Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients
NCT ID: NCT02946645
Last Updated: 2021-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2016-10-31
2020-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Manual Physiotherapy
TMD patients will treat with orofacial physiotherapy by one expert operator according to literature
Mandibular Physiotherapy
Mandibular Stabilisation Exercises
1. Place knuckle of index finger between top and bottom teeth.
2. Remove it, keeping the teeth separated one-knuckle apart.
3. Apply gentle pressure to the to the jaw using your index finger/thumb as demonstrated in the pictures above.
Neuromuscular Bite
TMD patients will receive an intraoral neuromuscular bite according to literature
Neuromuscular Bite (orthotic/sub-lingual)
Bite is a device which simulates a set of properly positioned teeth
Placebo
TMD placebo group.
Placebo
No interventions.
Interventions
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Neuromuscular Bite (orthotic/sub-lingual)
Bite is a device which simulates a set of properly positioned teeth
Mandibular Physiotherapy
Mandibular Stabilisation Exercises
1. Place knuckle of index finger between top and bottom teeth.
2. Remove it, keeping the teeth separated one-knuckle apart.
3. Apply gentle pressure to the to the jaw using your index finger/thumb as demonstrated in the pictures above.
Placebo
No interventions.
Eligibility Criteria
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Inclusion Criteria
* pain duration longer than 3 months;
* presence of complete permanent dentition, with the possible exception of the third molars;
* normal occlusion.
Exclusion Criteria
* presence of systemic or metabolic diseases;
* eye diseases or visual defects;
* history of local or general trauma;
* neurological or psychiatric disorders;
* muscular diseases;
* cervical pain;
* bruxism, as diagnosed by the presence of parafunctional facets and/or anamnesis of parafunctional tooth clenching and/or grinding;
* pregnancy;
* assumed use of anti-inflammatory, analgesic, anti-depressant, opioid, or myorelaxant - - drugs;
* smoking;
* fixed or removable prostheses;
* fixed restorations that affected the occlusal surfaces;
* and either previous or concurrent orthodontic or orthognathic treatment. For comparison with previous literature, the diagnosis of myofascial-type TMD was provided after clinical examination by a trained clinician according to group 1a and 1b of the Research Diagnostic Criteria for TMD (RDC/TMD), in a blinded manner
25 Years
45 Years
FEMALE
Yes
Sponsors
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University of L'Aquila
OTHER
Responsible Party
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Davide Pietropaoli
PI
Locations
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Dental Clinic, University of L'Aquila, St. Salvatore Hospital,
L’Aquila, , Italy
Countries
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References
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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.
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.
Molin C. From bite to mind: TMD--a personal and literature review. Int J Prosthodont. 1999 May-Jun;12(3):279-88.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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16137/24.05.2016
Identifier Type: -
Identifier Source: org_study_id
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