Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT05830604
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2023-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Muscle Activity on Subjective Tinnitus in Temporomandibular Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}, {'id': 'D013705', 'term': 'Temporomandibular Joint Disorders'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-20', 'size': 310998, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-24T07:32', 'hasProtocol': True}, {'date': '2021-12-20', 'size': 185774, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-24T07:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2023-04-24', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Masseters Activity', 'timeFrame': '6th months', 'description': 'To evaluate the symmetry and electrical activity of masseters by surface EMG'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tinnitus, Subjective', 'Temporomandibular Disorder']}, 'descriptionModule': {'briefSummary': "Treatment of Temporomandibular Joint Disorder can help reduce subjective tinnitus levels. This treatment changes the electrical activity of the patient's chewing muscles. For this reason, the relationship between muscular change and tinnitus levels can be evaluated.", 'detailedDescription': "The study will be conducted with patients who routinely apply to Kütahya Health Sciences University Faculty of Dentistry. 70 patients with temporomandibular disease accompanied by tinnitus and bruxism will be included in the study. Demographic data such as age, gender, and systemic disease, drug and trauma history data will be collected.\n\nTMD findings of the patients will be classified according to Wilkes classification. The Wilkes classification is as follows:\n\n1. Stage 1 (early period): No pain or limitation of jaw movements, only reciprocal click during or after chewing. Mild anterior disc displacement in radiological evaluation.\n2. Stage 2 (early/intermediate): Mild to moderate pain with reciprocal clicking and periodic locking. Change in disc position.\n3. Stage 3 (intermediate): Joint tenderness with frequent pain. Ongoing crash. On the radiological image, changes in disc position and deformation with adhesions.\n4. Stage 4 (intermediate/late): Chronic pain that gets worse from time to time and limitation in jaw movements. Change in the shape and position of the disc and the shape of the condyle. Multiple adhesions with hard tissue changes.\n5. Stage 5 (late stage): pain that occurs from time to time with crepitation.\n\nBruxism data (time of onset, whether it is felt during the day/night, fatigue, difficulty in opening the mouth in the morning, stressful period) are questioned and examination findings (disc displacement, masseter hypertrophy on inspection, linea alba, attrition of teeth, fractures in restorations and teeth, muscle and joint pain) , facial asymmetry, mouth opening) will be recorded. The characteristics of tinnitus (objective/subjective, duration, in which ear, increasing and decreasing factors, type) and hearing loss, vertigo will be questioned.\n\nPatients will be divided into two groups. Group I will consist of Wilkes Stage 1-2 patients with temporomandibular intra-articular disorder. Group II will consist of patients with both Wilkes Stage 1-2 temporomandibular intra-articular disorder and bruxism.\n\nIn order to measure the muscle strength of the patients before the treatment, EMG containing right-left M. Masseters will be taken in order to easily reach the chewing muscles and to minimize the patient's discomfort. The analog EMG signal will be amplified using a differential amplifier with a high common-mode rejection ratio (bandwidth 5 KHz, peak-to-peak input range 200 μV). The average of the signals is over 500 ms. (Micromed, Italy)\n\nSuperficial EMG will be taken following the following protocol:\n\nTo reduce skin impedance, the skin will be cleaned before electrode placement and recordings will be made after 5-6 minutes.\n\nSuperficial electrodes will be placed on the right and left masseter muscles, with the upper pole of the electrode parallel to the intersection between the tragus-labial commissura and the exocantion-gonion lines. The grounding electrode will be placed in the forehead area.\n\nFor all tests, patients will be seated with their head unsupported and asked to maintain a natural upright position.\n\nTo avoid any effects of fatigue, a rest period of at least 3 minutes will be allowed between tests. The average EMG potential for each of the muscles will be set to 100%.\n\nTo standardize EMG potentials, two 10 mm thick cotton rolls will be placed on each subject's mandibular first and second molars, and maximum voluntary clamping of 5 seconds will be recorded. For 5 seconds, the patient will be encouraged to maintain the same level of contraction. EMG data analysis for all tests, the best 3-s period (the one with the most stable signal) will be automatically selected by the software and used for all subsequent analysis.\n\nElectromyographic activity will then be recorded with a maximum voluntary squeeze at the intercuspal position; The patient will be invited to squeeze as hard as possible and maintain the same level of contraction for 5 seconds. Electromyographic activity will also be taken again while the patient is at rest.\n\nFor each subject, the EMG potentials of the analyzed muscles recorded during the maximum voluntary clamping tests will be expressed as a percentage of the average potential recorded during the standardization test (maximum voluntary clamping on cotton rolls).\n\n(μV/μV×100). To assess muscle symmetry, the EMG waves of the masseter muscles will then be compared by calculating a percent overlap coefficient (POC, %). POC is an index of the symmetrical distribution of muscle activity determined by occlusion. The index ranges from 0% to 100%: a POC of 100% will be achieved when two paired muscles contract with perfect symmetry.\n\nTinnitus and bruxism will be evaluated by the patient with the VAS score. Tinnitus level will additionally be measured with the Tinnitus Handicap Inventory. Then, an occlusal splint will be prepared for the patients. It will be recommended to use them for 24 weeks. Postoperative EMG, Tinnitus Handicap Inventory and VAS scores will be re-evaluated after the use of the occlusal splint.\n\nThe obtained data beam when; Age, gender, disease findings, preoperative and postoperative Tinnitus Handicap Inventory and VAS scores, masseter and temporal muscle strength in EMG will be compared and evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients older than 18 years\n* Patients with chronic subjective tinnitus\n* Patients with Wilkes Stage 1-2\n\nExclusion Criteria:\n\n* Patients with Wilkes Stage 3-4-5\n* Patients with tinnitus due to audiological, neurological, metabolic or pathological reasons\n* Patients with objective tinnutus\n* Patients with normal tinnitus\n* Mentally retarded patients\n* Hearing loss, use of ototoxic drugs\n* Those with ear diseases such as acute ostitis media, perforated tympanic membrane\n* Those with Meniere's disease\n* Patients with middle ear pathology\n* Those with intracranial pathology\n* Those with traumatic cervical spine injury\n* Patients with severe depression diagnosed by a psychologist\n* Patients who have received TMB treatment in the last two months"}, 'identificationModule': {'nctId': 'NCT05830604', 'briefTitle': 'Evaluation of the Effect of Muscle Activity on Subjective Tinnitus in Temporomandibular Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Kutahya Health Sciences University'}, 'officialTitle': 'Evaluation of the Effect of Muscle Activity on Subjective Tinnitus in Temporomandibular Disorders', 'orgStudyIdInfo': {'id': '2021-09/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TMD Wilkes Stage I-II and Subjective Tinnitus', 'description': 'Patients with subjective tinnitus and temporomandibular disorder. It was treated with an occlusal splint.', 'interventionNames': ['Procedure: Occlusal Splint Treatment- Non Invasive treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TMD Wilkes Stage I-II, Subjective Tinnitus and Bruxism', 'description': 'Patients with subjective tinnitus and temporomandibular disorder and bruxism. It was treated with an occlusal splint.', 'interventionNames': ['Procedure: Occlusal Splint Treatment- Non Invasive treatment']}], 'interventions': [{'name': 'Occlusal Splint Treatment- Non Invasive treatment', 'type': 'PROCEDURE', 'description': 'Each patient in the study had temporomandibular disorder. The first-line routine treatment of this disease is an occlusal splint. This treatment was applied to each patient. Surgical intervention was not performed.', 'armGroupLabels': ['TMD Wilkes Stage I-II and Subjective Tinnitus', 'TMD Wilkes Stage I-II, Subjective Tinnitus and Bruxism']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43100', 'city': 'Kütahya', 'country': 'Turkey (Türkiye)', 'facility': 'Kütahya Health Science University', 'geoPoint': {'lat': 39.42417, 'lon': 29.98333}}], 'overallOfficials': [{'name': 'Elif Çoban, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'https://avesis.ksbu.edu.tr/elif.coban/iletisim'}, {'name': 'Mehmet Ç. Ulucan, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'https://avesis.ksbu.edu.tr/mehmetcagatay.ulucan'}, {'name': 'Selver S. Başak, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'https://avesis.ksbu.edu.tr/selversuna.basak'}, {'name': 'Berceste Güler, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'https://avesis.ksbu.edu.tr/berceste.guler'}, {'name': 'Merve Akdeniz Leblebiciler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'https://avesis.ksbu.edu.tr/merve.akdenizleblebicier'}, {'name': 'Vural Kavuncu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'https://avesis.ksbu.edu.tr/vural.kavuncu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kutahya Health Sciences University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, Assist. Prof. Department of Oral and Maxillofacial Surgery', 'investigatorFullName': 'Berkan Altay, DDS', 'investigatorAffiliation': 'Kutahya Health Sciences University'}}}}