Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-01-27 @ 3:41 AM
Study NCT ID:
NCT02745366
Status:
UNKNOWN
Last Update Posted:
2016-10-17
First Post:
2016-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buccal Fat Pad Derived Stem Cells With Cortical Tenting in Posterior Mandible Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016301', 'term': 'Alveolar Bone Loss'}, {'id': 'D001284', 'term': 'Atrophy'}], 'ancestors': [{'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2016-04-18', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amount of regenerated bone', 'timeFrame': '6 months', 'description': 'the amount of regenerated bone will be assessed by Image Pro software in CBCT images'}, {'measure': 'amount of regenerated bone', 'timeFrame': '6 months', 'description': 'the percent of regenerated bone will be assessed on bone biopsies obtained during implant insertion by H\\&E staining by microscope'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alveolar Bone Loss', 'Atrophy']}, 'descriptionModule': {'briefSummary': 'In this study the buccal fat pad derived stem cells (BFPSCs) is harvested from buccal fat pad tissue of the patients receiving posterior mandible augmentation. In the test group the patients receive a combination of platelet rich fibrin (PRF) and freeze dried bone allograft (FDBA) (SureOss, Hansbiomed, Korea) loaded with BFPSCs. The control group receivesFDBA (without any cells)+PRF. In all the groups the combination are placed between the recipient site and the block graft obtained from lateral ramus. The results will be evaluated by cone beam computed tomography (CBCT)and hematoxylin and eosin staining in 6 months.', 'detailedDescription': 'Autogenous bone blocks are harvested from lateral ramus.The buccal fat pad derived stem cells (BFPSCs) is harvested from buccal fat pad tissues. The BFPSCs will be loaded on freeze dried bone allograft (FDBA) (SureOss, Hansbiomed, Korea). Furthermore, twenty milliliters of the venous blood is obtained, placed and collected in a sterile tube, and centrifuged (GAC medical) for 14 minutes at 2800 rpm (approximately 400 g). Following centrifugation, three layers are separated in the tube: cellular plasma at the top, platelet rich fibrin (PRF) clot in the middle and red blood cells at the bottom of the tube. The PRF clot is separated by a sterile pincette.\n\nThe patients in the test group receives BFPSCs loaded on FDBA with PRF for posterior mandible augmentation and the control group receives combination of PRF and FDBA (lacking any cells). The BFPSCs+FDBA+PRF in the test group and FDBA+PRF in the control group are placed in the gap between the block graft and recipient site. The results will be evaluated by cone beam computed tomography (CBCT) in 6 months and microscopic evaluation of the biopsies by hematoxylin and eosine staining during implant placement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with posterior mandible edentulism and atrophic bone with less than 4mm bone width at bone crest or less than 8 mm bone height (considering 2-3 mm distance to anatomic structures)\n\nExclusion Criteria:\n\n* smoking, history of malignancy, radiation, chemotherapy, pregnancy, systemic diseases contradicting dental and surgical treatments, conditions or drugs affecting bone remodeling or bone metabolism and connective tissue'}, 'identificationModule': {'nctId': 'NCT02745366', 'briefTitle': 'Buccal Fat Pad Derived Stem Cells With Cortical Tenting in Posterior Mandible Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'The Effect of Buccal Fat Pad Derived Mesenchymal Stem Cells Loaded on Allograft and Platelet-rich Plasma in Posterior Mandible Augmentation', 'orgStudyIdInfo': {'id': 'sbmu9217'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BFPSC+', 'description': 'The combination of BFPSC+FDBA+PRF is utilized in cortical tenting technique with block graft obtained from lateral ramus for posterior mandible augmentation procedure.', 'interventionNames': ['Procedure: BFPSC+FDBA+PRF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BFPSC-', 'description': 'The combination of FDBA+PRF is utilized in cortical tenting technique with block graft obtained from lateral ramus for posterior mandible augmentation procedure', 'interventionNames': ['Procedure: FDBA+PRF']}], 'interventions': [{'name': 'BFPSC+FDBA+PRF', 'type': 'PROCEDURE', 'armGroupLabels': ['BFPSC+']}, {'name': 'FDBA+PRF', 'type': 'PROCEDURE', 'armGroupLabels': ['BFPSC-']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19839', 'city': 'Tehran', 'state': 'Tehran Province', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Arash Khojasteh, DDS, OMFS', 'role': 'CONTACT', 'email': 'arashkhojasteh@yahoo.com', 'phone': '00989121060032'}], 'facility': 'School of Dentristry at Shahid Beheshti University of Medical Sciences', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Arash Khojasteh, DMD, OMFS', 'role': 'CONTACT', 'email': 'arashkhojasteh@yahoo.com', 'phone': '00989121060032'}], 'overallOfficials': [{'name': 'Arash Khojasteh, DMD, OMFS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shahid Beheshti University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Arash Khojasteh', 'investigatorAffiliation': 'Shahid Beheshti University of Medical Sciences'}}}}