Zirconia and Metal-based Single Crown Posterior Restorations.

April 28, 2016 updated by: carlo monaco, University of Bologna

Zirconia-based and Metal-based Single Crown Posterior Restorations: 5-year Results of a Randomized Controlled Clinical Study.

The objective of this study was to compare the 5-year survival and clinical behavior of single posterior ceramic crowns made with pressable ceramic on zirconia or on a metal framework. If failures occurred, the further aim of the study was to delineate the factors contributing to the failure. The null hypothesis stated that the survival of zirconia-based restorations would be no worse that those made with metal-based material.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 4

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

  • Italy
      • Bologna, Italy, 40125
        • Department of Biomedical and Neuromotor Sciences, Division of Prosthotontics and Maxilla-Facial Rehabilitation

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:

  • Informed Consent as documented by signature
  • Male and female patients from 18-70 years of age
  • Need for a single crown restoration
  • Presence of antagonist
  • minimum of 20 teeth
  • moderate to good oral hygiene with the ability to perform mechanical oral hygiene techniques including tooth brushing
  • low to moderate caries risk, and no active periodontal disease.

Exclusion Criteria:

  • Women who are pregnant at the date of inclusion
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Smoking more than 15 cigarettes a day
  • Poor oral hygiene (Plaque Index over 30%)
  • Bruxism
  • vital teeth
  • allergic reaction or hypersensitivity to ingredients of the adhesive or restorative material

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: metal-based restorations
single crown with a metal framework and pressed ceramic
Device: dental crowns
EXPERIMENTAL: zirconia-based restorations
single crown with a zirconia framework and pressed ceramic
Device: dental crowns

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical complication rate
Time Frame: 5 years
assessed by USPHS-criteria
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate
Time Frame: 1, 3, 5 years
assessed by bleeding on probing
1, 3, 5 years
Survival rate
Time Frame: 1, 3, 5 years
pocket probing depth
1, 3, 5 years

Collaborators and Investigators

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

Sponsor

University of Bologna

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

January 1, 2008

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

April 23, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (ESTIMATE)

May 2, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 222893

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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