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

NCT ID: NCT05365932

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-29
• Study Completion Date: 2019-12-10

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 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.

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 of TMD pain according to the Diagnostic Criteria of Temporomandibular Disorders

Conditions

Temporomandibular Disorder; Pain; Psychosocial Impairment; Myofascial Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TMD Pain group

Arm included patients with TMD Pain intensity \>3 on a VAS scale and with diagnosis of myofascial pain, either alone or in combination with arthralgia, headache attributable to TMD or with disc displacement with reduction. Participants had to be 18 years of age or older. All subjects had to wear the device for 6 months and it should not be used for more than 23 hours in a 24-hour period

Group Type: EXPERIMENTAL

Intra auricular device (IAD)

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Valeria Donnarumma

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Donnarumma Valeria

Afragola, , Italy

Countries

Italy

Other Identifiers

303/18

Identifier Type: -

Identifier Source: org_study_id