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T-116_Procera-Bridge Zirconia - A Clinical Study

NCT ID: NCT02186808

Last Updated: 2016-10-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2015-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Partial Edentulism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Procera® Bridge Zirconia

Intervention Type DEVICE

Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nobel Biocare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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

Reference Type BACKGROUND

Other Identifiers

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T-116

Identifier Type: -

Identifier Source: org_study_id