Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-29 @ 12:42 AM
Study NCT ID:
NCT04662333
Status:
UNKNOWN
Last Update Posted:
2020-12-10
First Post:
2020-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}, {'id': 'D000099066', 'term': 'Atrophic Maxilla'}], 'ancestors': [{'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D001862', 'term': 'Bone Resorption'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D008439', 'term': 'Maxillary Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-05', 'studyFirstSubmitDate': '2020-11-29', 'studyFirstSubmitQcDate': '2020-12-05', 'lastUpdatePostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications rate', 'timeFrame': '12 months', 'description': 'amount of complications assessed at patient level'}], 'secondaryOutcomes': [{'measure': 'Peri-implant bone stability', 'timeFrame': '12 months', 'description': 'the amount (mm) of crestal bone resorption after implant placement assessed through intraoral radiographs'}, {'measure': 'Implant stability quotient', 'timeFrame': 'baseline, 1 month, 3 months, 6 months', 'description': 'implant stability assessed by resonance frequency analysis'}, {'measure': 'Soft tissue inflammation', 'timeFrame': '6 months', 'description': 'percentage of peri-implant soft tissue affected by inflamed connective tissue'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental implant', 'Sinus lift', 'maxillary atrophy', 'biomaterials'], 'conditions': ['Edentulous Jaw']}, 'descriptionModule': {'briefSummary': 'Patients in need for implant-supported restoration in maxillary posterior sites with insufficient residual bone height will be randomly allocated to two different arms. Crestal sinus lift with simultaneous implant placement will be performed in both groups.\n\nControl group: crestal sinus lift with no adjunctive biomaterial; Test group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; Six months after implant placement, implants will be loaded with definitive screw-retained prostheses.\n\nSix months later, patients will be recalled for clinical and radiographic assessment.', 'detailedDescription': 'Patients in need for implant-supported restoration in maxillary posterior sites with bone deficiencies will be randomly allocated to two different arms.\n\nFull-mouth periodontal chart and standardized radiographs will be evaluated at the time of inclusion.\n\nCrestal sinus lift with simultaneous implant placement will be performed in both groups.\n\nControl group: crestal sinus lift with no adjunctive biomaterial; the healing abutment in this group is made up of PEEK (poly-ether-ether-ketone).\n\nTest group: crestal sinus lift associated with xenogenic bone graft and collagen membrane; the healing abutment in this group is made up of titanium;\n\nResonance frequency analysis will be performed at the time of implant placement and at 1, 3, 6 months of follow-up.\n\nBoth healing abutment will be undersized: this characteristic will allow to harvest a 1mm-wide biopsy of the transmucosal tract at the end of the healing phase (6 months).\n\nSix months after implant placement, impression will be taken and implants loaded with definitive screw-retained prostheses.\n\nSix months later, patients will be recalled for clinical and radiographic assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more than 18 years old\n* edentulous in posterior maxilla\n* patient in need of sinus augmentation procedure\n* residual bone height greater than 3mm\n\nExclusion Criteria:\n\n* systemic chronic diseases affecting osseointegration\n* contraindication for implant therapy\n* less than 18 years\n* uncontrolled periodontitis\n* smoker (more than 10 cig/day)'}, 'identificationModule': {'nctId': 'NCT04662333', 'briefTitle': 'Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach', 'organization': {'class': 'OTHER', 'fullName': 'University of Siena'}, 'officialTitle': 'Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach', 'orgStudyIdInfo': {'id': 'CLS001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Crestal sinus lift', 'description': 'Implant site preparation with detachment of Schneiderian membrane and subsequent implant placement. The corresponding healing abutment is made up of PEEK (poly-ether-ether-ketone)', 'interventionNames': ['Procedure: Transcrestal approach for sinus lift']}, {'type': 'EXPERIMENTAL', 'label': 'Crestal sinus lift with adjunctive xenograft', 'description': 'Implant site preparation with detachment of Schneiderian membrane. After that, collagen membrane plus xenogenic bone substitute will be placed into the site before implant placement. The corresponding healing abutment is made up of titanium.', 'interventionNames': ['Procedure: Transcrestal approach for sinus lift', 'Procedure: Xenograft application']}], 'interventions': [{'name': 'Transcrestal approach for sinus lift', 'type': 'PROCEDURE', 'description': "After surgical exposure of maxillary alveolar crest, implant site preparation and transcrestal detachment of Schneiderian's membrane will be performed. Thereafter implant will be placed, protruding in the maxillary sinus with its apical part.", 'armGroupLabels': ['Crestal sinus lift', 'Crestal sinus lift with adjunctive xenograft']}, {'name': 'Xenograft application', 'type': 'PROCEDURE', 'description': "Before implant placement, xenogenic collagen membrane and bone granules will be pushed under the Schneiderian's membrane through the surgical site.", 'armGroupLabels': ['Crestal sinus lift with adjunctive xenograft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53100', 'city': 'Siena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Discepoli', 'role': 'CONTACT', 'email': 'ndiscepoli@me.com'}], 'facility': 'AOUS', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}], 'centralContacts': [{'name': 'Nicola D Discepoli, Professor', 'role': 'CONTACT', 'email': 'ndiscepoli@me.com', 'phone': '3392491188'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Siena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nicola Discepoli', 'investigatorAffiliation': 'University of Siena'}}}}