Temporomandibular Joint DisordersNCT05402228
Investigation of the Aural Symptoms and Dizziness in Patients With Temporomandibular Joint Disorders
An observational study of Temporomandibular Joint Disorders and Dizziness, run by Kanuni Sultan Suleyman Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
120 male and female patients aged between 18-65 years who apply to the outpatient clinic and diagnosed with TMD will be included in the study. Patients will be divided into 3 groups as Muscle Disorders (Group 1), Temporomandibular Joint Disorders (Group 2) and degenerative joint diseas (osteoarthrosis) (Group 3)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Dizziness, Tinnitus
- What is being tested?
- temporomandbular joint disorders
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 27 Mar 2022to 15 Jun 2022
- How long will I take part?
- 1 Day
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: participants aged 18-65 years with TMD
Who may be able to join
- being 18-65 years of age
- diagnosed with TMD
Who cannot join
- Lack of cognitive ability to understand test instructions, illliteracy, aphasia, presence of a known psychiatric illness
- Patients under the age of 18 and over the age of 65
- Having another systemic disease that will cause TMD (cancer, rheumatological diseases)
- Presence of disease that will increase a anotherural symptoms or cause d d (presence of disease of vertigo, history of vertigo)
- Presence of a history of cervical pain, cervical spondylosis, cervical disc herniation
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Kucukcekmece, 34303
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Kucukcekmece, 34307
About this study
120 male and female patients aged between 18-65 years who apply to the outpatient clinic and diagnosed with TMD will be included in the study. Patients will be divided into 3 groups as Muscle Disorders (Group 1), Temporomandibular Joint Disorders (Group 2) and degenerative joint diseas (osteoarthrosis) (Group 3) according to DC/TMD axis I diagnostic criteria.
maximum mouth opening, TMJ sound, pain levels, tinnitus, and dizziness are evaluated.
Read the detailed description
120 male and female patients aged between 18-65 years who apply to the outpatient clinic and diagnosed with TMD will be included in the study. Patients will be divided into 3 groups as Muscle Disorders (Group 1), Temporomandibular Joint Disorders (Group 2) and degenerative joint diseas (osteoarthrosis) (Group 3) according to DC/TMD axis I diagnostic criteria.
Demographic data of all patients participating in the study will be obtained. Then, physical examination will reveal maximum mouth opening, right and left lateral movement, deflexion, deviation. Accompanying tinnitus, ear fullness and dizziness will be questioned.
All measurements, including maximum mouth opening, and physical examination will be performed with patients sitting upright in an anatomical position in a chair. All measurements will be performed by the same physical therapist with 7 years of experience in TMD.
In the measurement of maximum mouth opening, patients will be asked to open their mouths as wide as possible. The distance between the anterior incisors is measured with the help of a ruler suitable for millimeter measurement. Maximum mouth opening distance is a physical examination method frequently used to determine the motion and function of the jaw joint. Functional mouth opening is accepted as 35-40 mm (12).
For the evaluation of TMJ sound, the TMJ is palpated with the thumb and middle fingers and the sound heard when opening and closing the mesh is noted.
Pain levels are measured using a 10-point visual analog scale (VAS). The presence of bruxism is determined on physical examination based on the presence of abnormal tooth wear, tooth marks in the buccal region, tooth marks on the tongue, and hypertrophy of the masseter muscle.
The sense of fullness in the ear, tinnitus, and dizzyness, which the patients reported themselves, is questioned. The relationship between having TMD, clinical characteristics and dizziness will be evaluated.
- Conditions
- Temporomandibular Joint Disorders, Dizziness, Tinnitus
- Being tested
- temporomandbular joint disorders
- Keywords
- temporomandibular joint, dizziness, aural sypmtoms, tinnitus
- Medical subject headings
- Temporomandibular Joint Disorders, Dizziness, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temporomandbular joint disordersDiagnostic test
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum mouth opening
maximum mouth opening
Measured: 1 day
right and left lateral movement, deflexion, and deviation
right and left lateral movement, deflexion, and deviation
Measured: 1 day
TMJ sound
the TMJis palpated with the thumb and middle fingers and the sound heard when opening and closing the mesh was noted.
Measured: 1 day
visual analog scale
It is use for evaluate the pain intensity.
Measured: 1 day
Secondary outcomes (2)
bruxism
it is determined on physical examination based on the presence of abnormal tooth wear, tooth marks in the buccal region, tooth marks on the tongue, and hypertrophy of the masseter muscle.
Measured: 1 day
the presence of bruxism, tinnitus and dizzeness
the presence of bruxism, tinnitus and dizzeness
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start27 Mar 2022
- Primary completion1 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kirsehir Ahi Evran Universitesi
- Responsible party
- Principal investigator, Merve Damla Korkmaz, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402228
- Sponsor's protocol ID
- KAEK/2022.03.55
- Status last verified
- Jul 2022
- First submitted
- 28 May 2022
- Last updated
- 13 Jul 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 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Aural Symptoms and Dizziness in Patients With Temporomandibular Joint Disorders
- ClinicalTrials.gov ID
- NCT05402228
- Acronym / sponsor ID
- KAEK/2022.03.55
- Conditions
- Temporomandibular Joint Disorders, Dizziness, Tinnitus
- Keywords
- temporomandibular joint, dizziness, aural sypmtoms, tinnitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Collaborators
- Kirsehir Ahi Evran Universitesi
- Study start
- 27 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 2 Jun 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.
120 male and female patients aged between 18-65 years who apply to the outpatient clinic and diagnosed with TMD will be included in the study. Patients will be divided into 3 groups as Muscle Disorders (Group 1), Temporomandibular Joint Disorders (Group 2) and degenerative joint diseas (osteoarthrosis) (Group 3) according to DC/TMD axis I diagnostic criteria.
maximum mouth opening, TMJ sound, pain levels, tinnitus, and dizziness are evaluated.
Detailed description
120 male and female patients aged between 18-65 years who apply to the outpatient clinic and diagnosed with TMD will be included in the study. Patients will be divided into 3 groups as Muscle Disorders (Group 1), Temporomandibular Joint Disorders (Group 2) and degenerative joint diseas (osteoarthrosis) (Group 3) according to DC/TMD axis I diagnostic criteria.
Demographic data of all patients participating in the study will be obtained. Then, physical examination will reveal maximum mouth opening, right and left lateral movement, deflexion, deviation. Accompanying tinnitus, ear fullness and dizziness will be questioned.
All measurements, including maximum mouth opening, and physical examination will be performed with patients sitting upright in an anatomical position in a chair. All measurements will be performed by the same physical therapist with 7 years of experience in TMD.
In the measurement of maximum mouth opening, patients will be asked to open their mouths as wide as possible. The distance between the anterior incisors is measured with the help of a ruler suitable for millimeter measurement. Maximum mouth opening distance is a physical examination method frequently used to determine the motion and function of the jaw joint. Functional mouth opening is accepted as 35-40 mm (12).
For the evaluation of TMJ sound, the TMJ is palpated with the thumb and middle fingers and the sound heard when opening and closing the mesh is noted.
Pain levels are measured using a 10-point visual analog scale (VAS). The presence of bruxism is determined on physical examination based on the presence of abnormal tooth wear, tooth marks in the buccal region, tooth marks on the tongue, and hypertrophy of the masseter muscle.
The sense of fullness in the ear, tinnitus, and dizzyness, which the patients reported themselves, is questioned. The relationship between having TMD, clinical characteristics and dizziness will be evaluated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- participants aged 18-65 years with TMD
Key inclusion criteria (2 listed)
- being 18-65 years of age
- diagnosed with TMD
Key exclusion criteria (5 listed)
- Lack of cognitive ability to understand test instructions, illliteracy, aphasia, presence of a known psychiatric illness
- Patients under the age of 18 and over the age of 65
- Having another systemic disease that will cause TMD (cancer, rheumatological diseases)
- Presence of disease that will increase a anotherural symptoms or cause d d (presence of disease of vertigo, history of vertigo)
- Presence of a history of cervical pain, cervical spondylosis, cervical disc herniation
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 |
|---|---|---|
| temporomandbular joint disordersno intervention | Diagnostic test | – |
Primary outcome
maximum mouth opening
Time frame: 1 day
maximum mouth opening
right and left lateral movement, deflexion, and deviation
Time frame: 1 day
right and left lateral movement, deflexion, and deviation
TMJ sound
Time frame: 1 day
the TMJis palpated with the thumb and middle fingers and the sound heard when opening and closing the mesh was noted.
visual analog scale
Time frame: 1 day
It is use for evaluate the pain intensity.
2 secondary outcomes
bruxism
Time frame: 1 day
the presence of bruxism, tinnitus and dizzeness
Time frame: 1 day
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 13 Jul 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Disorders and Dizziness, run by Kanuni Sultan Suleyman Training and Research Hospital at 2 sites in Turkey (Türkiye).
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 2 inclusion and 5 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 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
maximum mouth opening (time frame: 1 day). The study lists 4 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 13 Jul 2022.