NobelProceraTM Bridge Shaded Zirconia | NCT02197312

Studies
NobelProceraTM Bridge Shaded Zirconia

NCT02197312

Sponsor

Nobel Biocare

Status

Terminated

Last Update Posted

Mar 30, 2017Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Posterior Bridge Restoration

Interventions

NobelProcera Bridge Shaded Zirconia

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Business reasons

Expanded Access Info

Start Date

Jun 18, 2010Actual

Primary Completion Date

Nov 23, 2013Actual

Completion Date

Nov 23, 2013Actual

First Submitted Date

Jul 3, 2014

First Submission Date that Met QC Criteria

Jul 18, 2014

First Posted Date

Jul 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2017

Last Update Posted Date

Mar 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings and a sufficient survival rate after 5 years

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Label	Type	Description	Intervention Names
NobelProcera Bridge Shaded Zirconia	Other	posterior region	Device: NobelProcera Bridge Shaded Zirconia

Name	Type	Description	Arm Group Labels	Other Names
NobelProcera Bridge Shaded Zirconia	Device		NobelProcera Bridge Shaded Zirconia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region with the proportion of patients with CDA ratings "R" (excellent) or "S"(acceptable)		yearly up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region		yearly up to 5 years

Other Outcomes

Measure	Description	Time Frame
esthetic performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region as determined by overall patient satisfaction survey		yearly up to 5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion.
The subject is healthy and compliant with good oral hygiene
The subject is in need of a posterior fixed partial denture restoration 3 or 4 units distal of the canines in the maxilla or mandible.
The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
Obtained informed consent from the subject prior to the study.
No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth.
Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed.
The subject should be available for the 5-year term of the investigation.

Exclusion Criteria:

The subject is not able to give her/his informed consent to participate.
Alcohol or drug abuse as noted in patient records or in patient history.
Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history.
An existing condition where acceptable retention of the restoration is impossible to attain
Mobility greater than grade 1 of the tooth to be restored.
Pathologic pocket formation of 4 mm or greater around the tooth to be restored
Severe bruxism or other destructive habits
Amount of attached soft tissue is insufficient (attached gingiva less than 2 mm or attachment loss greater than half of the root length).
Health conditions, which do not permit the restorative procedure

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided