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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02946645
Other study ID # 16137/24.05.2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date December 31, 2020

Study information

Verified date April 2021
Source University of L'Aquila
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Neuromuscular Bite (orthotic/sub-lingual)
Bite is a device which simulates a set of properly positioned teeth
Procedure:
Mandibular Physiotherapy
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.
Other:
Placebo
No interventions.

Locations

Country Name City State
Italy Dental Clinic, University of L'Aquila, St. Salvatore Hospital, L'Aquila

Sponsors (1)

Lead Sponsor Collaborator
University of L'Aquila

Country where clinical trial is conducted

Italy, 

References & Publications (12)

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Outcome

Type Measure Description Time frame Safety issue
Primary Surface electromiography of cranial muscles (sEMG) Evaluation of surface electromiography of cranial muscles (expressed in microvolts) Average of 1 year
Primary Mandibular kinesiography (KNG) Evaluation of mandibular kinetics (expressed in millimeters/seconds) Average of 1 year
Secondary Pain scale Evaluation of subjective pain perception by Visual Analog Scale (expressed in unit) 15 days
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