Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT05876169
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-05-25
First Post:
2023-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}], 'ancestors': [{'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057909', 'term': 'Orthognathic Surgery'}, {'id': 'D019416', 'term': 'Head Movements'}, {'id': 'D001732', 'term': 'Bite Force'}], 'ancestors': [{'id': 'D013515', 'term': 'Surgery, Oral'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D003766', 'term': 'Dental Occlusion'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-16', 'studyFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2023-05-16', 'lastUpdatePostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Kinematic outcome variables', 'timeFrame': 'Preoperatively, postoperatively 8 weeks, 18 months', 'description': 'Jaw and head movement amplitudes (mm)'}, {'measure': 'Change in Kinematic outcome variables', 'timeFrame': 'Preoperatively, postoperatively 8 weeks, 18 months', 'description': 'Movement cycle time (s)'}, {'measure': 'Change in Kinematic outcome variables', 'timeFrame': 'Preoperatively, postoperatively 8 weeks, 18 months', 'description': 'Movement acceleration from start to peak (mm/s2)'}, {'measure': 'Change in Kinematic outcome variables', 'timeFrame': 'Preoperatively, postoperatively 8 weeks, 18 months', 'description': 'Jaw movement area (mm2)'}, {'measure': 'Change in Kinematic outcome variables', 'timeFrame': 'Preoperatively, postoperatively 8 weeks, 18 months', 'description': 'Jaw movement volume (mm3)'}, {'measure': 'Change in Electromyography (EMG)', 'timeFrame': 'Preoperatively, postoperatively 8 weeks, 18 months', 'description': 'Muscle activity in micro-Volt in jaw and neck muscles bilaterally'}, {'measure': 'Change in Maximum voluntary occlusal bite force (MVOBF)', 'timeFrame': 'Preoperatively, postoperatively 8 weeks, 18 months', 'description': 'Newton (N)'}, {'measure': 'Change in Occlusal contact area', 'timeFrame': 'Preoperatively, postoperatively 8 weeks, 18 months', 'description': 'mm2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Orthognathic Surgery', 'Cleft Lip and Palate'], 'conditions': ['Cleft Lip and Palate']}, 'descriptionModule': {'briefSummary': 'In a prospective longitudinal study design, details in jaw-neck kinematics and electromyography (EMG) activity changes in patients (women and men) referred for surgical correction of basal relations between the maxilla and mandible over time; pre-operative and during follow-up 8 weeks and 18 months after surgical correction will be evaluated. The results will contribute with novel insights on jaw-neck motor function before, in short- and long-term after the surgical process. We will have blinded evaluation of outcomes.', 'detailedDescription': 'Consecutive patients referred to department of Oral and Maxillofacial Surgery, Umeå University Hospital for corrective maxillofacial-mandibular surgery, will offer opportunity to be included in the study. Expected number of patients: 20 - 25 patients annually. Blinded evaluation will be pre-operative and during follow-up 8 weeks and 18 months after surgical correction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criterias:\n\n* Patients accepted for orthognathic surgery due to jaw discrepancies.\n* Patients given their consent for participation\n\nExclusion Criterias:\n\n* Patients with syndromes\n* Patients not given their consent for participation\n* Patients unable to follow instructions due to lack of knowledge in Swedish and/or English language'}, 'identificationModule': {'nctId': 'NCT05876169', 'briefTitle': 'How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'How Does Orthognathic Surgery Affect Jaw and Neck Motor Function?', 'orgStudyIdInfo': {'id': '2022-kakfunktion'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Prospective longitudinal study design', 'description': 'Patients that will undergo orthognatic surgery will be given opportunity to participate in jaw and neck motor function analysis.', 'interventionNames': ['Procedure: Orthognathic surgery']}], 'interventions': [{'name': 'Orthognathic surgery', 'type': 'PROCEDURE', 'otherNames': ['Kinematic of jaw and head movements, muscle activity, bite force, occlusal contact area'], 'description': 'Surgical corrections of the maxilla and/or the mandible. Integrated jaw-neck movement patterns, muscle activity, bite force and occlusal contact area will be registered and mapped with quantitative objective functional variables. The state-of-the-art core equipment to evaluate jaw-neck motor function in detail is located in the Movement Lab (Department of Odontology, Umeå University).', 'armGroupLabels': ['Prospective longitudinal study design']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Umeå', 'country': 'Sweden', 'facility': 'Faculty of Medicine, Department of Odontology, Umeå University', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}