Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT06537661
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-05
First Post:
2024-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality on TMD Following Maxillofacial Surgery
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-07-02', 'studyFirstSubmitQcDate': '2024-08-01', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure pain', 'timeFrame': '6weeks', 'description': 'Measure by visual analog scale (VAS) 0: low in pain 10:high in pain'}], 'secondaryOutcomes': [{'measure': 'Maximum mouth opnening (MMO )', 'timeFrame': '6weeks', 'description': 'Measure by milemeter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VR', 'TMD', 'Maxillofacial surgery'], 'conditions': ['Temporomandibular Disorder']}, 'descriptionModule': {'briefSummary': 'Sixty eight patients who have TMJ pain and ROM restriction after maxillofacial surgery participated in this study , they are selected from government hospitals (general and insurance ).\n\nWill be randomly divided into two equal groups ( group A, group B ). Their ages range from 20 - 35 years.\n\nThe Purpose of the study is to evaluate the therapeutic efficacy of VR in decreasing pain and improve ROM for Patients after maxillofacial surgery.', 'detailedDescription': 'Sixty eight patients who have TMJ pain and ROM restriction after maxillofacial surgery participated in this study , they are selected from government hospitals (general and insurance ).\n\nWill be randomly divided into two equal groups ( group A, group B ). Their ages range from 20 - 35 years.\n\nThe VR glasses which were the source of visual and auditory feedback, were connected by Bluetooth to a mobile phone and all the videos of selected tasks (tasks of Active mobility exercises and isometric contraction exercises, massage exercises) were turned on. Active mobility exercises (jaw opening 6 times of 30 s; lateralization 10 times of 5 s; protrusion 10 times Of 5 s).\n\n* Self-massage masticatory Muscles, After each session.\n* Isometric contraction exercises The Purpose of the study is to evaluate the therapeutic efficacy of VR in decreasing pain and improve ROM for Patients after maxillofacial surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject selection will be according to the following criteria:\n\n * Patients after Arthrocentesis .\n * Patients after Temporomandibular joint condylar discopexy.\n * Age ranges between 30 - 45 years.\n * All patients will have informed consent .Exclusion Criteria:\n* • Surgery That conducted on the temporomandibular joint (meniscectomy, arthroscopy, etc.).\n\n * oral surgery (e.g., surgery for impaction of the third molar), as well as patients with concomitant systemic or neurological conditions.'}, 'identificationModule': {'nctId': 'NCT06537661', 'briefTitle': 'Effect of Virtual Reality on TMD Following Maxillofacial Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'VIRTUAL REALITY and TEMPOROMANDIBULAR DISORDER FOLLOWING MAXILLOFACIAL SURGERY', 'orgStudyIdInfo': {'id': 'P.T.REC/012/005153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'VR and traditional Ex', 'interventionNames': ['Other: Virtual reality']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'traditional physical therapy ex', 'interventionNames': ['Other: Traditional exercises']}], 'interventions': [{'name': 'Virtual reality', 'type': 'OTHER', 'description': 'Virtual reality (VR): is the artificial construction of a 3D environment viaThe VR glasses which were the source of visual and auditory feedback, were connected by Bluetooth to a mobile phone and all the videos of selected tasks.', 'armGroupLabels': ['Study group']}, {'name': 'Traditional exercises', 'type': 'OTHER', 'description': 'Active mobility exercises (jaw opening 6 times of 30 s; lateralization 10 times of 5 s; protrusion 10 times Of 5 s). Self-massage masticatory Muscles, After each session.\n\n* Isometric contraction exercises Were included (3 times of 10 s)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Nehal mohamed', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}, {'city': 'Giza', 'country': 'Egypt', 'facility': 'Nehal mohamed', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Nehal mohamed soliman Elbkery', 'investigatorAffiliation': 'Cairo University'}}}}