Clinical trial NCT02197312: NobelProceraTM Bridge Shaded Zirconia
Official title: A Clinical Evaluation of NobelProceraTM Bridge Shaded Zirconia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Posterior Bridge Restoration
Keywords: yttrium-oxide
Y-TZP
bridge
NobelProcera
Shaded Zirconia
Lead sponsor: Nobel Biocare
Sponsor class: INDUSTRY
First posted: 2014-07-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 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)
timeFrame: yearly up to 5 years
Secondary outcomes:
measure: survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region
timeFrame: yearly up to 5 years
Other outcomes:
measure: esthetic performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region as determined by overall patient satisfaction survey
timeFrame: yearly up to 5 years
Locations:
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
Study officials:
References: