TinnitusTMDTINNCT04434859
Temporomandibular Disorders Among Patients With Tinnitus
An observational study of Tinnitus and Temporomandibular Disorder, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The incidence of temporomandibular disorders will be studied among patients with tinnitus, by the use of patient's history and physical examination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Temporomandibular Disorder
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 30 Jun 2021
- Phase
- Observational
- 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
Study population: Patients with tinnitus lasting more than 3 months
Who may be able to join
- Tinnitus lasting more than 3 months
Who cannot join
- Head and Neck Space Occupying Lesion
- Previous degenerative disease of the temporomandibular koint
About this study
Official title: Incidence of Temporomandibular Disorders Among Patients With Tinnitus
The incidence of temporomandibular disorders will be studied among patients with tinnitus, by the use of patient's history and physical examination.
Read the detailed description
The patients with tinnituswill be asked about symptoms related to temporomandibular disorders, and also will be examined in order to diagnose such disorders.
- Conditions
- Tinnitus, Temporomandibular Disorder
- Being tested
- No intervention
- Medical subject headings
- Tinnitus, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with tinnitus | Patients (over 18 years old) seen at the medical center due to tinnitus, lasting at least 3 months. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of temporomandibular disorders in the patient's history
A questioannaire asking specifically about pain in the tempromandibular joint, headaches, clicks, tempromandibular joint locking and dislocation
Measured: 1 year
Positive findings in the physical examination of the temporomandibular joint and muscles
The following parameters will be documented: clicks, maximal opening of the mouth, signs of teeth grinding, tenderness on the mastication muscles
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434859
- Sponsor's protocol ID
- 256-20
- Acronym
- TMDTIN
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Temporomandibular Disorders Among Patients With Tinnitus
- ClinicalTrials.gov ID
- NCT04434859
- Acronym / sponsor ID
- TMDTIN / 256-20
- Conditions
- Tinnitus, Temporomandibular Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 17 Jun 2020 (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.
The incidence of temporomandibular disorders will be studied among patients with tinnitus, by the use of patient's history and physical examination.
Detailed description
The patients with tinnituswill be asked about symptoms related to temporomandibular disorders, and also will be examined in order to diagnose such disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with tinnitus | – | Other: No interventionPatients (over 18 years old) seen at the medical center due to tinnitus, lasting at least 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tinnitus lasting more than 3 months
Key inclusion criteria (1 listed)
- Tinnitus lasting more than 3 months
Key exclusion criteria (2 listed)
- Head and Neck Space Occupying Lesion
- Previous degenerative disease of the temporomandibular koint
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 |
|---|---|---|
| No interventionNo intervention | Other | Patients with tinnitus |
Primary outcome
Description of temporomandibular disorders in the patient's history
Time frame: 1 year
A questioannaire asking specifically about pain in the tempromandibular joint, headaches, clicks, tempromandibular joint locking and dislocation
Positive findings in the physical examination of the temporomandibular joint and muscles
Time frame: 1 year
The following parameters will be documented: clicks, maximal opening of the mouth, signs of teeth grinding, tenderness on the mastication muscles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus and Temporomandibular Disorder, run by Tel-Aviv Sourasky Medical Center.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Description of temporomandibular disorders in the patient's history (time frame: 1 year). The study lists 2 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 17 Jun 2020.