Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Yozgat, 66100, Turkey (Türkiye)
NCT Number: NCT07292103
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Observational
Yozgat, 66100, Turkey (Türkiye)
Temporomandibular disorder encompasses a spectrum of neuromuscular and musculoskeletal conditions affecting the temporomandibular joint, masticatory muscles, and related structures. Although its etiology is complex, psychological and social factors have been shown to strongly influence symptom severity and persistence. Previous studies have demonstrated associations between temporomandibular disorder, anxiety, depression, and somatization. Childhood trauma and lifetime traumatic experiences are important determinants of long-term psychological and physical health. However, limited research has investigated the combined influence of adverse childhood experiences and cumulative trauma exposure on functional impairment and quality of life in patients with temporomandibular disorder.
This study was designed to evaluate the prevalence and impact of childhood trauma and lifetime trauma exposure on mandibular function and quality of life in patients with temporomandibular disorder compared with healthy controls.
Study Design
This is a prospective, cross-sectional, observational, case-control study conducted between May 2025 and October 2025. The study protocol was approved by the Human Research Ethics Committee (Approval No: 197/2025). Written and verbal informed consent was obtained from all participants prior to enrollment.
Participants
The patient group consists of adults aged 18 to 65 years with a clinical diagnosis of temporomandibular disorder who are cognitively competent, literate, and willing to participate. The control group consists of healthy individuals without a diagnosis of temporomandibular disorder who are matched with the patient group for age and sex. Control participants are also required to be cognitively competent, literate, and willing to provide informed consent.
Data Collection and Assessments
Data are collected through structured, face-to-face interviews conducted by trained researchers at the otorhinolaryngology outpatient clinic of Gaziantep City Hospital. Participants complete a sociodemographic questionnaire and the following validated assessment instruments:
Mandibular Function Impairment Questionnaire: A seventeen-item self-report measure assessing functional limitations of the mandible, with higher scores indicating greater impairment.
Hospital Anxiety and Depression Scale: A fourteen-item questionnaire assessing symptoms of anxiety and depression through two separate subscales.
International Trauma Exposure Measure: A checklist used to identify exposure to potentially traumatic events across childhood, adolescence, and adulthood. It provides subscale scores for each developmental stage as well as a cumulative lifetime trauma score.
Childhood Trauma Questionnaire: A twenty-eight-item instrument assessing retrospective experiences of childhood maltreatment across five domains, including physical abuse, emotional abuse, sexual abuse, physical neglect, and emotional neglect.
Short Form 36 Health Survey: A thirty-six-item questionnaire evaluating health-related quality of life across eight domains, including physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health.
All instruments are administered in person by the same research team to ensure consistency, reliability, and minimization of measurement bias.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
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
Time frame: At baseline
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.
Time frame: At baseline
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.
Time frame: At baseline
The Mandibular Function Impairment Questionnaire is a 17-item self-report questionnaire that evaluates perceived limitations in mandibular function. Each item is rated on a five-point Likert scale ranging from 0 (no difficulty) to 4 (very severe difficulty). Total scores range from 0 to 68, with higher scores indicating greater functional impairment. The questionnaire assesses functional limitations during activities such as chewing, speaking, yawning, and other daily tasks. The Turkish adaptation of the Mandibular Function Impairment Questionnaire has been validated and shown to have high reliability and validity.
Time frame: At baseline
The Hospital Anxiety and Depression Scale is a 14-item questionnaire comprising two subscales: anxiety (7 items) and depression (7 items). Each item is scored from 0 to 3, yielding subscale scores ranging from 0 to 21. Higher scores indicate greater symptom severity. Cut-off values for the depression subscale are defined as follows: 0-7 (normal), 8-10 (mild), 11-14 (moderate), and 15-21 (severe). Similar cut-off values are applied to the anxiety subscale. The Turkish version of the Hospital Anxiety and Depression Scale has been validated and demonstrates good reliability.
Time frame: At baseline
The Short Form 36 Health Survey is a 36-item instrument that assesses health-related quality of life across eight domains: physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored on a scale from 0 to 100, with higher scores indicating better perceived health status. The Turkish version of the Short Form 36 Health Survey has been validated and shown to have strong reliability.
Gulseren Demir Karakilic
Other
Effects of Trauma Exposure and Childhood Trauma on Function and Quality of Life in Patients With Temporomandibular Joint Disorders
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.
Published trials that share one or more normalized conditions with this study.
NCT05183503
Anxiety, Anxiety Disorders
Wroclaw, Poland
View Trial DetailsNCT06186817
Core Stabilization Exercise Therapy, Craniomandibular Disorders
Ankara, Turkey (Türkiye)
View Trial DetailsNCT04214561
Anxiety, Anxiety Disorders
Wroclaw, Poland
View Trial DetailsNCT07125404
Anxiety Disorders, Anxiety State
Santiago, Santiago Metropolitan, Chile
View Trial Details