/or orthodontic rehabilitation. By evaluating the patient for common signs and symptoms associated with overclosure, one can determine the need for re-establishing a physiologic vertical dimension. Opening of the bite can be accomplished in a number of ways by following specific guidelines. The use of objective diagnostic aids are extremely helpful by allowing the clinician to optimize TMJ and craniofacial muscle function at the new VDO. The correction of the vertical dimension during a rehabilitative procedure should result in enhanced comfort and improved function in the finished case.

13. Grossi, D, Chaves, T Physiotherapeutic treatment for temporomandibular disorders (TMD) Braz J Oral Sci. July/September 2004. Vol3, Num 10

Abstract

To a correct approach for TMD patient, the physiotherapist must perform a diagnostic and anamnesis evaluation to make an effective therapeutic intervention. Literature presents some schemes, anamnesis indexes, and standardized and validated questionnaires to evaluate TMD. Another important aspect is the biomechanical evaluation of the cervical spine alterations in TMD patients, due to the evidences of symptoms and biomechanical associations between cervical and masticatory systems. Manual therapy, therapeutical resources (like as ultra-sound, TENS) and postural re-education must be applied in a physical therapy treatment for TMD patients, but an appropriate intervention should be related not only to symptoms relief but look for TMD´s etiology. In view of such considerations, one of the most important approaches for TMD physical therapy treatment must be the modification of craniocervical biomechanics and its effects to posture as an etiologic or perpetuating TMD factor.

Claim 2. To relieve symptoms associated with muscle spasm

1. Wessberg, G, Carroll, W, Dinham, R Wolford G. Transcutaneous electrical stimulation as an adjunct in the management of myofascial pain-dysfunciton syndrome The Journal of Prosthetic Dentistry, 1981

Abstract

Twenty-one patients, 14 women and seven men, presenting with symptoms of the MPD syndrome, were treated with a regimen based on a neuromuscular theory of occlusion involving TES. Evaluation of treatment results shows 95% success immediately after therapy and an 86% success 1 year after therapy. No effort was made to establish a personality profile on the patients nor to incorporate active psychotherapy in treatment.

2. Cooper, BC The Role of bioelectronic instrumentation in the documentation and management of temporomandibular disorders. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Jam; 83(1):91-100

Abstract

Temporomandibular disorders (TMDs) can affect the form and function of the temporomandibular joint, masticatory muscles, and dental apparatus. Electronic measurement of mandibular movement and masticatory muscle function provides objective data that are defined by commonly accepted parameters in patients with TMDs; these data can then be used to design and monitor therapy and enhance treatment therapy. In this study, data on 3681 patients with TMD are presented, including electronic test data on 1182 treated patients with TMDs. Electronic jaw tracking was used to record mandibular movement and to compare the presenting and therapeutic dental occlusal positions. Electromyography was used to analyze the resting status of masticatory muscles and occlusal function at presentation and after therapeutic intervention. Transcutaneous electrical nerve stimulation therapy relaxed masticatory muscles and aided in the determination of a therapeutic occlusal position. The data show a positive correlation between the clinical symptoms of TMD and the presenting occlusion, accompanied by muscle activity. A strong positive correlation also appears to exist between a therapeutic change in the dental occlusion to a neuromuscularly healthy position with use of a precision orthotic appliance and the significant relief of symptoms within 1 month and at 3 months.

3. Jankelson, B, Sparks, S, Crane, P Radke, J. Neural Conduction of the Myo-Monitor Stimulus: A Quantitative Analysis Journal of Prosthetic Dentistry, 1975

​Abstract

With the introduction of the Myo-Monitor to dentistry, the question has arisen whether the stimulus is neurally mediated or results from direct depolarization of only the fibers of the masseter muscle. Intensity-duration curves recorded for 10 subjects quantified the relationship between stimulus intensity and the duration of the stimulus required to elicit a consistent contraction response to transcutaneous stimulation via the Myo-Monitor. Individual chronaxies ranged from 0.125 to 0.180 msec., with a mean calculated at 0.158 msec. Stimulating the muscle fibers directly, without transmission of the signal across the neuromuscular junction, would have produced chronaxy values at least 50 to 100 times greater. The distinction is clear-cut. The chronaxy values unequivocally establish transmission of the stimulus across the neuromuscular junction. In all 10 subjects, contraction of muscles remote from the site of stimulation was evident by inspection and palpation. These data lend support to the conclusion of Choi and Mitani that the Myo-Monitor stimulates the fifth and seventh cranial nerves. The data derived here correlate with those of other investigations and clearly establish that the transmission of the Myo-Monitor stimulus is accomplished by transcutaneous neural stimulation.

​4. Jach. E. Relief of Myo-facial Pain: Treatment of 5 Patients. Dental Survey 1975
No Abstract Available

5. Vesanen, E, Vesanen R. The Jankelson Myo-Monitor and its Clinical Use. Finnish Dental Society, 1973

​Abstract

The Myo Monitor is an electronic instrument that gives programmed impulses to the motor nerves of the mandible and produces involuntary contraction of the corresponding muscles. The instrument and its clinical use are briefly described with two case reports: A patient with Eustachian tube and inner ear disturbances; a joint problem. The instrument offers new possibilities not only in practice but also in research.

​6. Monaco, A, Sgolastra, F, Ciarrocchi,I, Cattaneo R. Effects of transcutaneous electrical nervous stimulation on electromyographic and kinesiographic activity of patients with temporomandibular disorders: a placebo-controlled study. J Electomyogr Kinesiol. 2012 Jun, 22(3):463-8

Abstract

The purpose of this study was to assess the effect of a single 60 min TENS application on sEMG and kinesiographic activity in TMD patients in remission, and to assess the sEMG and kinesiographic effect of TENS in placebo and untreated groups. Sixty female subjects, selected according to the inclusion/exclusion criteria, suffering from unilateral TMD in remission were assigned to one of the following group: Group TENS, that received a single session of 60 min of TENS; Group Placebo that received a single session of 60 min of sham TENS; Group Control, that received no treatment. Pre- and post-treatment differences in sEMG of TA, MM, SCM, and DA and interocclusal distance values within groups were tested using the Wilcoxon test. Differences in sEMG and kinesiographic data, among the three groups, were assessed by Kruskal-Wallis test. Significant differences were only observed in the TENS group, for masticatory muscles of both sides; one-way analysis of variance revealed that sEMG values of masticatory muscles of both sides in the TENS group were significantly reduced, in comparison with placebo and control groups. Kinesiographic results showed that the vertical component of the interocclusal distance was significantly increased after TENS only in the TENS group. TENS could be effective to reduce the sEMG activity of masticatory muscles and to improve the interocclusal distance of TMD patients in remission; the placebo effect seems not present in the TENS application.

​7. Chipaila, N, Sgolastra, F, Spadaro, A, Pietropaoli, D, Msci, C, Cattaneo, R, Monaco, A The Effects of ULF-TENS stimulatin on gnathology: the state of the art Cranio: the Journal of Craniomandibular & Sleep Practice, 2014

Abstract

AIMS:

The aim of this study was to evaluate the state of the art in the current literature regarding the effect of ultra low frequency-transcutaneous electrical nerve stimulation (ULF-TENS) on patients with temporomandibular disorders (TMD).

​METHODOLOGY:

The authors reviewed the literature through a thorough manual and electronic research on PubMed database (using the Medical Subject Headings thesaurus) and subsequent analysis of all the found papers regarding the effect of TENS on TMD patients. No randomized controlled trials on the investigated topic were found. Only eight papers regarding controlled clinical trials (CCT) were selected according to the search strategy selection criteria.

​RESULTS:

According to the available literature and the authors’ experience, ULF-TENS seems to be a valid support in the management of TMD patients, but also a ‘provocative’ tool, so its application should always be monitored by electromyographic and electrognathographic analysis (before and after TENS).

​CONCLUSIONS:

Further clinical studies (mainly randomized controlled trials) on ULF-TENS application in neuromuscular gnathology are needed.

​8. Kamyszek, G, Ketcham R, Garcia, R, Jr, Radke, J. Electromyographic evidence of reduced muscle activity when ULF-TENS is applied to the Vth and VIIth cranial nerves Cranio, 2001: Jul:19(3):162-8

​Abstract

The object of this study was to determine if the resting muscle activity of TMD patients with measured hyperactivity (EMGave > 2.0 microvolts) could be reduced by the application of ULF-TENS (Ultra-Low-Frequency-Transcutaneous Electrical Neural Stimulation) [(BioTENS) BioResearch, Inc. Milwaukee, WI]. Twenty-nine patients with resting muscle hyperactivity and ten without resting muscle hyperactivity were selected from a series of 124 consecutively diagnosed TMD patients. Electromyographic records were taken bilaterally (with the mandible at rest) from the superficial masseter, anterior temporalis, anterior digastric, and posterior temporalis muscles before and after the application of ULF-TENS. The EMG data were averaged. For the 85 muscles that were found initially to exceed the usual cutoff of 2.0 microvolts, means and standard deviations were calculated. The “before TENS” levels were: mean = 3.353 +/- 1.44227 and the “after TENS” values were: mean = 1.844 +/- 0.92421. Using a student t-test, we found the difference between the before and after levels significant (p < .0005). Additionally, means and standard deviations were calculated for each muscle (Ta, Mm, etc.) separately and also found to be significantly different (before Vs after TENS). In these “hyperactive” patients, the nonhyperactive muscles were also pooled, the means calculated before (mean = 1.21 +/- 0.456) and after (mean = 1.00 +/- 0.345) TENS and found to be significantly different (p < 0.01). For the ten patients exhibiting no muscle exceeding the 2.0 microvolt cutoff (mean = 1.08 +/- 0.415), no significant change (in levels) was observed after ULF-TENS (mean = 0.96 +/- 0.359; p > 0.88); however, when we calculated the “paired difference,” we found a significant reduction, albeit very slight, in these patients’ muscles, too. We conclude that ULF-TENS has an activity-reducing effect on the resting EMG levels of both hyperactive and relaxed muscles. It also appears that while the > 2.0 microvolt cutoff is useful for identifying patients that are hyperactive at rest, it does not identify complete relaxation of masticatory muscles.

​9. Mahony, D. Re-establishing Physiologic Vertical Dimension for an Overclosed Patient Orthodontic Journal of Nepal, Vol 4, No1 June 2014

Abstract

Overclosure is a common condition among patients seeking restorative and/or orthodontic rehabilitation. By evaluating the patient for common signs and symptoms associated with overclosure, one can determine the need for re-establishing a physiologic vertical dimension. Opening of the bite can be accomplished in a number of ways by following specific guidelines. The use of objective diagnostic aids are extremely helpful by allowing the clinician to optimize TMJ and craniofacial muscle function at the new VDO. The correction of the vertical dimension during a rehabilitative procedure should result in enhanced comfort and improved function in the finished case.

10. Frucht, S, Jonas, I, Kappert, HF Muscle Relaxation by transcutaneous electric nerve stimulation (TENS) in bruxism. An electromyographic study. Fortschr Kieferothop. 1995 Sep; 56(5): 245-53

Abstract

In recent years transcutaneous electrical neuromuscular stimulation (TENS) has become increasingly more common in the treatment of functional diseases of the masticatory muscles and currently the practitioner can choose among a variety of stimulators. In an electromyographic study of 17 adults suffering from nocturnal bruxism and of a control group consisting of 18 adults without any functional disturbances of the masticatory muscles, the effect of this kind of neuromuscular stimulation on the temporal and masseter muscle was examined. The myoelectric signals were registered before and after TENS treatment in 3 different positions of the mandible. Each person was treated 3 times with both the Myo-Monitor (Myo-Tronics, Seattle) and the TNS SM2 MF stimulator (schwa-medico, Giessen). The different effects of continuous low frequency and intermittent high frequency muscular stimulation were studied simultaneously. Muscular activity was determined by computer aided integration of the electromyographically measured raw signals. A fourier analysis of the power spectrum yielded information on the frequency behavior of the studied muscles resulting from the TENS treatment. A statistical analysis of the results led to the following significant conclusions: 1. TENS treatment decreased the values of the registered integrated signals on all test persons, however, the treatment increased the median frequency and the mean power frequency (MPF). Since this effect is contrary to muscle fatigue, these electromyographic results can be interpreted as providing objective proof of a relaxation in the treated muscles. 2. The electromyographic changes after TENS treatment were similar when using either the Myo-Monitor or the TNS SM2 MF stimulator. In addition, the 2 different types of stimulation (high or low frequency) showed the same effects. 3. Compared to the persons in the control group, there was no significant increased muscular activity in patients with nocturnal bruxism. Following TENS treatment both groups showed the same alterations in the electromyograms. The results of the study provide further evidence that TENS treatment is an adequate supportive procedure in the treatment of nocturnal bruxism.

Claim 3. To relax muscles and establish a physiologic occlusion

​1. Wessberg, G, Carroll, W, Dinham, R Wolford G. Transcutaneous electrical stimulation as an adjunct in the management of myofascial pain-dysfunction syndrome The Journal of Prosthetic Dentistry, 1981

Abstract

Twenty-one patients, 14 women and seven men, presenting with symptoms of the MPD syndrome, were treated with a regimen based on a neuromuscular theory of occlusion involving TES. Evaluation of treatment results shows 95% success immediately after therapy and an 86% success 1 year after therapy. No effort was made to establish a personality profile on the patients nor to incorporate active psychotherapy in treatment.

2. Cooper, B, Kleinberg, I. Establishment of Temporomandibular Physiological State with Neuromuscular Orthosis Treatment Affects Reduction of TMD Symptoms in 313 Patients Journal of Cranio Mandibular Practice, 2008

​Abstract

The objective of this investigation was to test the hypothesis that alteration of the occlusions of patients suffering from temporomandibular disorders (TMD) to one that is neuromuscularly, rather than anatomically based, would result in reduction or resolution of symptoms that characterize the TMD condition. This hypothesis was proven correct in the present study, where 313 patients with TMD symptoms were examined for neuromuscular dysfunction, using several electronic instruments before and after treatment intervention. Such instrumentation enabled electromyographic (EMG) measurement of the activities of the masticatory muscles during rest and in function, tracking and assessment of various movements of the mandible, and listening for noises made by the TMJ during movement of the mandible. Ultra low frequency and low amplitude, transcutaneous electrical neural stimulation (TENS) of the mandibular division of the trigeminal nerve (V) was used to relax the masticatory muscles and to facilitate location of a physiological rest position for the mandible. TENS also made it possible to select positions of the mandible that were most relaxed above and anterior to the rest position when the mandible was moved in an arc that began at rest position. Once identified, the neuromuscular occlusal position was recorded in the form of a bite registration, which was subsequently used to fabricate a removable mandibular orthotic appliance that could be worn continuously by the patient. Such a device facilitated retention and stabilization of the mandible in its new-found physiological position, which was confirmed by follow up testing. Three months of full-time appliance usage showed that the new therapeutic positions achieved remained intact and were associated with improved resting and functioning activities of the masticatory muscles. Patients reported overwhelming symptom relief, including reduction of headaches and other pain symptoms. Experts consider relief of symptoms as the gold standard for assessment of effectiveness of TMD treatment. It is evident that this outcome has been achieved in this study and that taking patients from a less to a more physiological state is an effective means for reducing or eliminating TMD symptoms, especially those related to pain, most notably, headaches.

​3. Cooper, BC The Role of bioelectronic instrumentation in the documentation and management of temporomandibular disorders. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Jam; 83(1):91-100

Abstract

Temporomandibular disorders (TMDs) can affect the form and function of the temporomandibular joint, masticatory muscles, and dental apparatus. Electronic measurement of mandibular movement and masticatory muscle function provides objective data that are defined by commonly accepted parameters in patients with TMDs; these data can then be used to design and monitor therapy and enhance treatment therapy. In this study, data on 3681 patients with TMD are presented, including electronic test data on 1182 treated patients with TMDs. Electronic jaw tracking was used to record mandibular movement and to compare the presenting and therapeutic dental occlusal positions. Electromyography was used to analyze the resting status of masticatory muscles and occlusal function at presentation and after therapeutic intervention. Transcutaneous electrical nerve stimulation therapy relaxed masticatory muscles and aided in the determination of a therapeutic occlusal position. The data show a positive correlation between the clinical symptoms of TMD and the presenting occlusion, accompanied by muscle activity. A strong positive correlation also appears to exist between a therapeutic change in the dental occlusion to a neuromuscularly healthy position with use of a precision orthotic appliance and the significant relief of symptoms within 1 month and at 3 months.

​4. Jankelson, B, Sparks, S, Crane, P Radke, J. Neural Conduction of the Myo-Monitor Stimulus: A Quantitative Analysis Journal of Prosthetic Dentistry, 1975

Abstract

With the introduction of the Myo-Monitor to dentistry, the question has arisen whether the stimulus is neurally mediated or results from direct depolarization of only the fibers of the masseter muscle. Intensity-duration curves recorded for 10 subjects quantified the relationship between stimulus intensity and the duration of the stimulus required to elicit a consistent contraction response to transcutaneous stimulation via the Myo-Monitor. Individual chronaxies ranged from 0.125 to 0.180 msec., with a mean calculated at 0.158 msec. Stimulating the muscle fibers directly, without transmission of the signal across the neuromuscular junction, would have produced chronaxy values at least 50 to 100 times greater. The distinction is clear-cut. The chronaxy values unequivocally establish transmission of the stimulus across the neuromuscular junction. In all 10 subjects, contraction of muscles remote from the site of stimulation was evident by inspection and palpation. These data lend support to the conclusion of Choi and Mitani that the Myo-Monitor stimulates the fifth and seventh cranial nerves. The data derived here correlate with those of other investigations and clearly establish that the transmission of the Myo-Monitor stimulus is accomplished by transcutaneous neural stimulation.

5. Vesanen, E, Vesanen R. The Jankelson Myo-Monitor and its Clinical Use. Finnish Dental Society, 1973

​Abstract

The Myo Monitor is an electronic instrument that gives programmed impulses to the motor nerves of the mandible and produces involuntary contraction of the corresponding muscles. The instrument and its clinical use are briefly described with two case reports: A patient with Eustachian tube and inner ear disturbances; a joint problem. The instrument offers new possibilities not only in practice but also in research.

6. Jach. E. Relief of Myo-facial Pain: Treatment of 5 Patients. Dental Survey 1975
No Abstract Available

​7. Chipaila, N, Sgolastra, F, Spadaro, A, Pietropaoli, D, Msci, C, Cattaneo, R, Monaco, A The Effects of ULF-TENS stimulatin on gnathology: the state of the art Cranio: the Journal of Craniomandibular & Sleep Practice, 2014

Abstract

AIMS:

The aim of this study was to evaluate the state of the art in the current literature regarding the effect of ultra low frequency-transcutaneous electrical nerve stimulation (ULF-TENS) on patients with temporomandibular disorders (TMD).

​METHODOLOGY:

The authors reviewed the literature through a thorough manual and electronic research on PubMed database (using the Medical Subject Headings thesaurus) and subsequent analysis of all the found papers regarding the effect of TENS on TMD patients. No randomized controlled trials on the investigated topic were found. Only eight papers regarding controlled clinical trials (CCT) were selected according to the search strategy selection criteria.

​RESULTS:

According to the available literature and the authors’ experience, ULF-TENS seems to be a valid support in the management of TMD patients, but also a ‘provocative’ tool, so its application should always be monitored by electromyographic and electrognathographic analysis (before and after TENS).

​CONCLUSIONS:

Further clinical studies (mainly randomized controlled trials) on ULF-TENS application in neuromuscular gnathology are needed.

​8. Eble, OS, Jonas, IE, Kapppert, HF. Transcutaneous electrical nerve stimulation (TENS): its short-term and long-term effects on the masticatory muscles. J Orofac Orthop, 200;61 (2):100-11

Abstract

In an electromyographic study on subjects with no functional disturbances of the masticatory muscles, the duration of the post-therapeutic effects of transcutaneous electrical nerve stimulation (= TENS) on the superficial masseter and anterior temporal muscle was analyzed. The myoelectric signals were registered from 20 healthy volunteers in 3 different mandibular positions. The recordings were performed before a 20-minute TENS application with the J-4 Myomonitor and continued with a sequence of follow-up registrations with increasing interval to the initial stimulation. The EMG signals underwent computer-aided analysis and were evaluated by determining the integrated values as a parameter of muscle activity, and after Fourier transformation by 7 describing parameters of the power spectrum (e.g. mean power frequency = MPF). A detailed analysis of variance of all data was used to investigate significant changes of the parameters during the observation period. Muscular response to TENS includes a decrease in muscular activity (= reduction in integrated EMG signals) and a shift in the power spectrum to higher frequencies (increase in MPF). These changes were statistically highly significant for both analyzed muscles and for all different mandibular exercises. As these reactions to TENS are contrary to muscle fatigue, the results can be interpreted as indicating that this type of therapy stimulates a change in the biochemical and physiological muscular conditions, which leads to muscle relaxation. Electromyographically, the post-therapeutic effect lasted for 2 hours in case of normal masticatory muscle activity but for more than 7 hours in case of low muscular loading. The alterations of the integrated EMG values were more persistent than those of the parameters of the power spectrum.

​9. Monaco, A, Sgolastra, F, Ciarrocchi,I, Cattaneo R. Effects of transcutaneous electrical nervous stimulation on electromyographic and kinesiographic activity of patients with temporomandibular disorders: a placebo-controlled study. J Electomyogr Kinesiol. 2012 Jun, 22(3):463-8

Abstract

The purpose of this study was to assess the effect of a single 60 min TENS application on sEMG and kinesiographic activity in TMD patients in remission, and to assess the sEMG and kinesiographic effect of TENS in placebo and untreated groups. Sixty female subjects, selected according to the inclusion/exclusion criteria, suffering from unilateral TMD in remission were assigned to one of the following group: Group TENS, that received a single session of 60 min of TENS; Group Placebo that received a single session of 60 min of sham TENS; Group Control, that received no treatment. Pre- and post-treatment differences in sEMG of TA, MM, SCM, and DA and interocclusal distance values within groups were tested using the Wilcoxon test. Differences in sEMG and kinesiographic data, among the three groups, were assessed by Kruskal-Wallis test. Significant differences were only observed in the TENS group, for masticatory muscles of both sides; one-way analysis of variance revealed that sEMG values of masticatory muscles of both sides in the TENS group were significantly reduced, in comparison with placebo and control groups. Kinesiographic results showed that the vertical component of the interocclusal distance was significantly increased after TENS only in the TENS group. TENS could be effective to reduce the sEMG activity of masticatory muscles and to improve the interocclusal distance of TMD patients in remission; the placebo effect seems not present in the TENS application.

​10. Kamyszek, G, Ketcham R, Garcia, R, Jr, Radke, J. Electromyographic evidence of reduced muscle activity when ULF-TENS is applied to the Vth and VIIth cranial nerves Cranio, 2001: Jul:19(3):162-8

​Abstract

The object of this study was to determine if the resting muscle activity of TMD patients with measured hyperactivity (EMGave > 2.0 microvolts) could be reduced by the application of ULF-TENS (Ultra-Low-Frequency-Transcutaneous Electrical Neural Stimulation) [(BioTENS) BioResearch, Inc. Milwaukee, WI]. Twenty-nine patients with resting muscle hyperactivity and ten without resting muscle hyperactivity were selected from a series of 124 consecutively diagnosed TMD patients. Electromyographic records were taken bilaterally (with the mandible at rest) from the superficial masseter, anterior temporalis, anterior digastric, and posterior temporalis muscles before and after the application of ULF-TENS. The EMG data were averaged. For the 85 muscles that were found initially to exceed the usual cutoff of 2.0 microvolts, means and standard deviations were calculated. The “before TENS” levels were: mean = 3.353 +/- 1.44227 and the “after TENS” values were: mean = 1.844 +/- 0.92421. Using a student t-test, we found the difference between the before and after levels significant (p < .0005). Additionally, means and standard deviations were calculated for each muscle (Ta, Mm, etc.) separately and also found to be significantly different (before Vs after TENS). In these “hyperactive” patients, the nonhyperactive muscles were also pooled, the means calculated before (mean = 1.21 +/- 0.456) and after (mean = 1.00 +/- 0.345) TENS and found to be significantly different (p < 0.01). For the ten patients exhibiting no muscle exceeding the 2.0 microvolt cutoff (mean = 1.08 +/- 0.415), no significant change (in levels) was observed after ULF-TENS (mean = 0.96 +/- 0.359; p > 0.88); however, when we calculated the “paired difference,” we found a significant reduction, albeit very slight, in these patients’ muscles, too. We conclude that ULF-TENS has an activity-reducing effect on the resting EMG levels of both hyperactive and relaxed muscles. It also appears that while the > 2.0 microvolt cutoff is useful for identifying patients that are hyperactive at rest, it does not identify complete relaxation of masticatory muscles.

​11. Bazzotti, L. Electromyography tension and frequency spectrum analysis at rest of masticatory muscles before and after TENS Electromyogr Clin Neurophysiol. 1997 Sept; 37(6): 365-78

Abstract

On a population of 52 subjects surface electromyographic recordings were performed of 13.5 sec. of duration before and after ULF (Ultra Low Frequency)-TENS relaxing procedure, while they were holding their mandible at rest. For each recording the average of tension (IEMG) and the median of frequency was calculated. To compute the median of frequencies a Fast Fourier Transformer (FFT) was applied. In order to compare modifications induced by the 45′ ULF-TENS relaxing procedure, so that the influence of ULF-TENS could be well isolated from any influence due simply to the time passing between one recording and another, three recordings were performed at different times: the first at time 0′, the second at time 0′ + 20′, and only the third after TENS, time 0′ + 20′ + 45′. The results of the study permit us to draw the following conclusions: 1. it is confirmed that ULF-TENS can decrease muscle IEMG; 2. the study of the IEMG and frequency of the electromyographic signal at rest can be carried out starting from a window whose size and position in the 13.5 sec. of recording is arbitrary; 3. there is no connection between IEMG and frequency: in other words, at rest, there is no necessary correspondence between high or low IEMG and a high or low frequency values; 4. on application of the neurodiagnostic test of ULF-TENS, the IEMG of the electromyographic signal decreases, while the frequency of the signal remains unchanged. These last two observations permit us to hypothesize that the IEMG and the frequency of the electromyographic signal reflect some different and independent characteristics of the electrical activity of the muscle at rest.

​12. Weiselmann-Penkner, K, Janda, M, Lorenzoni, M Polansky R. A comparison of the muscle relation effect on TENS and EMG-biofeedback in patients with bruxism .J Oral Rehabil, 2001 Sep; 28(9): 849:53

Abstract

This study investigated effects of electromyographic (EMG) biofeedback (BFB) and transcutaneous electrical neuromuscular stimulation (TENS) on the EMG activity of the masticatory muscles and skin conductance level (SCL) of patients, suffering from myofacial pain syndrome. In the course of the investigation, EMG activity as well as the SCL was measured after a 20 min BFB or, respectively, after a myomonitor session in 20 patients and pre- and post-treatment values were compared. Results showed tendencies of decreased mean-EMG levels for both groups after the treatment sessions, with higher EMG values for the myomonitor group. There was no indication of a significant decrease in mean EMG levels over the sessions. Furthermore, an increase of the SCL during the period of treatment was observed for both groups in session I and II, while session III produced nearly stable values. No existing correlations for changes in SCL and EMG-activity could be established.

13 . de Braganca, RMF, Rodrigues, CA, Melchior, MO, Magri, LV, Mazzetto, MO. Ultra-low frequency transcutanteous eletrical nerve stimulation does not affect the centric relation registration. Cranio, 2018:

Abstract

OBJECTIVE:

To evaluate the influence of ULF-TENS on the displacement of the mandibular condyle and on the repeatability of centric relation (CR) registration of three different techniques: bimanual manipulation (BM), long strip technique, and harmonic centric occlusal relationship (R.O.C.A. wires).

​METHODS:

Twenty-five participants without temporomandibular disorder (TMD) underwent two study stages conducted via electronic position analysis: (1) three CR records were made, one for each manipulation technique; (2) the ULF-TENS was applied for 30 min, and after that the same CR records were repeated.

STATISTICAL ANALYSES:

Mann-Whitney, ICC, and one-tailed F test.

RESULTS:

The ULF-TENS did not influence the condyle total displacement, regardless of CR recording technique used (p > 0.05). BM showed an improvement in repeatability after ULF-TENS.

DISCUSSION:

Concerning the variance, BM showed less variation at the X-axis. Long strip technique and R.O.C.A. wires varied less at the Y-axis. Long strip technique was again less variable at the Z-axis.

14. Monaco, A, Cattaneo, R, Marci MC, Marzo G, Gatto, R, Giannoni, M Neuromuscular diagnosis in orthodontics: effects of TENS on maxillo-mandibular relationship. European Journal Paediatric Dentistry, 2007 Sept 8(3):143-148

Abstract

AIMS:

The aim of this study was to evaluate the state of the art in the current literature regarding the effect of ultra-low frequency-transcutaneous electrical nerve stimulation (ULF-TENS) on patients with temporomandibular disorders (TMD).

METHODOLOGY:

The authors reviewed the literature through a thorough manual and electronic research on PubMed database (using the Medical Subject Headings thesaurus) and subsequent analysis of all the found papers regarding the effect of TENS on TMD patients. No randomized controlled trials on the investigated topic were found. Only eight papers regarding controlled clinical trials (CCT) were selected according to the search strategy selection criteria.

RESULTS:

According to the available literature and the authors’ experience, ULF-TENS seems to be a valid support in the management of TMD patients, but also a ‘provocative’ tool, so its application should always be monitored by electromyographic and electrognathographic analysis (before and after TENS).

CONCLUSIONS:

Further clinical studies (mainly randomized controlled trials) on ULF-TENS application in neuromuscular gnathology are needed.

15. Frucht, S, Jonas, I, Kappert, HF Muscle Relaxation by transcutaneous electric nerve stimulation (TENS) in bruxism. An electromyographic study. Fortschr Kieferothop. 1995 Sep; 56(5): 245-53

Abstract

In recent years transcutaneous electrical neuromuscular stimulation (TENS) has become increasingly more common in the treatment of functional diseases of the masticatory muscles and currently the practitioner can choose among a variety of stimulators. In an electromyographic study of 17 adults suffering from nocturnal bruxism and of a control group consisting of 18 adults without any functional disturbances of the masticatory muscles, the effect of this kind of neuromuscular stimulation on the temporal and masseter muscle was examined. The myoelectric signals were registered before and after TENS treatment in 3 different positions of the mandible. Each person was treated 3 times with both the Myo-Monitor (Myo-Tronics, Seattle) and the TNS SM2 MF stimulator (schwa-medico, Giessen). The different effects of continuous low frequency and intermittent high frequency muscular stimulation were studied simultaneously. Muscular activity was determined by computer aided integration of the electromyographically measured raw signals. A fourier analysis of the power spectrum yielded information on the frequency behavior of the studied muscles resulting from the TENS treatment. A statistical analysis of the results led to the following significant conclusions: 1. TENS treatment decreased the values of the registered integrated signals on all test persons, however, the treatment increased the median frequency and the mean power frequency (MPF). Since this effect is contrary to muscle fatigue, these electromyographic results can be interpreted as providing objective proof of a relaxation in the treated muscles. 2. The electromyographic changes after TENS treatment were similar when using either the Myo-Monitor or the TNS SM2 MF stimulator. In addition, the 2 different types of stimulation (high or low frequency) showed the same effects. 3. Compared to the persons in the control group, there was no significant increased muscular activity in patients with nocturnal bruxism. Following TENS treatment both groups showed the same alterations in the electromyograms. The results of the study provide further evidence that TENS treatment is an adequate supportive procedure in the treatment of nocturnal bruxism.

16. Mahony, D. Re-establishing Physiologic Vertical Dimension for an Overclosed Patient Orthodontic Journal of Nepal, Vol 4, No1 June 2014

Abstract

Overclosure is a common condition among patients seeking restorative and/or orthodontic rehabilitation. By evaluating the patient for common signs and symptoms associated with overclosure, one can determine the need for re-establishing a physiologic vertical dimension. Opening of the bite can be accomplished in a number of ways by following specific guidelines. The use of objective diagnostic aids are extremely helpful by allowing the clinician to optimize TMJ and craniofacial muscle function at the new VDO. The correction of the vertical dimension during a rehabilitative procedure should result in enhanced comfort and improved function in the finished case.

Claim 4. To take occlusal registrations

1. Wessberg, G, Carroll, W, Dinham, R Wolford G. Transcutaneous electrical stimulation as an adjunct in the management of myofascial pain-dysfunciton syndrome The Journal of Prosthetic Dentistry, 1981

Abstract

Twenty-one patients, 14 women and seven men, presenting with symptoms of the MPD syndrome, were treated with a regimen based on a neuromuscular theory of occlusion involving TES. Evaluation of treatment results shows 95% success immediately after therapy and an 86% success 1 year after therapy. No effort was made to establish a personality profile on the patients nor to incorporate active psychotherapy in treatment.

2. Cooper, B, Kleinberg, I. Establishment of Temporomandibular Physiological State with Neuromuscular Orthosis Treatment Affects Reduction of TMD Symptoms in 313 Patients Journal of Cranio Mandibular Practice, 2008

Abstract

The objective of this investigation was to test the hypothesis that alteration of the occlusions of patients suffering from temporomandibular disorders (TMD) to one that is neuromuscularly, rather than anatomically based, would result in reduction or resolution of symptoms that characterize the TMD condition. This hypothesis was proven correct in the present study, where 313 patients with TMD symptoms were examined for neuromuscular dysfunction, using several electronic instruments before and after treatment intervention. Such instrumentation enabled electromyographic (EMG) measurement of the activities of the masticatory muscles during rest and in function, tracking and assessment of various movements of the mandible, and listening for noises made by the TMJ during movement of the mandible. Ultra low frequency and low amplitude, transcutaneous electrical neural stimulation (TENS) of the mandibular division of the trigeminal nerve (V) was used to relax the masticatory muscles and to facilitate location of a physiological rest position for the mandible. TENS also made it possible to select positions of the mandible that were most relaxed above and anterior to the rest position when the mandible was moved in an arc that began at rest position. Once identified, the neuromuscular occlusal position was recorded in the form of a bite registration, which was subsequently used to fabricate a removable mandibular orthotic appliance that could be worn continuously by the patient. Such a device facilitated retention and stabilization of the mandible in its new-found physiological position, which was confirmed by follow up testing. Three months of full-time appliance usage showed that the new therapeutic positions achieved remained intact and were associated with improved resting and functioning activities of the masticatory muscles. Patients reported overwhelming symptom relief, including reduction of headaches and other pain symptoms. Experts consider relief of symptoms as the gold standard for assessment of effectiveness of TMD treatment. It is evident that this outcome has been achieved in this study and that taking patients from a less to a more physiological state is an effective means for reducing or eliminating TMD symptoms, especially those related to pain, most notably, headaches.

3. Cooper, BC The Role of bioleectronic instrumentation in the documentation and management of temporomandibular disorders. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Jam; 83(1):91-100

Abstract

Temporomandibular disorders (TMDs) can affect the form and function of the temporomandibular joint, masticatory muscles, and dental apparatus. Electronic measurement of mandibular movement and masticatory muscle function provides objective data that are defined by commonly accepted parameters in patients with TMDs; these data can then be used to design and monitor therapy and enhance treatment therapy. In this study, data on 3681 patients with TMD are presented, including electronic test data on 1182 treated patients with TMDs. Electronic jaw tracking was used to record mandibular movement and to compare the presenting and therapeutic dental occlusal positions. Electromyography was used to analyze the resting status of masticatory muscles and occlusal function at presentation and after therapeutic intervention. Transcutaneous electrical nerve stimulation therapy relaxed masticatory muscles and aided in the determination of a therapeutic occlusal position. The data show a positive correlation between the clinical symptoms of TMD and the presenting occlusion, accompanied by muscle activity. A strong positive correlation also appears to exist between a therapeutic change in the dental occlusion to a neuromuscularly healthy position with use of a precision orthotic appliance and the significant relief of symptoms within 1 month and at 3 months.

4. Jankelson, B, Sparks, S, Crane, P Radke, J. Neural Conduction of the Myo-Monitor Stimulus: A Quantitative Analysis. Journal of Prosthetic Dentistry, 1975

​Abstract

With the introduction of the Myo-Monitor to dentistry, the question has arisen whether the stimulus is neurally mediated or results from direct depolarization of only the fibers of the masseter muscle. Intensity-duration curves recorded for 10 subjects quantified the relationship between stimulus intensity and the duration of the stimulus required to elicit a consistent contraction response to transcutaneous stimulation via the Myo-Monitor. Individual chronaxies ranged from 0.125 to 0.180 msec., with a mean calculated at 0.158 msec. Stimulating the muscle fibers directly, without transmission of the signal across the neuromuscular junction, would have produced chronaxy values at least 50 to 100 times greater. The distinction is clear-cut. The chronaxy values unequivocally establish transmission of the stimulus across the neuromuscular junction. In all 10 subjects, contraction of muscles remote from the site of stimulation was evident by inspection and palpation. These data lend support to the conclusion of Choi and Mitani that the Myo-Monitor stimulates the fifth and seventh cranial nerves. The data derived here correlate with those of other investigations and clearly establish that the transmission of the Myo-Monitor stimulus is accomplished by transcutaneous neural stimulation.

5. Jach. E. Relief of Myo-facial Pain: Treatment of 5 Patients. Dental Survey 1975
No Abstract Available.

​6. Vesanen, E, Vesanen R. The Jankelson Myo-Monitor and its Clinical Use. Finnish Dental Society, 1973

​Abstract

The Myo Monitor is an electronic instrument that gives programmed impulses to the motor nerves of the mandible and produces involuntary contraction of the corresponding muscles. The instrument and its clinical use are briefly described with two case reports: A patient with Eustachian tube and inner ear disturbances; a joint problem. The instrument offers new possibilities not only in practice but also in research.

7. Monaco, A, Cattaneo, R, Marci MC, Marzo G, Gatto, R, Giannoni, M Neuromuscular diagnosis in orthodontics: effects of TENS on maxillo-mandibular relationship. European Journal Paediatric Dentistry, 2007 Sept 8(3):143-148

Abstract

AIMS:

The aim of this study was to evaluate the state of the art in the current literature regarding the effect of ultra low frequency-transcutaneous electrical nerve stimulation (ULF-TENS) on patients with temporomandibular disorders (TMD).

METHODOLOGY:

The authors reviewed the literature through a thorough manual and electronic research on PubMed database (using the Medical Subject Headings thesaurus) and subsequent analysis of all the found papers regarding the effect of TENS on TMD patients. No randomized controlled trials on the investigated topic were found. Only eight papers regarding controlled clinical trials (CCT) were selected according to the search strategy selection criteria.

RESULTS:

According to the available literature and the authors’ experience, ULF-TENS seems to be a valid support in the management of TMD patients, but also a ‘provocative’ tool, so its application should always be monitored by electromyographic and electrognathographic analysis (before and after TENS).

CONCLUSIONS:

Further clinical studies (mainly randomized controlled trials) on ULF-TENS application in neuromuscular gnathology are needed.

8. Inatomi, K, Kobayashi, Y. A Study of muscle pressure in making functional impression. Horizontal and vertical forces on oral vestibulum of maxilla with full natural dentition. Shigaku, 1989 Feb; 76(6):1166-206

Abstract

The purpose of this thesis was to establish objectively a technique for muscle training in functional impression of denture space. Ten normal subjects in their twenties were employed. Small transducers were placed in labial and buccal sides of gingival mucosa of the maxilla. The horizontal and vertical muscular forces of the molar, premolar and anterior regions were recorded simultaneously during rest position, during the application of Myomonitor, during pronunciation and during the fourteen types of functional movements relating to muscle training. The data were statistically analyzed and the following results were obtained. 1. The average muscular force during rest position was minimal in all areas measured and could be used as standard for other functional movements. 2. Each type of functional movement had its distinct muscular force in all areas measured and there were significant differences among the areas of measurement and among the directions of measurement. 3. The functional movements that showed maximum muscular force were, in the anterior region, suction of the index finger for both vertical and horizontal directions, in the premolar region, suction of the index finger for horizontal direction and rotation of the cheek for vertical direction, in the molar region, inward rolling of upper lip for both directions. 4. The number of functional movement which showed significant differences in the muscular forces among directions tend to increase as one move from anterior to premolar and to molar region. In this case the horizontal forces became larger than the vertical forces. Also both the horizontal and vertical forces tend to increase as one move anteriorly. 5. The muscular forces obtained from the rotation movement made by the subject were larger than the forces of the rotation movement made by the clinicians in all areas measured. 6. The average muscular force during the application of Myo-monitor was minimal and similar to the force during rest position. 7. There was a large difference among individuals in the muscular forces during pronunciation, and all were below the average force of the fourteen functional movements. 8. From the above results it is suggested that a technique for muscle training be established objectively for the functional impression of maxillary labial and buccal denture space.

9. Chipaila, N, Sgolastra, F, Spadaro, A, Pietropaoli, D, Msci, C, Cattaneo, R, Monaco, A The Effects of ULF-TENS stimulatin on gnathology: the state of the art Cranio: the Journal of Craniomandibular & Sleep Practice, 2014

Abstract

AIMS:

The aim of this study was to evaluate the state of the art in the current literature regarding the effect of ultra low frequency-transcutaneous electrical nerve stimulation (ULF-TENS) on patients with temporomandibular disorders (TMD).

METHODOLOGY:

The authors reviewed the literature through a thorough manual and electronic research on PubMed database (using the Medical Subject Headings thesaurus) and subsequent analysis of all the found papers regarding the effect of TENS on TMD patients. No randomized controlled trials on the investigated topic were found. Only eight papers regarding controlled clinical trials (CCT) were selected according to the search strategy selection criteria.

RESULTS:

According to the available literature and the authors’ experience, ULF-TENS seems to be a valid support in the management of TMD patients, but also a ‘provocative’ tool, so its application should always be monitored by electromyographic and electrognathographic analysis (before and after TENS).

CONCLUSIONS:

Further clinical studies (mainly randomized controlled trials) on ULF-TENS application in neuromuscular gnathology are needed.

10.Mahony, D. Re-establishing Physiologic Vertical Dimension for an Overclosed Patient Orthodontic Journal of Nepal, Vol 4, No1 June 2014

Abstract

Overclosure is a common condition among patients seeking restorative and/or orthodontic rehabilitation. By evaluating the patient for common signs and symptoms associated with overclosure, one can determine the need for re-establishing a physiologic vertical dimension. Opening of the bite can be accomplished in a number of ways by following specific guidelines. The use of objective diagnostic aids are extremely helpful by allowing the clinician to optimize TMJ and craniofacial muscle function at the new VDO. The correction of the vertical dimension during a rehabilitative procedure should result in enhanced comfort and improved function in the finished case.

​11. de Braganca, RMF, Rodrigues, CA, Melchior, MO, Magri, LV, Mazzetto, MO. Ultra-low frequency transcutanteous eletrical nerve stimulation does not affect the centric relation registration. Cranio, 2018:

Abstract

OBJECTIVE:

To evaluate the influence of ULF-TENS on the displacement of the mandibular condyle and on the repeatability of centric relation (CR) registration of three different techniques: bimanual manipulation (BM), long strip technique, and harmonic centric occlusal relationship (R.O.C.A. wires).

METHODS:

Twenty-five participants without temporomandibular disorder (TMD) underwent two study stages conducted via electronic position analysis: (1) three CR records were made, one for each manipulation technique; (2) the ULF-TENS was applied for 30 min, and after that the same CR records were repeated.

STATISTICAL ANALYSES:

Mann-Whitney, ICC, and one-tailed F test.

RESULTS:

The ULF-TENS did not influence the condyle total displacement, regardless of CR recording technique used (p > 0.05). BM showed an improvement in repeatability after ULF-TENS.

DISCUSSION:

Concerning the variance, BM showed less variation at the X-axis. Long strip technique and R.O.C.A. wires varied less at the Y-axis. Long strip technique was again less variable at the Z-axis.

Claim 5. To take denture impressions

1. Jankelson, B, Sparks, S, Crane, P Radke, J. Neural Conduction of the Myo-Monitor Stimulus: A Quantitative Analysis Journal of Prosthetic Dentistry, 1975

Abstract

With the introduction of the Myo-Monitor to dentistry, the question has arisen whether the stimulus is neurally mediated or results from direct depolarization of only the fibers of the masseter muscle. Intensity-duration curves recorded for 10 subjects quantified the relationship between stimulus intensity and the duration of the stimulus required to elicit a consistent contraction response to transcutaneous stimulation via the Myo-Monitor. Individual chronaxies ranged from 0.125 to 0.180 msec., with a mean calculated at 0.158 msec. Stimulating the muscle fibers directly, without transmission of the signal across the neuromuscular junction, would have produced chronaxy values at least 50 to 100 times greater. The distinction is clear-cut. The chronaxy values unequivocally establish transmission of the stimulus across the neuromuscular junction. In all 10 subjects, contraction of muscles remote from the site of stimulation was evident by inspection and palpation. These data lend support to the conclusion of Choi and Mitani that the Myo-Monitor stimulates the fifth and seventh cranial nerves. The data derived here correlate with those of other investigations and clearly establish that the transmission of the Myo-Monitor stimulus is accomplished by transcutaneous neural stimulation.

2. Vesanen, E, Vesanen R. The Jankelson Myo-Monitor and its Clinical Use. Finnish Dental Society, 1973

Abstract

The Myo Monitor is an electronic instrument that gives programmed impulses to the motor nerves of the mandible and produces involuntary contraction of the corresponding muscles. The instrument and its clinical use are briefly described with two case reports: A patient with Eustachian tube and inner ear disturbances; a joint problem. The instrument offers new possibilities not only in practice but also in research.

3. George, JP, Boone, ME. A Clinical study of rest position using the Kinesiograph and Myomonitor. The Journal of Prosthetic Dentistry, 1979 Apr, 41(4):456-62

Abstract

The clinical study was designed to study the vertical dimension of rest position and mandibular closure to maximum intercuspation of the teeth before, during, and after relaxation procedures on 14 subjects with stable dentitions. The findings call attention to the potential of both the Myomonitor and the Kinesiograph for research and clinical use, to the physiologic need for flexibility of the vertical dimension of rest position, and to the importance of measuring all three dimensions when examining the rest position.

4. Inatomi, K, Kobayashi, Y. A Study of muscle pressure in making functional impression. Horizontal and vertical forces on oral vestibulum of maxilla with full natural dentition. Shigaku, 1989 Feb; 76(6):1166-206

Abstract

The purpose of this thesis was to establish objectively a technique for muscle training in functional impression of denture space. Ten normal subjects in their twenties were employed. Small transducers were placed in labial and buccal sides of gingival mucosa of the maxilla. The horizontal and vertical muscular forces of the molar, premolar and anterior regions were recorded simultaneously during rest position, during the application of Myomonitor, during pronunciation and during the fourteen types of functional movements relating to muscle training. The data were statistically analyzed and the following results were obtained. 1. The average muscular force during rest position was minimal in all areas measured and could be used as standard for other functional movements. 2. Each type of functional movement had its distinct muscular force in all areas measured and there were significant differences among the areas of measurement and among the directions of measurement. 3. The functional movements that showed maximum muscular force were, in the anterior region, suction of the index finger for both vertical and horizontal directions, in the premolar region, suction of the index finger for horizontal direction and rotation of the cheek for vertical direction, in the molar region, inward rolling of upper lip for both directions. 4. The number of functional movement which showed significant differences in the muscular forces among directions tend to increase as one move from anterior to premolar and to molar region. In this case the horizontal forces became larger than the vertical forces. Also both the horizontal and vertical forces tend to increase as one move anteriorly. 5. The muscular forces obtained from the rotation movement made by the subject were larger than the forces of the rotation movement made by the clinicians in all areas measured. 6. The average muscular force during the application of Myo-monitor was minimal and similar to the force during rest position. 7. There was a large difference among individuals in the muscular forces during pronunciation, and all were below the average force of the fourteen functional movements. 8. From the above results it is suggested that a technique for muscle training be established objectively for the functional impression of maxillary labial and buccal denture space.

​5. Koli, D, Nanda, A, Naur, H, Verma, M, Jain, C. Cameo surface recording in complete denture fabricaton using transcutaneus electrical enver stimulation: A clinical report Journal Prosthetic dentistry 2017 Aug; 118(2):127-130

Abstract

Severe bone loss in patients with complete edentulism poses a treatment challenge. In fabricating a denture, the stability of the prosthesis must be enhanced by recording the cameo surface within the confines of the physiological position of the cheek and tongue muscles (the neutral zone) and by shaping it accordingly. The treatment of a patient with a completely edentulous maxillary arch and severe maxillary anterior bone loss is described. The cameo surface was recorded within the physiological limits during the fabrication of a complete denture by using transcutaneous electrical nerve stimulation (TENS).

Claim 6. To increase local blood circulation

1. Vesanen, E, Vesanen R. The Jankelson Myo-Monitor and its Clinical Use. Finnish Dental Society, 1973

​Abstract

The Myo Monitor is an electronic instrument that gives programmed impulses to the motor nerves of the mandible and produces involuntary contraction of the corresponding muscles. The instrument and its clinical use are briefly described with two case reports: A patient with Eustachian tube and inner ear disturbances; a joint problem. The instrument offers new possibilities not only in practice but also in research.

2. Kamali F, Mirkhani, H, Nematollahi, A, Heidari, S, Moosavi, E Mohamadi, M. The Effect of Transcutaneous Electrical Nerve Stimulation of Sympathetic Ganglions and Acupuncture Points on Distal Blood Flow. J Acupunct Meridian Stud. 2017 Apr;10(2):120-124

Abstract

Transcutaneous electrical nerve stimulation (TENS) is a widely-practiced method to increase blood flow in clinical practice. The best location for stimulation to achieve optimal blood flow has not yet been determined. We compared the effect of TENS application at sympathetic ganglions and acupuncture points on blood flow in the foot of healthy individuals. Seventy-five healthy individuals were randomly assigned to three groups. The first group received cutaneous electrical stimulation at the thoracolumbar sympathetic ganglions. The second group received stimulation at acupuncture points. The third group received stimulation in the mid-calf area as a control group. Blood flow was recorded at time zero as baseline and every 3 minutes after baseline during stimulation, with a laser Doppler flow-meter. Individuals who received sympathetic ganglion stimulation showed significantly greater blood flow than those receiving acupuncture point stimulation or those in the control group (p<0.001). Data analysis revealed that blood flow at different times during stimulation increased significantly from time zero in each group. Therefore, the application of low-frequency TENS at the thoracolumbar sympathetic ganglions was more effective in increasing peripheral blood circulation than stimulation at acupuncture points.

3. Meyerspeer, M, Mandl T, Reichel M Mayr, W Hofer, C, Kern, H, Moser E Effects of functional electrical stimulation in denervated thigh muscles of paraplegic patients mapped with T2 imaging. MAGMA. 2008 May;21(3):219-26.

Abstract

OBJECT:

Functional electrical stimulation (FES) for paraplegic patients, with the long-term goal of ultimately restoring muscle function, is associated with several positive effects: improvement of blood circulation, skin condition, peripheral trophism and metabolism, prophylaxis against decubitus ulcer and better physical fitness. Since fibres of denervated muscles (lacking a supplying nerve) need to be activated directly, the fraction of elicited muscle tissue follows the geometric distribution of the electrical field, which can be simulated using electrophysiological computer models. Experimental validation of these results, however, has not yet been established.

MATERIALS AND METHODS:

We acquired T (2) parameter images using a multislice multi-spin-echo MR sequence before and immediately after FES in nine denervated paraplegic patients and three healthy subjects in order to visualise the geometric distribution of activation by electrically induced muscle stimulation in denervated versus innervated (healthy) thigh muscle.

RESULTS AND CONCLUSION:

After realigning and normalisation, maps of relative T (2) increase were calculated. The results demonstrate that the spatial distribution of short-term effects of FES of denervated muscle tissue of paraplegic patients who regularly perform FES can be visualised by T (2) parameter images. This may be used to refine models of the electrical field of FES in muscle and fibre activation in the future.

4. Cosmo, P, Svensson, H, Bornmyr, S, Wirkstrom SO Effects of transcutaneous nerve stimulation on the microcirculation in chronic leg ulcers. Scand J Plast Reconstr Surg Hand Surg. 2000 Mar;34(1):61-4

Abstract

The purpose of this study was to find out to what extent transcutaneous electrical nerve stimulation (TENS) affects the blood flow in and around chronic lower leg ulcers, as measured with a new technique, laser Doppler imaging (LDI). Fifteen patients, mean age 73 years (range 38-85) with chronic leg ulcers of various causes participated in the study. The duration of the ulcers ranged from 3 months to 16 years. Low-frequency (2 Hz; 10-45 mA) TENS was given for 60 minutes. The changes in blood flow were measured every 5 minutes by LDI. After 60 minutes, mean blood flow had increased in the ulcer by 35%, and in the intact skin surrounding the ulcer by 15%. Even 15 minutes after the TENS had finished there was still a mean blood flow increase of 29% in the ulcer and 9% in the skin. The present results show that TENS has a stimulating effect on local blood circulation in and around chronic ulcers.

5. Evans, DR, Williams, KJ, Strutton, PH, Davies AH. The comparative hemodynamic efficiacy of lower limb muscles using transcutanteous electrical stimulation. J Vasc Surg Venous Lymphat Disord 2016, Apr, 4(2):206-14

Abstract

BACKGROUND:

Circulation in the limbs can be augmented using transcutaneous electrical stimulation devices. The optimum muscle stimulation sites for enhancement of vascular hemodynamic parameters have not been identified.

METHODS:

Seven suitable anatomic sites were identified within the right leg. Twelve healthy participants were recruited (mean age, 23.1 ± 3 years; body mass index, 23.1 ± 3 kg/m(2)). Muscles were stimulated by transcutaneous bipolar electrodes at a current twice their motor threshold, at 1 Hz, for 5 minutes. Hemodynamic ultrasound measurements were taken from the right femoral vein. Laser Doppler measurements from the feet of the stimulated and nonstimulated sides were obtained. Baseline measurements were compared with readings after 5 minutes of stimulation, with device active. Discomfort experienced for stimulation of each muscle was rated out of 100.

RESULTS:

Hemodynamic changes displayed large intersubject variation, with no muscle statistically superior to the others. All muscles increased peak velocity; contraction of medial gastrocnemius increased time-averaged maximum velocity and volume flow. All muscles increased foot fluximetry (P < .05). Discomfort correlated weakly with current applied. Tibialis anterior and vastus lateralis were most tenable.​

CONCLUSIONS:

Transcutaneous stimulation increases hemodynamic parameters significantly, locally and systemically. No optimum stimulation site has been identified, and it is limited by comfort and variability in the subject’s response. Gastrocnemius, tibialis anterior, and vastus lateralis all provoke large changes in hemodynamic parameters, but clinical efficacy in disease prevention and management has not been explored.​

Claim 7. To maintain or increase mandibular range of motion.

1. Wessberg, G, Carroll, W, Dinham, R Wolford G. Transcutaneous electrical stimulation as an adjunct in the management of myofascial pain-dysfunciton syndrome. The Journal of Prosthetic Dentistry, 1981

Abstract

Twenty-one patients, 14 women and seven men, presenting with symptoms of the MPD syndrome, were treated with a regimen based on a neuromuscular theory of occlusion involving TES. Evaluation of treatment results shows 95% success immediately after therapy and an 86% success 1 year after therapy. No effort was made to establish a personality profile on the patients nor to incorporate active psychotherapy in treatment.

2. Cooper, B, Kleinberg, I. Establishment of Temporomandibular Physiological State with Neuromuscular Orthosis Treatment Affects Reduction of TMD Symptoms in 313 Patients Journal of Cranio Mandibular Practice, 2008

Abstract

The objective of this investigation was to test the hypothesis that alteration of the occlusions of patients suffering from temporomandibular disorders (TMD) to one that is neuromuscularly, rather than anatomically based, would result in reduction or resolution of symptoms that characterize the TMD condition. This hypothesis was proven correct in the present study, where 313 patients with TMD symptoms were examined for neuromuscular dysfunction, using several electronic instruments before and after treatment intervention. Such instrumentation enabled electromyographic (EMG) measurement of the activities of the masticatory muscles during rest and in function, tracking and assessment of various movements of the mandible, and listening for noises made by the TMJ during movement of the mandible. Ultra low frequency and low amplitude, transcutaneous electrical neural stimulation (TENS) of the mandibular division of the trigeminal nerve (V) was used to relax the masticatory muscles and to facilitate location of a physiological rest position for the mandible. TENS also made it possible to select positions of the mandible that were most relaxed above and anterior to the rest position when the mandible was moved in an arc that began at rest position. Once identified, the neuromuscular occlusal position was recorded in the form of a bite registration, which was subsequently used to fabricate a removable mandibular orthotic appliance that could be worn continuously by the patient. Such a device facilitated retention and stabilization of the mandible in its new-found physiological position, which was confirmed by follow up testing. Three months of full-time appliance usage showed that the new therapeutic positions achieved remained intact and were associated with improved resting and functioning activities of the masticatory muscles. Patients reported overwhelming symptom relief, including reduction of headaches and other pain symptoms. Experts consider relief of symptoms as the gold standard for assessment of effectiveness of TMD treatment. It is evident that this outcome has been achieved in this study and that taking patients from a less to a more physiological state is an effective means for reducing or eliminating TMD symptoms, especially those related to pain, most notably, headaches.

3. Chipaila, N, Sgolastra, F, Spadaro, A, Pietropaoli, D, Msci, C, Cattaneo, R, Monaco, A The Effects of ULF-TENS stimulatin on gnathology: the state of the art Cranio: the Journal of Craniomandibular & Sleep Practice, 2014

Abstract

AIMS:

The aim of this study was to evaluate the state of the art in the current literature regarding the effect of ultra low frequency-transcutaneous electrical nerve stimulation (ULF-TENS) on patients with temporomandibular disorders (TMD).

METHODOLOGY:

The authors reviewed the literature through a thorough manual and electronic research on PubMed database (using the Medical Subject Headings thesaurus) and subsequent analysis of all the found papers regarding the effect of TENS on TMD patients. No randomized controlled trials on the investigated topic were found. Only eight papers regarding controlled clinical trials (CCT) were selected according to the search strategy selection criteria.

RESULTS:

According to the available literature and the authors’ experience, ULF-TENS seems to be a valid support in the management of TMD patients, but also a ‘provocative’ tool, so its application should always be monitored by electromyographic and electrognathographic analysis (before and after TENS).

CONCLUSIONS:

Further clinical studies (mainly randomized controlled trials) on ULF-TENS application in neuromuscular gnathology are needed.

4. George, JP, Boone, ME. A Clinical study of rest position using the Kinesiograph and Myomonitor. The Journal of Prosthetic Dentistry, 1979 Apr, 41(4):456-62

Abstract

The clinical study was designed to study the vertical dimension of rest position and mandibular closure to maximum intercuspation of the teeth before, during, and after relaxation procedures on 14 subjects with stable dentitions. The findings call attention to the potential of both the Myomonitor and the Kinesiograph for research and clinical use, to the physiologic need for flexibility of the vertical dimension of rest position, and to the importance of measuring all three dimensions when examining the rest position.

5. Kato, MT, Kogawa, EM, Santos, CN, Conti, PC. TENS and low-level laser therapy in the management of temporomandibular disorders. J Appl Oral Sci. 2006 Apr;14(2):130-5.

Abstract

Pain relief and reestablishment of normal jaw function are the main goals of conservative management of Temporomandibular Disorders (TMD). Transcutaneous electrical nerve stimulation (TENS) and laser therapy are part of these modalities, although little is known about their real efficacy in controlled studies. This research compared these two treatments in a sample of 18 patients with chronic TMD of muscular origin, divided into two groups (LASER and TENS). Treatment consisted of ten sessions, in a period of 30 days. Active range of motion (AROM), visual analogue scale (VAS) of pain and muscle (masseter and anterior temporalis) palpation were used for follow-up analysis. Data were analyzed by Friedman test and ANOVA for repeated measurements. Results showed decrease in pain and increase in AROM for both groups (p<0.05), and improvement in muscle tenderness for the LASER group. Authors concluded that both therapies are effective as part of TMD management and a cumulative effect may be responsible for the improvement. Caution is suggested when analyzing these results because of the self-limiting feature of musculoskeletal conditions like TMD.

6. Nunez, SC, Garcez, AS, Suzuki SS, Ribeiro, MS. Management of mouth opening in patients with temporomandibular disorders through low-level laser therapy and transcutaneous electrical neural stimulation. Photomed Laser Surg. 2006 Feb;24(1):45-9.

Abstract

OBJECTIVE:

The aim of this study was to evaluate the effectiveness of low-level laser therapy (LLLT) and transcutaneous electrical neural stimulation (TENS) on the improvement of mouth opening in patients with temporomandibular disorder (TMD).

BACKGROUND DATA:

TMDs are conditions that affect the form and/or function of the temporomandibular joint (TMJ), masticatory muscles, and dental apparatus. Often TMD is associated with pain localized in the TMJ and/or in the muscles of the face and neck.

METHODS:

This clinical trial was performed in 10 patients, 18-56 years old, diagnosed with TMD of multiple causes. All patients received both methods of treatment in two consecutive weeks. LLLT was delivered via a 670-nm diode laser, output power 50 mW, fluence 3 J per site/4 sites (masseter muscle, temporal muscle, mandibular condyle, and intrauricular). TENS therapy was applied with a two-electrode machine at 20 W, maximum frequency of 60 Hz, adjusted by the patient according to their sensitivity. The amplitude of mouth opening was recorded before treatment and immediately after using a millimeter rule; the measurements were performed from the incisal of the upper incisors to the incisal of the lower incisors. A paired t-test was applied to verify the significance of the results.

RESULTS:

A significant improvement in the range of motion for both therapies was observed immediately after treatment. Comparing the two methods, the values obtained after LLLT were significantly higher than those obtained after TENS (p < 0.01).

​CONCLUSIONS:

Both methods are effective to improve mouth opening. Comparing the two methods, LLLT was more effective than TENS applications.

7. Mahony, D. Re-establishing Physiologic Vertical Dimensionf or an Overclosed Patient . Orthodontic Journal of Nepal, Vol 4, No1 June 2014

Abstract

Overclosure is a common condition among patients seeking restorative and/or orthodontic rehabilitation. By evaluating the patient for common signs and symptoms associated with overclosure, one can determine the need for re-establishing a physiologic vertical dimension. Opening of the bite can be accomplished in a number of ways by following specific guidelines. The use of objective diagnostic aids are extremely helpful by allowing the clinician to optimize TMJ and craniofacial muscle function at the new VDO. The correction of the vertical dimension during a rehabilitative procedure should result in enhanced comfort and improved function in the finished case.

Summary Conclusion

The J5 Myomonitor has been established via the consensus of scientific literature to meet the current state of the art, as well as the safety, performance, design characteristics and intended purposes, with all claims supported via sufficient clinical evidence, gathered from comprehensive searches of medical journals and studies, conducted annually as part of post-market surveillance.

Essential requirements for safety and performance have been demonstrated both clinically and historically with sufficient clinical evidence, with 15 years of production of the J5 Dental TENS.