An interventional study of Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB) and porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM-GA) in Jaw, Edentulous, Partially and Missing Teeth, sponsored by University of Geneva, Switzerland. Recruiting at 1 site in Switzerland. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-23.
Sponsored by University of Geneva, Switzerland · Not applicable, Interventional, and Treatment
The aim of is to compare the survival rate and technical outcomes of cantilever implant-supported fixed denture prosthetics (cFDPs) made either out of monolithic zirconia bonded to a titanium base in a digital workflow, or porcelain fused-to metal using a gold abutment in a conventional workflow. In addition, biological outcomes, wear patterns, PROMs and time efficiency will be recorded. The null hypothesis is: the reconstruction type does not influence the survival rate and technical outcomes of 2-unit implant-supported cFDP.
76 studies on the registry are indexed under Jaw, Edentulous, Partially; 7 are open to participants now.
This study's planned enrollment of 38 is close to the median of 38 across 67 interventional studies indexed under Jaw, Edentulous, Partially.
Browse Jaw, Edentulous, Partially studies →University of Geneva, Switzerland is the lead sponsor of 43 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
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Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR)
Device: Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB)
Porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM)
Device: porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM-GA)
In group ZR-TiB the implant impressions will be taken using an intra-oral scanner and the respective scanbody. The restorations will be manufactured by means of CAD/CAM procedures using monolithic zirconia. For sufficient aesthetics, the zirconia restorations can be manually veneered with veneering ceramic only at the buccal surface, while the occlusal surface will remain monolithic and will be high-gloss polished. The zirconia restorations will be extra-orally cemented onto titanium base abutments (Straumann® Variobase® for crown, Straumann AG), correctly polished and delivered to the patient, by screw-retention onto the implant.
Also known as: Straumann® Variobase® for crown
In group PFM-GA implant impression will be taken using a polyvinyl siloxane or polyether impression material in a conventional manner with the use of stock trays and corresponding impression copings. The framework will be manufactured by the lost wax-technique using a gold-abutment (Straumann® Gold abutment for crown, Straumann AG) and a gold-alloy. All metal frameworks will be manually veneered with veneering ceramic, polished and glazed, and delivered to the patient, by screw-retention onto the implant.
Also known as: Straumann® Gold abutment for crown
Technical complication rate
assessed by USPHS-criteria
Time frame: 5 years
Survival rate
Time frame: 1, 3, 5 years
Biological parameters
assessed by clinical examination by measuring with a periodontal probe: bleeding on probing (yes/no per site), pocket probing depth (mm), width of keratinized mucosa (mm), assessed by evaluation of standardized x-rays: marginal bone level changes (mm)
Time frame: 1, 3, 5 years
Wear rate of restoration and antagonist
assessed by a volumetric analysis software
Time frame: 1, 3, 5 years
Patient Reported Outcomes Measures (PROMs)
assessed through questionnaires: Oral Health Impact Profile (OHIP-14) to evaluate oral health-related quality of life \[0-4 for each of the 14 questions, where 4 represents the worst outcome\]; Visual Analogue Scales (VAS) to evaluate patient experience with the impression procedure \[0-10, where 10 represents the best outcome\]
Time frame: 1, 3, 5 years
Cost-efficiency
assessed by measuring time and counting costs of materials between the two workflows procedures (digital vs. analogue)
Time frame: single-point measure at baseline
Accuracy of fabrication
measured in terms of occlusal adjustment needed between the two fabrication procedures (digital vs. analogue workflow)
Time frame: single-point measure at baseline
Operator Reported Outcomes Measures
assessed through Visual Analogue Scales (VAS) to evaluate operator experience with the impression procedure and with the adjustment of the restoration \[0-10, where 10 represents the best outcome\]
Time frame: single-point measure at baseline
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University of Geneva, Switzerland