Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-04 @ 10:31 PM
Study NCT ID:
NCT03180658
Status:
UNKNOWN
Last Update Posted:
2017-06-08
First Post:
2017-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017823', 'term': 'Furcation Defects'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016025', 'term': 'Bone Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-07', 'studyFirstSubmitDate': '2017-05-29', 'studyFirstSubmitQcDate': '2017-06-07', 'lastUpdatePostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical measurement', 'timeFrame': '1 year', 'description': 'Probing depth'}, {'measure': 'clinical parameter', 'timeFrame': '1 year', 'description': 'clinical attachment loss'}], 'secondaryOutcomes': [{'measure': 'radiographic parameter', 'timeFrame': '1 year', 'description': 'cone beam computerized tomographic scanning'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Concentrated Growth Factors', 'Periodontal Regeneration', 'Furcation Defects']}, 'descriptionModule': {'briefSummary': 'Objective: To compare the effect of guided tissue regeneration (GTR) + concentrated growth factors (CGF) + bone graft and CGF + bone graft in the treat of II° furcations of human mandibular molars. Methods: At least thirty II°furcation involvements in mandibular molars will be included and randomly divided into two groups. The experimental group will accept GTR + CGF + bone graft therapy, and the control group will accept CGF + bone graft therapy. The clinical examination and cone beam computed tomography (CBCT) will be performed at baseline and 1 year post-surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* II° furcation involvements in mandibular molars\n* after periodontal therapy.\n\nExclusion Criteria:\n\n* not healthy'}, 'identificationModule': {'nctId': 'NCT03180658', 'briefTitle': 'Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'The Effect of Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans', 'orgStudyIdInfo': {'id': '81600868'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental', 'description': 'GTR+CGF+bone graft, CGF', 'interventionNames': ['Procedure: GTR + CGF + bone graft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'controlled', 'description': 'CGF+bone graft', 'interventionNames': ['Procedure: CGF + bone graft']}], 'interventions': [{'name': 'GTR + CGF + bone graft', 'type': 'PROCEDURE', 'otherNames': ['CGF Centrifuge machine'], 'description': 'Guided tissue regeneration (GTR) combined with CGF and bone graft to treat mandibular furcation involvements', 'armGroupLabels': ['experimental']}, {'name': 'CGF + bone graft', 'type': 'PROCEDURE', 'otherNames': ['CGF Centrifuge machine'], 'description': 'CGF combined with bone graft to treat mandibular furcation involvements', 'armGroupLabels': ['controlled']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100081', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jing qiao, doctor', 'role': 'CONTACT'}], 'facility': 'Peking university School and Hospital of Stomatology', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'qiao jing, doctor', 'role': 'CONTACT', 'email': 'donaldshushu@aliyun.com', 'phone': '86-13241892143'}], 'overallOfficials': [{'name': 'yan zu zhang, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'dean'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jing Qiao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jing Qiao', 'investigatorAffiliation': 'Peking University'}}}}