Temporomandibular Joint DisordersNCT04277052
Investigation of Masseter and Temporalis Muscles Sections in Individuals With Temporomandibular Disorders
A study testing Determination muscles sections by Ultrasonography in people with Temporomandibular Joint Disorders, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to examine masseter and temporal muscle sections with Ultrasonography in this individuals depending on the origin of Temporomandibular Disorders. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Determination muscles sections by Ultrasonography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2019to 1 Dec 2022
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a temporomandibular disorder,
- Individuals who suited Temporomandibular Disorders/ Research Diagnostic Criteria classification
Who cannot join
- Pregnant,
- Canser,
- Trauma,
- Neurologic disorder,
- Infection,
- Trigeminal or postherpatic neuralgia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Halime ARIKAN
Ankara, Yenimahalle, 06560
Halime ARIKAN, MSc, 05465765132, halimearikan92@hotmail.com
Seyit ÇITAKER, Prof. Dr., 05336212449, scitaker@gazi.edu.tr
About this study
The aim of the study is to examine masseter and temporal muscle sections with Ultrasonography in this individuals depending on the origin of Temporomandibular Disorders.
Read the detailed description
Multidirectional evaluations are needed to examine the symptoms of Temporomandibular Disorders (TMD). Physical examination, questionnaires towards symptoms, and imaging techniques provide objective data on pathology. The chewing muscles should also be evaluated in this way and the approaches to be followed in subsequent processes should be determined. It is known that muscle sections are changed in TMD, which develops due to muscle disorders. However, regardless of the origin of TMD chewing muscles are affected depending on the condition.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Determination muscles sections by Ultrasonography
- Keywords
- Temporomandibular Joint Disorders, Ultrasonography, Cross sectional
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination muscles sections by UltrasonographyDevice
Determination muscles sections by Ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Muscle disorders Receives: Device: Determination muscles sections by Ultrasonography |
| Group 2 | Experimental | Disc displacements Receives: Device: Determination muscles sections by Ultrasonography |
| Group 3 | Experimental | Other common joint disorders Receives: Device: Determination muscles sections by Ultrasonography |
| Group 4 | Experimental | Mix type Receives: Device: Determination muscles sections by Ultrasonography |
| Group 5 | Experimental | Healthy individuals Receives: Device: Determination muscles sections by Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the thickness of the masseter and temporalis muscles sections by Ultrasonography and the changes in the biomechanical properties of the masticatory muscles in individuals with temporomandibular disorders.
US has been described as an accurate and reliable imaging technique to assess the thickness and cross-sectional area of the chewing muscles and to determine changes in the local cross-sectional dimensions of the head and neck muscles in livings. It allows large-scale long-term studies of changes in the thickness of the jaw muscles during the development associated with changes in the biomechanical properties of the masticatory muscles.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Apr 2019
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
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.
- More trials run by Gazi 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime ARIKAN, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277052
- Sponsor's protocol ID
- 2019-112
- Status last verified
- Jan 2021
- First submitted
- 16 Feb 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Masseter and Temporalis Muscles Sections in Individuals With Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT04277052
- Acronym / sponsor ID
- 2019-112
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Temporomandibular Joint Disorders, Ultrasonography, Cross sectional
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 20 Feb 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 aim of the study is to examine masseter and temporal muscle sections with Ultrasonography in this individuals depending on the origin of Temporomandibular Disorders.
Detailed description
Multidirectional evaluations are needed to examine the symptoms of Temporomandibular Disorders (TMD). Physical examination, questionnaires towards symptoms, and imaging techniques provide objective data on pathology. The chewing muscles should also be evaluated in this way and the approaches to be followed in subsequent processes should be determined. It is known that muscle sections are changed in TMD, which develops due to muscle disorders. However, regardless of the origin of TMD chewing muscles are affected depending on the condition.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Determination muscles sections by UltrasonographyMuscle disorders |
| Group 2 | Experimental | Device: Determination muscles sections by UltrasonographyDisc displacements |
| Group 3 | Experimental | Device: Determination muscles sections by UltrasonographyOther common joint disorders |
| Group 4 | Experimental | Device: Determination muscles sections by UltrasonographyMix type |
| Group 5 | Experimental | Device: Determination muscles sections by UltrasonographyHealthy individuals |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Having a temporomandibular disorder,
- Individuals who suited Temporomandibular Disorders/ Research Diagnostic Criteria classification
Key exclusion criteria (6 listed)
- Pregnant,
- Canser,
- Trauma,
- Neurologic disorder,
- Infection,
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 |
|---|---|---|
| Determination muscles sections by UltrasonographyDetermination muscles sections by Ultrasonography | Device | Group 1, Group 2, Group 3, Group 4, Group 5 |
Primary outcome
Determination of the thickness of the masseter and temporalis muscles sections by Ultrasonography and the changes in the biomechanical properties of the masticatory muscles in individuals with temporomandibular disorders.
Time frame: Day 1
US has been described as an accurate and reliable imaging technique to assess the thickness and cross-sectional area of the chewing muscles and to determine changes in the local cross-sectional dimensions of the head and neck muscles in livings. It allows large-scale long-term studies of changes in the thickness of the jaw muscles during the development associated with changes in the biomechanical properties of the masticatory muscles.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: Yes
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Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Determination muscles sections by Ultrasonography in people with Temporomandibular Joint Disorders, run by Gazi University at 1 site 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 6 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 5 Jan 2021. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the thickness of the masseter and temporalis muscles sections by Ultrasonography and the changes in the biomechanical properties of the masticatory muscles in individuals with temporomandibular disorders. (time frame: Day 1). 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 5 Jan 2021.