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Completed

NCT Number: NCT02758457

Zirconia and Metal-based Single Crown Posterior Restorations.

The objective of this study was to compare the 5-year survival and clinical behavior of single posterior ceramic crowns made with pressable ceramic on zirconia or on a metal framework. If failures occurred, the further aim of the study was to delineate the factors contributing to the failure. The null hypothesis stated that the survival of zirconia-based restorations would be no worse that those made with metal-based material.

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Key information

Conditions

Dental Crowns Dental Prosthesis Prosthodontics

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Biomedical and Neuromotor Sciences, Division of Prosthotontics and Maxilla-Facial Rehabilitation

Bologna, 40125, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed Consent as documented by signature
  • Male and female patients from 18-70 years of age
  • Need for a single crown restoration
  • Presence of antagonist
  • minimum of 20 teeth
  • moderate to good oral hygiene with the ability to perform mechanical oral hygiene techniques including tooth brushing
  • low to moderate caries risk, and no active periodontal disease.

Exclusion criteria

  • Women who are pregnant at the date of inclusion
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
  • Smoking more than 15 cigarettes a day
  • Poor oral hygiene (Plaque Index over 30%)
  • Bruxism
  • vital teeth
  • allergic reaction or hypersensitivity to ingredients of the adhesive or restorative material

Treatment and study plan

dental crowns

Device

Primary outcomes

  1. Technical complication rate

    Time frame: 5 years

    assessed by USPHS-criteria

Secondary outcomes

  1. Survival rate

    Time frame: 1, 3, 5 years

    assessed by bleeding on probing

  2. Survival rate

    Time frame: 1, 3, 5 years

    pocket probing depth

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

Zirconia-based and Metal-based Single Crown Posterior Restorations: 5-year Results of a Randomized Controlled Clinical Study.

Important dates

Study start
2008
Primary completion
2013
Study completion
2015
First posted
May 2, 2016
Registry last updated
May 2, 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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