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

NCT ID: NCT04713800

Last Updated: 2022-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-28

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Jaw, Edentulous, Partially Missing Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ZR-TiB

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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.

PFM-GA

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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Straumann® Variobase® for crown Straumann® Gold abutment for crown

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ITI Foundation

INDUSTRY

Sponsor Role collaborator

University of Geneva, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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João Pitta

Principal Investigator, Research and Teaching Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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João Pitta, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

Irena Sailer, Prof

Role: STUDY_CHAIR

University of Geneva

Locations

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University of Geneva

Geneva, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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João Pitta, Dr

Role: CONTACT

+41223794088

Facility Contacts

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João Pitta, Dr

Role: primary

Other Identifiers

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Cantilver study

Identifier Type: -

Identifier Source: org_study_id

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