Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT01905306
Status:
UNKNOWN
Last Update Posted:
2013-07-23
First Post:
2013-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Full-Arch Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-18', 'studyFirstSubmitDate': '2013-07-16', 'studyFirstSubmitQcDate': '2013-07-18', 'lastUpdatePostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'implant success rate', 'timeFrame': '3 years', 'description': '1. No pain or tenderness upon function\n2. 0 mobility\n3. 2 mm radiographic bone loss from initial surgery\n4. No exudates history'}], 'primaryOutcomes': [{'measure': 'bone-to-implant contact', 'timeFrame': '3 years', 'description': '2D radiographic assessment of the implant surface in contact with bone expressed in percentage'}], 'secondaryOutcomes': [{'measure': 'implant survival rate', 'timeFrame': '3 years', 'description': '1. the absence of clinically detectable implant mobility\n2. a lack of persistent or irreversible signs and symptoms such as pain or any subjective sensation\n3. the absence of recurrent peri-implant infection\n4. the absence of concrete evidence of continuous periimplant radiolucency'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dental implants', 'immediate loading', 'full-arch', 'computer guided implant surgery'], 'conditions': ['Bone-to-implant Contact', 'Success Rate', 'Survival Rate']}, 'referencesModule': {'references': [{'pmid': '21070431', 'type': 'BACKGROUND', 'citation': 'Drago C, del Castillo R, Peterson T. Immediate occlusal loading in edentulous jaws, CT-guided surgery and fixed provisional prosthesis: a maxillary arch clinical report. J Prosthodont. 2011 Apr;20(3):209-17. doi: 10.1111/j.1532-849X.2010.00661.x. Epub 2010 Nov 11.'}, {'pmid': '23316558', 'type': 'BACKGROUND', 'citation': 'Case study: computer-guided implant successful in high-risk patient. J Calif Dent Assoc. 2012 Oct;40(10):784. No abstract available.'}, {'pmid': '22976712', 'type': 'BACKGROUND', 'citation': 'Margonar R, Queiroz TP, Luvizuto ER, Santos PL, Wady AF, Paleari AG. Anterior tooth rehabilitation with frozen homogenous bone graft and immediately loaded titanium implant using computer-guided surgery. J Craniofac Surg. 2012 Sep;23(5):e470-2. doi: 10.1097/SCS.0b013e3182587516.'}, {'pmid': '22930944', 'type': 'BACKGROUND', 'citation': 'Nickenig HJ, Eitner S, Rothamel D, Wichmann M, Zoller JE. Possibilities and limitations of implant placement by virtual planning data and surgical guide templates. Int J Comput Dent. 2012;15(1):9-21. English, German.'}, {'pmid': '22908535', 'type': 'BACKGROUND', 'citation': 'Shibly O, Kutkut A, Albandar JM. One-year re-entry results of guided bone regeneration around immediately placed implants with immediate or conventional loading: a case series. J Int Acad Periodontol. 2012 Jul;14(3):62-8.'}, {'pmid': '22783940', 'type': 'BACKGROUND', 'citation': 'Schnitman PA, Lee SJ, Campard GJ, Dona M. Guided flapless surgery with immediate loading for the high narrow ridge without grafting. J Oral Implantol. 2012 Jun;38(3):279-88. doi: 10.1563/AAID-JOI-D-11-00215.'}]}, 'descriptionModule': {'briefSummary': 'This clinical study has the objective to compare the radiographic evaluations after 3 years of follow-up of immediate loaded implant-prosthetic rehabilitation, carried out randomly using the methodology for computer guided implant planning with software polyvalent or free hand implants placement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Edentulous patients with an adequate area: at least two teeth in the posterior area\n* Age over 18 years\n* Adequate width of the bone crest without the need for bone regeneration\n* Consensus to participate in a oral hygiene maintenance program\n* Consensus to participate in a long-term study\n* Availability to provide their free and informed consensus.\n\nExclusion Criteria:\n\n* Systemic diseases that preclude participation in the study\n* History of radiation therapy\n* Bone lesions\n* Cigarette smoking (more than 10 cigarettes per day)\n* Inadequate oral hygiene\n* Untreated periodontitis affecting residual teeth'}, 'identificationModule': {'nctId': 'NCT01905306', 'briefTitle': 'Randomized Controlled Trial of Full-Arch Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'University of Siena'}, 'officialTitle': 'Clinical Evaluation of Immediate Loading Full Arch Rehabilitation Made With Methodology for Computer Guided Implant Planning With Software Polyvalent vs Free Hand Implants Placement', 'orgStudyIdInfo': {'id': 'RCTGIS1'}, 'secondaryIdInfos': [{'id': 'RCTGIS1s', 'type': 'OTHER', 'domain': 'University of Siena'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'computer guided implant planning', 'description': 'radiographic and clinical evaluation of full-arch dental implant rehabilitation', 'interventionNames': ['Procedure: computer guided implant planning']}, {'type': 'EXPERIMENTAL', 'label': 'free hand implants placement', 'description': 'radiographic and clinical evaluation of full-arch dental implant rehabilitation', 'interventionNames': ['Procedure: free hand implants placement']}], 'interventions': [{'name': 'computer guided implant planning', 'type': 'PROCEDURE', 'armGroupLabels': ['computer guided implant planning']}, {'name': 'free hand implants placement', 'type': 'PROCEDURE', 'armGroupLabels': ['free hand implants placement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53100', 'city': 'Siena', 'state': 'Siena', 'country': 'Italy', 'facility': 'Department of Dental Materials and Fixed Prosthodontics of Siena, Tuscan School of Dental Medicine, University of Florence and Siena', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}], 'overallOfficials': [{'name': 'Marco Ferrari, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florence and Siena, Siena, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Siena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Marco Ferrari', 'investigatorAffiliation': 'University of Siena'}}}}