Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-25 @ 3:12 PM
Study NCT ID:
NCT05676268
Status:
UNKNOWN
Last Update Posted:
2023-03-23
First Post:
2022-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implant-supported Fixed Dental Prostheses (FDPs) With Cantilever Extension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011475', 'term': 'Prosthesis Failure'}, {'id': 'D057873', 'term': 'Peri-Implantitis'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2022-12-22', 'lastUpdatePostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant survival rate', 'timeFrame': '12 months', 'description': 'Percentage of dental implants present at follow-up visit'}], 'secondaryOutcomes': [{'measure': 'Peri-implant marginal bone level changes', 'timeFrame': '12 months'}, {'measure': 'Number of technical complications', 'timeFrame': '12 months'}, {'measure': 'Number of mechanical complications', 'timeFrame': '12 months'}, {'measure': 'Number of Biological complications', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Implant Failed', 'Prosthesis Failure', 'Peri-Implantitis']}, 'descriptionModule': {'briefSummary': 'To report the clinical and radiographic outcomes of implant-supported fixed dental prostheses with full-ceramic cantilever extensions (FDPCs) after a function time ≥ 12 months.', 'detailedDescription': 'Patients with full ceramic FDPCs in anterior and posterior areas will be clinically and radiographically re-evaluated. Mesial and distal radiographic marginal bone levels (mBLs) from baseline (i.e. delivery of FDPC) to the follow-up examination were calculated and compared between implant surfaces adjacent to and distant from the cantilever extension. Implant survival rate (%), pocket probing depth (PPD), presence/ absence of bleeding on probing (BoP) and presence/absence of mechanical/technical and biological complications were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with missing teeth rehabilitated with dental implants supporting partial fixed dental prostheses with cantilever extensions', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≥18 years\n* Written informed consent\n* Patients with systemic health or controlled medical conditions\n* Patients with healthy or treated periodontal conditions\n* Patients enrolled in regular supportive periodontal therapy (SPT)\n* Patients without clinical signs of bruxism and/or oral parafunctions\n* 2 osseointegrated dental implants in the canine or posterior areas of maxilla and mandible following transmucosal placement and healing of 3-6 months\n* Tissue level solid-screw implants with a sand-blasted and acid- etched (SLA) surface with an endosseous diameter of 3.3, 4.1 or 4.8 mm, a length of 8, 10 or 12 mm, a shoulder diameter of 4.8 mm and a supracrestal machined neck with a height of 1.8 or 2.8 mm (Straumann® Dental Implant System, Institut Straumann AG, Basel, Switzerland)\n* Full-ceramic\n* Utilization of prefabricated titanium abutments\n* Cemented (3M™ ESPE Ketac™ Cem, Seefeld, Germany) or screw-retained fixed dental prostheses with a mesial or distal cantilever extension (FDPCs)\n* Cantilever extension corresponding to 1 premolar unit (i.e., 6-7 mm)\n* Absence of occlusal contacts or guidance on the cantilever extension at baseline\n* Opposing dentition consisting of natural teeth or fixed or removable prosthetic restorations\n* Availability of a periapical radiograph at baseline (i.e. FDPC delivery)\n* Availability of PPD measurements (mm) taken at baseline at 4 sites/implant with a graduated Michigan periodontal probe (Deppeler SA, Rolle, Switzerland)\n* Availability of BoP measurements (%) (Lang et al., 1986) taken at baseline at 4 sites/implant with a graduated Michigan periodontal probe (Deppeler SA, Rolle, Switzerland).\n\nExclusion Criteria:\n\n* Untreated or active periodontal diseases\n* Immediate implant placement (i.e., Type I implant placement according to Hämmerle et al., 2004)\n* FDPCs in the aesthetic zone (i.e., replacement of maxillary or mandibular incisors)\n* FDPCs supported by hollow-screw and hollow-cylinder implants'}, 'identificationModule': {'nctId': 'NCT05676268', 'briefTitle': 'Implant-supported Fixed Dental Prostheses (FDPs) With Cantilever Extension', 'organization': {'class': 'OTHER', 'fullName': 'University of Bern'}, 'officialTitle': 'Clinical and Radiographic Outcomes of Implant-supported Full-ceramic Partial Fixed Dental Prostheses With Cantilever Extension: A Proof of Principle Study With a Follow-up of at Least 1 Year', 'orgStudyIdInfo': {'id': 'FDPs with cantilever'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with oral implants supporting full ceramic fixed dental prostheses', 'interventionNames': ['Procedure: Implant-supported fixed dental prostheses with cantilever extension']}], 'interventions': [{'name': 'Implant-supported fixed dental prostheses with cantilever extension', 'type': 'PROCEDURE', 'description': 'Healthy patients in need of replacement of missing teeth with dental implants supporting partial fixed dental prostheses with cantilever extensions', 'armGroupLabels': ['Patients with oral implants supporting full ceramic fixed dental prostheses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Andrea Roccuzzo, Dr.', 'role': 'CONTACT', 'email': 'andrea.roccuzzo@zmk.unibe.ch', 'phone': '0041 31 632 86 29'}, {'name': 'Stähli Alexandra, Dr.', 'role': 'CONTACT', 'email': 'alexandra.staehli@zmk.unibe.ch', 'phone': '0041 31 632 86 29'}, {'name': 'Andrea Roccuzzo, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Giovanni Salvi, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexandra Stähli, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Periodontology, University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'Jean-Claude Imber, DDS', 'role': 'CONTACT', 'email': 'jean-claude.imber@zmk.unibe.ch', 'phone': '+41 31 632 25 89'}, {'name': 'Giovanni Salvi, DDS', 'role': 'CONTACT', 'email': 'giovanni.salvi@zmk.unibe.ch', 'phone': '+41 31 632 35 51'}], 'overallOfficials': [{'name': 'Andrea Roccuzzo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}