T-116_Procera-Bridge Zirconia - A Clinical Study

Not Applicable

Completed

• Conditions: Partial Edentulism

• Registration Number: NCT02186808
• Lead Sponsor: Nobel Biocare

Brief Summary

The objective of the study is to evaluate the clinical performance of Procera® Bridge Zirconia veneered with NobelRondo Zirconia.

Detailed Description

The study was designed to be an open, 5-year, prospective, multi-center clinical post-market study. The objectives of this clinical study were that industrial centrally produced 3- or 4-unit bridges of yttrium-oxide partially-stabilized (Y-TZP) zirconia (Procera Zirconia) in combination with the veneering ceramic material NobelRondo will show sufficient CDA ratings (90% R+S) and a sufficient survival rate after 1 and 5 years.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2014-06-27
• Study First Submitted QC: 2014-07-08
• Study First Posted: 2014-07-10
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2016-03-23
• Results First Submitted QC: 2016-03-23
• Results First Posted: 2016-04-25
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-23
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion criteria

• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Success Rate of Bridge Procera Bridge Zirconia	prosthesis delivery, 1 year	The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.

Secondary Outcome Measures

Name	Time	Method
Success Rate of Bridge Procera Bridge Zirconia	prosthesis delivery, 5 years	The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading.