Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 Identifier:
First received: April 5, 2013
Last updated: July 4, 2014
Last verified: July 2014

April 5, 2013
July 4, 2014
March 2010
September 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01835821 on Archive Site
survival of Porcelain-fused and IPS e.Max CAD Crowns [ Time Frame: 5 years ] [ Designated as safety issue: No ]
A "surviving crown" is when the crown remains in occlusion, and when the subject's treatment is functionally successful even though all the individual success criteria are not fulfilled.
Same as current
CDA index [ Time Frame: 5 years ] [ Designated as safety issue: No ]
California Dental Association. Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977.
Same as current
Clinical Study of Porcelain-fused and IPS e.Max CAD Crowns
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

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.

Not Provided
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Success
  • Survival
  • CDA Index
Device: prosthetic crowns
prosthetic crowns
Experimental: prosthesis

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

Intervention: Device: prosthetic crowns
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
March 2016
September 2015   (final data collection date for primary outcome measure)

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.
18 Years to 70 Years
Contact information is only displayed when the study is recruiting subjects
T-158, T-158s
Prof. Marco Ferrari, University of Siena
University of Siena
Not Provided
Not Provided
University of Siena
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP