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Completed

NCT Number: NCT02946645

Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients

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.

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Key information

Conditions

TMD

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

L’Aquila, 67100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular Bite (orthotic/sub-lingual)

Device

Bite is a device which simulates a set of properly positioned teeth

Mandibular Physiotherapy

Procedure

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.

Placebo

Other

No interventions.

Primary outcomes

  1. Surface electromiography of cranial muscles (sEMG)

    Time frame: Average of 1 year

    Evaluation of surface electromiography of cranial muscles (expressed in microvolts)

  2. Mandibular kinesiography (KNG)

    Time frame: Average of 1 year

    Evaluation of mandibular kinetics (expressed in millimeters/seconds)

Secondary outcomes

  1. Pain scale

    Time frame: 15 days

    Evaluation of subjective pain perception by Visual Analog Scale (expressed in unit)

Sponsors and collaborators

Lead sponsor

University of L'Aquila

Other

Registry information

Official study title

Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients BENEFIT Study

Acronym: BENEFIT

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Oct 27, 2016
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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