Temporomandibular Joint DisordersNCT07292077
Restless Legs Syndrome in Temporomandibular Joint Disorders
An observational study of Temporomandibular Joint Disorders and Restless Legs Syndrome, run by Gulseren Demir Karakilic at 1 site in Turkey (Türkiye).
Trial summary
This observational, cross-sectional, descriptive study aims to evaluate the prevalence of restless legs syndrome in patients with temporomandibular joint dysfunction and to investigate its effects on sleep quality and health-related quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders, Restless Legs Syndrome, Sleep Quality
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2025to 6 Oct 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study included adults aged 18 to 65 years who were recruited from the otorhinolaryngology outpatient clinic of Gaziantep City Hospital. The patient group consisted of individuals with a clinical diagnosis of temporomandibular joint disorder, while the control group comprised healthy volunteers without temporomandibular joint disorder who were matched to the patient group for age and sex.
Who may be able to join
- Adults aged 18 to 65 years
- For the patient group: clinical diagnosis of temporomandibular joint disorder
- Cognitively intact and able to understand study procedures
- Literate and able to complete self-report questionnaires
- Willing to participate and provided written informed consent
Who cannot join
- Presence of neurological or psychiatric disorders
- Cognitive impairment that interferes with questionnaire completion
- Systemic diseases that may affect sleep or motor function
- Current use of medications that may influence sleep or motor function
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Yozgat, Yozgat, 66100
About this study
Official title: Frequency of Restless Legs Syndrome in Patients With Temporomandibular Joint Disorders and Its Effect on Sleep Quality
This observational, cross-sectional, descriptive study aims to evaluate the prevalence of restless legs syndrome in patients with temporomandibular joint dysfunction and to investigate its effects on sleep quality and health-related quality of life. The study will be conducted in the otolaryngology outpatient clinic of Gaziantep City Hospital, Türkiye.
Adults aged 18 to 65 years who are clinically diagnosed with temporomandibular joint dysfunction and meet the inclusion criteria will be invited to participate. An age- and sex-matched control group consisting of individuals without temporomandibular joint dysfunction will also be recruited.
All participants will undergo face-to-face structured interviews during which standardized and validated questionnaires will be administered. The study will collect sociodemographic data, clinical characteristics, and responses to validated assessment tools measuring mandibular function, anxiety and depression symptoms, restless legs syndrome, sleep quality, and health-related quality of life.
Read the detailed description
This observational, cross-sectional, descriptive study aims to evaluate the prevalence of restless legs syndrome in patients with temporomandibular joint dysfunction and to investigate its effects on sleep quality and health-related quality of life. The study will be conducted in the otolaryngology outpatient clinic of Gaziantep City Hospital, Türkiye.
Adults aged 18 to 65 years who are clinically diagnosed with temporomandibular joint dysfunction and meet the inclusion criteria will be invited to participate. An age- and sex-matched control group consisting of individuals without temporomandibular joint dysfunction will also be recruited.
All participants will undergo face-to-face structured interviews during which standardized and validated questionnaires will be administered. The study will collect sociodemographic data, clinical characteristics, and responses to validated assessment tools measuring mandibular function, anxiety and depression symptoms, restless legs syndrome, sleep quality, and health-related quality of life.
The temporomandibular joint is a complex musculoskeletal structure, and temporomandibular joint dysfunction is a clinical condition involving the joint, the masticatory muscles, and surrounding tissues. Restless legs syndrome is a neurological disorder characterized by uncomfortable sensations in the legs and an uncontrollable urge to move, particularly during periods of rest or at night. Previous studies have suggested possible associations between temporomandibular joint dysfunction, bruxism, sleep disturbances, and restless legs syndrome. However, the prevalence of restless legs syndrome and its impact on sleep quality in patients with temporomandibular joint dysfunction remain insufficiently investigated.
This study is designed as an observational, cross-sectional, descriptive investigation. It will be conducted in the otolaryngology outpatient clinic of Gaziantep City Hospital and Gaziantep Dr. Ersin Arslan Training and Research Hospital. The study population will consist of adults aged 18 to 65 years who are clinically diagnosed with temporomandibular joint dysfunction, are cognitively intact, literate, and voluntarily agree to participate.
The control group will include healthy volunteers without a diagnosis of temporomandibular joint dysfunction, matched to the patient group for age and sex. Control participants will also be cognitively intact, literate, and willing to provide written informed consent.
Data Collection Tools (Final Version) Sociodemographic Questionnaire
This 25-item form records age, sex, marital status, educational level, income status, comorbidities, disease duration, and other relevant clinical characteristics.
Mandibular Functional Impairment Questionnaire
This is a 17-item questionnaire scored on a five-point Likert scale, yielding total scores ranging from 0 to 68. Higher scores indicate greater functional impairment of the mandible. The instrument evaluates patient-perceived difficulty in performing mandibular movements and daily functional tasks.
Hospital Anxiety and Depression Scale
This 14-item self-report questionnaire includes two subscales assessing anxiety and depression symptoms. Each item is scored from 0 to 3. Subscale scores range from 0 to 21, with higher scores indicating greater symptom severity.
International Restless Legs Syndrome Study Group Diagnostic Criteria
These clinical diagnostic criteria focus on the core symptoms of restless legs syndrome. Diagnosis is based on patient history and the presence of all essential diagnostic features.
International Restless Legs Syndrome Severity Scale
This 10-item rating scale evaluates symptom severity, frequency, and impact on daily life and mood. Each item is scored from 0 to 4, producing a total score between 0 and 40. Higher scores indicate greater symptom severity.
Pittsburgh Sleep Quality Index
This 24-item questionnaire assesses sleep quality over the previous month across seven components, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Short Form 12 Health Survey
This 12-item questionnaire evaluates health-related quality of life across physical and mental health domains, including physical functioning, role limitations, bodily pain, general health perception, vitality, social functioning, emotional role limitations, and mental health.
- Keywords
- Temporomandibular Disorder, Restless Legs Syndrome, Sleep Quality, Mandibular Function, Quality of Life, The International Restless Legs Syndrome Study Group Diagnostic Criteria, The International Restless Legs Syndrome Study Group Criteria Severity Rating Scale, the Pittsburgh Sleep Quality Index, SF-12, Cross-sectional Study
- Medical subject headings
- Temporomandibular Joint Disorders, Restless Legs Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Temporomandibular Disorder Group | This group includes adults aged 18 to 65 years who were clinically diagnosed with temporomandibular joint disorder at the otorhinolaryngology outpatient clinic of Gaziantep City Hospital, Türkiye. All participants were cognitively competent, literate, and provided written informed consent. Participants completed standardized questionnaires assessing mandibular function, symptoms of anxiety and depression, severity of restless legs syndrome, sleep quality, and health-related quality of life. | |
| Healthy Control Group | This group includes healthy adults without a diagnosis of temporomandibular joint disorder who were matched to the patient group for age and sex. All participants were cognitively competent, literate, and provided written informed consent. Control participants completed the same standardized questionnaires as the patient group to allow comparison of sleep quality, emotional status, and health-related quality of life between groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Restless Legs Syndrome Study Group Diagnostic Criteria
This diagnostic framework defines the presence of restless legs syndrome based on standardized clinical features, including an urge to move the legs, worsening of symptoms during rest, partial or complete relief with movement, and worsening of symptoms in the evening or at night. These diagnostic criteria have been adapted for use in Turkish-speaking populations and are used to determine whether participants meet the clinical diagnosis of restless legs syndrome.
Measured: At baseline
International Restless Legs Syndrome Study Group Severity Rating Scale
This scale consists of 10 questions assessing the severity, frequency, and impact of restless legs syndrome symptoms on daily life. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 40. Higher scores indicate greater symptom severity. Severity categories are defined as mild (1-10), moderate (11-20), severe (21-30), and very severe (31-40). The Turkish version of this scale has demonstrated acceptable reliability and validity for clinical and research use.
Measured: At baseline
Pittsburgh Sleep Quality Index
This questionnaire evaluates sleep quality over the previous month. It includes 24 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, with a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality, and a total score greater than 5 reflects poor sleep quality. The Turkish version has been shown to be valid and reliable in adult populations.
Measured: At baseline
Secondary outcomes (3)
Mandibular Function Impairment Questionnaire
This questionnaire contains 17 items assessing the individual's perceived difficulty in performing mandibular movements and daily activities such as chewing, speaking, and yawning. Each item is scored on a five-point Likert scale ranging from 0 (no difficulty) to 4 (very severe difficulty). The total score ranges from 0 to 68, with higher scores indicating greater functional impairment of the mandible. The Turkish version of this questionnaire has demonstrated satisfactory validity and reliability
Measured: At baseline
Hospital Anxiety and Depression Scale
This self-report instrument consists of 14 items designed to assess symptoms of anxiety and depression in adults. Seven items assess anxiety symptoms and seven items assess depressive symptoms. Each item is scored from 0 to 3, producing subscale scores ranging from 0 to 21. Higher scores indicate greater symptom severity. The Turkish version has been shown to be valid and reliable in clinical populations.
Measured: At baseline
12-Item Short Form Health Survey
This health-related quality of life questionnaire includes 12 items that assess physical and mental well-being. The instrument provides summary scores reflecting physical and mental health status, with higher scores indicating better perceived health and functioning. The Turkish version has demonstrated adequate psychometric properties for use in population-based and clinical studies
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start20 Feb 2025
- Primary completion30 Jun 2025
- Study completion6 Oct 2025
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 Temporomandibular Joint DisordersStudies 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulseren Demir Karakilic
- Sponsor type
- University, hospital or other
- Collaborators
- Bozok University, Gaziantep City Hospital
- Responsible party
- Sponsor-investigator, Gulseren Demir Karakilic, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292077
- Sponsor's protocol ID
- 140/2025
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the study that are directly related to the primary and secondary outcomes will be made available upon reasonable request. The data will be shared exclusively for scientific and research purposes.
Publications
Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.
PubMed 35730511Ağargün, M.Y., Validity and reliability of Turkish version of Pittsburgh Sleep Quality Index. Türk Psikiyatri Dergisi, 1996. 7: p. 107.
Ay, E., Huzursuz bacaklar sendromunda kullanılan uluslararası huzursuz bacaklar sendromu çalışma grubu şiddet ölçeğinin türkçe geçerlilik ve güvenilirliğinin araştırılması. 2017, Sağlık Bilimleri Enstitüsü.
Allen RP, Picchietti DL, Garcia-Borreguero D, Ondo WG, Walters AS, Winkelman JW, Zucconi M, Ferri R, Trenkwalder C, Lee HB; International Restless Legs Syndrome Study Group. Restless legs syndrome/Willis-Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria--history, rationale, description, and significance. Sleep Med. 2014 Aug;15(8):860-73. doi: 10.1016/j.sleep.2014.03.025. Epub 2014 May 17.
PubMed 25023924Aydemir, Ö., et al., Validity and reliability of Turkish version of hospital anxiety and depression scale. Turk Psikiyatri Derg, 1997. 8(4): p. 280-7
Kılınç, H.E., et al., Further Validity and Reliability of Turkish Version of the Mandibular Functional Impairment Questionnaire in Patients with Temporomandibular Dysfunction. Journal of Basic and Clinical Health Sciences, 2022. 7(1): p. 214-222.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Restless Legs Syndrome in Patients With Temporomandibular Joint Disorders and Its Effect on Sleep Quality
- ClinicalTrials.gov ID
- NCT07292077
- Acronym / sponsor ID
- 140/2025
- Keywords
- Temporomandibular Disorder, Restless Legs Syndrome, Sleep Quality, Mandibular Function, Quality of Life, The International Restless Legs Syndrome Study Group Diagnostic Criteria, The International Restless Legs Syndrome Study Group Criteria Severity Rating Scale, the Pittsburgh Sleep Quality Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Gulseren Demir KarakilicUniversity, hospital or other
- Collaborators
- Bozok University, Gaziantep City Hospital
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 18 Dec 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.
This observational, cross-sectional, descriptive study aims to evaluate the prevalence of restless legs syndrome in patients with temporomandibular joint dysfunction and to investigate its effects on sleep quality and health-related quality of life. The study will be conducted in the otolaryngology outpatient clinic of Gaziantep City Hospital, Türkiye.
Adults aged 18 to 65 years who are clinically diagnosed with temporomandibular joint dysfunction and meet the inclusion criteria will be invited to participate. An age- and sex-matched control group consisting of individuals without temporomandibular joint dysfunction will also be recruited.
All participants will undergo face-to-face structured interviews during which standardized and validated questionnaires will be administered. The study will collect sociodemographic data, clinical characteristics, and responses to validated assessment tools measuring mandibular function, anxiety and depression symptoms, restless legs syndrome, sleep quality, and health-related quality of life.
Detailed description
This observational, cross-sectional, descriptive study aims to evaluate the prevalence of restless legs syndrome in patients with temporomandibular joint dysfunction and to investigate its effects on sleep quality and health-related quality of life. The study will be conducted in the otolaryngology outpatient clinic of Gaziantep City Hospital, Türkiye.
Adults aged 18 to 65 years who are clinically diagnosed with temporomandibular joint dysfunction and meet the inclusion criteria will be invited to participate. An age- and sex-matched control group consisting of individuals without temporomandibular joint dysfunction will also be recruited.
All participants will undergo face-to-face structured interviews during which standardized and validated questionnaires will be administered. The study will collect sociodemographic data, clinical characteristics, and responses to validated assessment tools measuring mandibular function, anxiety and depression symptoms, restless legs syndrome, sleep quality, and health-related quality of life.
The temporomandibular joint is a complex musculoskeletal structure, and temporomandibular joint dysfunction is a clinical condition involving the joint, the masticatory muscles, and surrounding tissues. Restless legs syndrome is a neurological disorder characterized by uncomfortable sensations in the legs and an uncontrollable urge to move, particularly during periods of rest or at night. Previous studies have suggested possible associations between temporomandibular joint dysfunction, bruxism, sleep disturbances, and restless legs syndrome. However, the prevalence of restless legs syndrome and its impact on sleep quality in patients with temporomandibular joint dysfunction remain insufficiently investigated.
This study is designed as an observational, cross-sectional, descriptive investigation. It will be conducted in the otolaryngology outpatient clinic of Gaziantep City Hospital and Gaziantep Dr. Ersin Arslan Training and Research Hospital. The study population will consist of adults aged 18 to 65 years who are clinically diagnosed with temporomandibular joint dysfunction, are cognitively intact, literate, and voluntarily agree to participate.
The control group will include healthy volunteers without a diagnosis of temporomandibular joint dysfunction, matched to the patient group for age and sex. Control participants will also be cognitively intact, literate, and willing to provide written informed consent.
Data Collection Tools (Final Version) Sociodemographic Questionnaire
This 25-item form records age, sex, marital status, educational level, income status, comorbidities, disease duration, and other relevant clinical characteristics.
Mandibular Functional Impairment Questionnaire
This is a 17-item questionnaire scored on a five-point Likert scale, yielding total scores ranging from 0 to 68. Higher scores indicate greater functional impairment of the mandible. The instrument evaluates patient-perceived difficulty in performing mandibular movements and daily functional tasks.
Hospital Anxiety and Depression Scale
This 14-item self-report questionnaire includes two subscales assessing anxiety and depression symptoms. Each item is scored from 0 to 3. Subscale scores range from 0 to 21, with higher scores indicating greater symptom severity.
International Restless Legs Syndrome Study Group Diagnostic Criteria
These clinical diagnostic criteria focus on the core symptoms of restless legs syndrome. Diagnosis is based on patient history and the presence of all essential diagnostic features.
International Restless Legs Syndrome Severity Scale
This 10-item rating scale evaluates symptom severity, frequency, and impact on daily life and mood. Each item is scored from 0 to 4, producing a total score between 0 and 40. Higher scores indicate greater symptom severity.
Pittsburgh Sleep Quality Index
This 24-item questionnaire assesses sleep quality over the previous month across seven components, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Short Form 12 Health Survey
This 12-item questionnaire evaluates health-related quality of life across physical and mental health domains, including physical functioning, role limitations, bodily pain, general health perception, vitality, social functioning, emotional role limitations, and mental health.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporomandibular Disorder Group | – | –This group includes adults aged 18 to 65 years who were clinically diagnosed with temporomandibular joint disorder at the otorhinolaryngology outpatient clinic of Gaziantep City Hospital, Türkiye. All participants were cognitively competent, literate, and provided written informed consent. Participants completed standardized questionnaires assessing mandibular function, symptoms of anxiety and depression, severity of restless legs syndrome, sleep quality, and health-related quality of life. |
| Healthy Control Group | – | –This group includes healthy adults without a diagnosis of temporomandibular joint disorder who were matched to the patient group for age and sex. All participants were cognitively competent, literate, and provided written informed consent. Control participants completed the same standardized questionnaires as the patient group to allow comparison of sleep quality, emotional status, and health-related quality of life between groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study included adults aged 18 to 65 years who were recruited from the otorhinolaryngology outpatient clinic of Gaziantep City Hospital. The patient group consisted of individuals with a clinical diagnosis of temporomandibular joint disorder, while the control group comprised healthy volunteers without temporomandibular joint disorder who were matched to the patient group for age and sex.
Key inclusion criteria (5 listed)
- Adults aged 18 to 65 years
- For the patient group: clinical diagnosis of temporomandibular joint disorder
- Cognitively intact and able to understand study procedures
- Literate and able to complete self-report questionnaires
- Willing to participate and provided written informed consent
Key exclusion criteria (5 listed)
- Presence of neurological or psychiatric disorders
- Cognitive impairment that interferes with questionnaire completion
- Systemic diseases that may affect sleep or motor function
- Current use of medications that may influence sleep or motor function
- Refusal or inability to provide informed consent
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
International Restless Legs Syndrome Study Group Diagnostic Criteria
Time frame: At baseline
This diagnostic framework defines the presence of restless legs syndrome based on standardized clinical features, including an urge to move the legs, worsening of symptoms during rest, partial or complete relief with movement, and worsening of symptoms in the evening or at night. These diagnostic criteria have been adapted for use in Turkish-speaking populations and are used to determine whether participants meet the clinical diagnosis of restless legs syndrome.
International Restless Legs Syndrome Study Group Severity Rating Scale
Time frame: At baseline
This scale consists of 10 questions assessing the severity, frequency, and impact of restless legs syndrome symptoms on daily life. Each item is scored from 0 to 4, yielding a total score ranging from 0 to 40. Higher scores indicate greater symptom severity. Severity categories are defined as mild (1-10), moderate (11-20), severe (21-30), and very severe (31-40). The Turkish version of this scale has demonstrated acceptable reliability and validity for clinical and research use.
Pittsburgh Sleep Quality Index
Time frame: At baseline
This questionnaire evaluates sleep quality over the previous month. It includes 24 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, with a total score ranging from 0 to 21. Higher scores indicate poorer sleep quality, and a total score greater than 5 reflects poor sleep quality. The Turkish version has been shown to be valid and reliable in adult populations.
3 secondary outcomes
Mandibular Function Impairment Questionnaire
Time frame: At baseline
Hospital Anxiety and Depression Scale
Time frame: At baseline
12-Item Short Form Health Survey
Time frame: At 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 29 Dec 2025.
- Background: PubMed 35730511Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.
- BackgroundAğargün, M.Y., Validity and reliability of Turkish version of Pittsburgh Sleep Quality Index. Türk Psikiyatri Dergisi, 1996. 7: p. 107.
- BackgroundAy, E., Huzursuz bacaklar sendromunda kullanılan uluslararası huzursuz bacaklar sendromu çalışma grubu şiddet ölçeğinin türkçe geçerlilik ve güvenilirliğinin araştırılması. 2017, Sağlık Bilimleri Enstitüsü.
- Background: PubMed 25023924Allen RP, Picchietti DL, Garcia-Borreguero D, Ondo WG, Walters AS, Winkelman JW, Zucconi M, Ferri R, Trenkwalder C, Lee HB; International Restless Legs Syndrome Study Group. Restless legs syndrome/Willis-Ekbom disease diagnostic criteria: updated International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria--history, rationale, description, and significance. Sleep Med. 2014 Aug;15(8):860-73. doi: 10.1016/j.sleep.2014.03.025. Epub 2014 May 17.
- BackgroundAydemir, Ö., et al., Validity and reliability of Turkish version of hospital anxiety and depression scale. Turk Psikiyatri Derg, 1997. 8(4): p. 280-7
- BackgroundKılınç, H.E., et al., Further Validity and Reliability of Turkish Version of the Mandibular Functional Impairment Questionnaire in Patients with Temporomandibular Dysfunction. Journal of Basic and Clinical Health Sciences, 2022. 7(1): p. 214-222.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the study that are directly related to the primary and secondary outcomes will be made available upon reasonable request. The data will be shared exclusively for scientific and research purposes.
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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 Temporomandibular Joint Disorders and Restless Legs Syndrome, run by Gulseren Demir Karakilic 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 5 inclusion and 5 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 29 Dec 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?
International Restless Legs Syndrome Study Group Diagnostic Criteria (time frame: At baseline). The study lists 3 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 NCT07292077, 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 29 Dec 2025.