Two-unit Cantilever Implant Prostheses Made of Monolithic Zirconia or PFM
Cantilever
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
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 19, 2021
CompletedStudy Start
First participant enrolled
July 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
November 23, 2022
November 1, 2022
5.9 years
January 12, 2021
November 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Technical complication rate
assessed by USPHS-criteria
5 years
Secondary Outcomes (7)
Survival rate
1, 3, 5 years
Biological parameters
1, 3, 5 years
Wear rate of restoration and antagonist
1, 3, 5 years
Patient Reported Outcomes Measures (PROMs)
1, 3, 5 years
Cost-efficiency
single-point measure at baseline
- +2 more secondary outcomes
Study Arms (2)
ZR-TiB
EXPERIMENTALMonolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR)
PFM-GA
ACTIVE COMPARATORPorcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Severe bruxism or clenching habits
- Patients with inadequate oral hygiene or persistent intraoral infection
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Geneva, Switzerlandlead
- ITI Foundationcollaborator
Study Sites (1)
University of Geneva
Geneva, 1211, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
João Pitta, Dr
University of Geneva
- STUDY CHAIR
Irena Sailer, Prof
University of Geneva
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Research and Teaching Fellow
Study Record Dates
First Submitted
January 12, 2021
First Posted
January 19, 2021
Study Start
July 28, 2021
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
November 23, 2022
Record last verified: 2022-11