Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-02 @ 1:07 AM
Study NCT ID:
NCT05274256
Status:
COMPLETED
Last Update Posted:
2022-03-10
First Post:
2022-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implant Placement in Horizontally Deficient Maxillary Aesthetic Zone With Simultaneous Soft Tissue Augmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012059', 'term': 'Rejection, Psychology'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-01', 'studyFirstSubmitDate': '2022-02-02', 'studyFirstSubmitQcDate': '2022-03-01', 'lastUpdatePostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pink esthetic score', 'timeFrame': '6 month', 'description': "pink esthetic score evaluated pre-operative and 6 month post-operative (PES scale 0-1-2 , ''2'' the best , ''0'' the worst"}], 'secondaryOutcomes': [{'measure': 'Implant stability quotient', 'timeFrame': '6 month'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Implant or Graft; Rejection']}, 'descriptionModule': {'briefSummary': 'Tooth extraction in maxillary esthetic zone is accomplished with great dimensional changes of the alveolar ridge, different procedures have been tested to compensate these dimensional alteration, such as Hard bone augmentation, Soft tissue augmentation Or augmentation of both together. Hence, the present study aimed to evaluate pink esthetic score, clinical implant stability and bucco-palatal dimensional changes in the maxillary esthetic zone treated by implant placement with simultaneous soft tissue augmentation using de-epithelialized free gingival graft.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient of both sexes with missing teeth in the maxillary aesthetic zone.\n\nExclusion Criteria:\n\n* Patients with systemic disease that may affect bone quality or bone healing.'}, 'identificationModule': {'nctId': 'NCT05274256', 'briefTitle': 'Implant Placement in Horizontally Deficient Maxillary Aesthetic Zone With Simultaneous Soft Tissue Augmentation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Implant Placement in Horizontally Deficient Maxillary Aesthetic Zone With Simultaneous Soft Tissue Augmentation Using De-epithelialized Free Gingival Graft and Its Effect on Esthetics. a Case Series Study', 'orgStudyIdInfo': {'id': '1975'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'patients with missing teeth in maxillary aesthetic zone', 'interventionNames': ['Procedure: implant placement with simultaneous soft tissue augmentation']}], 'interventions': [{'name': 'implant placement with simultaneous soft tissue augmentation', 'type': 'PROCEDURE', 'description': 'implant placement with simultaneous soft tissue augmentation using De-epithelialized free gingival graft and immediate temporization in the maxillary aesthetic zone .', 'armGroupLabels': ['patients with missing teeth in maxillary aesthetic zone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maged Maher Hakeem', 'investigatorAffiliation': 'Cairo University'}}}}