Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients

Study Overview
=================
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.

Official Title
-----------------
Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients BENEFIT Study

Conditions
-----------------
TMD

Intervention / Treatment
-----------------
* Device: Neuromuscular Bite (orthotic/sub-lingual)
* Procedure: Mandibular Physiotherapy
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Testing Bite device A
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual Physiotherapy<br>TMD patients will treat with orofacial physiotherapy by one expert operator according to literature | Procedure: Mandibular Physiotherapy<br>* 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.<br>|
| Active Comparator: Neuromuscular Bite<br>TMD patients will receive an intraoral neuromuscular bite according to literature | Device: Neuromuscular Bite (orthotic/sub-lingual)<br>* Bite is a device which simulates a set of properly positioned teeth<br>|
| Placebo Comparator: Placebo<br>TMD placebo group. | Other: Placebo<br>* No interventions.<br>|

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 |