Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT05670067
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2022-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alveolar Ridge and Soft Tissue Augmentation Using Graft From the Maxillary Tuberosity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014182', 'term': 'Transplantation, Autologous'}, {'id': 'D016025', 'term': 'Bone Transplantation'}, {'id': 'D014183', 'term': 'Transplantation, Heterologous'}], 'ancestors': [{'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'the outcome assessor will not know the grouping of the study he will only know that immediate implant was placed in both groups'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two group in which the same procedure is done ( immediate implant placement) using different bone grafts'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2022-12-11', 'studyFirstSubmitQcDate': '2022-12-20', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'buccal bone thickness', 'timeFrame': 'at baseline and 9 months', 'description': 'measuring the buccal bone thickness using CBCT'}], 'secondaryOutcomes': [{'measure': 'soft tissue assessment using pink esthetic score', 'timeFrame': '9 months post opertive', 'description': 'The pink esthetic score (PES) evaluates the esthetic outcome of soft tissue around implant-supported single crowns in the anterior zone by awarding seven points for the mesial and distal papilla, soft-tissue level, soft-tissue contour, soft-tissue color, soft-tissue texture, and alveolar process deficiency, Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14'}, {'measure': 'patient satisfaction', 'timeFrame': 'after 9 months', 'description': 'questionnaire in which the scale is from (0 to 10) where 0 is completely unsatisfied and 10 totally satisfied'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immediate Implant Placement']}, 'descriptionModule': {'briefSummary': 'In the study immediate implant is placed in the anterior region with autogenous bone grafting from the maxillary tuberosity in one group and in the other group immediate implant is placed with xenograft .IN both groups soft tissue grafting is done using connective tissue assessment of buccal bone thickness and soft tissue will be done 6 months post operative', 'detailedDescription': 'immediate implant will be placed in the anterior region with autogenous graft from the maxillary tuberosity and in the other group immediate implant will be laced with xenograft soft tissue grafting using sub-epithelial connective tissue will in both groups assessment of buccal bone thickness is the primary outcome of the study, while volumetric assessment of the soft tissue and patient satisfaction are the secondary and tertiary outcome the assessment of all outcome will be 6 months post operative the extraction socket in which the implant will be placed are class I\\&II'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systemically healthy patients (American Society of Anesthesiologists I; ASA I).\n* Age range (20-40) years.\n* Good compliance with the plaque control instructions following initial therapy.\n* Patients diagnosed with bone defect in the maxillary anterior esthetic zone (class 1 \\& 2)\n* Availability for follow up and maintenance program.\n\nExclusion Criteria:\n\n* Peri apically infected teeth\n* Presence of smoking habit.\n* Presence of occlusal interferences.\n* Pregnant females.\n* Vulnerable group of patients (handicapped, mentally retarded and prisoners) (according to the recommendation of esthetical committee of Faculty of Dentistry Ain Shams University).'}, 'identificationModule': {'nctId': 'NCT05670067', 'briefTitle': 'Alveolar Ridge and Soft Tissue Augmentation Using Graft From the Maxillary Tuberosity', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Localized Alveolar Ridge Reconstruction and Soft Tissue Augmentation Using a Triple Graft From the Maxillary Tuberosity Simultaneous With Immediate Implant Placement ( a Randomized Clinical Clinical Study)', 'orgStudyIdInfo': {'id': 'no 948'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'immediate implant with bone graft (autogenous)', 'description': 'with immediate implant placement autogenous grafting using maxillary tuberosity will be done', 'interventionNames': ['Procedure: maxillary tuberosity bone graft (autogenous graft)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'immediate implant with bonegraft (xenograft)', 'description': 'with immediate implant placement grafting with xenograft will be done', 'interventionNames': ['Procedure: Bone graft (xenograft)']}], 'interventions': [{'name': 'maxillary tuberosity bone graft (autogenous graft)', 'type': 'PROCEDURE', 'description': 'the usage of maxillary tuberosity as source of autogenous graft supplying the needed cells for bone regeneration', 'armGroupLabels': ['immediate implant with bone graft (autogenous)']}, {'name': 'Bone graft (xenograft)', 'type': 'PROCEDURE', 'description': 'xenograft is bone graft material that is obtained from porcine, bovine or equine source', 'armGroupLabels': ['immediate implant with bonegraft (xenograft)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Hala Abu el ela, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of dentistry ain shams university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Ahmed Hesham Mohamed', 'investigatorAffiliation': 'Ain Shams University'}}}}