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

NCT05365932 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-05-09

No results posted yet for this study

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 the IAD on pain, psychosocial domain and Pressure Pain Threshold (PPT) of masticatory muscles in patients with TMD pain. Methods: Ten subjects with TMD pain and with pain intensity higher than 30 mm on a VAS scale were included in the study. Patients received the IAD and counselling. Assessments included questionnaires of the DC/TMD Axis II questionnaires (Characteristic Pain Index, Interference, Jaw Functional Limitation Scale, Patient Health Questionnaire 9, Patient Health Questionnaire 15, Generalized Anxiety Disorder scale, Oral Behavior Checklist and Oral Health Impact Profile-22, Axis I clinical examination and PPTs at baseline (T0), after one month (T1), three months (T2) and six months (T3) from the first use of the device. PPTs were measured at anterior temporalis muscles, masseter muscles and right thenar as a control site.The Shapiro-Wilk test was used for the normal distribution of data. The difference among the longitudinal timepoints for variable was analysed with ANOVA. Statistical significance was accepted at p \< 0.05.

Conditions

  • Temporomandibular Disorder
  • Pain
  • Psychosocial Impairment
  • Myofascial Pain

Interventions

DEVICE

Intra auricular device (IAD)

The Intra Auricular Device (IADs) are a pair of inconspicuous, custom fit auricular prosthetic devices.The ear inserts are manufactured using computer-aided design/computer-aided manufacturing (CAD/CAM) technology and are made from a liquid, photo-reactive acrylate (EShell 300), used in hearing aid shells and otoplastics for the last 10 years. They are designed to be placed into the outer third of the ear canals, and they have a small retraction post used to facilitate removal . A red or blue dot, respectively, indicates the right and the left side. The device do not interfere with hearing or speech

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-29
Primary Completion
2019-05-08
Completion
2019-12-10

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05365932 on ClinicalTrials.gov