Y-TZP and In-mouth Low Thermal Degradation: A Prospective Clinical Study

August 6, 2019 updated by: Mainjot Amélie, University of Liege

Low Thermal Degradation of Monolithic Zirconia Prostheses: an up to 5-year Original Prospective Clinical Study Using ex Vivo Analyses

The objective of this work is to study in-mouth aging and LTD of monolithic zirconia restorations. Microstructural changes characteristic of LTD processes, wear, and clinical behaviour following standard parameters will be evaluated. Notably Raman spectroscopy and 3D laser surface analysis will be used, directly on the restorations, which will be removed at regular intervals.The working hypothesis is that LTD process is very slow at the scale at the lifespan of dental prostheses.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

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

  • Belgium
      • Liege, Belgium, 4000
        • Institute of Dentistry University of Liege

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Full zirconia crowns in the posterior region (molar/premolar)
  • On teeth or implants
  • Single unit restorations cemented on natural teeth and implants (including screw-retained restorations if possible, but no internal connections)
  • Multi-unit restorations on implants
  • If nightguard: to be performed on the antagonist

Exclusion Criteria:

  • Patients with removable prosthesis as an antagonist

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Zirconia monolithic crowns and bridges
Evaluation of Lava Plus zirconia dental crowns and bridges
Device: Lava plus (3M) crowns and bridges
Zirconia monolithic dental crowns and bridges evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
in-mouth LTD of monolithic zirconia restorations on natural teeth and implants
Time Frame: up to 5 years
up to 5 years

Collaborators and Investigators

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

Sponsor

University of Liege

Collaborators

DMG Paris Descartes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • FZ001

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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