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Nobel Procera Crown Shaded Zirconia and NobelProceraTM Full Contour Crown IPS e.Max CAD

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.
 
ClinicalTrials.gov Identifier: NCT02188212
Recruitment Status : Terminated
First Posted : July 11, 2014
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Nobel Biocare

Tracking Information
First Submitted Date  ICMJE July 3, 2014
First Posted Date  ICMJE July 11, 2014
Last Update Posted Date September 26, 2016
Study Start Date  ICMJE March 2010
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2014)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 9, 2014)
survival rate [ Time Frame: yearly, up to 5 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Nobel Procera Crown Shaded Zirconia and NobelProceraTM Full Contour Crown IPS e.Max CAD
Official Title  ICMJE A Clinical Evaluation of Hand-veneered, Porcelain-fused NobelProceraTM Crown Shaded Zirconia and NobelProceraTM Full Contour Crown IPS e.Max CAD on Molars
Brief Summary Open, controlled, 5-year, prospective, clinical, multi-center study. A total of 143 adult patients will be treated. Female or male, with an age range from 18 (or age of consent) to 70 years, provided they fulfill the inclusion criteria and need two single tooth restorations on contralateral teeth in the same arch. Each patient will receive in minimum one NobelProceraTM Crown Shaded Zirconia and one NobelProceraTM full contour crown IPS e.max CAD in lithium disilicate on the 1st or 2nd molar randomly allocated to the same tooth position contra-laterally in the maxilla or mandible. The patients will be followed for 5 years after receiving their final prosthetic restorations. Possible dropouts and withdrawals, as well as possible adverse events, will be carefully monitored during the entire investigation period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Partial Edentulism
Intervention  ICMJE Device: NobelProcera Crown Shaded Zirconia
Study Arms  ICMJE NobelProcera Crown Shaded Zirconia
NobelProcera Crown Shaded Zirconia molar
Intervention: Device: NobelProcera Crown Shaded Zirconia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 9, 2014)
53
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188212
Other Study ID Numbers  ICMJE T-158
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nobel Biocare
Study Sponsor  ICMJE Nobel Biocare
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stefan Wolfarth, Prof University of Aachen, Germany
PRS Account Nobel Biocare
Verification Date July 2014

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