Status:
TERMINATED
NobelProceraTM Bridge Shaded Zirconia
Lead Sponsor:
Nobel Biocare
Conditions:
Posterior Bridge Restoration
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 18 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02197312
Start Date
June 18 2010
End Date
November 23 2013
Last Update
March 30 2017
Active Locations (1)
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1
Universitätsklinikum Aachen
Aachen, Germany, 52074