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Zirconia and Metal-based Single Crown Posterior Restorations.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02758457
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : May 2, 2016
Information provided by (Responsible Party):
carlo monaco, University of Bologna

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Crowns Dental Prosthesis Prosthodontics Device: dental crowns Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zirconia-based and Metal-based Single Crown Posterior Restorations: 5-year Results of a Randomized Controlled Clinical Study.
Study Start Date : January 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

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

Primary Outcome Measures :
  1. Technical complication rate [ Time Frame: 5 years ]
    assessed by USPHS-criteria

Secondary Outcome Measures :
  1. Survival rate [ Time Frame: 1, 3, 5 years ]
    assessed by bleeding on probing

  2. Survival rate [ Time Frame: 1, 3, 5 years ]
    pocket probing depth

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02758457

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: carlo monaco, Dr. Carlo Monaco, DDS, PhD, University of Bologna Identifier: NCT02758457    
Other Study ID Numbers: 222893
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by carlo monaco, University of Bologna:
dental porcelain
press on metal