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Trial record 26 of 119 for:    ZIRCONIUM

T-116_Procera-Bridge Zirconia - A Clinical Study

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ClinicalTrials.gov Identifier: NCT02186808
Recruitment Status : Completed
First Posted : July 10, 2014
Results First Posted : April 25, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Nobel Biocare

Brief Summary:
The objective of the study is to evaluate the clinical performance of Procera® Bridge Zirconia veneered with NobelRondo Zirconia.

Condition or disease Intervention/treatment Phase
Partial Edentulism Device: Procera® Bridge Zirconia Not Applicable

Detailed Description:
The study was designed to be an open, 5-year, prospective, multi-center clinical post-market study. The objectives of this clinical study were that industrial centrally produced 3- or 4-unit bridges of yttrium-oxide partially-stabilized (Y-TZP) zirconia (Procera Zirconia) in combination with the veneering ceramic material NobelRondo will show sufficient CDA ratings (90% R+S) and a sufficient survival rate after 1 and 5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Procera-Bridge Zirconia - A Clinical Study
Study Start Date : May 2005
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
Procera® Bridge Zirconia
Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
Device: Procera® Bridge Zirconia
Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.




Primary Outcome Measures :
  1. Success Rate of Bridge Procera Bridge Zirconia [ Time Frame: prosthesis delivery, 1 year ]
    The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.


Secondary Outcome Measures :
  1. Success Rate of Bridge Procera Bridge Zirconia [ Time Frame: prosthesis delivery, 5 years ]
    The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible
  • Indication: same indication as for metal supported bridges
  • Obtained informed consent from the patient

Exclusion criteria

  • Currently known alcohol, drug or medication abuse, judged by the investigator, which might influence the follow-up program
  • Patients where a bridge part connection area of 3 mm of diameter is not possible to obtain (short clinical crowns)
  • Mobility of the abutment teeth exceeding grade I
  • Patients with pathologic pocket formation at abutment teeth
  • Patients with complete dentures in the opposing jaw
  • Patients with a removable partial denture in the same jaw

Publications:
Association, C.D., Quality Evaluation for Dental Care. Guidelines for the Assessment of Clinical Quality and Professional Performance. Los Angeles: CDA, 1977.

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Responsible Party: Nobel Biocare
ClinicalTrials.gov Identifier: NCT02186808     History of Changes
Other Study ID Numbers: T-116
First Posted: July 10, 2014    Key Record Dates
Results First Posted: April 25, 2016
Last Update Posted: October 27, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No