T-116_Procera-Bridge Zirconia - A Clinical Study
Procera-Bridge Zirconia - A Clinical Study
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
The objective of the study is to evaluate the clinical performance of Procera® Bridge Zirconia veneered with NobelRondo Zirconia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2005
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 27, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
April 25, 2016
CompletedOctober 27, 2016
September 1, 2016
9.9 years
June 27, 2014
March 23, 2016
September 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Success Rate of Bridge Procera Bridge Zirconia
The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.
prosthesis delivery, 1 year
Secondary Outcomes (1)
Success Rate of Bridge Procera Bridge Zirconia
prosthesis delivery, 5 years
Study Arms (1)
Procera® Bridge Zirconia
OTHERPatients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Interventions
Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Eligibility Criteria
You may qualify if:
- Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible
- Indication: same indication as for metal supported bridges
- Obtained informed consent from the patient
You may not qualify if:
- Currently known alcohol, drug or medication abuse, judged by the investigator, which might influence the follow-up program
- Patients where a bridge part connection area of 3 mm of diameter is not possible to obtain (short clinical crowns)
- Mobility of the abutment teeth exceeding grade I
- Patients with pathologic pocket formation at abutment teeth
- Patients with complete dentures in the opposing jaw
- Patients with a removable partial denture in the same jaw
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nobel Biocarelead
Related Publications (1)
Association, C.D., Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977.
BACKGROUND
Results Point of Contact
- Title
- Head of Clinical Trial Management
- Organization
- Nobel Biocare
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2014
First Posted
July 10, 2014
Study Start
May 1, 2005
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
October 27, 2016
Results First Posted
April 25, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share