Posterior Bridge Restoration Clinical Trial
Official title:
A Clinical Evaluation of NobelProceraTM Bridge Shaded Zirconia
| Verified date | March 2017 |
| Source | Nobel Biocare |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 25 |
| Est. completion date | November 23, 2013 |
| Est. primary completion date | November 23, 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Universitätsklinikum Aachen | Aachen |
| Lead Sponsor | Collaborator |
|---|---|
| Nobel Biocare |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | esthetic performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region as determined by overall patient satisfaction survey | yearly up to 5 years | ||
| Primary | 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) | yearly up to 5 years | ||
| Secondary | survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region | yearly up to 5 years |