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

University of Geneva, Switzerland1 site in 1 country38 target enrollmentJuly 28, 2021

ConditionsJaw, Edentulous, Partially Missing Teeth

Overview

Phase: N/A
Intervention: Not specified
Conditions: Jaw, Edentulous, Partially
Sponsor: University of Geneva, Switzerland
Enrollment: 38
Locations: 1
Primary Endpoint: Technical complication rate
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 28, 2021

End Date

July 2027

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Geneva, Switzerland

Responsible Party

Principal Investigator

João Pitta

Principal Investigator, Research and Teaching Fellow

University of Geneva, Switzerland

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