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

University of L'Aquila

Status: Completed

Conditions: TMD

Treatments: Device: Neuromuscular Bite (orthotic/sub-lingual); Procedure: Mandibular Physiotherapy; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02946645

16137/24.05.2016

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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63 participants in 3 patient groups, including a placebo group

Manual Physiotherapy

Active Comparator group

Description:

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

Treatment:

Procedure: Mandibular Physiotherapy

Neuromuscular Bite

Active Comparator group

Description:

TMD patients will receive an intraoral neuromuscular bite according to literature

Treatment:

Device: Neuromuscular Bite (orthotic/sub-lingual)

Placebo

Placebo Comparator group

Description:

TMD placebo group.

Treatment:

Other: Placebo