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Clinical Trials in Switzerland / NCT04713800
Recruiting Not applicable

Two-unit Cantilever Implant Prostheses Made of Monolithic Zirconia or PFM

NCT04713800 · tracked via the Priya Life Science Switzerland tracker
Sponsor
University of Geneva, Switzerland
Phase
Not applicable
Started
2021-07-28
Last updated
2022-11-23

Condition(s) studied

Jaw, Edentulous, PartiallyMissing Teeth

Investigational drug(s) / intervention(s)

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-GA)

Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB): 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.

porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM-GA): 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Minimal age of 22 years old. * No general medical condition which represents a contraindication to implant treatment * Good oral hygiene (PII ≤ 20%), and healthy periodontal tissues (BOP≤ 20%) * Two adjacent-teeth gap in posterior maxilla or mandible arch (first premolar, second premolar, first molar, second molar) with an osseointegrated regular or wide-diameter bone-level implant in a prosthetically correct position to allow occlusal screw-retention. Free-end edentulous gaps can also be included * Presence of antagonist occlusal units Exclusion Criteria: * Severe bruxism or clenching habits * Patients with inadequate oral hygiene or persistent intraoral infection * Women who are pregnant or breast feeding at the day of inclusion * Smokers exceeding 15 cigarettes / day, or equivalent; patients chewing tobacco * Unable or unwilling to cooperate for the trial period * Estimated cantilever crown mesial-distal length \> 10 mm * Estimated implant crown height (from implant platform to occlusal contact points) \> 15 mm

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University of Geneva Geneva Switzerland Recruiting

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Other trials for the same condition

Post Market Clinical Follow up (PMCF) Medical Device Registry of Z-Systems Zirconia Dental Products: Z-Systems Registry Recruiting
Post Market Clinical FoIIow up (PMCF) Medical Device (MD) of Z-Systems Monotype Zirconia Dental Product: Z5m Dental Implants Registry Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04713800 on ClinicalTrials.gov ↗ ← All trials in Switzerland