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Completed

NCT Number: NCT02186808

T-116_Procera-Bridge Zirconia - A Clinical Study

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

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Key information

Conditions

Partial Edentulism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Procera® Bridge Zirconia

Device

Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nobel Biocare

Industry

Registry information

Official study title

Procera-Bridge Zirconia - A Clinical Study

Important dates

Study start
2005
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2014
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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