T-116_Procera-Bridge Zirconia - A Clinical Study

Procera-Bridge Zirconia - A Clinical Study

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

Study Overview

• Status: Completed
• Conditions: Partial Edentulism
• Intervention / Treatment: Device: Procera® Bridge 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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Procera® Bridge Zirconia; Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.	Device: Procera® Bridge Zirconia; Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nobel Biocare

Publications and helpful links

General Publications

• Association, C.D., Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977.

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: July 8, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Estimate): October 27, 2016
• Last Update Submitted That Met QC Criteria: September 23, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: T-116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No