Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT05748756
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2023-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bone Marrow Aspirate Concentrate in Treating Mandibular Cystic Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-19', 'studyFirstSubmitDate': '2023-02-19', 'studyFirstSubmitQcDate': '2023-02-19', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain scores', 'timeFrame': '1st day, 1 week, 4 weeks, 6 weeks', 'description': 'pain was assessed through a 10-point Visual Analogue Scale (VAS) the scores are categorizied as follows: (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)'}, {'measure': 'Change in bone density', 'timeFrame': 'at baseline, 3 months, 6 months', 'description': 'An immediate postoperative CBCT was be obtained, followed by another one taken after 3 and 6 months postoperatively. The Region of Interest (ROI) feature was used to estimate the mean bone density in the immediate and 6 months scans. The mean bone density in the 6 months CBCT-scan was compared with the immediate postoperative and the preoperative scans and the mean difference between the scans was calculated.'}], 'secondaryOutcomes': [{'measure': 'change in wound dehiscence', 'timeFrame': '1st day, 1 week, 4 weeks, 6 weeks', 'description': 'any signs of wound dehiscence were observed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mandible Cyst']}, 'descriptionModule': {'briefSummary': 'Mandibular cystic defect healing is a complex process. Various methods have been developed to shorten the bone regeneration time and improve its quality. Autogenous grafting is the gold standard for filling cystic defects due to the osteogenesis property provided by the viable cells but is related to donor site morbidity. Allografts and Xenografts are used for the same purpose. However, the increased cost is their main disadvantage. Bone marrow aspirate concentrate is now used to enhance the healing and regeneration process in many areas of the body with no morbidity and low cost.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from mandibular cystic defect.\n* Cystic defect width of 4-8 cm that requires removal under general anesthesia.\n\nExclusion Criteria:\n\n* Medically compromised patients contradicting operation.\n* Previously enucleated lesions.\n* Previous surgery, tumor, infection to the pelvis affecting the anterior iliac crest.\n* Infected Cysts'}, 'identificationModule': {'nctId': 'NCT05748756', 'briefTitle': 'Bone Marrow Aspirate Concentrate in Treating Mandibular Cystic Defects', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'The Effect of Bone Marrow Aspirate Concentrate in the Treatment of Mandibular Cystic Defects (Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'BM_22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group', 'interventionNames': ['Other: Enucleation and filling by Bone marrow aspirate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Other: Conventional enucleation only']}], 'interventions': [{'name': 'Enucleation and filling by Bone marrow aspirate', 'type': 'OTHER', 'description': 'The iliac crest is palpated along its widest part forming the iliac tubercle ( 5-6 cm posterior to the anterior superior iliac spine), then a 5 mm incision is made 3-4 cm posterior to the ASIS directly on the crest.\n\nThe needle is advanced between the outer and inner plates of the ileum for a 4-6 cm into the cancellous bone and 10 ml of bone marrow is aspirated.\n\nBone marrow aspirate is processed by a dual centrifugation technique.', 'armGroupLabels': ['Test group']}, {'name': 'Conventional enucleation only', 'type': 'OTHER', 'description': 'patients were treated conventionally by enucleation and plain collagen sponge only.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00203', 'city': 'Alexandria', 'state': 'Azarita', 'country': 'Egypt', 'facility': 'Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hams Hamed Abdelrahman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of DPH and Clinical statistician', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}