Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-28 @ 10:47 AM
Study NCT ID:
NCT06034132
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2023-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healing Abutment Materials on Matrix Metalloproteinase-8 Level in Peri-implant Crevicular Fluid
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': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2023-09-05', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in MMP8 levels', 'timeFrame': 'at 2 weeks and 4 weeks', 'description': 'Measuring MMP-8 level around composite and titanium healing abutments with ELISA kit'}], 'secondaryOutcomes': [{'measure': 'Change in gingival condition', 'timeFrame': 'at 2 weeks and 4 weeks', 'description': 'Modified gingival index was used to assess gingival condition The MGI uses a rating score between 0 and 4 0 = absence of inflammation\n\n1. = mild inflammation\n2. = mild inflammation\n3. = moderate inflmmation\n4. = severe inflammation'}, {'measure': 'Change in gingival bleeding', 'timeFrame': 'at 2 weeks and 4 weeks', 'description': 'Bleeding index will be recorded as present or absent'}, {'measure': 'Change in plaque accumulation', 'timeFrame': 'at 2 weeks and 4 weeks', 'description': 'Plaque index 0: No plaque is in the area adjacent to the gingiva. Plaque index 1: There is a plaque in the form of a thin film on the gingival margin.\n\nPlaque index 2: There is a visible plaque in the gingival pocket and gingival margin.\n\nPlaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Implants']}, 'descriptionModule': {'briefSummary': 'Numerous materials are nowadays used in the fabrication of healing abutments to be used for dental implants. soft tissue response to different healing abutment materials is still to be unraveled. the Aim of this study is to compare the soft tissue response to titanium stock healing abutments to customized composite healing abutments through assessing the level of matrix metalloproteinase-8 in the peri-implant crevicular fluid'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with no systemic and/or oral health disease\n* absence of any lesions in the oral cavity\n* wide band of keratinized tissue more than 1mm at implant site\n\nExclusion Criteria:\n\n* smoking more than 20 cigarettes per day\n* localized radiation therapy of the oral cavity,\n* antitumor chemotherapy, liver diseases, blood diseases, kidney diseases, immunosuppressed patients, patients taking corticosteroids, pregnancy, inflammatory and autoimmune diseases of the oral cavity'}, 'identificationModule': {'nctId': 'NCT06034132', 'briefTitle': 'Healing Abutment Materials on Matrix Metalloproteinase-8 Level in Peri-implant Crevicular Fluid', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effect of Two Different Healing Abutment Materials on Matrix Metalloproteinase-8 Level in Peri-implant Crevicular Fluid (a Randomised Clinical Trial)', 'orgStudyIdInfo': {'id': 'Implants_2022_MP8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group', 'interventionNames': ['Other: Compoiste healing abutments']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Other: Stock healing abutments']}], 'interventions': [{'name': 'Stock healing abutments', 'type': 'OTHER', 'description': '2ND stage surgery will be performed and stock healing abutment were placed', 'armGroupLabels': ['Control group']}, {'name': 'Compoiste healing abutments', 'type': 'OTHER', 'description': '2ND stage surgery will be performed and composite healing abutment were placed', 'armGroupLabels': ['Test group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of DPH and Clinical statistician', 'investigatorFullName': 'Hams Hamed Abdelrahman', 'investigatorAffiliation': 'Alexandria University'}}}}