Actively Recruiting

Phase Not Applicable
Age: 22Years +
All Genders
Healthy Volunteers
ID04713800

Randomized Controlled Clinical Trial Comparing Two-unit Cantilever Implant Prostheses Made of Monolithic Zirconia on Titanium Bases or Porcelain-Fused-to-Metal on Gold Abutments

Led by University of Geneva, Switzerland · Updated on 2022-11-23

38

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Geneva, Switzerland

Lead Sponsor

I

ITI Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare two types of two-unit cantilever implant-supported fixed denture prosthetics used to replace missing teeth in the jaw. The study evaluates monolithic zirconia prosthetics bonded to titanium base abutments created through a digital workflow versus porcelain fused-to-metal prosthetics using gold abutments in a conventional workflow. Researchers are assessing differences in survival rates, technical complications, biological outcomes, wear patterns, patient-reported outcomes, and time efficiency. Participants will receive one of two implant-supported cantilever reconstructions. One group will get monolithic zirconia restorations made by CAD/CAM and bonded to titanium bases, with possible ceramic veneering on the visible buccal surface. The other group will receive porcelain fused-to-metal restorations made with a gold abutment using the lost wax technique and conventional impression methods. Both restorations are screw-retained onto implants. The study is randomized and compares outcomes over several years. During the study, participants will be monitored at 1, 3, and 5 years for technical complications, survival rates, biological parameters, wear of the restoration and opposing teeth, and patient-reported outcomes. Additional measures like cost-efficiency, fabrication accuracy, and operator-reported outcomes will be evaluated at baseline. The total study duration includes long-term follow-up to assess both the technical and biological performance of these implant prostheses.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 22Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Minimal age of 22 years old
  • No general medical condition that contraindicates implant treatment
  • Good oral hygiene (Plaque Index 3 20%) and healthy periodontal tissues (Bleeding on Probing 3 20%)
  • Two adjacent missing teeth in the posterior upper or lower jaw (first premolar to second molar) with an osseointegrated implant in a correct position for screw-retained prosthesis
  • Presence of opposing teeth units
Not Eligible

You will not qualify if you...

  • Severe bruxism or clenching habits
  • Inadequate oral hygiene or persistent mouth infection
  • Pregnant or breastfeeding women at inclusion
  • Smoking more than 15 cigarettes per day or using chewing tobacco
  • Unable or unwilling to cooperate for the trial duration
  • Estimated cantilever crown length over 10 mm
  • Estimated implant crown height over 15 mm

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Single-point intervention at baseline

Participants receive either monolithic zirconia screw retained implant-supported cantilever prostheses on titanium base abutments or porcelain fused-to-metal screw retained implant-supported cantilever prostheses on gold abutments as part of the treatment.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for technical complications, survival, biological parameters, wear rate, and patient-reported outcomes over 5 years following the prosthesis placement.

Visits at 1, 3, and 5 years

Trial Site Locations

Total: 1 location

1

University of Geneva

Geneva, Switzerland, 1211

Actively Recruiting

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Research Team

J

João Pitta, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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