Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-25 @ 3:09 PM
Study NCT ID:
NCT01821092
Status:
COMPLETED
Last Update Posted:
2016-09-02
First Post:
2013-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dimensional Changes of Peri-implant Facial Bone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007576', 'term': 'Jaw, Edentulous, Partially'}], 'ancestors': [{'id': 'D007575', 'term': 'Jaw, Edentulous'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077280', 'term': 'Bone-Anchored Prosthesis'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-01', 'studyFirstSubmitDate': '2013-03-26', 'studyFirstSubmitQcDate': '2013-03-28', 'lastUpdatePostDateStruct': {'date': '2016-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'horizontal buccal bone thickness', 'timeFrame': '12 months after abutment connection', 'description': 'On Cone Beam images, the horizontal dimensional changes of peri-implant facial bone will be measured'}], 'secondaryOutcomes': [{'measure': 'vertical bone level', 'timeFrame': '1 year after abutment connection', 'description': 'On Cone Beam images, the vertical dimensional changes of peri-implant facial bone will be measured'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['osseointegrated Implant, bone level'], 'conditions': ['Jaw, Edentulous, Partially']}, 'descriptionModule': {'briefSummary': "40 consecutive adult patients, requiring the insertion of dental implants in the aesthetic area (from second premolar to second premolar) will be enrolled in the study. At the time of surgery, a full thickness flap will be elevated, the implant bed will be prepared according to the manufacturer's instruction and the implants will be then seated into the bone. T0 corresponds to the time of implant insertion, T1 to the time of healing abutment's connection (T0=T1 for single stage implants), and T2 corresponds to 1-year follow-up from healing abutment's connection.\n\nCone Beam Computed Tomography (CBCT) scans will be taken immediately after abutment connection (T1) and 1-year after (T2). The midsagittal cut of each implant will be identified, and measurements will be made at predetermined levels. Horizontal facial bone thickness (HFBT) and Vertical facial bone level (VFBL) will be measured. HFBT will be measured at 0, 3, 6 and 9 mm apical to the implant platform. VFBL wil be the perpendicular distance from the implant platform to the most coronal point of the facial bone. Changes between T1 and T2 will be calculated.", 'detailedDescription': "The long term results and benefit of implant insertion in the aesthetic area have been well documented.\n\nIn the past few years, facial dimensional changes to the alveolar process following implant placement are object os study for both humans and animals investigations Recent studies suggest that platform switching decreases bone loss by 30% to 50%. It seems that the creation of a biologic width affects peri-implant bone loss to a significant extent and that platform switching is effective when the mucosal thickness allows the establishment of an horizontal biologic width.\n\nA new implant with an hybrid surface (T3) has been recently launched by Biomet 3i.Aim of the present study will be to evaluate the degree of 3D marginal bone remodelling around T3 Prevail implants.\n\nMATERIALS \\& METHODS:\n\n40 consecutive adult patients, requiring the insertion of dental implants in the aesthetic area (from second premolar to second premolar) will be enrolled in the study. At the time of surgery, a full thickness flap will be elevated, the implant bed will be prepared according to the manufacturer's instruction and the implants will be then seated into the bone. Implants can be placed both with a single-stage or two-stage procedure. Implants inserted with a two-stage procedure will be re-opened after a submerged period of three months.\n\nT0 corresponds to the time of implant insertion, T1 to the time of healing abutment's connection (T0=T1 for single stage implants), and T2 corresponds to 1-year follow-up from healing abutment's connection.\n\nIt is supposed that the creation of the biological width starts with the healing abutment's connection.\n\nCBCT scans will be taken immediately after abutment connection (T1) and 1-year after (T2). The midsagittal cut of each implant will be identified, and measurements will be made at predetermined levels. Horizontal facial bone thickness (HFBT) and Vertical facial bone level (VFBL) will be measured. HFBT will be measured at 0, 3, 6 and 9 mm apical to the implant platform. VFBL wil be the perpendicular distance from the implant platform to the most coronal point of the facial bone. Changes between T1 and T2 will be calculated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy adult patients requiring implant insertion -\n\nExclusion Criteria:\n\nPregnancy history of malignancy history of radiotherapy or chemotherapy in the last 5 years long term steroidal or antibiotic therapy\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01821092', 'briefTitle': 'Dimensional Changes of Peri-implant Facial Bone', 'organization': {'class': 'OTHER', 'fullName': 'Proed, Torino, Italy'}, 'officialTitle': 'Horizontal and Vertical Dimensional Changes of Peri-implant Facial Bone Following Placement of T3 Implants: a 1-year Cone Beam Computed Tomography Study', 'orgStudyIdInfo': {'id': '03.2013.Don Bosco.PROED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard implant, switching platform', 'description': 'osseointegrated implant insertion and abutment connection Implants inserted in healed ridge, prosthetic connection with switching platform', 'interventionNames': ['Procedure: implant insertion and abutment connection', 'Device: osseointegrated implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'immediate implant, switching platform', 'description': 'osseointegrated implant insertion and abutment connection Implants inserted in immediate post-extraction sites, prosthetic connection with switching platform', 'interventionNames': ['Procedure: implant insertion and abutment connection', 'Device: osseointegrated implant']}], 'interventions': [{'name': 'implant insertion and abutment connection', 'type': 'PROCEDURE', 'description': 'After implant insertion, immediate or in healed ridge, the titanium abutment with switching platform will be connected', 'armGroupLabels': ['immediate implant, switching platform', 'standard implant, switching platform']}, {'name': 'osseointegrated implant', 'type': 'DEVICE', 'otherNames': ['T3 implant, Biomet 3i'], 'description': 'Osseointegrated Implant Insertion', 'armGroupLabels': ['immediate implant, switching platform', 'standard implant, switching platform']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10129', 'city': 'Torino', 'country': 'Italy', 'facility': 'PROED, Institute for Professional Education in Dentistry', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Daniele Cardaropoli, DDS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Proed, Torino, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Proed, Torino, Italy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}