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NCT Number: NCT07292077

Restless Legs Syndrome in Temporomandibular Joint Disorders

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Yozgat, 66100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Mandibular Function Impairment Questionnaire

    Time frame: At baseline

    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

  2. Hospital Anxiety and Depression Scale

    Time frame: At baseline

    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.

  3. 12-Item Short Form Health Survey

    Time frame: At baseline

    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

Sponsors and collaborators

Lead sponsor

Gulseren Demir Karakilic

Other

Collaborators

  • Bozok University
  • Gaziantep City Hospital

Registry information

Official study title

Frequency of Restless Legs Syndrome in Patients With Temporomandibular Joint Disorders and Its Effect on Sleep Quality

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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