Ankylosing SpondylitisNCT05839925
Prevalence of Temporomandibular Joint Dysfunction in Patients With Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study included 113 patients diagnosed with ankylosing spondylitis and 110 healthy volunteers. Participants in both groups were evaluated using the 'Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)' diagnostic criteria. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I and II
- How many people
- 223 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Apr 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 113 patients with ankylosing spondylitis were diagnosed and 110 healthy volunteers.
Who may be able to join
- Patients diagnosed with Ankylosing Spondylitis according to the Modified New York Criteria between the ages of 18-75.
- Healthy volunteers between the ages of 18 and 75.
Who cannot join
- Changes in the treatment of ankylosing spondylitis within the last 6 months
- Patients with pathology related to the temporomandibular joint and associated structures prior to the diagnosis of ankylosing spondylitis
- Use of medication that affects bone metabolism
- Presence of neurological or cognitive deficits
- History of trauma, malignancy, infection, and surgery in the head and neck area
- Presence of dental or periodontal pain
- History of orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Istanbul
About this study
Official title: Prevalence of Temporomandibular Joint Dysfunction in Patients With Ankylosing Spondylitis and Comparison of the Findings With Healthy Controls
This study included 113 patients diagnosed with ankylosing spondylitis and 110 healthy volunteers. Participants in both groups were evaluated using the 'Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)' diagnostic criteria. In addition, the relationship between temporomandibular joint dysfunction and disease activity was investigated in patients with ankylosing spondylitis.
Read the detailed description
Ankylosing spondylitis (AS) is a chronic, inflammatory disease with an unknown etiology that primarily affects the axial spine, especially the sacroiliac joints, and can also involve peripheral joints and extra-articular clinical manifestations. Complaints related to temporomandibular joint pathologies are commonly observed in the general population but more frequent in the group of patients diagnosed with ankylosing spondylitis compared to the average population. Although the mechanism of temporomandibular joint involvement in ankylosing spondylitis is not fully understood, destruction of the joint capsule or disk, synovitis in the joint, and craniovertebral postural changes have been suggested as possible mechanisms. In addition, pain due to temporomandibular joint dysfunction can significantly affect daily life activities, quality of life, social participation, and the emotional status of the individual. Determining the level of relationship between quality of life and psychological status will support the development of new interventions and treatment approaches to improve patient's quality of life further.
The age, gender, body mass index, marital status, duration of ankylosing spondylitis (AS) diagnosis, symptom onset, treatment for AS, occupation, smoking status, and Human Leukocyte Antigen (HLA)-B27 positivity status were recorded for the patient. The 'Diagnostic Criteria for Temporomandibular Disorders (DC/TMD),' published in 2014 and translated into Turkish in 2016, was used to assess the presence of temporomandibular joint dysfunction in the patients. This evaluation system consists of two parts: the clinical evaluation and examination findings of the current pathology on Axis I, and the psychosocial status of the disease on Axis II. The questions in the Symptom Questionnaire on the first axis were directed to the patient, and then the results were recorded by performing the examinations indicated on the examination form. The diagnosis was determined according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) decision tree, and marked on the examination form. Two groups were created based on the decision tree: pain and joint disorders. Pain disorders were further subdivided into muscle pain, joint pain, and TMD-related headaches; muscle pain was further subdivided into local muscle pain, muscle-fascial pain, and referred muscle-fascial pain subgroups. Joint disorders were classified as disc displacement with reduction, disc displacement with reduction-intermittent locking, disc displacement without reduction-limited mouth opening, disc displacement without reduction-limited mouth opening, degenerative joint disease, and dislocation.
On Axis II, the patients were asked to mark the areas where they felt pain on the pain drawing form. The marked area was divided into categories according to its size. The level of experienced pain was evaluated with the Graded Chronic Pain Scale (GCPS), jaw function limitations were assessed with the Jaw Functional Limitation Scale-20 (JFLS-20), depression was evaluated with the Patient Health Questionnaire-9 (PHQ-9), anxiety was assessed with the General Anxiety Disorder 7 (GAD-7), physical symptoms were evaluated with the Patient Health Questionnaire-15 (PHQ-15), and parafunctional activities were evaluated with the Oral Behavior Checklist (OBC). Additionally, the relationship between the identified diagnosis and psychosocial factors, disease activity, and other disease-specific factors was investigated.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I and II
- Keywords
- Ankylosing Spondylitis, Temporomandibular Joint Disorders, Temporomandibular Disorders, TMJ, Spondyloarthropathy
- Medical subject headings
- Spondylitis, Ankylosing, Temporomandibular Joint Disorders, Spondylarthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I and IIDiagnostic test
The presence of temporomandibular joint dysfunction was evaluated using the diagnostic criteria for temporomandibular disorders (DC/TMD).
| Study group | Role | What they receive |
|---|---|---|
| Ankylosing spondylitis group | The patients were selected on a randomized form among the patients with a diagnosis of AS according to the modified New York criteria who referred to Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Receives: Diagnostic Test: Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I and II | |
| Healthy volunteers | Healthy volunteers between the ages of 18-75 were selected randomly. Receives: Diagnostic Test: Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I and II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I Symptom questionnaire
The presence of temporomandibular joint dysfunction will be evaluated using the The questionnaire that investigates temporomandibular region pain and characteristics, joint sounds, and headache was used.
Measured: A single point in time (1 day)
Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I Clinical Examination Form questionnaire
Clinical Examination form assesses the site of pain, incisal relationships, mouth opening position, mouth opening and closing movements, lateral and protrusive movements, jaw noise, joint locking, and evaluation of muscle and joint pain by palpation.
Measured: A single point in time (1 day)
Secondary outcomes (10)
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was used to assess the disease activity.
Measured: A single point in time (1 day)
Bath Ankylosing Spondylitis Functional Index (BASFI)
Bath Ankylosing Spondylitis Functional Index (BASFI) is a tool used to assess the functional ability of patients with ankylosing spondylitis. It includes questions about the patient's ability to perform daily activities such as dressing, grooming, standing, and bending.
Measured: A single point in time (1 day)
The Bath Ankylosing Spondylitis Metrology Index (BASMI)
The Bath Ankylosing Spondylitis Metrology Index (BASMI) was used to assess spinal mobility. The Bath Ankylosing Spondylitis Metrology Index (BASMI) includes measurements of tragus-to-wall distance, intermalleolar distance, modified Schober's test, lateral flexion, and cervical rotation.
Measured: A single point in time (1 day)
DC/TMD Axis II-Pain Drawing questionnaire
Pain Drawing which assesses pain location and spread.
Measured: A single point in time (1 day)
DC/TMD Axis II-Patient Health Questionnaire-9 (PHQ-9)
Patient Health Questionnaire-9 (PHQ-9), which assesses depressed mood state.
Measured: A single point in time (1 day)
DC/TMD Axis II- Oral Behaviors Checklist (OBC)
Oral Behaviors Checklist (OBC), which assesses parafunctional behaviors
Measured: A single point in time (1 day)
DC/TMD Axis II-Jaw Functional Limitation Scale-20 (JFLS-20)
Jaw Functional Limitation Scale-20 (JFLS-20) , which assesses limitation of mastication, mobility and verbal end emotional expressions.
Measured: A single point in time (1 day)
DC/TMD Axis II-Patient Health Questionnaire-15 (PHQ-15)
Patient Health Questionnaire-15, which assesses non-specific physical symptoms
Measured: A single point in time (1 day)
DC/TMD Axis II-Graded Chronic Pain Scale; GCPS v2.0
Graded Chronic Pain Scale (GCPS) is a tool used to assess the severity and impact of chronic pain on a person's life. It involves rating the intensity of pain, as well as how much pain interferes with daily activities and quality of life.
Measured: A single point in time (1 day)
DC/TMD Axis II- General Anxiety Disorder 7 (GAD-7)
The General Anxiety Disorder 7 (GAD-7) is a brief self-report questionnaire that is used to assess the severity of generalized anxiety disorder
Measured: A single point in time (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Apr 2022
- Primary completion1 Jul 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies 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
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fatma Nur Kesiktaş, Prof, Study director, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839925
- Sponsor's protocol ID
- IstanbulPRMTRH
- Status last verified
- Feb 2024
- First submitted
- 21 Apr 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bilgin E, Bilgin E, Ozdemir O, Kalyoncu U. Temporomandibular disorders in ankylosing spondylitis: a cross-sectional, monocentric study. Rheumatol Int. 2020 Jun;40(6):933-940. doi: 10.1007/s00296-020-04563-y. Epub 2020 Apr 1.
PubMed 32239320Braun J, Sieper J. Ankylosing spondylitis. Lancet. 2007 Apr 21;369(9570):1379-1390. doi: 10.1016/S0140-6736(07)60635-7.
PubMed 17448825Huang YF, Chang CT, Muo CH, Chiu KM, Tsai CH, Liu SP. Bidirectional relationship between temporomandibular disorder and ankylosing spondylitis: a population-based cohort study. Clin Oral Investig. 2021 Nov;25(11):6377-6384. doi: 10.1007/s00784-021-03938-0. Epub 2021 Apr 14.
PubMed 33855657Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17.
PubMed 19297344Souza RC, de Sousa ET, Sousa D, Sales M, Dos Santos Oliveira R, Mariano MH, Rushansky E, Amorim Gomes AC, Silva E. Prevalence of Temporomandibular Joint Disorders in Patients with Ankylosing Spondylitis: A Cross-Sectional Study. Clin Cosmet Investig Dent. 2021 Nov 11;13:469-478. doi: 10.2147/CCIDE.S320537. eCollection 2021.
PubMed 34795532Ahisha BS, Kesiktas FN. Prevalence of temporomandibular joint dysfunction in patients with ankylosing spondylitis and comparison of the findings with healthy controls. Rev Assoc Med Bras (1992). 2024 Sep 30;70(10):e20240807. doi: 10.1590/1806-9282.20240807. eCollection 2024.
PubMed 39356963
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Temporomandibular Joint Dysfunction in Patients With Ankylosing Spondylitis and Comparison of the Findings With Healthy Controls
- ClinicalTrials.gov ID
- NCT05839925
- Acronym / sponsor ID
- IstanbulPRMTRH
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis, Temporomandibular Joint Disorders, Temporomandibular Disorders, TMJ, Spondyloarthropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 3 May 2023 (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.
This study included 113 patients diagnosed with ankylosing spondylitis and 110 healthy volunteers. Participants in both groups were evaluated using the 'Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)' diagnostic criteria. In addition, the relationship between temporomandibular joint dysfunction and disease activity was investigated in patients with ankylosing spondylitis.
Detailed description
Ankylosing spondylitis (AS) is a chronic, inflammatory disease with an unknown etiology that primarily affects the axial spine, especially the sacroiliac joints, and can also involve peripheral joints and extra-articular clinical manifestations. Complaints related to temporomandibular joint pathologies are commonly observed in the general population but more frequent in the group of patients diagnosed with ankylosing spondylitis compared to the average population. Although the mechanism of temporomandibular joint involvement in ankylosing spondylitis is not fully understood, destruction of the joint capsule or disk, synovitis in the joint, and craniovertebral postural changes have been suggested as possible mechanisms. In addition, pain due to temporomandibular joint dysfunction can significantly affect daily life activities, quality of life, social participation, and the emotional status of the individual. Determining the level of relationship between quality of life and psychological status will support the development of new interventions and treatment approaches to improve patient's quality of life further.
The age, gender, body mass index, marital status, duration of ankylosing spondylitis (AS) diagnosis, symptom onset, treatment for AS, occupation, smoking status, and Human Leukocyte Antigen (HLA)-B27 positivity status were recorded for the patient. The 'Diagnostic Criteria for Temporomandibular Disorders (DC/TMD),' published in 2014 and translated into Turkish in 2016, was used to assess the presence of temporomandibular joint dysfunction in the patients. This evaluation system consists of two parts: the clinical evaluation and examination findings of the current pathology on Axis I, and the psychosocial status of the disease on Axis II. The questions in the Symptom Questionnaire on the first axis were directed to the patient, and then the results were recorded by performing the examinations indicated on the examination form. The diagnosis was determined according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) decision tree, and marked on the examination form. Two groups were created based on the decision tree: pain and joint disorders. Pain disorders were further subdivided into muscle pain, joint pain, and TMD-related headaches; muscle pain was further subdivided into local muscle pain, muscle-fascial pain, and referred muscle-fascial pain subgroups. Joint disorders were classified as disc displacement with reduction, disc displacement with reduction-intermittent locking, disc displacement without reduction-limited mouth opening, disc displacement without reduction-limited mouth opening, degenerative joint disease, and dislocation.
On Axis II, the patients were asked to mark the areas where they felt pain on the pain drawing form. The marked area was divided into categories according to its size. The level of experienced pain was evaluated with the Graded Chronic Pain Scale (GCPS), jaw function limitations were assessed with the Jaw Functional Limitation Scale-20 (JFLS-20), depression was evaluated with the Patient Health Questionnaire-9 (PHQ-9), anxiety was assessed with the General Anxiety Disorder 7 (GAD-7), physical symptoms were evaluated with the Patient Health Questionnaire-15 (PHQ-15), and parafunctional activities were evaluated with the Oral Behavior Checklist (OBC). Additionally, the relationship between the identified diagnosis and psychosocial factors, disease activity, and other disease-specific factors was investigated.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankylosing spondylitis group | – | Diagnostic Test: Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I and IIThe patients were selected on a randomized form among the patients with a diagnosis of AS according to the modified New York criteria who referred to Istanbul Physical Medicine Rehabilitation Training and Research Hospital. |
| Healthy volunteers | – | Diagnostic Test: Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I and IIHealthy volunteers between the ages of 18-75 were selected randomly. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 113 patients with ankylosing spondylitis were diagnosed and 110 healthy volunteers.
Key inclusion criteria (2 listed)
- Patients diagnosed with Ankylosing Spondylitis according to the Modified New York Criteria between the ages of 18-75.
- Healthy volunteers between the ages of 18 and 75.
Key exclusion criteria (7 listed)
- Changes in the treatment of ankylosing spondylitis within the last 6 months
- Patients with pathology related to the temporomandibular joint and associated structures prior to the diagnosis of ankylosing spondylitis
- Use of medication that affects bone metabolism
- Presence of neurological or cognitive deficits
- History of trauma, malignancy, infection, and surgery in the head and neck area
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 |
|---|---|---|
| Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I and IIThe presence of temporomandibular joint dysfunction was evaluated using the diagnostic criteria for temporomandibular disorders (DC/TMD). | Diagnostic test | Ankylosing spondylitis group, Healthy volunteers |
Primary outcome
Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I Symptom questionnaire
Time frame: A single point in time (1 day)
The presence of temporomandibular joint dysfunction will be evaluated using the The questionnaire that investigates temporomandibular region pain and characteristics, joint sounds, and headache was used.
Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I Clinical Examination Form questionnaire
Time frame: A single point in time (1 day)
Clinical Examination form assesses the site of pain, incisal relationships, mouth opening position, mouth opening and closing movements, lateral and protrusive movements, jaw noise, joint locking, and evaluation of muscle and joint pain by palpation.
10 secondary outcomes
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: A single point in time (1 day)
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: A single point in time (1 day)
The Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: A single point in time (1 day)
DC/TMD Axis II-Pain Drawing questionnaire
Time frame: A single point in time (1 day)
DC/TMD Axis II-Patient Health Questionnaire-9 (PHQ-9)
Time frame: A single point in time (1 day)
DC/TMD Axis II- Oral Behaviors Checklist (OBC)
Time frame: A single point in time (1 day)
DC/TMD Axis II-Jaw Functional Limitation Scale-20 (JFLS-20)
Time frame: A single point in time (1 day)
DC/TMD Axis II-Patient Health Questionnaire-15 (PHQ-15)
Time frame: A single point in time (1 day)
DC/TMD Axis II-Graded Chronic Pain Scale; GCPS v2.0
Time frame: A single point in time (1 day)
DC/TMD Axis II- General Anxiety Disorder 7 (GAD-7)
Time frame: A single point in time (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 20 Feb 2024.
- Background: PubMed 32239320Bilgin E, Bilgin E, Ozdemir O, Kalyoncu U. Temporomandibular disorders in ankylosing spondylitis: a cross-sectional, monocentric study. Rheumatol Int. 2020 Jun;40(6):933-940. doi: 10.1007/s00296-020-04563-y. Epub 2020 Apr 1.
- Background: PubMed 17448825Braun J, Sieper J. Ankylosing spondylitis. Lancet. 2007 Apr 21;369(9570):1379-1390. doi: 10.1016/S0140-6736(07)60635-7.
- Background: PubMed 33855657Huang YF, Chang CT, Muo CH, Chiu KM, Tsai CH, Liu SP. Bidirectional relationship between temporomandibular disorder and ankylosing spondylitis: a population-based cohort study. Clin Oral Investig. 2021 Nov;25(11):6377-6384. doi: 10.1007/s00784-021-03938-0. Epub 2021 Apr 14.
- Background: PubMed 19297344Rudwaleit M, van der Heijde D, Landewe R, Listing J, Akkoc N, Brandt J, Braun J, Chou CT, Collantes-Estevez E, Dougados M, Huang F, Gu J, Khan MA, Kirazli Y, Maksymowych WP, Mielants H, Sorensen IJ, Ozgocmen S, Roussou E, Valle-Onate R, Weber U, Wei J, Sieper J. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009 Jun;68(6):777-83. doi: 10.1136/ard.2009.108233. Epub 2009 Mar 17.
- Background: PubMed 34795532Souza RC, de Sousa ET, Sousa D, Sales M, Dos Santos Oliveira R, Mariano MH, Rushansky E, Amorim Gomes AC, Silva E. Prevalence of Temporomandibular Joint Disorders in Patients with Ankylosing Spondylitis: A Cross-Sectional Study. Clin Cosmet Investig Dent. 2021 Nov 11;13:469-478. doi: 10.2147/CCIDE.S320537. eCollection 2021.
- Derived from this study: PubMed 39356963Ahisha BS, Kesiktas FN. Prevalence of temporomandibular joint dysfunction in patients with ankylosing spondylitis and comparison of the findings with healthy controls. Rev Assoc Med Bras (1992). 2024 Sep 30;70(10):e20240807. doi: 10.1590/1806-9282.20240807. eCollection 2024.
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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.
Fatma Nur Kesiktaş, Prof study director
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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 Ankylosing Spondylitis, run by Istanbul Physical Medicine Rehabilitation 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 2 inclusion and 7 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 20 Feb 2024. 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?
Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I Symptom questionnaire (time frame: A single point in time (1 day)). 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?
On the ClinicalTrials.gov record for NCT05839925, which also lists 6 linked publications.
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 20 Feb 2024.