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Recruiting NCT04713800

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

No phase Interventional Jaw, Edentulous, Partially Missing Teeth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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).
Who it may be relevant to
Registry conditions: Jaw, Edentulous, Partially, Missing Teeth. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device 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 abutme
  • 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 th

Primary outcome measures

  • Technical complication rate [Time frame: 5 years]
Secondary outcome measures (7)
  • Survival rate [Time frame: 1, 3, 5 years]
  • Biological parameters [Time frame: 1, 3, 5 years]
  • Wear rate of restoration and antagonist [Time frame: 1, 3, 5 years]
  • Patient Reported Outcomes Measures (PROMs) [Time frame: 1, 3, 5 years]
  • Cost-efficiency [Time frame: single-point measure at baseline]
  • Accuracy of fabrication [Time frame: single-point measure at baseline]
  • Operator Reported Outcomes Measures [Time frame: single-point measure at baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 1 center
  • University of Geneva — Geneva

Identifiers

NCT: NCT04713800 · Cantilver study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗