RecruitingNot ApplicableNCT04713800

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

Randomized Controlled Clinical Trial of Two-unit Cantilever Implant Prostheses Made of Monolithic Zirconia on Titanium Base Abutments or Porcelain-fused to Metal on Gold Abutments

Sponsor

University of Geneva, Switzerland

Enrollment

38 participants

Start Date

Jul 28, 2021

Study Type

INTERVENTIONAL

Conditions

Missing Teeth Jaw, Edentulous, Partially

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

Min Age: 22 Years

Inclusion Criteria5

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 Criteria7

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

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Interventions

DEVICEMonolithic 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.

DEVICEporcelain 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.