Clinical trial NCT04713800: Two-unit Cantilever Implant Prostheses Made of Monolithic Zirconia or PFM
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Jaw, Edentulous, Partially
Missing Teeth
Keywords: Dental Implants
Cantilever
Titanium base
Dental abutment
Fixed dental prosthesis
Monolithic zirconia
Porcelain fused to metal
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
Collaborators: name: ITI Foundation
First posted: 2021-01-19
Enrollment: 38
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Technical complication rate
timeFrame: 5 years
Secondary outcomes:
measure: Survival rate
timeFrame: 1, 3, 5 years
measure: Biological parameters
timeFrame: 1, 3, 5 years
measure: Wear rate of restoration and antagonist
timeFrame: 1, 3, 5 years
measure: Patient Reported Outcomes Measures (PROMs)
timeFrame: 1, 3, 5 years
measure: Cost-efficiency
timeFrame: single-point measure at baseline
measure: Accuracy of fabrication
timeFrame: single-point measure at baseline
measure: Operator Reported Outcomes Measures
timeFrame: single-point measure at baseline
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University of Geneva
Study officials:
affiliation: University of Geneva
name: João Pitta, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Geneva
name: Irena Sailer, Prof
role: STUDY_CHAIR
References: