Nobel Procera Crown Shaded Zirconia and NobelProceraTM Full Contour Crown IPS e.Max CAD
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ClinicalTrials.gov Identifier: NCT02188212 |
Recruitment Status :
Terminated
First Posted : July 11, 2014
Last Update Posted : September 26, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Partial Edentulism | Device: NobelProcera Crown Shaded Zirconia | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 53 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Clinical Evaluation of Hand-veneered, Porcelain-fused NobelProceraTM Crown Shaded Zirconia and NobelProceraTM Full Contour Crown IPS e.Max CAD on Molars |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | November 2013 |

Arm | Intervention/treatment |
---|---|
NobelProcera Crown Shaded Zirconia
NobelProcera Crown Shaded Zirconia molar
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Device: NobelProcera Crown Shaded Zirconia |
- To compare the longevity of single cemented ceramic crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full contour crowns IPS e.max CAD lithium disilicate on molars. [ Time Frame: yearly up to 5 years ]
- Clinical behaviour (CDA Index, soft tissue behavior) of single cemented ceramic crowns made with shaded zirconia (NobelProceraTM Shaded Zirconia) and NobelProceraTM full contour crowns IPS e.max CAD lithium disilicate on molars. [ Time Frame: yearly up to 5 years ]
- survival rate [ Time Frame: yearly, up to 5 years ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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 at least two paired contalateral single-tooth full coverage molar restorations in the maxilla and/or mandible.
- The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
- Obtained informed consent from the subject.
- 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 is 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 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 (no attached gingiva on the buccal side of the tooth).
- Health conditions, which do not permit the restorative procedure.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188212
Germany | |
Universitätsklinikum Aachen | |
Aachen, Germany, 52074 |
Principal Investigator: | Stefan Wolfarth, Prof | University of Aachen, Germany |
Responsible Party: | Nobel Biocare |
ClinicalTrials.gov Identifier: | NCT02188212 |
Other Study ID Numbers: |
T-158 |
First Posted: | July 11, 2014 Key Record Dates |
Last Update Posted: | September 26, 2016 |
Last Verified: | July 2014 |