Clinical Investigation on Zirconia-ceramic Three-unit Bridges With CAD-on Veneering

February 11, 2020 updated by: Ivoclar Vivadent AG

A Randomized Clinical Trial of 3-unit Posterior Zirconia-ceramic Fixed Dental Prosthesis (FDPs) Veneered With Layered and Milled (CAD-on) Veneering Ceramics

60 bridge frameworks are CAD/CAM manufactured from zirconia-ceramic; 30 bridges are veneered with CAD/CAM fabricated lithium disilicate ceramic, 30 bridges are manually layered. The goal is to compare clinical survival , biological or technical behaviour of the restorations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized prospective controlled clinical study with three-unit posterior bridges made of zirconia-ceramic to compare veneering with manually layering or CAD/CAM fabricated lithium disilicate ceramic veneers. The hypothesis is that there is no difference in clinical survival of the restorations and no difference in biological or technical behaviour.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8032
        • Universität Zürich, Zentrum für Zahn-, Mund- und Kieferheilkunde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • single missing posterior tooth with two adjacent posterior teeth
  • no acute conservative or paradontal treatment need except for the teeth to be treated in the study
  • sufficient oral hygiene

Exclusion Criteria:

  • known allergies to components
  • bruxism
  • missing antagonist tooth
  • pregnancy or lactation
  • missing written consent
  • patients which are not expected to be compliant
  • severe systemic diseases
  • untreated carious lesions
  • untreated parodontitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAD/CAM veneering
CAD/CAM manufactured e.max CAD veneers on zirconia framework
Device: CAD/CAM Veneering
CAD/CAM fabricated zirconia bridge framework is veneered with CAD/CAM fabricated lithium disilicate ceramic veneer
Active Comparator: manually layered
Manually layered veneering on CAD/CAM fabricated zirconia bridge framework
Device: Manually layered veneering

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with clinical success
Time Frame: 2 years
Clinical success is defined as more than 95% survival of the restoration after 2 years.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration quality
Time Frame: 1 week, 1 year, 2 years, 3 years, 4 years, 5 years
Characterisation of the restorations according to United States Public Health Services (USPHS) criteria
1 week, 1 year, 2 years, 3 years, 4 years, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ivoclar Vivadent AG

Investigators

  • Principal Investigator: Andreas Bindl, Dr.med.dent., Universität Zürich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAD-On

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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