Restless Legs Syndrome in Temporomandibular Joint Disorders
NCT ID: NCT07292077
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
102 participants
OBSERVATIONAL
2025-02-20
2025-10-06
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
65 Years
ALL
Yes
Sponsors
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Bozok University
OTHER
Gaziantep City Hospital
OTHER
Gulseren Demir Karakilic
OTHER
Responsible Party
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Gulseren Demir Karakilic
Assistant Professor, Principal Investigator
Locations
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Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Yozgat, Yozgat, Turkey (Türkiye)
Countries
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References
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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.
Ağargün, 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.
Aydemir, 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.
Other Identifiers
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140/2025
Identifier Type: -
Identifier Source: org_study_id