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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prof. Marco Ferrari, University of Siena
ClinicalTrials.gov Identifier:
NCT01835821
First received: April 5, 2013
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

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 Intervention
Success
Survival
CDA Index
Device: prosthetic crowns

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Siena:

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:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 11
Study Start Date: March 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Locations
Italy
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
  More Information

No publications provided

Responsible Party: Prof. Marco Ferrari, Professor, University of Siena
ClinicalTrials.gov Identifier: NCT01835821     History of Changes
Other Study ID Numbers: T-158, T-158s
Study First Received: April 5, 2013
Last Updated: July 4, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by University of Siena:
zirconia
crown
IPS e.max CAD

ClinicalTrials.gov processed this record on July 29, 2014