Clinical trial NCT02946645: Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients
Official title: Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients BENEFIT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TMD
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 63
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Testing Bite device "A"
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Surface electromiography of cranial muscles (sEMG)
timeFrame: Average of 1 year
measure: Mandibular kinesiography (KNG)
timeFrame: Average of 1 year
Secondary outcomes:
measure: Pain scale
timeFrame: 15 days
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: Dental Clinic, University of L'Aquila, St. Salvatore Hospital,
Study officials:
References:
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