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

University of Geneva, Switzerland

Status: Enrolling

Conditions: Jaw, Edentulous, Partially; Missing Teeth

Treatments: Device: Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB); Device: porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM-GA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04713800

Cantilver study

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

ZR-TiB

Experimental group

Description:

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

Treatment:

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

PFM-GA

Active Comparator group

Description:

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

Treatment:

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