Sjogren SyndromeSjögrenNCT07248306
Temporomandibular Joint Dysfunction in Sjögren's Syndrome
An observational study of Sjogren Syndrome, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Study Purpose The purpose of this observational study is to determine the prevalence of temporomandibular dysfunction (TMD) in individuals diagnosed with Sjögren's syndrome and to examine the relationship between disease activity and TMD. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Sjogren Syndrome
- What is being tested?
- Temporomandibular Joint Function
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 15 Sep 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with Sjögren's Syndrome
-Inclusion Criteria Individuals between 18 and 65 years of age. Must have a confirmed diagnosis of Sjögren's Syndrome. Must possess the mental capacity and education to understand the significance of the research.
Must be volunteers willing to participate in the study.
-Exclusion Criteria Incomplete questionnaires/scales. History of orthodontic treatment within the last six months. Presence of neurological or cognitive deficit. Patients with a history of pathology related to the temporomandibular joint (TMJ) and associated structures prior to the diagnosis of Sjögren's Syndrome.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Pamukkale, Denizli, 20000
About this study
Official title: Investigation of Temporomandibular Joint Function and Related Factors in Patients With Primary Sjögren's Syndrome
Study Purpose The purpose of this observational study is to determine the prevalence of temporomandibular dysfunction (TMD) in individuals diagnosed with Sjögren's syndrome and to examine the relationship between disease activity and TMD.
The main question to be answered is: Is TMD more common in individuals with Sjögren's syndrome, and is there a relationship between disease activity and TMD?
Method Participants diagnosed with Sjögren's syndrome will be evaluated. The prevalence and severity of TMD will be examined along with mouth opening, head posture, and oral health parameters.
- Conditions
- Sjogren Syndrome
- Being tested
- Temporomandibular Joint Function
- Keywords
- Sjogren syndrome, temporamandibular joint
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporomandibular Joint FunctionDiagnostic test
Temporomandibular joint function and predictive parameters in patients with primary Sjögren Syndrome (pSS)
| Study group | Role | What they receive |
|---|---|---|
| Group I | patients with primary Sjögren syndrome (pSS) Receives: Diagnostic Test: Temporomandibular Joint Function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fonseca Anamnestic Index (FAI)
Assesses the severity of TMD. As the score increases, the TMD severity (none, mild, moderate, severe) worsens. (0-15: None, 20-45: Mild, 50-65: Moderate, 70-100: Severe)
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
Evaluates disease activity. A high score (5 and above) indicates high disease activity. (The higher the average score, the more severe the symptoms of fatigue, pain, and dryness.)
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Secondary outcomes (3)
Xerostomia Inventory
Measures the severity of dry mouth (xerostomia) symptoms. A higher score indicates more severe xerostomia symptoms.
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Oral Health-Related Quality of Life - UK Scale
Assesses oral health-related quality of life. An increase in score generally indicates a greater deterioration in quality of life (i.e., worse oral health impact).
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Visual Analog Scale (VAS) for Disease Involvement
Numerically evaluates the severity of specific symptoms like dry mouth, dry eyes, facial skin dryness, and lip dryness. As the score approaches 10, the severity of dryness reaches its highest level.
Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start15 May 2025
- Primary completion15 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren SyndromeStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begüm AKAR, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248306
- Sponsor's protocol ID
- Pamukkale U
- Other IDs
- Pamukkale University
- Acronym
- Sjögren
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Temporomandibular Joint Function and Related Factors in Patients With Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT07248306
- Acronym / sponsor ID
- Sjögren / Pamukkale U
- Conditions
- Sjogren Syndrome
- Keywords
- Sjogren syndrome, temporamandibular joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 25 Nov 2025 (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.
Study Purpose The purpose of this observational study is to determine the prevalence of temporomandibular dysfunction (TMD) in individuals diagnosed with Sjögren's syndrome and to examine the relationship between disease activity and TMD.
The main question to be answered is: Is TMD more common in individuals with Sjögren's syndrome, and is there a relationship between disease activity and TMD?
Method Participants diagnosed with Sjögren's syndrome will be evaluated. The prevalence and severity of TMD will be examined along with mouth opening, head posture, and oral health parameters.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: Temporomandibular Joint Functionpatients with primary Sjögren syndrome (pSS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with Sjögren's Syndrome
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 |
|---|---|---|
| Temporomandibular Joint FunctionTemporomandibular joint function and predictive parameters in patients with primary Sjögren Syndrome (pSS) | Diagnostic test | Group I |
Primary outcome
Fonseca Anamnestic Index (FAI)
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Assesses the severity of TMD. As the score increases, the TMD severity (none, mild, moderate, severe) worsens. (0-15: None, 20-45: Mild, 50-65: Moderate, 70-100: Severe)
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Evaluates disease activity. A high score (5 and above) indicates high disease activity. (The higher the average score, the more severe the symptoms of fatigue, pain, and dryness.)
3 secondary outcomes
Xerostomia Inventory
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Oral Health-Related Quality of Life - UK Scale
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Visual Analog Scale (VAS) for Disease Involvement
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
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 Nov 2025.
- Individual participant dataSharing planned: No
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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.
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 Sjogren Syndrome, run by Pamukkale 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?
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 Nov 2025. 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?
Fonseca Anamnestic Index (FAI) (time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.). 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?
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 Nov 2025.