Zirconia and Metal-based Single Crown Posterior Restorations.
Zirconia-based and Metal-based Single Crown Posterior Restorations: 5-year Results of a Randomized Controlled Clinical Study.
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 23, 2016
CompletedFirst Posted
Study publicly available on registry
May 2, 2016
CompletedMay 2, 2016
April 1, 2016
5 years
April 23, 2016
April 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Technical complication rate
assessed by USPHS-criteria
5 years
Secondary Outcomes (2)
Survival rate
1, 3, 5 years
Survival rate
1, 3, 5 years
Study Arms (2)
metal-based restorations
ACTIVE COMPARATORsingle crown with a metal framework and pressed ceramic
zirconia-based restorations
EXPERIMENTALsingle crown with a zirconia framework and pressed ceramic
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Biomedical and Neuromotor Sciences, Division of Prosthotontics and Maxilla-Facial Rehabilitation
Bologna, 40125, Italy
Related Publications (1)
Monaco C, Llukacej A, Baldissara P, Arena A, Scotti R. Zirconia-based versus metal-based single crowns veneered with overpressing ceramic for restoration of posterior endodontically treated teeth: 5-year results of a randomized controlled clinical study. J Dent. 2017 Oct;65:56-63. doi: 10.1016/j.jdent.2017.07.004. Epub 2017 Jul 21.
PMID: 28736293DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Carlo Monaco, DDS, PhD
Study Record Dates
First Submitted
April 23, 2016
First Posted
May 2, 2016
Study Start
January 1, 2008
Primary Completion
January 1, 2013
Study Completion
April 1, 2015
Last Updated
May 2, 2016
Record last verified: 2016-04