Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT06138535
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009135', 'term': 'Muscular Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System 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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'single arm group study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-11-17', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluation of muscle activation with surface electromyography (EMG)', 'timeFrame': '3 months', 'description': 'Evaluation of muscle activation with surface electromyography (EMG) for each of the eight patients enrolled in our study, and the records were taken before and after 3 months of treatment.\n\nThe surface electrodes were placed on the anterior temporalis and the superficial masseter muscles.\n\nA Fast Fourier Transform ( FFT ) was carried out using the software of electromyography. The mean value of the EMG activity of each muscle was calculated from the amplitude in microvolts ( μV ).\n\nThe decrease in the muscle records was an indication of improvement of muscle activity.'}], 'primaryOutcomes': [{'measure': 'Patient questionnaire (clinical symptoms).', 'timeFrame': '3 months', 'description': 'Patient questionnaire (clinical symptoms) . The questionnaire was used to detect the clinical symptoms scoring that ranges from 0 to 10 (10 being greatest pain/dysfunction and 0 signifying no pain/proper function).\n\nThe success or failure was determined by the reduction in pain and dysfunction postoperatively.\n\nthe scales were taken for all eight patients before and after 3 months of treatment.\n\nthe questionnaire included questions about different clinical symptoms as following: headaches, facial discomfort, jaw joint pain, pain during mastication, neck pain, difficulty opening the mouth, difficulty in jaw movements, complaints during chewing, and clenching habits.'}], 'secondaryOutcomes': [{'measure': 'Clinical sign such as mouth opening', 'timeFrame': '3 months', 'description': 'Clinical sign such as mouth opening that was recorded by measuring the distance between the upper and lower central incisors by a caliper in millimeters unit.\n\nthe increase in mouth opening indicates positive clinical improvement. the mouth opening was measured before and after 3 months of treatment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscle Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the digital stabilizing splint in management of masticatory muscle disorder. The main question it aims to answer are:\n\n• is the digital stabilizing splint effective in treatment of masticatory muscle disorder signs and symptoms after 3 months follow up ? Participants will be asked to ware the splint and progressively increasing the duration of splint wear, starting from 8 hours per day for 3 months .', 'detailedDescription': "The current research was conducted for evaluation of the digital stabilizing splint in the management of masticatory muscle disorder. Subjects and Methods: Eight patients over the age of 18 with masticatory muscle disorders received treatment using a stabilizing splint that was digitally created. The Each patient's response to therapy modifications was assessed and compared before and after splint insertion for each patient subjective symptoms were assessed using a patient questionnaire that was repeated before treatment (baseline), one month, and 3 months post-insertion. Moreover, The masseter and temporalis muscles' electrical activity was measured using electromyography at baseline and after three months.post-splint insertion. Clinical signs such as mouth-opening lateral movements and protrusive movements were measured before and 3 months after the splint was inserted."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'inclusion criteria\n\n1-Anterior disc displacement without reduction or osteoarthritis cases 2-Pain and/or tenderness of masticatory muscles exclusion criteria\n\n1. Absence of previous occlusal splint therapy.\n2. Absence of apparent dental or periodontal diseases.\n3. Patients having full or partial dentures that would compromise the support of an occlusal splint were excluded.\n4. Patient taking analgesics, muscle relaxants, or Anti-inflammatory medications will not be included because they may affect the outcome.\n5. Patients with multiple teeth loss that affects occlusal splint support were excluded.'}, 'identificationModule': {'nctId': 'NCT06138535', 'briefTitle': 'Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Evaluation of Digital Stabilizing Splint in Management of Masticatory Muscle Disorder', 'orgStudyIdInfo': {'id': 'AZJD-D-23-00044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Masticatory Muscle Disorder patients treated by digital stabilizing splint', 'description': 'digital stabilizing splint', 'interventionNames': ['Device: digital stabilizing splint']}], 'interventions': [{'name': 'digital stabilizing splint', 'type': 'DEVICE', 'otherNames': ['occlusal splint'], 'description': '3D Printed stabilizing splint that has been digitally designed on a modern software', 'armGroupLabels': ['Masticatory Muscle Disorder patients treated by digital stabilizing splint']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11765', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Al Azhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'zahraa hassan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Azhar University'}]}, 'ipdSharingStatementModule': {'url': 'https://azjd.researchcommons.org/', 'infoTypes': ['ICF'], 'timeFrame': 'one yaer', 'ipdSharing': 'YES', 'description': 'Data may be obtained either from study investigators or via data-sharing repositories or platforms.', 'accessCriteria': 'Al-Azhar Journal of Dentistry'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'zahraa hassan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Al-Azhar University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'zahraa hassan', 'investigatorAffiliation': 'Al-Azhar University'}}}}