Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients

Not Applicable

Completed

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

• Registration Number: NCT02946645
• Lead Sponsor: University of L'Aquila

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Primary Completion: 2018-07
• Study Completion: 2020-12-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neuromuscular Bite	Neuromuscular Bite (orthotic/sub-lingual)	TMD patients will receive an intraoral neuromuscular bite according to literature
Manual Physiotherapy	Mandibular Physiotherapy	TMD patients will treat with orofacial physiotherapy by one expert operator according to literature
Placebo	Placebo	TMD placebo group.

Primary Outcome Measures

Name	Time	Method
Mandibular kinesiography (KNG)	Average of 1 year	Evaluation of mandibular kinetics (expressed in millimeters/seconds)
Surface electromiography of cranial muscles (sEMG)	Average of 1 year	Evaluation of surface electromiography of cranial muscles (expressed in microvolts)

Secondary Outcome Measures

Name	Time	Method
Pain scale	15 days	Evaluation of subjective pain perception by Visual Analog Scale (expressed in unit)

Trial Locations

Locations (1)

Dental Clinic, University of L'Aquila, St. Salvatore Hospital,; 🇮🇹 L'Aquila, Italy