NobelProceraTM Bridge Shaded Zirconia

Nobel Biocare

Status: Terminated

Conditions: Posterior Bridge Restoration

Treatments: Device: NobelProcera Bridge Shaded Zirconia

Study type: Interventional

Funder types: Industry

Identifiers

NCT02197312

T-159

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

NobelProcera Bridge Shaded Zirconia

Other group

Description:

posterior region

Treatment:

Device: NobelProcera Bridge Shaded Zirconia