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

Not Applicable

Recruiting

• Conditions: Jaw, Edentulous, Partially; Missing Teeth
• Interventions: 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)

• Registration Number: NCT04713800
• Lead Sponsor: University of Geneva, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-19
• Study Start: 2021-07-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-23
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Technical complication rate	5 years	assessed by USPHS-criteria

Secondary Outcome Measures

Name	Time	Method
Biological parameters	1, 3, 5 years	assessed by clinical examination by measuring with a periodontal probe: bleeding on probing (yes/no per site), pocket probing depth (mm), width of keratinized mucosa (mm), assessed by evaluation of standardized x-rays: marginal bone level changes (mm)
Patient Reported Outcomes Measures (PROMs)	1, 3, 5 years	assessed through questionnaires: Oral Health Impact Profile (OHIP-14) to evaluate oral health-related quality of life \[0-4 for each of the 14 questions, where 4 represents the worst outcome\]; Visual Analogue Scales (VAS) to evaluate patient experience with the impression procedure \[0-10, where 10 represents the best outcome\]
Operator Reported Outcomes Measures	single-point measure at baseline	assessed through Visual Analogue Scales (VAS) to evaluate operator experience with the impression procedure and with the adjustment of the restoration \[0-10, where 10 represents the best outcome\]
Wear rate of restoration and antagonist	1, 3, 5 years	assessed by a volumetric analysis software
Accuracy of fabrication	single-point measure at baseline	measured in terms of occlusal adjustment needed between the two fabrication procedures (digital vs. analogue workflow)
Cost-efficiency	single-point measure at baseline	assessed by measuring time and counting costs of materials between the two workflows procedures (digital vs. analogue)
Survival rate	1, 3, 5 years

Trial Locations

Locations (1)

University of Geneva; 🇨🇭 Geneva, Switzerland