Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT05410405
Status:
COMPLETED
Last Update Posted:
2022-06-08
First Post:
2022-05-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Osseodensification Drills Versus Piezoelectric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D001284', 'term': 'Atrophy'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'implant stability assessment was blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'split mouth'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-04', 'studyFirstSubmitDate': '2022-05-31', 'studyFirstSubmitQcDate': '2022-06-04', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'implant insertion torque', 'timeFrame': 'at implant insertion', 'description': 'insertion torque'}, {'measure': 'implant stability quotient', 'timeFrame': 'at implant insertion', 'description': 'resonance frequency'}], 'secondaryOutcomes': [{'measure': 'implant secondary stability', 'timeFrame': '7 days after implant insertion', 'description': 'resonance frequency'}, {'measure': 'implant secondary stability', 'timeFrame': '14 days after implant insertion', 'description': 'resonance frequency'}, {'measure': 'implant secondary stability', 'timeFrame': '21 days after implant insertion', 'description': 'resonance frequency'}, {'measure': 'implant secondary stability', 'timeFrame': '28 days after implant insertion', 'description': 'resonance frequency'}, {'measure': 'implant secondary stability', 'timeFrame': '2 months after implant insertion', 'description': 'resonance frequency'}, {'measure': 'implant secondary stability', 'timeFrame': '3 months after implant insertion', 'description': 'resonance frequency'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Edentulous; Alveolar Process, Atrophy']}, 'descriptionModule': {'briefSummary': 'implant stability is the first requirement for implant success. the aim is to assess whether different implant site preparation technique may impact the value of the primary stability.', 'detailedDescription': 'Impianti stability represents one of the most fundamental issue for implant success. Different techniques of implant site preparation are available such as twist drill, osteotome, piezosurgery and lastly, osseodensification. Due to their different approach an biological rationale, piezosurgery and osseodensification might show diverse impact on implant first and secondary stability, therefore the aim of the present study was the assessment of primary and secondary stability changes of values between implant sites prepared with piezoelectric bone surgery and with specific osseodensification drills.\n\nPatients with bilateral single maxillary edentulism will randomly receive implant site preparation with piezoelectric approach or with osseodensification drills. standardized implants will be therefore inserted and primary stability will be assessed at the time of implant insertion and during the subsequent timepoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bilateral single maxillary edentulism\n\nExclusion Criteria:\n\n* smoking habit\n* history of periodontal disease\n* uncontrolled diabetes\n* pregnancy or breastfeeding\n* head and neck radiotherapy or chemotherapy\n* bone antiresorptive therapy\n* coagulopaties'}, 'identificationModule': {'nctId': 'NCT05410405', 'briefTitle': 'Osseodensification Drills Versus Piezoelectric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'International Piezosurgery Academy'}, 'officialTitle': 'Changes in Implant Stability Using Different Site Preparation Techniques: Osseodensification Drills Versus Piezoelectric Surgery. A Multicenter Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'piezodensi'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '8 millimeter implants', 'description': 'implant insertion with piezo surgical osteotomy and with osseodensification drills', 'interventionNames': ['Procedure: implant site preparation']}, {'type': 'EXPERIMENTAL', 'label': '10 millimeter implants', 'description': 'implant insertion with piezo surgical osteotomy and with osseodensification drills', 'interventionNames': ['Procedure: implant site preparation']}], 'interventions': [{'name': 'implant site preparation', 'type': 'PROCEDURE', 'otherNames': ['implant insertion'], 'description': 'piezoelectric bone surgery osseodensification drills', 'armGroupLabels': ['10 millimeter implants', '8 millimeter implants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87011', 'city': 'Cassano Allo Ionio', 'state': 'CS', 'country': 'Italy', 'facility': 'Hesire'}, {'zip': '43100', 'city': 'Parma', 'country': 'Italy', 'facility': 'Piezosurgery Academy', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'overallOfficials': [{'name': 'Claudio Stacchi, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'International Piezoelectric Surgery Academy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no sharing is planned'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Piezosurgery Academy', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Foggia', 'class': 'OTHER'}, {'name': 'University of Trieste', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}