T-116_Procera-Bridge Zirconia - A Clinical Study

Nobel Biocare

Status

Completed

Conditions

Partial Edentulism

Treatments

Device: Procera® Bridge Zirconia

Study type

Interventional

Funder types

Industry

Identifiers

NCT02186808

T-116

Details and patient eligibility

About

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

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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