Zirconia Based Fixed Dental Prostheses
Prospective Evaluation of Zirconia Based Tooth- and Implant- Supported Fixed Dental Prostheses
1 other identifier
interventional
32
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2008
Longer than P75 for not_applicable
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
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 16, 2014
CompletedFirst Posted
Study publicly available on registry
August 20, 2014
CompletedResults Posted
Study results publicly available
March 24, 2015
CompletedMarch 24, 2015
March 1, 2015
5.5 years
July 16, 2014
March 4, 2015
March 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Fixed Dental Prostheses (FDPs) With Failure
"Failure" was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period.
3 years
Secondary Outcomes (1)
Number of Fixed Dental Prostheses (FDPs) With Chip/s
3 years
Other Outcomes (1)
Number of of Fixed Dental Prostheses (FDPs) With Rough Surface
3 years
Study Arms (2)
Tooth-supported
EXPERIMENTALLong-span tooth-supported zirconia based fixed dental prostheses
Implant-supported
ACTIVE COMPARATORLong-span implant-supported zirconia based fixed dental prostheses
Interventions
Eligibility Criteria
You may qualify if:
- Patients older than 18 years
- Missing of at least two adjacent teeth in the maxilla or mandibular
- Sufficient oral hygiene
You may not qualify if:
- Addiction to alcohol or drugs
- Severe craniomandibular disorders
- Severe systematic diseases
- Patients unable or unwilling to sign the informed consent form
- Untreated periodontitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Konstantinidis IK, Jacoby S, Radel M, Boning K. Prospective evaluation of zirconia based tooth- and implant-supported fixed dental prostheses: 3-year results. J Dent. 2015 Jan;43(1):87-93. doi: 10.1016/j.jdent.2014.10.011. Epub 2014 Nov 5.
PMID: 25446240DERIVED
Results Point of Contact
- Title
- Dr. Konstantinidis Ioannis
- Organization
- Zahnärztliche Prothetik
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2014
First Posted
August 20, 2014
Study Start
May 1, 2008
Primary Completion
November 1, 2013
Study Completion
December 1, 2013
Last Updated
March 24, 2015
Results First Posted
March 24, 2015
Record last verified: 2015-03