Temporomandibular DysfunctionNCT05572541
Temporomandibular Joint Dysfunction in Patients With Traumatic Brain Injury
An observational study of Temporomandibular Dysfunction, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Trauma, neurological disorders and psychological problems, which are the etiological factors of temporomandibular joint dysfunction, can be seen in patients with traumatic brain injury. The aim of this study is to investigate temporomandibular joint dysfunction in patients with traumatic brain injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Dysfunction
- What is being tested?
- Fonseca questionnaire
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2022to 1 Apr 2023
- 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
- Adult, Older adult
Study population: 30 Patient with traumatic brain injury 30 healthy volunteer
Who may be able to join
- clinical diagnosis of traumatic brain injury not receiving treatment for temporomandibular joint dysfunction
Who cannot join
- communication and cooperation problems, congenital or systemic disease affecting the head and neck region, being treated for TMED and having a history of orthognathic surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya Beyhekim Research and Training Hospital
Konya, Selçuklu, 42060
Savaş Karpuz, 05552057860, svskrpz@hotmail.com
Ramazan YIlmaz, MD
About this study
Official title: Assessment of Temporomandibular Joint Dysfunction in Patients With Traumatic Brain Injury
Trauma, neurological disorders and psychological problems, which are the etiological factors of temporomandibular joint dysfunction, can be seen in patients with traumatic brain injury.
The aim of this study is to investigate temporomandibular joint dysfunction in patients with traumatic brain injury.
Participants (traumatic brain injury patients and healthy volunteers) will be evaluated once for temporomandibular joint dysfunction.
Read the detailed description
Temporomandibular joint range of motion, Fonseca questionnaire, facial asymmetry, and massater and temporal pain threshold will be evaluated by measuring both TBI patients and healthy individuals. In addition, post-injury dietary intake and dominant chewing side will be questioned in TBI patients. Temporomandibular movements will be measured with a disposable cardboard ruler.
Exclusion criteria; communication and cooperation problems, congenital or systemic disease affecting the head and neck region, being treated for TMED and having a history of orthognathic surgery.
- Conditions
- Temporomandibular Dysfunction
- Being tested
- Fonseca questionnaire
- Keywords
- Temporomandibular Dysfunction,, traumatic brain injury, headache
- Medical subject headings
- Temporomandibular Joint Disorders, Brain Injuries, Traumatic, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fonseca questionnaireDiagnostic test
Also called Joint range of motion measurement,, pressure pain threshold measurement
Fonseca questionnaire for the evaluation of temporomandibular dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Patients with traumatic brain injury | Temporomandibular joint range of motion, Fonseca questionnaire, facial asymmetry, and massater and temporal pain threshold will be evaluated by measuring both TBI patients and healthy individuals. In addition, post-injury dietary intake and dominant chewing side will be questioned in TBI patients. Temporomandibular movements will be measured with a disposable cardboard ruler. Receives: Diagnostic Test: Fonseca questionnaire | |
| healthy volunteers | Temporomandibular joint range of motion, Fonseca questionnaire, facial asymmetry, and massater and temporal pain threshold will be evaluated by measuring both TBI patients and healthy individuals. Temporomandibular movements will be measured with a disposable cardboard ruler. Receives: Diagnostic Test: Fonseca questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of temporomandibular joint dysfunction in patients with traumatic brain injury
Measured: 01.11.2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start5 Nov 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DysfunctionStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Savaş Karpuz, Konya Beyhekim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572541
- Sponsor's protocol ID
- 2022-01-04
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share if requested.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Temporomandibular Joint Dysfunction in Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05572541
- Acronym / sponsor ID
- 2022-01-04
- Conditions
- Temporomandibular Dysfunction
- Keywords
- Temporomandibular Dysfunction,, traumatic brain injury, headache
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 5 Nov 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 7 Oct 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.
Trauma, neurological disorders and psychological problems, which are the etiological factors of temporomandibular joint dysfunction, can be seen in patients with traumatic brain injury.
The aim of this study is to investigate temporomandibular joint dysfunction in patients with traumatic brain injury.
Participants (traumatic brain injury patients and healthy volunteers) will be evaluated once for temporomandibular joint dysfunction.
Detailed description
Temporomandibular joint range of motion, Fonseca questionnaire, facial asymmetry, and massater and temporal pain threshold will be evaluated by measuring both TBI patients and healthy individuals. In addition, post-injury dietary intake and dominant chewing side will be questioned in TBI patients. Temporomandibular movements will be measured with a disposable cardboard ruler.
Exclusion criteria; communication and cooperation problems, congenital or systemic disease affecting the head and neck region, being treated for TMED and having a history of orthognathic surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with traumatic brain injury | – | Diagnostic Test: Fonseca questionnaireTemporomandibular joint range of motion, Fonseca questionnaire, facial asymmetry, and massater and temporal pain threshold will be evaluated by measuring both TBI patients and healthy individuals. In addition, post-injury dietary intake and dominant chewing side will be questioned in TBI patients. Temporomandibular movements will be measured with a disposable cardboard ruler. |
| healthy volunteers | – | Diagnostic Test: Fonseca questionnaireTemporomandibular joint range of motion, Fonseca questionnaire, facial asymmetry, and massater and temporal pain threshold will be evaluated by measuring both TBI patients and healthy individuals. Temporomandibular movements will be measured with a disposable cardboard ruler. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 30 Patient with traumatic brain injury 30 healthy volunteer
Key inclusion criteria (1 listed)
- clinical diagnosis of traumatic brain injury not receiving treatment for temporomandibular joint dysfunction
Key exclusion criteria (1 listed)
- communication and cooperation problems, congenital or systemic disease affecting the head and neck region, being treated for TMED and having a history of orthognathic surgery.
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 |
|---|---|---|
| Fonseca questionnaireAlso: Joint range of motion measurement,, pressure pain threshold measurementFonseca questionnaire for the evaluation of temporomandibular dysfunction | Diagnostic test | Patients with traumatic brain injury, healthy volunteers |
Primary outcome
Frequency of temporomandibular joint dysfunction in patients with traumatic brain injury
Time frame: 01.11.2022
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: Undecided. We will share if requested.
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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?
An observational study of Temporomandibular Dysfunction, run by Konya Beyhekim Training and Research Hospital 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 1 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 26 Oct 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 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?
Contact Savaş Karpuz (+905552057860, svskrpz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of temporomandibular joint dysfunction in patients with traumatic brain injury (time frame: 01.11.2022). 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 26 Oct 2022.