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Trial record 25 of 119 for:    ZIRCONIUM

NobelProceraTM Bridge Shaded Zirconia

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: NCT02197312
Recruitment Status : Terminated (Business reasons)
First Posted : July 22, 2014
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Nobel Biocare

Brief Summary:
Industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings and a sufficient survival rate after 5 years

Condition or disease Intervention/treatment Phase
Posterior Bridge Restoration Device: NobelProcera Bridge Shaded Zirconia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of NobelProceraTM Bridge Shaded Zirconia
Actual Study Start Date : June 18, 2010
Actual Primary Completion Date : November 23, 2013
Actual Study Completion Date : November 23, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
NobelProcera Bridge Shaded Zirconia
posterior region
Device: NobelProcera Bridge Shaded Zirconia



Primary Outcome Measures :
  1. clinical performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region with the proportion of patients with CDA ratings "R" (excellent) or "S"(acceptable) [ Time Frame: yearly up to 5 years ]

Secondary Outcome Measures :
  1. survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region [ Time Frame: yearly up to 5 years ]

Other Outcome Measures:
  1. esthetic performance of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region as determined by overall patient satisfaction survey [ Time Frame: yearly up to 5 years ]


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 a posterior fixed partial denture restoration 3 or 4 units distal of the canines in the maxilla or mandible.
  • The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition.
  • Obtained informed consent from the subject prior to the study.
  • 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 should be 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 greater than grade 1 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 (attached gingiva less than 2 mm or attachment loss greater than half of the root length).
  • 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 ClinicalTrials.gov identifier (NCT number): NCT02197312


Locations
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Germany
Universitätsklinikum Aachen
Aachen, Germany, 52074
Sponsors and Collaborators
Nobel Biocare

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Responsible Party: Nobel Biocare
ClinicalTrials.gov Identifier: NCT02197312     History of Changes
Other Study ID Numbers: T-159
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Keywords provided by Nobel Biocare:
yttrium-oxide
Y-TZP
bridge
NobelProcera
Shaded Zirconia