Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients

NCT02946645 | Completed

• 1 other identifier: 16137/24.05.2016
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TMD

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Pain scale

  15 days

Study Arms (3)

Manual Physiotherapy

ACTIVE COMPARATOR

TMD patients will treat with orofacial physiotherapy by one expert operator according to literature

Procedure: Mandibular Physiotherapy

Neuromuscular Bite

ACTIVE COMPARATOR

TMD patients will receive an intraoral neuromuscular bite according to literature

Device: Neuromuscular Bite (orthotic/sub-lingual)

Placebo

PLACEBO COMPARATOR

TMD placebo group.

Other: Placebo

Interventions

Neuromuscular Bite (orthotic/sub-lingual) DEVICE

Bite is a device which simulates a set of properly positioned teeth

Neuromuscular Bite

Mandibular Physiotherapy PROCEDURE

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.

Manual Physiotherapy

Placebo OTHER

No interventions.

Placebo

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• myogenous TMD;
• pain duration longer than 3 months;
• presence of complete permanent dentition, with the possible exception of the third molars;
• normal occlusion.

You may not qualify if:

• Patients were excluded from the study if they met one or more of the following 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

Sponsors & Collaborators

• University of L'Aquila: lead

Study Sites (1)

Dental Clinic, University of L'Aquila, St. Salvatore Hospital,

L’Aquila, 67100, Italy

Location

Related Publications (12)

• 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.

  PMID: 23250156 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.

  PMID: 20438615 BACKGROUND

• Molin C. From bite to mind: TMD--a personal and literature review. Int J Prosthodont. 1999 May-Jun;12(3):279-88.

  PMID: 10635197 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.

  PMID: 16202040 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.

  PMID: 19089025 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.

  PMID: 9863432 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.

  PMID: 25000166 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.

  PMID: 9656890 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.

  PMID: 11902010 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.

  PMID: 21370770 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.

  PMID: 18468270 BACKGROUND

• 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.

  PMID: 31198477 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: Testing Bite device "A"

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: October 27, 2016
• Study Start: October 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: December 31, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)