Clinical Study of Porcelain-fused and IPS e.Max CAD Crowns
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Prof. Marco Ferrari, University of Siena
First received: April 5, 2013
Last updated: July 4, 2014
Last verified: July 2014
This clinical study has the objective to compare the longevity and the clinical behaviour (CDA Index, soft tissue behavior, success and survival rates) 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.
Device: prosthetic crowns
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Clinical Evaluation of Hand-veneered, Porcelain-fused NobelProcera(TM) Crown Shaded Zirconia and NobelProcera(TM) Full Contour Crown IPS e.Max CAD on Molars
Primary Outcome Measures:
- success of Porcelain-fused and IPS e.Max CAD Crowns [ Time Frame: 5 years ] [ Designated as safety issue: No ]
A "successful crown" is when the CDA index (Marginal integrity, Color match, Surface texture and Anatomic form) shall be Romeo or Sierra (excellent or acceptable) at delivery and remain so during the study period.
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2015 (Final data collection date for primary outcome measure)
NobelProcera™ Crown shaded zirconia:
The device is an individual, ceramic core (figure a) made of shaded zirconium with an anatomic contour providing homogenous veneering material thickness and a minimum core thickness of 0.4 or 0.7mm. The core is veneered with dental porcelain (IPS e.max Ceram) at the dental laboratory
Device: prosthetic crowns
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01835821
|Department of Dental Materials and Fixed Prosthodontics of Siena, Tuscan School of Dental Medicine, University of Florence and Siena, Siena, Italy
|Siena, SI, Italy, 53100 |
University of Siena
||Prof. Marco Ferrari, Professor, University of Siena
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 5, 2013
||July 4, 2014
||Italy: Ethics Committee
Keywords provided by University of Siena:
ClinicalTrials.gov processed this record on May 30, 2016
IPS e.max CAD