Temporomandibular DisorderIADNCT05365932
Evaluation of an Intra Auricular Device as a Treatment for Painful Temporo-Mandibular Disorders
A study testing Intra auricular device (IAD) in people with Temporomandibular Disorder and Pain, run by Federico II University at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorder, Pain, Psychosocial Impairment
- What is being tested?
- Intra auricular device (IAD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 29 Nov 2018to 10 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18
- TMD-pain diagnosed according to the DC/TMD (myalgia, myofascial pain, arthralgia, headache attributable to TMD)
- disc displacement with reduction
Who cannot join
- disc displacement without reduction
- intermittent locking
- degenerative TMJ disorder
- craniofacial anomaly
- history of prior TMJ
- orthognathic surgery
Show all 9Show fewer
- recent (within the past six months) trauma to the face or jaw
- current, active orthodontic treatment
- severe mental health disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Longitudinal Study for the Evaluation of an Intra Auricular Device as a Treatment for Painful Temporo-Mandibular Disorders
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.
Read the 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
- Being tested
- Intra auricular device (IAD)
- Keywords
- Pressure Pain Threshold, Intra auricular device
- Medical subject headings
- Temporomandibular Joint Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra auricular device (IAD)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
| Study group | Role | What they receive |
|---|---|---|
| TMD Pain group | Experimental | 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 Receives: Device: Intra auricular device (IAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain (evaluated with Characteristic pain intensity scale)
This questionnaire is a valid instrument assessing pain intensity, numbers of days with interference and pain-related disability in the last month. The characteristic pain intensity score, which ranges from 0-100, is calculated as the mean intensity ratings for reported current, worst, and average pain
Measured: Six months from the first use of the device
Change of Pain evaluated with instrumental exam( Pain Pressure Threshold)
Pain Pressure Threshold were assessed by a single examiner at the anterior temporalis and masseter muscles (respectively TdxM; TsxM; MdxM; MsxM). An additional measurement was performed at the right thenar muscle (TenM) selected as a control muscular site.
Measured: Six months from the first use of the device
Psychosocial domain positive change
Evaluation of psychosocial positive change through psychosocial questionnaires.
Measured: Six months from the first use of the device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start29 Nov 2018
- Primary completion8 May 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valeria Donnarumma, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365932
- Sponsor's protocol ID
- 303/18
- Acronym
- IAD
- Status last verified
- May 2022
- First submitted
- 7 Mar 2022
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Longitudinal Study for the Evaluation of an Intra Auricular Device as a Treatment for Painful Temporo-Mandibular Disorders
- ClinicalTrials.gov ID
- NCT05365932
- Acronym / sponsor ID
- IAD / 303/18
- Keywords
- Pressure Pain Threshold, Intra auricular device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 8 May 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMD Pain group | Experimental | Device: Intra auricular device (IAD)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age >18
- TMD-pain diagnosed according to the DC/TMD (myalgia, myofascial pain, arthralgia, headache attributable to TMD)
- disc displacement with reduction
Key exclusion criteria (9 listed)
- disc displacement without reduction
- intermittent locking
- degenerative TMJ disorder
- craniofacial anomaly
- history of prior TMJ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | TMD Pain group |
Primary outcome
Change of Pain (evaluated with Characteristic pain intensity scale)
Time frame: Six months from the first use of the device
This questionnaire is a valid instrument assessing pain intensity, numbers of days with interference and pain-related disability in the last month. The characteristic pain intensity score, which ranges from 0-100, is calculated as the mean intensity ratings for reported current, worst, and average pain
Change of Pain evaluated with instrumental exam( Pain Pressure Threshold)
Time frame: Six months from the first use of the device
Pain Pressure Threshold were assessed by a single examiner at the anterior temporalis and masseter muscles (respectively TdxM; TsxM; MdxM; MsxM). An additional measurement was performed at the right thenar muscle (TenM) selected as a control muscular site.
Psychosocial domain positive change
Time frame: Six months from the first use of the device
Evaluation of psychosocial positive change through psychosocial questionnaires.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra auricular device (IAD) in people with Temporomandibular Disorder and Pain, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pain (evaluated with Characteristic pain intensity scale) (time frame: Six months from the first use of the device). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.