Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-30 @ 10:12 PM
Study NCT ID:
NCT06285903
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2024-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing the Hydrodynamic Piezoelectric Technique With Osseodensification for the Assessment of Internal Sinus Iift-ing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of 20 patients were randomly divided into two groups: Group1: patients received dental implant using osseodensification via Densah bur, Group2: patients received dental implant using hydrodynamic piezoelectric sinus lifting. The patients in both groups underwent bone grafting under sinus membrane. Modified bleeding index and probing depth were evaluated at 3, 6 and 12months intervals. An Osstell device was used to de-termine implant stability by recording the values of implant stability quotient (ISQ) im-mediately after implant placement and after 3 months. CBCT was performed before, af-ter 6 months and after 12 months to evaluate ridge height, bone density. Marginal bone loss was evaluated after 3 months via periapical radiograph, after 6 months and after 12 months via CBCT.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-27', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bone Densityby mm', 'timeFrame': '3,6,12 months', 'description': 'Crestal Bone Loss (CBL)'}], 'primaryOutcomes': [{'measure': 'Implant stability using the Osstell device by percentage', 'timeFrame': 'baseline ,3 months', 'description': 'Primary implant stability (ISQ)'}], 'secondaryOutcomes': [{'measure': 'Modified sulcus bleeding index,Peri-implant pocket depth (PPD)by mm', 'timeFrame': '3,6,9 months', 'description': 'Clinical evaluation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental implant', 'Osseointegration', 'primary implant stability', ', internal sinus lifting', 'osseodensification,', 'piezoelectric'], 'conditions': ['Bone Density, Low']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://orcid.org/my-orcid?orcid=0000-0002-8404-438X', 'label': 'orchid'}, {'url': 'https://www.researchgate.net/profile/Shimaa-Hussein-Kotb', 'label': 'researchgate'}, {'url': 'https://www.webofscience.com/wos/author/record/ABE-1539-2022', 'label': 'web of science'}]}, 'descriptionModule': {'briefSummary': 'Successful osseointegration considered the cornerstone in implant stability which predict the highest implants success outcomes. Implant stability depend on many factors like the implant design, surgical technique, and bone density. Posterior maxilla considered as a challenging area in implant placement, this is due to less dense trabecular bone sur-rounded by a thin layer of cortical bone which result in suffering in implant stability. The aim of this study is to evaluate the bone density outcomes using bone densification technique and piezoelectric surgical technique in sinus lift to promote bone gain', 'detailedDescription': 'Objectives: This study was directed to compare the outcomes of internal sinus lifting between osseodensification approach and piezoelectric surgery approach on the primary stability and osseointegration of dental implant.\n\nBackground data: Successful osseointegration considered the cornerstone in implant sta-bility which predict the highest implants success outcomes. Implant stability depend on many factors like the implant design, surgical technique, and bone density. Posterior maxilla considered as a challenging area in implant placement, this is due to less dense trabecular bone surrounded by a thin layer of cortical bone which result in suffering in implant stability. The aim of this study is to evaluate the bone density outcomes using bone densification technique and piezoelectric surgical technique in sinus lift to promote bone gain.\n\nMaterials and Methods: A total of 20 patients were randomly divided into two groups: Group1: patients received dental implant using osseodensification via Densah bur, Group2: patients received dental implant using hydrodynamic piezoelectric sinus lifting. The patients in both groups underwent bone grafting under sinus membrane. Modified bleeding index and probing depth were evaluated at 3, 6 and 12months intervals. An Osstell device was used to determine implant stability by recording the values of implant stability quotient (ISQ) immediately after implant placement and after 3 months. CBCT was performed before, after 6 months and after 12 months to evaluate ridge height, bone density. Marginal bone loss was evaluated after 3 months via periapical radiograph, after 6 , 12 months via CBCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nfree of systemic disease bone height at the site of the implant is ≤ 6 mm. have good oral hygiene.\n\n\\-\n\nExclusion Criteria:\n\nsystemic diseases active periodontal disease , limited mouth-opening ability maxillary sinus disease or previous sinus surgery were also excluded smokers pregnant'}, 'identificationModule': {'nctId': 'NCT06285903', 'acronym': 'RCT', 'briefTitle': 'Comparing the Hydrodynamic Piezoelectric Technique With Osseodensification for the Assessment of Internal Sinus Iift-ing', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Comparing the Hydrodynamic Piezoelectric Technique With Osseodensification for the Assessment of Internal Sinus Iift-ing: (a Randomized Clinical Trial)', 'orgStudyIdInfo': {'id': 'AUAREC20220002-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Densah Bur', 'description': 'patients received dental implant using osseodensification via Densah bur', 'interventionNames': ['Procedure: internal sinus lift surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Group piezoelectric', 'description': 'patients received dental implant using hydrodynamic piezoelectric sinus lifting', 'interventionNames': ['Procedure: internal sinus lift surgery']}], 'interventions': [{'name': 'internal sinus lift surgery', 'type': 'PROCEDURE', 'description': 'surgery approach', 'armGroupLabels': ['Group Densah Bur', 'Group piezoelectric']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Asyut', 'state': 'Assuit', 'country': 'Egypt', 'facility': 'Alazhar university ,Assuit branch ,Egypt', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Ibrahim Hammad Ibrahim, lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Al-Azhar University'}, {'name': 'Khalid s Hassan, Dean of Badr University', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Dentistry ,Badr university ,Assuit branch ,Egypt'}]}, 'ipdSharingStatementModule': {'url': 'https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4759103', 'infoTypes': ['SAP'], 'timeFrame': '1 month', 'ipdSharing': 'YES', 'description': 'Comparing the Hydrodynamic Piezoelectric Technique with Osseodensification for the Assessment of Internal Sinus Iift-ing: (a Randomized Clinical Trial)', 'accessCriteria': 'DOI:10.21203/rs.3.rs-4132878/v1'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturere of oral medicine ,periodontology departement at sphinx university', 'investigatorFullName': 'Shaymaa Hussein Rafat Kotb', 'investigatorAffiliation': 'Al-Azhar University'}}}}