Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT04518956
Status:
COMPLETED
Last Update Posted:
2020-08-19
First Post:
2020-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Shockwave Therapy Versus LIPUS on Mandibular Fracture Bone Healing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008337', 'term': 'Mandibular Fractures'}], 'ancestors': [{'id': 'D007572', 'term': 'Jaw Fractures'}, {'id': 'D008446', 'term': 'Maxillofacial Injuries'}, {'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012887', 'term': 'Skull Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-16', 'studyFirstSubmitDate': '2020-08-16', 'studyFirstSubmitQcDate': '2020-08-16', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain scale', 'timeFrame': 'after 24 hours and 1 week', 'description': 'pain was scores using visual analouge scale from 0 to 10 0 means no pain 10 most severe pain'}, {'measure': 'Change in bone density', 'timeFrame': 'after 6 Weeks and 12 weeks', 'description': 'using CT'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mandibular Fractures']}, 'descriptionModule': {'briefSummary': 'compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on healing process of fresh mandibular fractures', 'detailedDescription': 'The mandible is the commonest facial bone to fracture. Mandibular fractures represent more than 74% of all maxillofacial fractures.\n\nTo compare between the effect of shockwave therapy and low-intensity pulsed ultrasound on healing process of fresh mandibular fractures.\n\nA total of 21 patients; aged between 20-40 years, who have mandibular fracture were selected for this study from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University. In this study all patients were subjected to closed reduction and intermaxillary fixation. This will be followed by shockwave therapy in seven patients as a study group and by low-intensity pulsed ultrasound in seven patients as study group. Seven patients will receive neither and will constitute the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria -Patients selected for this study will have fresh fracture mandible which is indicated for closed reduction.\n\nExclusion Criteria\n\n-Patients having the following criteria will be excluded scars, burns, infection in the Skin in the relevant working area'}, 'identificationModule': {'nctId': 'NCT04518956', 'briefTitle': 'Shockwave Therapy Versus LIPUS on Mandibular Fracture Bone Healing', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Comparative Study Between the Effect of Shockwave Therapy and Low-intensity Pulsed Ultrasound (LIPUS) on Bone Healing of Mandibular Fracture', 'orgStudyIdInfo': {'id': 'Mandibular fracture healing'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inter maxillary fixation and exposure to shockwave therapy', 'interventionNames': ['Procedure: inter maxillary fixation with shockwave therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Inter maxillary fixation and exposure to low intensity pulsed', 'interventionNames': ['Procedure: Inter maxillary fixation and exposure to low intensity pulsed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Inter maxillary fixation only', 'interventionNames': ['Procedure: Inter maxillary fixation']}], 'interventions': [{'name': 'inter maxillary fixation with shockwave therapy', 'type': 'PROCEDURE', 'description': 'Shockwave therapy device which give 1500-4000 pulses per session with or without anesthesia, and the treatment session takes approximately 5-10 minutes at the day after surgery.', 'armGroupLabels': ['Inter maxillary fixation and exposure to shockwave therapy']}, {'name': 'Inter maxillary fixation and exposure to low intensity pulsed', 'type': 'PROCEDURE', 'description': 'Low-intensity pulsed ultra sound was applied three times weekly for six weeks from the second day after surgery.', 'armGroupLabels': ['Inter maxillary fixation and exposure to low intensity pulsed']}, {'name': 'Inter maxillary fixation', 'type': 'PROCEDURE', 'description': 'Closed reduction will be done. Intermaxillary fixation (IMF) will be secured after proper reduction of the fractured segments to assure proper occlusion using upper and lower arch bars or eyelet wires for six weeks.', 'armGroupLabels': ['Inter maxillary fixation only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21526', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}