Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:03 PM
Study NCT ID:
NCT07292103
Status:
COMPLETED
Last Update Posted:
2025-12-18
First Post:
2025-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trauma Exposure and Childhood Trauma in Temporomandibular Joint Disorders
Sponsor:
Gulseren Demir Karakilic
Organization:
Study Overview
Official Title:
Effects of Trauma Exposure and Childhood Trauma on Function and Quality of Life in Patients With Temporomandibular Joint Disorders
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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, but psychosocial stressors and early life experiences also play a critical role. Adverse childhood experiences, such as neglect and abuse, have been identified as risk factors for long-term psychological vulnerability and physical health problems. Trauma exposure throughout life may also increase the risk of temporomandibular symptoms and worsen functional and quality of life outcomes.
The present prospective, cross-sectional case-control study aims to investigate the frequency and effects 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 that evaluate mandibular function, anxiety and depression symptoms, 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 how trauma contributes to the severity of temporomandibular disorder and its psychosocial burden. The findings are expected to highlight the importance of including trauma screening and psychological assessment in the routine evaluation and multidisciplinary management of patients with temporomandibular disorder.
The present prospective, cross-sectional case-control study aims to investigate the frequency and effects 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 that evaluate mandibular function, anxiety and depression symptoms, 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 how trauma contributes to the severity of temporomandibular disorder and its psychosocial burden. The findings are expected to highlight the importance of including trauma screening and psychological assessment in the routine evaluation and multidisciplinary management of patients with temporomandibular disorder.
Detailed Description:
Temporomandibular disorder encompasses a spectrum of neuromuscular and musculoskeletal conditions affecting the temporomandibular joint, masticatory muscles, and related structures. While the etiology is complex, psychological and social factors have been shown to strongly influence symptom severity and persistence. Previous studies have indicated 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, there is limited research investigating 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 to 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.
Participants
The patient group consists of adults aged 18 to 65 years who have a clinical diagnosis of temporomandibular disorder, are cognitively competent, literate, and provide voluntary consent to participate. The control group consists of healthy individuals without a diagnosis of temporomandibular disorder, matched with the patient group for age and sex. Control participants are also required to be cognitively competent, literate, and provide consent.
Data Collection and Assessments
Data are collected in structured, face-to-face interviews by trained researchers at the Otorhinolaryngology outpatient clinic of Gaziantep City Hospital. Participants complete a sociodemographic questionnaire and the following validated instruments:
Mandibular Function Impairment Questionnaire (MFIQ): A 17-item self-report measure assessing functional limitation of the mandible. Higher scores indicate greater impairment.
Hospital Anxiety and Depression Scale (HADS): A 14-item scale measuring symptoms of anxiety and depression, with two separate subscales.
International Trauma Exposure Measure (ITEM): A checklist identifying exposure to potentially traumatic events across childhood, adolescence, and adulthood. Provides subscale scores for each developmental stage and a cumulative lifetime trauma score.
Childhood Trauma Questionnaire (CTQ): A 28-item instrument assessing retrospective experiences of childhood maltreatment across five domains: physical abuse, emotional abuse, sexual abuse, physical neglect, and emotional neglect.
Short Form-36 Health Survey (SF-36): A 36-item instrument evaluating health-related quality of life across eight domains: 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 reliability and minimize bias.
Statistical Analysis
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 to 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.
Participants
The patient group consists of adults aged 18 to 65 years who have a clinical diagnosis of temporomandibular disorder, are cognitively competent, literate, and provide voluntary consent to participate. The control group consists of healthy individuals without a diagnosis of temporomandibular disorder, matched with the patient group for age and sex. Control participants are also required to be cognitively competent, literate, and provide consent.
Data Collection and Assessments
Data are collected in structured, face-to-face interviews by trained researchers at the Otorhinolaryngology outpatient clinic of Gaziantep City Hospital. Participants complete a sociodemographic questionnaire and the following validated instruments:
Mandibular Function Impairment Questionnaire (MFIQ): A 17-item self-report measure assessing functional limitation of the mandible. Higher scores indicate greater impairment.
Hospital Anxiety and Depression Scale (HADS): A 14-item scale measuring symptoms of anxiety and depression, with two separate subscales.
International Trauma Exposure Measure (ITEM): A checklist identifying exposure to potentially traumatic events across childhood, adolescence, and adulthood. Provides subscale scores for each developmental stage and a cumulative lifetime trauma score.
Childhood Trauma Questionnaire (CTQ): A 28-item instrument assessing retrospective experiences of childhood maltreatment across five domains: physical abuse, emotional abuse, sexual abuse, physical neglect, and emotional neglect.
Short Form-36 Health Survey (SF-36): A 36-item instrument evaluating health-related quality of life across eight domains: 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 reliability and minimize bias.
Statistical Analysis
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: