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Trial record 15 of 120 for:    ZIRCONIUM

Clinical Study on Zirconia Bridges

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: NCT01835834
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
Sponsor:
Information provided by (Responsible Party):
Prof. Marco Ferrari, University of Siena

Tracking Information
First Submitted Date  ICMJE April 5, 2013
First Posted Date  ICMJE April 19, 2013
Last Update Posted Date July 8, 2014
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2013)
survival rate of NobelProcera™ Bridge Shaded Zirconia [ Time Frame: 5 years ]
Success and Failure Criteria The CDA index will be used for the success criteria in this investigation. Please see also the criteria in the "clinical parameter" part of this protocol. The success and failure criteria to be used in this investigation have been determined as follows: A successful NobelProcera™ Bridge Shaded Zirconia is when: the CDA index is Romeo or Sierra at delivery and remains so during the study period. A surviving NobelProcera™ Bridge Shaded Zirconia is when: the restoration is in occlusion and in function, even though all the success criteria are not fulfilled, but is to be regarded as correctable. A failed NobelProcera™ Bridge Shaded Zirconia is when: the restoration has 1) been removed, 2) fractured, or 3) cannot be classified as a surviving or a successful restoration.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01835834 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study on Zirconia Bridges
Official Title  ICMJE Not Provided
Brief Summary To evaluate the clinical performance and survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region for a period of 5 years. The working hypothesis of this clinical study is that 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 (80% R+S) and a sufficient survival rate (93%) after 5 years in comparison with a reference level of 95%.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Missing Teeth
Intervention  ICMJE Procedure: zirconia bridge restoration
Study Arms  ICMJE Experimental: zirconia bridge restoration

The device is a ceramic core made of shaded zirconium with an anatomic contour core with a minimum of 0.6 mm** thickness and minimal connector size of 4.0 x 3.0 / 9.4 (height x width [mm] / area [mm2])** of high strength zirconia framework providing homogenous veneering material thickness as an external coating with 1.0 - 2.0 mm* wall thickness. The core is veneered with dental porcelain at the dental laboratory.

Intended use and indications:

NobelProceraTM Bridge Shaded Zirconia consists of an individualized, supporting substructure in a ceramic bridge construction for tooth/teeth replacement.

NobelProceraTM Bridge Zirconia is intended for patients in need of prosthetic oral reconstruction in order to restore chewing function. Zirconia bridges for natural tooth restorations are customized, designed, and milled from pre-sintered blanks of zirconia. The multi-unit restorations can be placed in all positions in the mouth.

Intervention: Procedure: zirconia bridge restoration
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 Unknown status
Actual Enrollment  ICMJE
 (submitted: April 18, 2013)
9
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date June 2015   (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 a posterior fixed partial denture restoration of up to 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 the subject should be available for the 5-year term of the investigation.
  • 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 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 No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01835834
Other Study ID Numbers  ICMJE T-159
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Marco Ferrari, University of Siena
Study Sponsor  ICMJE University of Siena
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Siena
Verification Date July 2014

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