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Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients

Efficiency of Neuromuscular Bite vs Physiotherapy in TMD Patients BENEFIT Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02946645
Acronym
BENEFIT
Enrollment
63
Registered
2016-10-27
Start date
2016-10-31
Completion date
2020-12-31
Last updated
2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TMD

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.

Interventions

DEVICENeuromuscular Bite (orthotic/sub-lingual)

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

PROCEDUREMandibular Physiotherapy

Mandibular Stabilisation Exercises 1. Place knuckle of index finger between top and bottom teeth. 2. Remove it, keeping the teeth separated one-knuckle apart. 3. Apply gentle pressure to the to the jaw using your index finger/thumb as demonstrated in the pictures above.

OTHERPlacebo

No interventions.

Sponsors

University of L'Aquila
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Testing Bite device A

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Surface electromiography of cranial muscles (sEMG)Average of 1 yearEvaluation of surface electromiography of cranial muscles (expressed in microvolts)
Mandibular kinesiography (KNG)Average of 1 yearEvaluation of mandibular kinetics (expressed in millimeters/seconds)

Secondary

MeasureTime frameDescription
Pain scale15 daysEvaluation of subjective pain perception by Visual Analog Scale (expressed in unit)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026