HemiplegiaNCT07698184
The Condition of the Temporomandibular Joint in Hemiplegia
An observational study of Hemiplegia and Temporomandibular Disorder (TMD), run by Ayşe Ukbe Baykut at 1 site in Turkey (Türkiye).
Trial summary
Stroke is one of the leading causes of acquired disability worldwide and frequently results in medical complications and long-term sequelae. Depending on the size of the lesions and the cerebral structures affected, sensory, motor, and cognitive impairments, as well as sensory-motor deficits related to the… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Hemiplegia, Temporomandibular Disorder (TMD)
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2026to 15 Jul 2026
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stroke patients
Who may be able to join
- Patients who have had a stroke Ages 18-95 Those who agreed to participate in the study
Who cannot join
- Patients who have previously received treatment for jaw problems
- Those who have undergone jaw surgery
- Those whose jaw area has been affected by trauma
- Those who declined to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
About this study
Official title: Bilateral Temporomandibular Joint Assessment and Its Relationship With Clinical Parameters in Patients Who Develop Stroke Following a Cerebrovascular Event.
Stroke is one of the leading causes of acquired disability worldwide and frequently results in medical complications and long-term sequelae. Depending on the size of the lesions and the cerebral structures affected, sensory, motor, and cognitive impairments, as well as sensory-motor deficits related to the stomatognathic system, may be present after a stroke. The stomatognathic system is a functional complex comprised of structures located in the oral and craniofacial cavities, including skeletal components, head and neck muscles, ligaments, soft tissues, the temporomandibular joint, dental arches, salivary glands, and masticatory muscles. Understanding stomatognathic system disorders is crucial for early diagnosis and implementing rehabilitation approaches to promote functional recovery. Ultrasonography is a widely available, low-cost, non-invasive, and safe medical imaging method that provides real-time observation. It offers several advantages for dentomaxillofacial imaging, including portability, dynamic and repeatable examination capabilities, patient comfort, and accessibility. It is a useful tool in identifying various pathological processes such as temporomandibular joint structures, articular disc displacement, joint effusion, and cortical erosion. There are few studies in the literature specifically on jaw disorders in stroke. The literature is quite limited in examining the jaw structure, muscles, and ligaments, as well as investigating the effect of chewing function on the clinical picture. The investigators aimed to evaluate the temporomandibular joint and chewing function in patients who developed stroke following a cerebrovascular event, and to investigate their relationship with clinical parameters.
Read the detailed description
Stroke is one of the leading causes of acquired disability worldwide and frequently leads to medical complications and long-term sequelae. Depending on the size of the lesions and the cerebral structures affected, sensory, motor, and cognitive impairments, along with sensory-motor deficits related to the stomatognathic system, may be present after stroke . These patients may develop reduced biting force, stomatognathic disorders related to chewing quality, bruxism, joint clicking, and other temporomandibular joint disorders, which can profoundly affect their swallowing, chewing, and phonation functions, and consequently their quality of life .
The stomatognathic system is a functional complex composed of structures located in the oral and craniofacial spaces, including skeletal components, head and neck muscles, ligaments, soft tissues, the temporomandibular joint, dental arches, salivary glands, and masticatory muscles. Understanding stomatognathic system disorders is crucial for early diagnosis and implementing rehabilitation approaches to support functional recovery . Diagnosis of temporomandibular joint disorders is usually based on medical history and physical examination. During the examination, attention is paid to temporomandibular joint (TMJ) range of motion, jaw sounds, and mandibular deviations. If there are suspicious findings in the anamnesis and physical evaluation, diagnostic tools such as computed tomography and magnetic resonance imaging can be used . Ultrasonography is a widely available, low-cost, non-invasive, and safe medical imaging method that provides real-time observation. It offers several advantages for dentomaxillofacial imaging, such as portability, dynamic and repeatable examination possibilities, patient comfort, and accessibility. It is a useful tool in identifying different pathological processes such as temporomandibular joint structures, joint disc displacement, joint effusion, and cortical erosion .
There are few studies in the literature, particularly regarding jaw disorders in stroke. The literature examining the jaw structure, muscles, and ligaments, as well as investigating the effect of chewing function on the clinical picture, is quite limited. The investigators aimed to evaluate temporomandibular joint and masticatory function in patients who developed stroke following a cerebrovascular event, and to investigate its relationship with clinical parameters.
The investigators aims to improve the quality of life and rehabilitation of participants by examining all areas of rehabilitation, including sensory, motor, and cognitive aspects, as well as evaluating their jaw function, particularly swallowing, in our stroke rehabilitation clinic. It is anticipated that this will enable steps towards early diagnosis and prevention.
- Conditions
- Hemiplegia, Temporomandibular Disorder (TMD)
- Keywords
- hemiplegia, Temporomandibular Joint Disorders
- Medical subject headings
- Hemiplegia, Temporomandibular Joint Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
temporomandibular joint disc thickness,
Bilateral temporomandibular joint ultrasound measurement: Participants were asked to keep their mouths closed, and then images of the right and left joint areas were taken. The joint space between the condyle and the fossa was measured.
Measured: Baseline
Secondary outcomes (3)
Ultrasound measurement of temporal muscle thickness
Ultrasound images of the right and left temporal muscle regions were taken and their thickness measured while the participants were at rest with their mouths closed.
Measured: Baseline
Ultrasound measurement of masseter muscle thickness.
Ultrasound images of the right and left masseter muscle regions were taken and their thickness measured while the participants were at rest with their mouths closed.
Measured: Baseline
mouth opening measurements
Mouth opening measurements were taken with a plastic millimeter ruler.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start2 Jan 2026
- Primary completion7 Jul 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayşe Ukbe Baykut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayşe Ukbe Baykut, Ankara City Hospital Bilkent
- Investigators
- Ayşe U Baykut, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698184
- Sponsor's protocol ID
- ACHBİLKENTAUBAYKUT004
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No decision has been made yet
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Temporomandibular Joint Assessment and Its Relationship With Clinical Parameters in Patients Who Develop Stroke Following a Cerebrovascular Event.
- ClinicalTrials.gov ID
- NCT07698184
- Acronym / sponsor ID
- ACHBİLKENTAUBAYKUT004
- Conditions
- Hemiplegia, Temporomandibular Disorder (TMD)
- Keywords
- hemiplegia, Temporomandibular Joint Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ayşe Ukbe BaykutUniversity, hospital or other
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 13 Jul 2026 (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.
Stroke is one of the leading causes of acquired disability worldwide and frequently results in medical complications and long-term sequelae. Depending on the size of the lesions and the cerebral structures affected, sensory, motor, and cognitive impairments, as well as sensory-motor deficits related to the stomatognathic system, may be present after a stroke. The stomatognathic system is a functional complex comprised of structures located in the oral and craniofacial cavities, including skeletal components, head and neck muscles, ligaments, soft tissues, the temporomandibular joint, dental arches, salivary glands, and masticatory muscles. Understanding stomatognathic system disorders is crucial for early diagnosis and implementing rehabilitation approaches to promote functional recovery. Ultrasonography is a widely available, low-cost, non-invasive, and safe medical imaging method that provides real-time observation. It offers several advantages for dentomaxillofacial imaging, including portability, dynamic and repeatable examination capabilities, patient comfort, and accessibility. It is a useful tool in identifying various pathological processes such as temporomandibular joint structures, articular disc displacement, joint effusion, and cortical erosion. There are few studies in the literature specifically on jaw disorders in stroke. The literature is quite limited in examining the jaw structure, muscles, and ligaments, as well as investigating the effect of chewing function on the clinical picture. The investigators aimed to evaluate the temporomandibular joint and chewing function in patients who developed stroke following a cerebrovascular event, and to investigate their relationship with clinical parameters.
Detailed description
Stroke is one of the leading causes of acquired disability worldwide and frequently leads to medical complications and long-term sequelae. Depending on the size of the lesions and the cerebral structures affected, sensory, motor, and cognitive impairments, along with sensory-motor deficits related to the stomatognathic system, may be present after stroke . These patients may develop reduced biting force, stomatognathic disorders related to chewing quality, bruxism, joint clicking, and other temporomandibular joint disorders, which can profoundly affect their swallowing, chewing, and phonation functions, and consequently their quality of life .
The stomatognathic system is a functional complex composed of structures located in the oral and craniofacial spaces, including skeletal components, head and neck muscles, ligaments, soft tissues, the temporomandibular joint, dental arches, salivary glands, and masticatory muscles. Understanding stomatognathic system disorders is crucial for early diagnosis and implementing rehabilitation approaches to support functional recovery . Diagnosis of temporomandibular joint disorders is usually based on medical history and physical examination. During the examination, attention is paid to temporomandibular joint (TMJ) range of motion, jaw sounds, and mandibular deviations. If there are suspicious findings in the anamnesis and physical evaluation, diagnostic tools such as computed tomography and magnetic resonance imaging can be used . Ultrasonography is a widely available, low-cost, non-invasive, and safe medical imaging method that provides real-time observation. It offers several advantages for dentomaxillofacial imaging, such as portability, dynamic and repeatable examination possibilities, patient comfort, and accessibility. It is a useful tool in identifying different pathological processes such as temporomandibular joint structures, joint disc displacement, joint effusion, and cortical erosion .
There are few studies in the literature, particularly regarding jaw disorders in stroke. The literature examining the jaw structure, muscles, and ligaments, as well as investigating the effect of chewing function on the clinical picture, is quite limited. The investigators aimed to evaluate temporomandibular joint and masticatory function in patients who developed stroke following a cerebrovascular event, and to investigate its relationship with clinical parameters.
The investigators aims to improve the quality of life and rehabilitation of participants by examining all areas of rehabilitation, including sensory, motor, and cognitive aspects, as well as evaluating their jaw function, particularly swallowing, in our stroke rehabilitation clinic. It is anticipated that this will enable steps towards early diagnosis and prevention.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stroke patients
Key inclusion criteria (1 listed)
- Patients who have had a stroke Ages 18-95 Those who agreed to participate in the study
Key exclusion criteria (4 listed)
- Patients who have previously received treatment for jaw problems
- Those who have undergone jaw surgery
- Those whose jaw area has been affected by trauma
- Those who declined to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
temporomandibular joint disc thickness,
Time frame: Baseline
Bilateral temporomandibular joint ultrasound measurement: Participants were asked to keep their mouths closed, and then images of the right and left joint areas were taken. The joint space between the condyle and the fossa was measured.
3 secondary outcomes
Ultrasound measurement of temporal muscle thickness
Time frame: Baseline
Ultrasound measurement of masseter muscle thickness.
Time frame: Baseline
mouth opening measurements
Time frame: Baseline
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 25 Aug 2026.
- Individual participant dataSharing planned: Undecided. No decision has been made yet
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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.
Ayşe U Baykut principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemiplegia and Temporomandibular Disorder (TMD), run by Ayşe Ukbe Baykut 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 1 inclusion and 4 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 25 Aug 2026. 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?
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?
temporomandibular joint disc thickness, (time frame: Baseline). 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 25 Aug 2026.