NobelProceraTM Bridge Shaded Zirconia

NCT ID: NCT02197312

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-18
• Study Completion Date: 2013-11-23

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

Conditions

Posterior Bridge Restoration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NobelProcera Bridge Shaded Zirconia

posterior region

Group Type: OTHER

NobelProcera Bridge Shaded Zirconia

Intervention Type: DEVICE

Interventions

NobelProcera Bridge Shaded Zirconia

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nobel Biocare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinikum Aachen

Aachen, , Germany

Countries

Germany

Other Identifiers

T-159

Identifier Type: -

Identifier Source: org_study_id