<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04435951</url>
  </required_header>
  <id_info>
    <org_study_id>Hacettepe FTR</org_study_id>
    <nct_id>NCT04435951</nct_id>
  </id_info>
  <brief_title>The Effect Of Temporomandibular Joint Dysfunction On Pain, Quality Of Life And Psychological Status</brief_title>
  <official_title>The Effect Of Temporomandibular Joint Dysfunction On Pain, Quality Of Life And Psychological Status</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to investigate the effects of temporomandibular joint dysfunction&#xD;
      (TMJD) on pain, quality of life and psychological status.&#xD;
&#xD;
      A total of one hundred twenty people participated in the study, sixty with TMJD symptoms&#xD;
      (according to the Research Diagnostic Criteria for Temporomandibular Disorders) and sixty&#xD;
      without TMJD symptoms. The severity of temporomandibular joint (TMJ) pain and headache was&#xD;
      assessed using a visual analog scale (VAS), pain threshold using an algometer, anxiety and&#xD;
      depression levels with the Hospital Anxiety and Depression Scale (HADS), and the quality of&#xD;
      life level was assessed by Short Form-36 (SF-36).&#xD;
&#xD;
      Treatment of TMJD with appropriate therapies and psychological support techniques may reduce&#xD;
      TMJD symptoms and improve patients' quality of life and psychological status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Temporomandibular joint dysfunction (TMJD) occurs as a result of the impaired functioning of&#xD;
      the structures of the masticatory system. This disruption affects the chewing muscles,&#xD;
      temporomandibular joint (TMJ), and related structures around the joint. TMJD can produce&#xD;
      signs and symptoms, including pain in the TMJ and chewing muscles, restricted mouth opening,&#xD;
      and articular sounds such as clicking and/or crepitus. Other symptoms include TMJ pain,&#xD;
      limitation in joint movements, difficulty in chewing, jaw locking (trismus), lateral&#xD;
      deviation of the jaw, tenderness in the TMJ and chewing muscles, tinnitus and pain,&#xD;
      dizziness, and head and neck pain.&#xD;
&#xD;
      However, to the best of the investigator's knowledge, no previous studies have examined the&#xD;
      relationship between quality of life, pain, and psychological status in individuals with&#xD;
      TMJD. This study was designed to investigate whether a relationship between pain, quality of&#xD;
      life, and psychological status in individuals with TMJD and asymptomatic individuals without&#xD;
      TMJD.&#xD;
&#xD;
      One hundred twenty individuals were included in this study performed between March and July&#xD;
      2017 at the Gazi University and Ankara Yıldırım Beyazıt University Dentistry Faculties,&#xD;
      Turkey. The research was designed as a controlled, observational, cross-sectional study.&#xD;
      Sixty of the 165 individuals presenting with TMJD symptoms were diagnosed with TMJD by a&#xD;
      specialist dentist, and those meeting the inclusion criteria were enrolled in the first&#xD;
      group. Sixty individuals who met the inclusion criteria out of 143 individuals who did not&#xD;
      exhibit TMJD symptoms were enrolled in the second group. These two groups were established&#xD;
      based on clinical and radiological examination results. TMJD was diagnosed by professional&#xD;
      and experienced dentists using the Research Diagnostic Criteria for Temporomandibular&#xD;
      Disorders (RDC/TMD). RDC/TMD has been described as the gold standard physical examination&#xD;
      method in the clinical diagnosis of TMD.&#xD;
&#xD;
      Individuals agreeing to take part in the study were included after signing informed consent&#xD;
      forms. Ethical committee permission was granted by the Ankara Yıldırım Beyazıt University&#xD;
      Social and Humanities Ethics Committee (date: 02.08.2016, no: 356).&#xD;
&#xD;
      Individuals who were able to understand and speak Turkish and cooperate, and aged 17 years or&#xD;
      older were included in the study.&#xD;
&#xD;
      Inclusion criteria for Group 1 were articular sounds in the form of clicks or crepitation&#xD;
      from the TMJ during mouth opening or chewing, sensitivity and pain in the TMJ at palpation,&#xD;
      no treatment for the TMJ in the previous six months, and presence of TMJD symptoms for at&#xD;
      least three months. Inclusion criteria for Group 2, maximum mouth opening exceeding 30 mm,&#xD;
      absence of articular sounds such as TMJ click or crepitation during mouth opening and closing&#xD;
      and/or chewing activity, and absence of tenderness and pain in the TMJ and chewing muscles at&#xD;
      palpation.&#xD;
&#xD;
      Exclusion criteria for Group 1 were the absence of at least one of the TMJD symptoms, absence&#xD;
      of diagnosis of TMJD and the presence of a history of tumor, cervical discopathy, orthopedic&#xD;
      and rheumatic pathologies, head, neck and/or jaw surgery and pregnancy.&#xD;
&#xD;
      Exclusion criteria for Group 2 were the presence of at least one of the symptoms of TMJD, the&#xD;
      presence of a history of tumor, cervical discopathy, orthopedic and rheumatic pathologies,&#xD;
      head, neck and/or jaw surgery, and pregnancy.&#xD;
&#xD;
      G * Power (V.3.1.9.2, Germany) software was used to calculate the sample size. Analyses were&#xD;
      performed to investigate significant differences in the pressure pain threshold (PTT),&#xD;
      quality of life, and psychological evaluation results between the groups (α = 0.05 and β =&#xD;
      0.20). The analysis showed that at least 19 individuals in each group and at least 38&#xD;
      individuals in total would be sufficient.&#xD;
&#xD;
      Socio-demographic (age, sex, height, weight, educational status) and clinical data (history&#xD;
      of bruxism, dominant side, side of the problem, duration of symptoms, dominant chewing side,&#xD;
      sleeping position, tinnitus/pain, chewing difficulty, and parafunctional oral habits status)&#xD;
      of individuals meeting the inclusion criteria were recorded onto an evaluation form.&#xD;
&#xD;
      Individuals in both groups were asked to mark TMJ pain and headache on a 10 cm straight line&#xD;
      using a visual analog scale (VAS), and the results were recorded in cm. Patients were asked&#xD;
      about pain in bilateral resting and mobile positions of the TMJ. On the VAS scale, &quot;0&quot;&#xD;
      indicates no pain, and &quot;10&quot; the most severe pain possible.&#xD;
&#xD;
      Muscle sensitivity was measured using an algometer (Baseline® dolorimeter/algometer, Pain&#xD;
      Diagnosis, and Treatment Inc., Great Neck, NY, USA). The algometer is pressed gradually to&#xD;
      the area where the sensitivity is to be measured, and the measurement is terminated as soon&#xD;
      as the subject experiences pain. The PPTs of the anterior part of the temporalis muscle, the&#xD;
      TMJ lateral capsule, and the masseter muscle were measured in the present study. Measurements&#xD;
      were performed three times at 30-second intervals on both right and left sides. The mean&#xD;
      values of the three measurements were recorded. PPT is defined as the lowest pressure force&#xD;
      required to be applied to the tissue for the pain to occur. Results are expressed as kg/cm2.&#xD;
&#xD;
      The Hospital Anxiety and Depression Scale (HADS) was used to measure participants' anxiety&#xD;
      and depression levels. The HADS scale was developed by Zigmond and Snaith and contains 14,&#xD;
      with two sub-scales, one of seven questions (odd numbers) measuring anxiety, and another of&#xD;
      seven questions (even numbers) measuring depression. Aydemir et al. conducted the Turkish&#xD;
      validity and reliability study of HADS. Each question is scored between 0 and 3. The lowest&#xD;
      possible scores for the depression and anxiety subscales were 0, and the maximum possible&#xD;
      scores were 21. Subjects' depression and anxiety status are evaluated as normal/no symptoms&#xD;
      (0-7 points), borderline abnormal/suspicious (8-10 points), and abnormal/definite (11-21&#xD;
      points), depending on the scores obtained.&#xD;
&#xD;
      Short Form-36 (SF-36) was used to assess the quality of life. Ware et al. developed the SF-36&#xD;
      in 1987 to determine overall health-related life quality. The scale consists of 36 questions&#xD;
      and evaluates life quality in the previous four weeks in eight subscales and two main&#xD;
      components. The subscales are; Physical Function (PF), Role Difficulty-Physical (RP), Body&#xD;
      Pain (BP), General Health (GH), Vitality (V), Social Function (SF), Role Difficulty-Emotional&#xD;
      (RE), and Mental Health (MH), while the main components are Physical Component Score (PCS)&#xD;
      and Mental Component Score (MCS). The eight subscales assess health from 0 to 100 points. &quot;0&quot;&#xD;
      indicates that health-related quality of life is poor, and 100 indicates the best possible&#xD;
      quality of life, so higher scores indicate better quality of life. SF-36 was translated into&#xD;
      Turkish by Koçyiğit et al. and has been subjected to validity and reliability studies.&#xD;
&#xD;
      The distributions of continuous variables such as age, body mass index (BMI), and SF-36&#xD;
      scores were examined using the Shapiro-Wilk test and normality graphs. Mean ± standard&#xD;
      deviation (mean ± sd) and median (min-max: minimum-maximum) were used to express all&#xD;
      continuous variables, while results for categorical variables such as gender and occupation&#xD;
      were expressed as percentages (%). The independent samples t-test and Mann-Whitney U test&#xD;
      were applied to determine the distribution of continuous variables such as SF-36 and HADS&#xD;
      scores between groups 1 and 2. The relationship between the scale scores and pain threshold&#xD;
      and pain severity was analyzed using Pearson and Spearman correlation analysis. The&#xD;
      consistency of responses to SF-36 and HADS was examined using Cronbach's alpha coefficient.&#xD;
      Statistical significance was set at p &lt;0.05. All statistical analyses and calculations were&#xD;
      performed on IBM SPSS Statistics 21.0 software (IBM Corp. Released 2012. IBM SPSS Statistics&#xD;
      for Windows, Armonk, NY: IBM Corp., USA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2017</start_date>
  <completion_date type="Actual">May 25, 2020</completion_date>
  <primary_completion_date type="Actual">July 24, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Temporomandibular joint pain severity and headache severity</measure>
    <time_frame>5 months</time_frame>
    <description>Individuals in both groups were asked to mark TMJ pain and headache on a 10 cm straight line using a visual analogue scale (VAS), and the results were recorded in cm. Patients were asked about pain in bilateral resting and mobile positions of the TMJ. On the VAS scale, &quot;0&quot; indicates no pain, and &quot;10&quot; the most severe pain possible.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychological status (anxiety and depression levels)</measure>
    <time_frame>5 months</time_frame>
    <description>The Hospital Anxiety and Depression Scale (HADS) was used to measure participants' anxiety and depression levels. Each question was scored between 0 and 3. The lowest possible scores for the depression and anxiety subscales were 0, and the maximum possible scores were 21. Subjects' depression and anxiety status was evaluated as normal/no symptoms (0-7 points), borderline abnormal/suspicious (8-10 points) and abnormal/definite (11-21 points), depending on the scores obtained.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form-36</measure>
    <time_frame>5 months</time_frame>
    <description>Short Form-36 (SF-36) was used to assess health-related quality of life. The scale consists of 36 questions and evaluates life quality in the previous four weeks in eight subscales and two main components. The eight subscales assess health from 0 to 100 points. &quot;0&quot; indicates that health-related quality of life is poor, and 100 indicates the best possible quality of life, so higher scores indicate better quality of life.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Temporomandibular Joint Dysfunction</condition>
  <arm_group>
    <arm_group_label>Group 1 (with TMJD)</arm_group_label>
    <description>Group 1, consists of 60 patients diagnosed with Temporomandibular Joint Dysfunction (TMJD) according to the Research Diagnostic Criteria for Temporomandibular Disorders by a specialist and experienced dentist in TMJD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (without TMJD)</arm_group_label>
    <description>Group 2, consists of 60 individuals who did not exhibit TMJD symptoms and have not TMJD diagnosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evaluation</intervention_name>
    <description>No attempt was made to the individuals in Group 1 and Group 2. Individuals were only evaluated.</description>
    <arm_group_label>Group 1 (with TMJD)</arm_group_label>
    <arm_group_label>Group 2 (without TMJD)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Group 1 (60 patients, group with TMJD) consists of patients diagnosed with TMJD according&#xD;
        to the Research Diagnostic Criteria for Temporomandibular Disorders by a specialist and&#xD;
        experienced dentist in TMJD.&#xD;
&#xD;
        Group 2 (60 healthy individuals, group without TMJD) consists of individuals who are&#xD;
        evaluated by a specialist and experienced dentist in TMJD and who do not show symptoms of&#xD;
        TMJD.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For Group 1 (group with TMJD):&#xD;
&#xD;
          -  Patients diagnosed with TMJD&#xD;
&#xD;
          -  Able to understand and speak Turkish and cooperate&#xD;
&#xD;
          -  Aged 17 years or older and 65 years or younger&#xD;
&#xD;
          -  Patients have articular sounds in the form of clicks or crepitation from the TMJ&#xD;
             during mouth opening or chewing&#xD;
&#xD;
          -  Sensitivity and pain in the TMJ at palpation&#xD;
&#xD;
          -  Not receiving TMJ treatment in the past six months&#xD;
&#xD;
          -  Presence of TMJD symptoms for at least three months For Group 2 (group without TMJD)&#xD;
&#xD;
          -  Able to understand and speak Turkish and cooperate&#xD;
&#xD;
          -  Aged 17 years or aged 17 years or older and 65 years or younger&#xD;
&#xD;
          -  Maximum mouth opening 30 mm or more&#xD;
&#xD;
          -  Absence of articular sounds such as TMJ click or crepitation during mouth opening and&#xD;
             closing and/or chewing activity.&#xD;
&#xD;
          -  Absence of tenderness and pain in the TMJ and chewing muscles at palpation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For Group 1 (group with TMJD):&#xD;
&#xD;
          -  Absence of at least one of the TMJD symptoms&#xD;
&#xD;
          -  Presence of a history of tumor, cervical discopathy, orthopedic and rheumatic&#xD;
             pathologies, head, neck and/or jaw surgery and pregnancy For Group 2 (group without&#xD;
             TMJD)&#xD;
&#xD;
          -  Presence of at least one of the symptoms of TMJD&#xD;
&#xD;
          -  Presence of a history of tumor, cervical discopathy, orthopedic and rheumatic&#xD;
             pathologies, head, neck and/or jaw surgery and pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>57 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nazım Tolgahan YILDIZ, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bahar KÜLÜNKOĞLU, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ankara Yildirim Beyazıt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ankara Yıldırım Beyazıt University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
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  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Tolgahan YILDIZ</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>Temporomandibular joint</keyword>
  <keyword>Dysfunction</keyword>
  <keyword>Pain</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
    <mesh_term>Temporomandibular Joint Disorders</mesh_term>
    <mesh_term>Temporomandibular Joint Dysfunction Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04435951
org study id: Hacettepe FTR
nct id: NCT04435951
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to investigate the effects of temporomandibular joint dysfunction
      (TMJD) on pain, quality of life and psychological status.

      A total of one hundred twenty people participated in the study, sixty with TMJD symptoms
      (according to the Research Diagnostic Criteria for Temporomandibular Disorders) and sixty
      without TMJD symptoms. The severity of temporomandibular joint (TMJ) pain and headache was
      assessed using a visual analog scale (VAS), pain threshold using an algometer, anxiety and
      depression levels with the Hospital Anxiety and Depression Scale (HADS), and the quality of
      life level was assessed by Short Form-36 (SF-36).

      Treatment of TMJD with appropriate therapies and psychological support techniques may reduce
      TMJD symptoms and improve patients' quality of life and psychological status.
Temporomandibular joint dysfunction (TMJD) occurs as a result of the impaired functioning of
      the structures of the masticatory system. This disruption affects the chewing muscles,
      temporomandibular joint (TMJ), and related structures around the joint. TMJD can produce
      signs and symptoms, including pain in the TMJ and chewing muscles, restricted mouth opening,
      and articular sounds such as clicking and/or crepitus. Other symptoms include TMJ pain,
      limitation in joint movements, difficulty in chewing, jaw locking (trismus), lateral
      deviation of the jaw, tenderness in the TMJ and chewing muscles, tinnitus and pain,
      dizziness, and head and neck pain.

      However, to the best of the investigator's knowledge, no previous studies have examined the
      relationship between quality of life, pain, and psychological status in individuals with
      TMJD. This study was designed to investigate whether a relationship between pain, quality of
      life, and psychological status in individuals with TMJD and asymptomatic individuals without
      TMJD.

      One hundred twenty individuals were included in this study performed between March and July
      2017 at the Gazi University and Ankara Yıldırım Beyazıt University Dentistry Faculties,
      Turkey. The research was designed as a controlled, observational, cross-sectional study.
      Sixty of the 165 individuals presenting with TMJD symptoms were diagnosed with TMJD by a
      specialist dentist, and those meeting the inclusion criteria were enrolled in the first
      group. Sixty individuals who met the inclusion criteria out of 143 individuals who did not
      exhibit TMJD symptoms were enrolled in the second group. These two groups were established
      based on clinical and radiological examination results. TMJD was diagnosed by professional
      and experienced dentists using the Research Diagnostic Criteria for Temporomandibular
      Disorders (RDC/TMD). RDC/TMD has been described as the gold standard physical examination
      method in the clinical diagnosis of TMD.

      Individuals agreeing to take part in the study were included after signing informed consent
      forms. Ethical committee permission was granted by the Ankara Yıldırım Beyazıt University
      Social and Humanities Ethics Committee (date: 02.08.2016, no: 356).

      Individuals who were able to understand and speak Turkish and cooperate, and aged 17 years or
      older were included in the study.

      Inclusion criteria for Group 1 were articular sounds in the form of clicks or crepitation
      from the TMJ during mouth opening or chewing, sensitivity and pain in the TMJ at palpation,
      no treatment for the TMJ in the previous six months, and presence of TMJD symptoms for at
      least three months. Inclusion criteria for Group 2, maximum mouth opening exceeding 30 mm,
      absence of articular sounds such as TMJ click or crepitation during mouth opening and closing
      and/or chewing activity, and absence of tenderness and pain in the TMJ and chewing muscles at
      palpation.

      Exclusion criteria for Group 1 were the absence of at least one of the TMJD symptoms, absence
      of diagnosis of TMJD and the presence of a history of tumor, cervical discopathy, orthopedic
      and rheumatic pathologies, head, neck and/or jaw surgery and pregnancy.

      Exclusion criteria for Group 2 were the presence of at least one of the symptoms of TMJD, the
      presence of a history of tumor, cervical discopathy, orthopedic and rheumatic pathologies,
      head, neck and/or jaw surgery, and pregnancy.

      G * Power (V.3.1.9.2, Germany) software was used to calculate the sample size. Analyses were
      performed to investigate significant differences in the pressure pain threshold (PTT),
      quality of life, and psychological evaluation results between the groups (α = 0.05 and β =
      0.20). The analysis showed that at least 19 individuals in each group and at least 38
      individuals in total would be sufficient.

      Socio-demographic (age, sex, height, weight, educational status) and clinical data (history
      of bruxism, dominant side, side of the problem, duration of symptoms, dominant chewing side,
      sleeping position, tinnitus/pain, chewing difficulty, and parafunctional oral habits status)
      of individuals meeting the inclusion criteria were recorded onto an evaluation form.

      Individuals in both groups were asked to mark TMJ pain and headache on a 10 cm straight line
      using a visual analog scale (VAS), and the results were recorded in cm. Patients were asked
      about pain in bilateral resting and mobile positions of the TMJ. On the VAS scale, "0"
      indicates no pain, and "10" the most severe pain possible.

      Muscle sensitivity was measured using an algometer (Baseline® dolorimeter/algometer, Pain
      Diagnosis, and Treatment Inc., Great Neck, NY, USA). The algometer is pressed gradually to
      the area where the sensitivity is to be measured, and the measurement is terminated as soon
      as the subject experiences pain. The PPTs of the anterior part of the temporalis muscle, the
      TMJ lateral capsule, and the masseter muscle were measured in the present study. Measurements
      were performed three times at 30-second intervals on both right and left sides. The mean
      values of the three measurements were recorded. PPT is defined as the lowest pressure force
      required to be applied to the tissue for the pain to occur. Results are expressed as kg/cm2.

      The Hospital Anxiety and Depression Scale (HADS) was used to measure participants' anxiety
      and depression levels. The HADS scale was developed by Zigmond and Snaith and contains 14,
      with two sub-scales, one of seven questions (odd numbers) measuring anxiety, and another of
      seven questions (even numbers) measuring depression. Aydemir et al. conducted the Turkish
      validity and reliability study of HADS. Each question is scored between 0 and 3. The lowest
      possible scores for the depression and anxiety subscales were 0, and the maximum possible
      scores were 21. Subjects' depression and anxiety status are evaluated as normal/no symptoms
      (0-7 points), borderline abnormal/suspicious (8-10 points), and abnormal/definite (11-21
      points), depending on the scores obtained.

      Short Form-36 (SF-36) was used to assess the quality of life. Ware et al. developed the SF-36
      in 1987 to determine overall health-related life quality. The scale consists of 36 questions
      and evaluates life quality in the previous four weeks in eight subscales and two main
      components. The subscales are; Physical Function (PF), Role Difficulty-Physical (RP), Body
      Pain (BP), General Health (GH), Vitality (V), Social Function (SF), Role Difficulty-Emotional
      (RE), and Mental Health (MH), while the main components are Physical Component Score (PCS)
      and Mental Component Score (MCS). The eight subscales assess health from 0 to 100 points. "0"
      indicates that health-related quality of life is poor, and 100 indicates the best possible
      quality of life, so higher scores indicate better quality of life. SF-36 was translated into
      Turkish by Koçyiğit et al. and has been subjected to validity and reliability studies.

      The distributions of continuous variables such as age, body mass index (BMI), and SF-36
      scores were examined using the Shapiro-Wilk test and normality graphs. Mean ± standard
      deviation (mean ± sd) and median (min-max: minimum-maximum) were used to express all
      continuous variables, while results for categorical variables such as gender and occupation
      were expressed as percentages (%). The independent samples t-test and Mann-Whitney U test
      were applied to determine the distribution of continuous variables such as SF-36 and HADS
      scores between groups 1 and 2. The relationship between the scale scores and pain threshold
      and pain severity was analyzed using Pearson and Spearman correlation analysis. The
      consistency of responses to SF-36 and HADS was examined using Cronbach's alpha coefficient.
      Statistical significance was set at p <0.05. All statistical analyses and calculations were
      performed on IBM SPSS Statistics 21.0 software (IBM Corp. Released 2012. IBM SPSS Statistics
      for Windows, Armonk, NY: IBM Corp., USA).
observational model: Other
time perspective: Cross-Sectional
measure: Temporomandibular joint pain severity and headache severity
time frame: 5 months
description: Individuals in both groups were asked to mark TMJ pain and headache on a 10 cm straight line using a visual analogue scale (VAS), and the results were recorded in cm. Patients were asked about pain in bilateral resting and mobile positions of the TMJ. On the VAS scale, "0" indicates no pain, and "10" the most severe pain possible.
measure: Psychological status (anxiety and depression levels)
time frame: 5 months
description: The Hospital Anxiety and Depression Scale (HADS) was used to measure participants' anxiety and depression levels. Each question was scored between 0 and 3. The lowest possible scores for the depression and anxiety subscales were 0, and the maximum possible scores were 21. Subjects' depression and anxiety status was evaluated as normal/no symptoms (0-7 points), borderline abnormal/suspicious (8-10 points) and abnormal/definite (11-21 points), depending on the scores obtained.
measure: Short Form-36
time frame: 5 months
description: Short Form-36 (SF-36) was used to assess health-related quality of life. The scale consists of 36 questions and evaluates life quality in the previous four weeks in eight subscales and two main components. The eight subscales assess health from 0 to 100 points. "0" indicates that health-related quality of life is poor, and 100 indicates the best possible quality of life, so higher scores indicate better quality of life.
arm group label: Group 1 (with TMJD)
description: Group 1, consists of 60 patients diagnosed with Temporomandibular Joint Dysfunction (TMJD) according to the Research Diagnostic Criteria for Temporomandibular Disorders by a specialist and experienced dentist in TMJD.
arm group label: Group 2 (without TMJD)
description: Group 2, consists of 60 individuals who did not exhibit TMJD symptoms and have not TMJD diagnosis.
intervention type: Other
intervention name: Evaluation
description: No attempt was made to the individuals in Group 1 and Group 2. Individuals were only evaluated.
arm group label: Group 1 (with TMJD)
arm group label: Group 2 (without TMJD)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 17 Years
maximum age: 57 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nazım Tolgahan YILDIZ, MSc
role: Principal Investigator
affiliation: Hacettepe University
last name: Bahar KÜLÜNKOĞLU, PhD
role: Principal Investigator
affiliation: Ankara Yildirim Beyazıt University
facility: 
country: Turkey
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responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Tolgahan YILDIZ
investigator title: Research Assistant
mesh term: Joint Diseases
mesh term: Temporomandibular Joint Disorders
mesh term: Temporomandibular Joint Dysfunction Syndrome
sharing ipd: No