NCT07292064

Brief Summary

This study aimed to investigate the relationship between Type D personality traits, somatization disorder, and perceived social support in individuals diagnosed with temporomandibular joint disorders. Temporomandibular joint disorders are musculoskeletal and neuromuscular conditions that affect the jaw joint, chewing muscles, and related structures, leading to pain and functional difficulties. Psychological and social factors, such as personality traits and emotional distress, have been shown to influence the development and persistence of these disorders. The research was conducted as a prospective cross-sectional study between February and June 2025 in Gaziantep City Hospital. Adult participants between 18 and 65 years of age who were diagnosed with temporomandibular joint disorders were compared with healthy individuals of similar age and gender. Participants completed validated questionnaires that assessed mandibular function, anxiety and depression symptoms, Type D personality traits, somatization tendencies, and levels of perceived social support. The purpose of this study was to provide a more comprehensive understanding of the psychological and social dimensions that may contribute to the onset and course of temporomandibular joint disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

December 5, 2025

Last Update Submit

December 21, 2025

Conditions

Keywords

Temporomandibular Joint PainPsychosocial FactorsPersonality TraitsSocial InhibitionNegative AffectivityMandibular FunctionAnxiety and DepressionBiopsychosocial Model

Outcome Measures

Primary Outcomes (3)

  • Type D Personality Traits

    The primary outcome of this study was the evaluation of Type D personality traits in individuals with temporomandibular joint disorders compared to healthy controls. Type D personality was assessed with a fourteen-item scale measuring two main dimensions: negative emotions and social inhibition. Each item is scored from zero to four. A score of ten or more in both dimensions indicates the presence of Type D personality traits. The Turkish version of the scale has been validated and shown to be reliable. Higher total scores indicate stronger negative emotional responses and greater social inhibition.

    At the time of study enrollment.

  • the Somatization Scale

    Somatic symptom severity was measured using a thirty-three-item true or false questionnaire. Seventeen items are reverse-coded to control for response bias. One point is given for each correct standard response and for incorrect responses to reverse-coded items. The total score ranges from zero to thirty-three, with higher scores reflecting more pronounced somatization tendencies. The Turkish version of this instrument has demonstrated reliability and construct validity in previous psychometric evaluations.

    At the time of study enrollment.

  • the Multidimensional Scale of Perceived Social Support

    Perceived emotional and practical support was evaluated using a twelve-item questionnaire measuring three main sources of support: family, friends, and a significant other. Each statement is rated on a seven-point scale ranging from one (very strongly disagree) to seven (very strongly agree). Subscale scores range from four to twenty-eight, and total scores range from twelve to eighty-four. Higher scores indicate greater perceived social support. The Turkish version of this scale has been shown to have high reliability and validity

    At the time of study enrollment.

Secondary Outcomes (2)

  • the Hospital Anxiety and Depression Scale

    At the time of study enrollment

  • the Mandibular Function Impairment Questionnaire

    At the time of study enrollment.

Study Arms (2)

Temporomandibular Joint Disorder Group

Adults aged 18-65 years who were clinically diagnosed with temporomandibular joint disorders at the Otorhinolaryngology outpatient clinic of Gaziantep City Hospital. Participants completed questionnaires evaluating mandibular function, anxiety, depression, personality traits, somatization, and perceived social support. No medical or pharmacological intervention was applied.

Healthy Control Group

Healthy adults aged 18-65 years with no diagnosis or symptoms of temporomandibular joint disorders. The control participants were matched to the patient group by age and gender and completed the same psychological and functional assessment questionnaires.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients aged 18 to 65 years who were diagnosed with temporomandibular joint disorders and presented to the Otorhinolaryngology outpatient clinic at Gaziantep City Hospital. In addition, age- and sex-matched healthy volunteers without temporomandibular joint disorders were included as the control group.

You may qualify if:

  • Adults aged 18-65 years
  • Ability to read and write
  • Cognitively intact
  • Patients diagnosed with temporomandibular joint disorders or healthy volunteers

You may not qualify if:

  • Younger than 18 years or older than 65 years
  • Illiteracy
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Yozgat, Yozgat, 66100, Turkey (Türkiye)

Location

Related Publications (7)

  • Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.

    PMID: 2280326BACKGROUND
  • Eker, D., Cok boyutlu algilanan sosyal destek olceginin gozden gecirilmis formunun faktor yapisi, gecerlik ve guvenirligi. Turk Psikiyatri Dergisi, 2001. 12: p. 17-25.

    BACKGROUND
  • Dülgerler, Ş., İlköğretim okulu öğretmenlerinde somatizasyon ölçeğinin geçerlik ve güvenirlik çalışması. Unpublished master dissertation). Ege University, İzmir, 2000.

    BACKGROUND
  • Öncü, E. and S.K. Vayısoğlu, D tipi kişilik ölçeğinin Türk toplumunda geçerlilik ve güvenirlilik çalışması. Ankara Medical Journal, 2018. 18(4): p. 646-656.

    BACKGROUND
  • Denollet J. DS14: standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosom Med. 2005 Jan-Feb;67(1):89-97. doi: 10.1097/01.psy.0000149256.81953.49.

    PMID: 15673629BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint DisordersSomatoform DisordersAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Gülseren Demir Karakılıç, Assistant Professor

    Yozgat Bozok University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Principal Investigator

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 18, 2025

Study Start

February 20, 2025

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

The datasets generated and analyzed during the current study will be available from the corresponding author upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The individual participant data and supporting documents will be available beginning six months after publication of the main results and will remain available for a minimum of five years.
Access Criteria
Individual participant data and supporting documents will be accessible to qualified researchers upon submission of a reasonable request to the corresponding author. Requests should include a methodologically sound research proposal and a commitment to use the data only for research purposes. Data will be shared in de-identified form to protect participant confidentiality.
More information

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