Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT06862505
Status:
COMPLETED
Last Update Posted:
2025-03-06
First Post:
2025-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Histological Analysis of Peri-implant Soft Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2025-02-25', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Histological analisys', 'timeFrame': '8 and 16 weeks', 'description': 'Histological analysis of peri-implant gengivaat 8 and 16 weeks to assess collagen fibre orientation'}], 'secondaryOutcomes': [{'measure': 'Histomorphometry', 'timeFrame': '8 and 16 weeks', 'description': 'Quantitative measure of soft tissues'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental implants', 'Biological width', 'Istological analysis'], 'conditions': ['Implant Therapy', 'Biological Width']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the histologically analysis in humans and the orientation of collagen fibers around screw-less, morse taper implant-abutment connection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older, affected by partial edentulism of posterior elements need for at least two single implant rehabilitations\n* able to understand a sign an informed consent\n\nExclusion Criteria:\n\n* Peapole having a systemic or local contraindications for implant placement;\n* Untreated periodontal disease;\n* smokers;\n* osteoporosis;\n* uncontrolled diabetes;\n* refusal to implant rehabilitation;\n* refusal to biopsy collection;\n* systemic pathologies that could compromise the healing of peri-implant tissues.'}, 'identificationModule': {'nctId': 'NCT06862505', 'briefTitle': 'Histological Analysis of Peri-implant Soft Tissue', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Sassari'}, 'officialTitle': 'Histological Analysis of Collagen Fibers Around Screw-less, Morse Taper Implant-abutment Connection 8 and 16 Weeks After Implant Uncovering: a Split-mouth Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '15-16/12/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biopsy at 8 weeks', 'interventionNames': ['Procedure: Biopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biopsy at 16 weeks', 'interventionNames': ['Procedure: Biopsy']}], 'interventions': [{'name': 'Biopsy', 'type': 'PROCEDURE', 'description': 'Biopsy of soft tissue were taken randomly at 8 or 16 weeks to compare soft tissue', 'armGroupLabels': ['Biopsy at 16 weeks', 'Biopsy at 8 weeks']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rome', 'state': 'Italy', 'country': 'Italy', 'facility': 'University of Rome', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Sassari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marco Tallarico', 'investigatorAffiliation': 'Università degli Studi di Sassari'}}}}