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

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

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of dental crowns — monolithic zirconia and porcelain-fused-to-metal (PFM) — for use in a two-unit cantilever implant prosthesis (a dental bridge supported by a single implant). Both materials are commonly used in dentistry, but there is limited long-term data comparing how well they perform in cantilever designs, where one crown hangs unsupported over the gap left by a missing tooth. Participants who already have a well-placed dental implant in the back part of the mouth will be fitted with one of the two crown types and followed over time. Dentists will assess function, appearance, and any complications such as fractures or loosening. You may be eligible if... - You are 22 years of age or older - You have a well-placed, osseointegrated implant in the back upper or lower jaw - You have good oral hygiene and healthy gum tissue - You have a two-tooth gap suitable for a cantilever prosthesis - You have opposing teeth to bite against You may NOT be eligible if... - You have severe teeth grinding or clenching habits - You are pregnant or breastfeeding - You smoke more than 15 cigarettes per day - You have poor oral hygiene or an active infection in the mouth - Your cantilever crown would be larger than 10 mm Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

University of Geneva

Geneva, Switzerland

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NCT04713800


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