Temporomandibular Joint DysfunctionNCT06655753
Craniocervical Dysfunction Index in Patients With Temporomandibular Joint Dysfunction
An observational study of Temporomandibular Joint Dysfunction and Craniocervical Dysfunction, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial summary
The aims of this study were to perform cultural adaptation of the Craniocervical Dysfunction Index in patients with Temporomandibular Joint Dysfunction, reliability and validity of the index Turkish speaking adults. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction, Craniocervical Dysfunction, Reliability
- What is being tested?
- Reliability and Validity
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 1 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: aproximately 5o patients with temporomandibular joint dysfunction between the ages of 20-60 years
Who may be able to join
- Between the ages of 20-60 years
- Clinical diagnosis of non-specific neck pain
- Being able to communicate in Turkish
- Volunteering to participate in the study
Who cannot join
- Over 60 years of age
- Those with impairments in cervical mobility that affected the postural assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Alanya Alaaddin Keykubat Üniversity
Antalya, Alanya, 07450
About this study
Official title: Turkish Validity and Reliability of the Craniocervical Dysfunction Index in Patients Temporomandibular Joint Dysfunction
The aims of this study were to perform cultural adaptation of the Craniocervical Dysfunction Index in patients with Temporomandibular Joint Dysfunction, reliability and validity of the index Turkish speaking adults.
- Being tested
- Reliability and Validity
- 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.
Reliability and ValidityOther
Reliability and validity of Craniocervical Dysfunction Index in Turkish Patients With Temporomandibular Joint Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Craniocervical Dysfunction Index
The assessment of craniocervical dysfunction is performed objectively and comprehensively through the Craniocervical Dysfunction Index (CDI), which was developed based on the Helkimo Dysfunction Index. The CDI numerically grades the severity of the functional disorders of the cervical spine. Through this index it is possible to assess the craniocervical dysfunction, regardless of the opinion of the patients, of the severity of the symptoms, and of the need for treatment. The CDI objectively indicates the dysfunction of the cervical region by numerical average, assessing the degree of dysfunction and enabling the differential diagnosis, suggesting the priority and monitoring of the treatment these changes may be reassessed over time.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint 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
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Araci, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655753
- Sponsor's protocol ID
- 22.10.2024/CDI-TMJ
- Status last verified
- Feb 2025
- First submitted
- 22 Oct 2024
- Last updated
- 11 Feb 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of the Craniocervical Dysfunction Index in Patients Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT06655753
- Acronym / sponsor ID
- 22.10.2024/CDI-TMJ
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 23 Oct 2024 (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 aims of this study were to perform cultural adaptation of the Craniocervical Dysfunction Index in patients with Temporomandibular Joint Dysfunction, reliability and validity of the index Turkish speaking adults.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- aproximately 5o patients with temporomandibular joint dysfunction between the ages of 20-60 years
Key inclusion criteria (4 listed)
- Between the ages of 20-60 years
- Clinical diagnosis of non-specific neck pain
- Being able to communicate in Turkish
- Volunteering to participate in the study
Key exclusion criteria (2 listed)
- Over 60 years of age
- Those with impairments in cervical mobility that affected the postural assessment
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 |
|---|---|---|
| Reliability and ValidityReliability and validity of Craniocervical Dysfunction Index in Turkish Patients With Temporomandibular Joint Disorders | Other | – |
Primary outcome
Craniocervical Dysfunction Index
Time frame: Baseline
The assessment of craniocervical dysfunction is performed objectively and comprehensively through the Craniocervical Dysfunction Index (CDI), which was developed based on the Helkimo Dysfunction Index. The CDI numerically grades the severity of the functional disorders of the cervical spine. Through this index it is possible to assess the craniocervical dysfunction, regardless of the opinion of the patients, of the severity of the symptoms, and of the need for treatment. The CDI objectively indicates the dysfunction of the cervical region by numerical average, assessing the degree of dysfunction and enabling the differential diagnosis, suggesting the priority and monitoring of the treatment these changes may be reassessed over time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 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.
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 Joint Dysfunction and Craniocervical Dysfunction, run by Alanya Alaaddin Keykubat 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 11 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayça ARACI (05307398203, uyanayca@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craniocervical Dysfunction Index (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 11 Feb 2025.