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Clinical Study of Porcelain-fused and IPS e.Max CAD Crowns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01835821
Recruitment Status : Unknown
Verified July 2014 by Prof. Marco Ferrari, University of Siena.
Recruitment status was:  Active, not recruiting
First Posted : April 19, 2013
Last Update Posted : July 8, 2014
Information provided by (Responsible Party):
Prof. Marco Ferrari, University of Siena

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Success Survival CDA Index Device: prosthetic crowns Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11 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 NobelProcera(TM) Crown Shaded Zirconia and NobelProcera(TM) Full Contour Crown IPS e.Max CAD on Molars
Study Start Date : March 2010
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
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

Device: prosthetic crowns
prosthetic crowns

Primary Outcome Measures :
  1. success of Porcelain-fused and IPS e.Max CAD Crowns [ Time Frame: 5 years ]
    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 :
  1. survival of Porcelain-fused and IPS e.Max CAD Crowns [ Time Frame: 5 years ]
    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.

Other Outcome Measures:
  1. CDA index [ Time Frame: 5 years ]
    California Dental Association. Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01835821

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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
Sponsors and Collaborators
University of Siena
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Marco Ferrari, Professor, University of Siena Identifier: NCT01835821    
Other Study ID Numbers: T-158
T-158s ( Registry Identifier: T-158s )
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Keywords provided by Prof. Marco Ferrari, University of Siena:
IPS e.max CAD