Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT06707467
Status:
RECRUITING
Last Update Posted:
2024-11-27
First Post:
2024-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Postural Exercises in the Treatment of Temporomandibular Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013705', 'term': 'Temporomandibular Joint 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017090', 'term': 'Occlusal Splints'}], 'ancestors': [{'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients with internal temporomandibular derangement are divided into three groups. The first group receives only occlusal splint therapy. The second group undergoes occlusal splint therapy combined with Rocabado exercises, while the third group is treated with occlusal splint therapy combined with postural exercises. The effectiveness of the treatment protocols is evaluated.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 57}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-23', 'studyFirstSubmitDate': '2024-11-21', 'studyFirstSubmitQcDate': '2024-11-23', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigation of the Effect of Postural Exercises and Rocabado Exercises on Pain Reduction', 'timeFrame': '2 months', 'description': "Three different treatment protocols will be applied to patients with internal temporomandibular derangement, and the results obtained after a 2-month treatment period will be compared to determine which method is the most effective. To evaluate treatment outcomes, the patients' pre- and post-treatment Visual Analog Scale (VAS) scores will be assessed, with a decrease in the mean VAS score indicating a reduction in pain. Additionally, the pain threshold in various facial regions will be measured with an algometer before and after treatment to identify which treatment protocol is more effective in reducing pain. By combining both outcomes, the most effective method for pain reduction will be determined."}, {'measure': 'Investigation of the Effect of Postural Exercises and Rocabado Exercises on Physiological Movements', 'timeFrame': '2 months', 'description': 'Changes in cervical range of motion (C-ROM) and the craniovertebral angle will also be evaluated to determine the impact of the treatment methods on these parameters. In this way, the method that is more effective in improving physiological movements will be identified.'}], 'secondaryOutcomes': [{'measure': "Investigation of the Secondary Effects of Postural Exercises and Rocabado Exercises on Patient's Psychology", 'timeFrame': '2 months', 'description': 'The effect of the treatment protocols applied to the three different groups on the general psychology of the patients will be measured using the Hospital Anxiety and Depression Scale (HADS). In this test, a higher score indicates a higher level of depressive symptoms, and a successful treatment is expected to result in a decrease in the test score.'}, {'measure': 'Investigation of the Effect of Postural Exercises and Rocabado Exercises on the Mobility of the Neck and Jaw', 'timeFrame': '2 month', 'description': "The patient's neck movements will be assessed, and the range of jaw movements will be evaluated. The study aims to identify which treatment protocol leads to the most significant improvement in jaw and neck mobility."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['temporomandibular disorders', 'rocabado', 'occlusal splints', 'posture excercise'], 'conditions': ['Occlusal Splints', 'Temporomandibular Disorders (TMD)']}, 'descriptionModule': {'briefSummary': 'Fifty-seven patients diagnosed with internal temporomandibular derangement will be included in the study and divided into three groups. All patients will be treated with a proven-effective occlusal splint. The first group will receive only occlusal splint therapy and will serve as the control group. The second group will receive occlusal splint therapy combined with Rocabado exercises, while the third group will receive occlusal splint therapy combined with postural exercises.\n\nBefore the treatment process, all patients will complete the Temporomandibular Disorders Diagnostic Criteria (TMD-DC) form. Pain intensity will be measured using the Visual Analog Scale (VAS), pain thresholds will be assessed using an algometer, and the following evaluations will be performed: Cervical Posture Assessment (Craniovertebral Angle with Goniometer)-Cervical Range of Motion Assessment (C-ROM)-Cervical Deep Flexor Muscle Endurance Test-Neck Disability Assessment (NDI - Neck Disability Index)-Psychiatric Assessment (HADS - Hospital Anxiety and Depression Scale).\n\nAfter two months, patients will be recalled, and all tests will be repeated. The effectiveness of the three treatment protocols will then be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosed with internal temporomandibular disarrangement\n* aged 18 years or older\n* Willingness to participate in the study\n* Ability to speak and understand Turkish, with no communication difficulties severe enough to impede understanding of the exercises\n\nExclusion Criteria:\n\n* History of acute trauma in the TMJ or surrounding area\n* TMJ dysfunction caused by a neurological condition\n* History of surgical/invasive procedures or treatments on the TMJ\n* Presence of infection or tumoral structures within intraoral structures\n* History of tooth loss or use of dental prostheses\n* History of surgical procedures in the cervical region'}, 'identificationModule': {'nctId': 'NCT06707467', 'briefTitle': 'Evaluation of Postural Exercises in the Treatment of Temporomandibular Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Determination of the Effectiveness of Postural Exercises Combined with Occlusal Splint Therapy in Internal Temporomandibular Derangements', 'orgStudyIdInfo': {'id': '2023-186'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nineteen patients with internal temporomandibular disarrangement-group 1', 'description': 'Nineteen randomly selected patients with internal temporomandibular disarrangement', 'interventionNames': ['Other: occlusal splints combined with rocabado exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nineteen patients with internal temporomandibular disarrangement-group 2', 'description': 'nineteen randomly selected patients with internal temporomanidbular disarrangement', 'interventionNames': ['Other: occlusal splint']}, {'type': 'EXPERIMENTAL', 'label': 'nineteen patients with internal temporomandibular disarrangement-group 3', 'description': 'nineteen selected patients with internal temporomandibular disarrangements', 'interventionNames': ['Other: occlusal splint combined with posture exercise']}], 'interventions': [{'name': 'occlusal splint', 'type': 'OTHER', 'description': 'nineteen patients diagnosed with internal temporomandibular derangement will receive occlusal splint therapy, a treatment method with proven effectiveness.', 'armGroupLabels': ['nineteen patients with internal temporomandibular disarrangement-group 2']}, {'name': 'occlusal splints combined with rocabado exercise', 'type': 'OTHER', 'description': 'Nineteen patients diagnosed with internal temporomandibular derangement will be provided with Rocabado exercises in addition to the proven-effective treatment method of occlusal splint therapy. This approach aims to evaluate whether Rocabado exercises have a positive effect on the treatment process.', 'armGroupLabels': ['nineteen patients with internal temporomandibular disarrangement-group 1']}, {'name': 'occlusal splint combined with posture exercise', 'type': 'OTHER', 'description': 'Nineteen patients diagnosed with internal temporomandibular derangement will be provided with posture exercises in addition to the proven-effective treatment method of occlusal splint therapy. This approach aims to evaluate whether posture exercises have a positive effect on the treatment process.', 'armGroupLabels': ['nineteen patients with internal temporomandibular disarrangement-group 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Berk Bilgen, Research Assistant', 'role': 'CONTACT', 'email': 'berk.bilgen@istanbul.edu.tr', 'phone': '+905385492774'}, {'name': 'Berk Bilgen, Research Assistant PhD', 'role': 'CONTACT'}, {'name': 'Tuğçe Bilgiç, Research Assistant', 'role': 'CONTACT'}, {'name': 'Olcay Sakar, Clinical Prof. Dr.', 'role': 'CONTACT'}], 'facility': 'Istanbul University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Berk Bilgen, Research Assistant', 'role': 'CONTACT', 'email': 'berk.bilgen@istanbul.edu.tr', 'phone': '+905385492774'}], 'overallOfficials': [{'name': 'Ebru K Mutlu, Clinical Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bandırma Onyedi Eylül University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bandırma Onyedi Eylül University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD DDS Research Assistant', 'investigatorFullName': 'Berk Bilgen', 'investigatorAffiliation': 'Istanbul University'}}}}