Zirconia Based Fixed Dental Prostheses

March 23, 2015 updated by: Technische Universität Dresden

Prospective Evaluation of Zirconia Based Tooth- and Implant- Supported Fixed Dental Prostheses

The objective of this prospective clinical study is to investigate the differences in the complication rates between tooth- and implant- supported zirconia based fixed dental prostheses (FDPs) with at least 4 units. The null-hypothesis is that there is no difference in the complication rates between implant- supported and tooth- supported zirconia FDPs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study aims to provide evidence regarding the clinical behaviour of long-span tooth- and implant-supported FDPs.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than 18 years
  • Missing of at least two adjacent teeth in the maxilla or mandibular
  • Sufficient oral hygiene

Exclusion Criteria:

  • Addiction to alcohol or drugs
  • Severe craniomandibular disorders
  • Severe systematic diseases
  • Patients unable or unwilling to sign the informed consent form
  • Untreated periodontitis

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tooth-supported
Long-span tooth-supported zirconia based fixed dental prostheses
Device: Teeth abutment
Other Names:
  • Zenotec system
Active Comparator: Implant-supported
Long-span implant-supported zirconia based fixed dental prostheses
Device: Implant abutments
Other Names:
  • Zenotec system
  • Wital (Implant system)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Fixed Dental Prostheses (FDPs) With Failure
Time Frame: 3 years
"Failure" was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Fixed Dental Prostheses (FDPs) With Chip/s
Time Frame: 3 years
Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported.
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of of Fixed Dental Prostheses (FDPs) With Rough Surface
Time Frame: 3 years
Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations.
3 years

Collaborators and Investigators

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

Sponsor

Technische Universität Dresden

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

May 1, 2008

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

August 19, 2014

First Posted (Estimate)

August 20, 2014

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 23, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • W-008

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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