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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D017271', 'term': 'Craniomandibular Disorders'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the International Trauma Exposure Measure', 'timeFrame': 'At baseline', 'description': 'The International Trauma Exposure Measure is a standardized checklist that evaluates exposure to potentially traumatic events based on the definition of trauma in the International Classification of Diseases 11th edition. It assesses events across three developmental periods: childhood (0-12 years), adolescence (13-18 years), and adulthood (after 18 years). Subscale scores are calculated for each developmental stage, and a cumulative lifetime trauma score is derived by summing all events across the lifespan. The Turkish version has been validated with strong reliability and psychometric properties'}, {'measure': 'the Childhood Trauma Questionnaire', 'timeFrame': 'At baseline', 'description': 'The Childhood Trauma Questionnaire is a 28-item self-report instrument that retrospectively assesses childhood maltreatment. It includes five subscales: physical abuse, emotional abuse, sexual abuse, physical neglect, and emotional neglect. Three additional items evaluate denial or minimization. Each item is scored on a five-point Likert scale ranging from 1 (never true) to 5 (very often true). The total score indicates the overall severity of childhood trauma. Higher scores in subscales reflect greater severity in the corresponding domain. The Turkish adaptation has been validated and shown to have high internal consistency and test-retest reliability.'}], 'secondaryOutcomes': [{'measure': 'the Mandibular Function Impairment Questionnaire', 'timeFrame': 'At baseline', 'description': '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). The total score ranges from 0 to 68, with higher scores indicating greater functional impairment. The instrument evaluates mandibular function in activities such as chewing, speaking, yawning, and other daily tasks. The Turkish adaptation and psychometric validation of the Mandibular Function Impairment Questionnaire have been conducted and shown to have high reliability and validity.'}, {'measure': 'the Hospital Anxiety and Depression Scale', 'timeFrame': 'At baseline', 'description': 'The Hospital Anxiety and Depression Scale consists of 14 items with two subscales: anxiety (7 items) and depression (7 items). Each item is scored from 0 to 3, producing subscale scores ranging from 0 to 21. Higher scores indicate more severe symptoms. Cut-off points for the depression subscale are as follows: 0-7 = normal, 8-10 = mild, 11-14 = moderate, and 15-21 = severe. Similar cut-offs are used for the anxiety subscale. The Turkish version of the scale has been validated and demonstrated good reliability.'}, {'measure': 'Short Form-36 Health Survey', 'timeFrame': 'At baseline', 'description': 'The Short Form-36 Health Survey is a 36-item questionnaire that evaluates quality of life across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored from 0 to 100, with higher scores reflecting better perceived health. The Turkish version has been validated and shown to have robust reliability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Temporomandibular Joint Disorder', 'Temporomandibular Disorder', 'Temporomandibular Dysfunction', 'Mandibular Function Impairment Questionnaire', 'Hospital Anxiety and Depression Scale', 'International Trauma Exposure Measure', 'Childhood Trauma Questionnaire', 'Short Form-36 Health Survey', 'Trauma Exposure', 'Childhood Maltreatment', 'Adverse Childhood Experiences', 'Anxiety', 'Depression', 'Psychosocial Factors', 'Quality of Life'], 'conditions': ['Temporomandibular Disorder', 'Temporomandibular Joint Dysfunction', 'Trauma Exposure', 'Childhood Traumas', 'Psychological Distress', 'Quality of Life Impairment']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Kocyigit, H., Turkish validity and reliability of short-form 36. Drug Treat, 1999. 12: p. 102-106'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32915045', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nBy 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.', 'detailedDescription': '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.\n\nThis 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.\n\nStudy Design\n\nThis 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.\n\nParticipants\n\nThe 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.\n\nData Collection and Assessments\n\nData 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:\n\nMandibular Function Impairment Questionnaire (MFIQ): A 17-item self-report measure assessing functional limitation of the mandible. Higher scores indicate greater impairment.\n\nHospital Anxiety and Depression Scale (HADS): A 14-item scale measuring symptoms of anxiety and depression, with two separate subscales.\n\nInternational 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.\n\nChildhood 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.\n\nShort 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.\n\nAll instruments are administered in person by the same research team to ensure reliability and minimize bias.\n\nStatistical Analysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study included adults aged 18-65 years recruited from the Otorhinolaryngology outpatient clinic of Gaziantep City Hospital, Türkiye. The patient group consisted of individuals clinically diagnosed with temporomandibular disorder (TMD), while the control group comprised healthy volunteers matched for age and gender without any diagnosis of TMD. All participants were cognitively intact, literate, and provided informed consent prior to participation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults aged 18-65 years\n\nClinically diagnosed with Temporomandibular Disorder (TMD) according to clinical evaluation\n\nCognitively competent and literate individuals\n\nVoluntarily agreed to participate and provided written informed consent\n\nExclusion Criteria:\n\nHistory of neurological, psychiatric, or systemic diseases that may affect participation or data reliability\n\nCognitive impairment preventing questionnaire completion\n\nPrevious major maxillofacial surgery or trauma unrelated to TMD\n\nCurrent substance abuse or alcohol dependency\n\nRefusal or inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07292103', 'briefTitle': 'Trauma Exposure and Childhood Trauma in Temporomandibular Joint Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Bozok University'}, 'officialTitle': 'Effects of Trauma Exposure and Childhood Trauma on Function and Quality of Life in Patients With Temporomandibular Joint Disorders', 'orgStudyIdInfo': {'id': '197/2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Temporomandibular Disorder Group', 'description': '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. They 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.'}, {'label': 'Healthy Control Group', 'description': 'Adults aged 18 to 65 years without a clinical diagnosis of temporomandibular disorder were included. The control group was matched to the patient group for age and sex. All participants were cognitively competent, literate, and provided written informed consent. They 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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66100', 'city': 'Yozgat', 'state': 'Yozgat', 'country': 'Turkey (Türkiye)', 'facility': 'Yozgat Bozok University Faculty of Medicine, Department of Physical Medicine and Rehabilitation', 'geoPoint': {'lat': 39.82, 'lon': 34.80444}}]}, 'ipdSharingStatementModule': {'url': 'https://hastane.bozok.edu.tr/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'De-identified individual participant data and supporting documents will be available after publication of the study results. Data will remain available for five years following publication.', 'ipdSharing': 'YES', 'description': '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 from the corresponding author upon reasonable request for research purposes.', 'accessCriteria': 'Researchers with 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 by email. Access will be granted after institutional and ethical approval through a secure data-sharing process.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gulseren Demir Karakilic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bozok University', 'class': 'OTHER'}, {'name': 'Gaziantep City Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Principal Investigator', 'investigatorFullName': 'Gulseren Demir Karakilic', 'investigatorAffiliation': 'Bozok University'}}}}