NCT07292103

Brief Summary

Temporomandibular disorder is a multifactorial condition that involves the temporomandibular joint, masticatory muscles, and surrounding structures and is influenced by biological, psychological, and social factors. Parafunctional habits, bruxism, trauma, and occlusal discrepancies have been recognized as important etiological contributors, while psychosocial stressors and early life experiences also play a critical role. Adverse childhood experiences, including neglect and abuse, have been identified as risk factors for long-term psychological vulnerability and physical health problems. Trauma exposure throughout life may further increase the risk of temporomandibular symptoms and negatively affect functional outcomes and quality of life. The present prospective, cross-sectional case-control study aims to investigate the frequency and impact of childhood trauma and lifetime trauma exposure on functional outcomes and health-related quality of life in patients with temporomandibular disorder. A clinical sample of patients diagnosed with temporomandibular disorder is compared with healthy individuals matched for age and sex. All participants complete standardized questionnaires assessing mandibular function, symptoms of anxiety and depression, cumulative trauma exposure across childhood, adolescence, and adulthood, childhood maltreatment, and health-related quality of life. By systematically integrating validated measures of both early and later traumatic experiences, this study seeks to provide a comprehensive understanding of the contribution of trauma to the severity and psychosocial burden of temporomandibular disorder. The findings are expected to emphasize the importance of incorporating trauma screening and psychological assessment into the routine evaluation and multidisciplinary management of patients with temporomandibular disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 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

May 22, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
2 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

5 months

First QC Date

December 5, 2025

Last Update Submit

December 20, 2025

Conditions

Keywords

Temporomandibular Joint DisorderTemporomandibular DisorderTemporomandibular DysfunctionMandibular Function Impairment QuestionnaireHospital Anxiety and Depression ScaleInternational Trauma Exposure MeasureChildhood Trauma QuestionnaireShort Form-36 Health SurveyTrauma ExposureChildhood MaltreatmentAdverse Childhood ExperiencesAnxietyDepressionPsychosocial FactorsQuality of Life

Outcome Measures

Primary Outcomes (2)

  • International Trauma Exposure Measure

    The International Trauma Exposure Measure is a standardized checklist designed to evaluate exposure to potentially traumatic events according to the definition of trauma in the International Classification of Diseases, Eleventh Revision. The instrument assesses trauma exposure across three developmental periods: childhood (0-12 years), adolescence (13-18 years), and adulthood (older than 18 years). Subscale scores are calculated separately for each developmental period, and a cumulative lifetime trauma score is obtained by summing all reported events across the lifespan. The Turkish version of the International Trauma Exposure Measure has been validated and demonstrates strong reliability and psychometric properties.

    At baseline

  • Childhood Trauma Questionnaire

    The Childhood Trauma Questionnaire is a 28-item self-report instrument that retrospectively assesses experiences of childhood maltreatment. It consists of five subscales: physical abuse, emotional abuse, sexual abuse, physical neglect, and emotional neglect. Three additional items assess denial or minimization of abuse. Each item is scored on a five-point Likert scale ranging from 1 (never true) to 5 (very often true). Higher subscale and total scores indicate greater severity of childhood trauma. The Turkish adaptation of the Childhood Trauma Questionnaire has been validated and has demonstrated high internal consistency and test-retest reliability.

    At baseline

Secondary Outcomes (3)

  • Mandibular Function Impairment Questionnaire

    At baseline

  • Hospital Anxiety and Depression Scale

    At baseline

  • Short Form 36 Health Survey

    At baseline

Study Arms (2)

Temporomandibular Disorder Group

Adults aged 18 to 65 years with a clinical diagnosis of temporomandibular disorder were included. Participants were cognitively competent, literate, and provided written informed consent. All participants completed structured interviews and standardized questionnaires, including the Mandibular Function Impairment Questionnaire, the Hospital Anxiety and Depression Scale, the International Trauma Exposure Measure, the Childhood Trauma Questionnaire, and the Short Form 36 Health Survey.

Healthy Control Group

Adults aged 18 to 65 years without a clinical diagnosis of temporomandibular disorder were included. The control group was matched to the patient group according to age and sex. All participants were cognitively competent, literate, and provided written informed consent. Participants in the control group completed the same structured interviews and standardized questionnaires as the patient group, including the Mandibular Function Impairment Questionnaire, the Hospital Anxiety and Depression Scale, the International Trauma Exposure Measure, the Childhood Trauma Questionnaire, and the Short Form 36 Health Survey.

Eligibility Criteria

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

This study included adults aged 18 to 65 years who were recruited from the Otorhinolaryngology outpatient clinic of Gaziantep City Hospital, Türkiye. The patient group consisted of individuals who were clinically diagnosed with temporomandibular disorder, while the control group comprised healthy volunteers without a diagnosis of temporomandibular disorder who were matched to the patient group for age and sex. All participants were cognitively intact, literate, and provided written informed consent prior to participation.

You may qualify if:

  • Adults aged 18 to 65 years
  • Clinically diagnosed with temporomandibular disorder according to standardized clinical evaluation
  • Cognitively competent and literate individuals capable of completing questionnaires
  • Voluntary agreement to participate and provision of written informed consent

You may not qualify if:

  • History of neurological, psychiatric, or systemic diseases that may affect study participation or data reliability
  • Cognitive impairment that prevents completion of questionnaires
  • History of major maxillofacial surgery or trauma not related to temporomandibular disorder
  • Current substance abuse or alcohol dependence
  • Refusal or inability to provide informed consent

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 (6)

  • Kocyigit, H., Turkish validity and reliability of short-form 36. Drug Treat, 1999. 12: p. 102-106

    BACKGROUND
  • Şar, V., P.E. ÖZTÜRK, and E. İkikardeş, Çocukluk çağı ruhsal travma ölçeğinin Türkçe uyarlamasının geçerlilik ve güvenilirliği. Turkiye Klinikleri Journal of Medical Sciences, 2012. 32(4): p. 1054-1063.

    BACKGROUND
  • Gündoğmuş, İ., et al., Psychometric properties of the Turkish version of the International Trauma Questionnaire. Journal of Aggression, Maltreatment & Trauma, 2023. 32(12): p. 1847-1865.

    BACKGROUND
  • Hyland P, Karatzias T, Shevlin M, McElroy E, Ben-Ezra M, Cloitre M, Brewin CR. Does requiring trauma exposure affect rates of ICD-11 PTSD and complex PTSD? Implications for DSM-5. Psychol Trauma. 2021 Feb;13(2):133-141. doi: 10.1037/tra0000908. Epub 2020 Sep 10.

    PMID: 32915045BACKGROUND
  • 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 DisordersDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesBehavioral SymptomsBehaviorMental Disorders

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

May 22, 2025

Primary Completion

October 10, 2025

Study Completion

October 10, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Individual participant data (individual participant data) collected during this study, including all de-identified questionnaire and assessment data related to temporomandibular disorder, trauma exposure, childhood experiences, and quality of life, will be made available by the corresponding author upon reasonable request for research purposes.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
De-identified individual participant data and supporting documents will be available after publication of the study results and will remain accessible for five years following publication.
Access Criteria
Researchers who submit a scientifically sound proposal may request access to the de-identified dataset for academic and non-commercial use. Requests should be submitted to the corresponding author via email. Access will be granted following institutional and ethical approval through a secure data-sharing process.
More information

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