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Temporomandibular joint dysfunction (TMD) therapy remains an open challenge for modern dentistry. Usually physiotherapy is considered a reliable approach to treatment of TMD patients. Moreover, neuromuscular bites (orthotic) are able to reduce signs and symptoms of TMD. To our knowledge, no specific trials have been designed for the evaluation of the efficiency of physiotherapy vs neuromuscular bites in TMD patients.
The aim of this trial is to evaluate the efficiency in term of cranial muscles electromyography (sEMG), mandibular kinetic (KNG) and subjective pain scores, of orthotic vs manual physiotherapy therapy compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual Physiotherapy | Active Comparator | TMD patients will treat with orofacial physiotherapy by one expert operator according to literature |
|
| Neuromuscular Bite | Active Comparator | TMD patients will receive an intraoral neuromuscular bite according to literature |
|
| Placebo | Placebo Comparator | TMD placebo group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular Bite (orthotic/sub-lingual) | Device | Bite is a device which simulates a set of properly positioned teeth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surface electromiography of cranial muscles (sEMG) | Evaluation of surface electromiography of cranial muscles (expressed in microvolts) | Average of 1 year |
| Mandibular kinesiography (KNG) | Evaluation of mandibular kinetics (expressed in millimeters/seconds) | Average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scale | Evaluation of subjective pain perception by Visual Analog Scale (expressed in unit) | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
Patients were excluded from the study if they met one or more of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental Clinic, University of L'Aquila, St. Salvatore Hospital, | L’Aquila | 67100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23250156 | Background | de Toledo EG Jr, Silva DP, de Toledo JA, Salgado IO. The interrelationship between dentistry and physiotherapy in the treatment of temporomandibular disorders. J Contemp Dent Pract. 2012 Sep 1;13(5):579-83. | |
| 20438615 | Background | List T, Axelsson S. Management of TMD: evidence from systematic reviews and meta-analyses. J Oral Rehabil. 2010 May;37(6):430-51. doi: 10.1111/j.1365-2842.2010.02089.x. Epub 2010 Apr 20. |
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Testing Bite device "A"
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| Mandibular Physiotherapy | Procedure | Mandibular Stabilisation Exercises
|
|
| Placebo | Other | No interventions. |
|
| 10635197 | Background | Molin C. From bite to mind: TMD--a personal and literature review. Int J Prosthodont. 1999 May-Jun;12(3):279-88. |
| 16202040 | Background | Michelotti A, de Wijer A, Steenks M, Farella M. Home-exercise regimes for the management of non-specific temporomandibular disorders. J Oral Rehabil. 2005 Nov;32(11):779-85. doi: 10.1111/j.1365-2842.2005.01513.x. |
| 19089025 | Background | Capellini VK, de Souza GS, de Faria CR. Massage therapy in the management of myogenic TMD: a pilot study. J Appl Oral Sci. 2006 Jan;14(1):21-6. doi: 10.1590/s1678-77572006000100005. |
| 9863432 | Background | Ash MM Jr, Ramfjord SP. Reflections on the Michigan splint and other intraocclusal devices. J Mich Dent Assoc. 1998 Oct;80(8):32-5, 41-6. |
| 25000166 | Background | Yamashita A, Kondo Y, Yamashita J. Thirty-year follow-up of a TMD case treated based on the neuromuscular concept. Cranio. 2014 Jul;32(3):224-34. doi: 10.1179/0886963413Z.00000000020. Epub 2014 Jan 24. |
| 9656890 | Background | Di Fabio RP. Physical therapy for patients with TMD: a descriptive study of treatment, disability, and health status. J Orofac Pain. 1998 Spring;12(2):124-35. |
| 11902010 | Background | Starnes LO. A bite orthotic for the resting period between two phases of treatment. J Clin Orthod. 2002 Feb;36(2):92-4. No abstract available. |
| 21370770 | Background | Heit T. Neuromuscular orthotics in the treatment of craniomandibular dysfunction and the effects on patients with multiple sclerosis: a pilot study. Cranio. 2011 Jan;29(1):57-70. doi: 10.1179/crn.2011.009. |
| 18468270 | Background | Cooper BC, Kleinberg I. Establishment of a temporomandibular physiological state with neuromuscular orthosis treatment affects reduction of TMD symptoms in 313 patients. Cranio. 2008 Apr;26(2):104-17. doi: 10.1179/crn.2008.015. |
| 31198477 | Result | Pietropaoli D, Cooper BC, Ortu E, Monaco A; I.A.P.N.O.R.. A Device Improves Signs and Symptoms of TMD. Pain Res Manag. 2019 May 6;2019:5646143. doi: 10.1155/2019/5646143. eCollection 2019. |