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OpenTrials
Completed

NCT Number: NCT02220764

Zirconia Based Fixed Dental Prostheses

The objective of this prospective clinical study is to investigate the differences in the complication rates between tooth- and implant- supported zirconia based fixed dental prostheses (FDPs) with at least 4 units. The null-hypothesis is that there is no difference in the complication rates between implant- supported and tooth- supported zirconia FDPs.

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Key information

Conditions

Zirconia Based Fixed Dental Prostheses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The study aims to provide evidence regarding the clinical behaviour of long-span tooth- and implant-supported FDPs.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients older than 18 years
  • Missing of at least two adjacent teeth in the maxilla or mandibular
  • Sufficient oral hygiene

Exclusion criteria

  • Addiction to alcohol or drugs
  • Severe craniomandibular disorders
  • Severe systematic diseases
  • Patients unable or unwilling to sign the informed consent form
  • Untreated periodontitis

Treatment and study plan

Teeth abutment

Device

Other names: Zenotec system

Implant abutments

Device

Other names: Zenotec system, Wital (Implant system)

Primary outcomes

  1. Number of Fixed Dental Prostheses (FDPs) With Failure

    Time frame: 3 years

    "Failure" was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period.

Secondary outcomes

  1. Number of Fixed Dental Prostheses (FDPs) With Chip/s

    Time frame: 3 years

    Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported.

Other outcomes

  1. Number of of Fixed Dental Prostheses (FDPs) With Rough Surface

    Time frame: 3 years

    Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations.

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

Prospective Evaluation of Zirconia Based Tooth- and Implant- Supported Fixed Dental Prostheses

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Aug 20, 2014
Registry last updated
Mar 24, 2015

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.