Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients (BENEFIT)

Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients BENEFIT Study

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.

Study Overview

• Status: Completed
• Conditions: TMD
• Intervention / Treatment: Procedure: Mandibular Physiotherapy; Device: Neuromuscular Bite (orthotic/sub-lingual); Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • L'Aquila, Italy, 67100
    • Dental Clinic, University of L'Aquila, St. Salvatore Hospital,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manual Physiotherapy; TMD patients will treat with orofacial physiotherapy by one expert operator according to literature	Procedure: Mandibular Physiotherapy; Mandibular Stabilisation Exercises; Place knuckle of index finger between top and bottom teeth.; Remove it, keeping the teeth separated one-knuckle apart.; Apply gentle pressure to the to the jaw using your index finger/thumb as demonstrated in the pictures above.
Active Comparator: Neuromuscular Bite; TMD patients will receive an intraoral neuromuscular bite according to literature	Device: Neuromuscular Bite (orthotic/sub-lingual); Bite is a device which simulates a set of properly positioned teeth
Placebo Comparator: Placebo; TMD placebo group.	Other: Placebo; No interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scale	Evaluation of subjective pain perception by Visual Analog Scale (expressed in unit)	15 days

Collaborators and Investigators

• Sponsor: University of L'Aquila

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: Pain Res Manag. 2020 Apr 17;2020:9465080.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 25, 2016
• First Posted (Estimate): October 27, 2016

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 16137/24.05.2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No