Zirconia and Metal-based Single Crown Posterior Restorations.

U

University of Bologna

Status and phase

Completed
Phase 4

Conditions

Dental Prosthesis
Prosthodontics
Dental Crowns

Treatments

Device: dental crowns

Study type

Interventional

Funder types

Other

Identifiers

NCT02758457
222893

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

metal-based restorations
Active Comparator group
Description:
single crown with a metal framework and pressed ceramic
Treatment:
Device: dental crowns
zirconia-based restorations
Experimental group
Description:
single crown with a zirconia framework and pressed ceramic
Treatment:
Device: dental crowns

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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