Status:

COMPLETED

Evaluation of an Intra Auricular Device as a Treatment for Painful Temporo-Mandibular Disorders

Lead Sponsor:

Federico II University

Conditions:

Temporomandibular Disorder

Pain

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Background: An innovative, non-invasive, and reversible Intra Auricular Device (IAD) has recently been introduced to treat temporomandibular muscle and joint disorders.Aim: To evaluate the effects of ...

Detailed Description

The goal of ths study is to evaluate the effects of a new intra auricular device, the IAD, on pain, psychosocial domain and Pressure Pain Threshold (PPT) of facial muscles in patients with diagnosis o...

Eligibility Criteria

Inclusion

  • age \>18
  • TMD-pain diagnosed according to the DC/TMD (myalgia, myofascial pain, arthralgia, headache attributable to TMD)
  • disc displacement with reduction

Exclusion

  • disc displacement without reduction
  • intermittent locking
  • degenerative TMJ disorder
  • craniofacial anomaly
  • history of prior TMJ
  • orthognathic surgery
  • recent (within the past six months) trauma to the face or jaw
  • current, active orthodontic treatment
  • severe mental health disorder

Key Trial Info

Start Date :

November 29 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 10 2019

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT05365932

Start Date

November 29 2018

End Date

December 10 2019

Last Update

May 9 2022

Active Locations (1)

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Donnarumma Valeria

Afragola, Italy, 80021