search
Back to results

Clinical Study on Zirconia Bridges

Primary Purpose

Missing Teeth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
zirconia bridge restoration
Sponsored by
University of Siena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missing Teeth focused on measuring zirconia crown

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    zirconia bridge restoration

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    survival rate of NobelProcera™ Bridge Shaded Zirconia
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 5, 2013
    Last Updated
    July 4, 2014
    Sponsor
    University of Siena
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01835834
    Brief Title
    Clinical Study on Zirconia Bridges
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    June 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Siena

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Missing Teeth
    Keywords
    zirconia crown

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    zirconia bridge restoration
    Arm Type
    Experimental
    Arm Description
    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 Type
    Procedure
    Intervention Name(s)
    zirconia bridge restoration
    Primary Outcome Measure Information:
    Title
    survival rate of NobelProcera™ Bridge Shaded Zirconia
    Description
    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.
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 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

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Study on Zirconia Bridges

    We'll reach out to this number within 24 hrs