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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Partial Edentulism Device: NobelProcera Crown Shaded Zirconia Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 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 NobelProceraTM Crown Shaded Zirconia and NobelProceraTM Full Contour Crown IPS e.Max CAD on Molars
Study Start Date : March 2010
Actual Primary Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arms and Interventions
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Arm Intervention/treatment
NobelProcera Crown Shaded Zirconia
NobelProcera Crown Shaded Zirconia molar
 Device: NobelProcera Crown Shaded Zirconia


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. survival rate [ Time Frame: yearly, up to 5 years ]

Eligibility Criteria
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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:   Yes
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
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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 ClinicalTrials.gov identifier (NCT number): NCT02188212


Locations
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Germany
Universitätsklinikum Aachen
Aachen, Germany, 52074
Sponsors and Collaborators
Nobel Biocare
Investigators
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Principal Investigator: Stefan Wolfarth, Prof University of Aachen, Germany
More Information
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Responsible Party: Nobel Biocare
ClinicalTrials.gov Identifier: NCT02188212    
Other Study ID Numbers: T-158
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: July 2014