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

Primary Purpose

Jaw, Edentulous, Partially, Missing Teeth

Status

Recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring Dental Implants, Cantilever, Titanium base, Dental abutment, Fixed dental prosthesis, Monolithic zirconia, Porcelain fused to metal

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

University of GenevaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ZR-TiB

PFM-GA

Arm Description

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

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

Outcomes

Primary Outcome Measures

Technical complication rate

assessed by USPHS-criteria

Secondary Outcome Measures

Survival rate

Biological parameters

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)

Wear rate of restoration and antagonist

assessed by a volumetric analysis software

Patient Reported Outcomes Measures (PROMs)

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]

Cost-efficiency

assessed by measuring time and counting costs of materials between the two workflows procedures (digital vs. analogue)

Accuracy of fabrication

measured in terms of occlusal adjustment needed between the two fabrication procedures (digital vs. analogue workflow)

Operator Reported Outcomes Measures

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]

Full Information

NCT ID

NCT04713800

First Posted

January 12, 2021

Last Updated

November 21, 2022

Sponsor

University of Geneva, Switzerland

Collaborators

ITI Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04713800

Brief Title

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

Acronym

Cantilever

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 28, 2021 (Actual)

Primary Completion Date

July 2027 (Anticipated)

Study Completion Date

July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Geneva, Switzerland

Collaborators

ITI Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Jaw, Edentulous, Partially, Missing Teeth

Keywords

Dental Implants, Cantilever, Titanium base, Dental abutment, Fixed dental prosthesis, Monolithic zirconia, Porcelain fused to metal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ZR-TiB

Arm Type

Experimental

Arm Description

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

Arm Title

PFM-GA

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

Straumann® Variobase® for crown

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

Straumann® Gold abutment for crown

Intervention Description

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.

Primary Outcome Measure Information:

Title

Technical complication rate

Description

assessed by USPHS-criteria

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Survival rate

Time Frame

1, 3, 5 years

Title

Biological parameters

Description

Time Frame

1, 3, 5 years

Title

Wear rate of restoration and antagonist

Description

assessed by a volumetric analysis software

Time Frame

1, 3, 5 years

Title

Patient Reported Outcomes Measures (PROMs)

Description

Time Frame

1, 3, 5 years

Title

Cost-efficiency

Description

assessed by measuring time and counting costs of materials between the two workflows procedures (digital vs. analogue)

Time Frame

single-point measure at baseline

Title

Accuracy of fabrication

Description

measured in terms of occlusal adjustment needed between the two fabrication procedures (digital vs. analogue workflow)

Time Frame

single-point measure at baseline

Title

Operator Reported Outcomes Measures

Description

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]

Time Frame

single-point measure at baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

João Pitta, Dr

Phone

+41223794088

joao.pitta@unige.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

João Pitta, Dr

Organizational Affiliation

University of Geneva

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Irena Sailer, Prof

Organizational Affiliation

University of Geneva

Official's Role

Study Chair

Facility Information:

Facility Name

University of Geneva

City

Geneva

ZIP/Postal Code

1211

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

João Pitta, Dr

12. IPD Sharing Statement

Learn more about this trial

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

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