Zirconia and Metal-based Single Crown Posterior Restorations.

NCT ID: NCT02758457

Last Updated: 2016-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2015-04-30

Brief Summary

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.

Conditions

Dental Crowns; Dental Prosthesis; Prosthodontics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

metal-based restorations

single crown with a metal framework and pressed ceramic

Group Type: ACTIVE_COMPARATOR

dental crowns

Intervention Type: DEVICE

zirconia-based restorations

single crown with a zirconia framework and pressed ceramic

Group Type: EXPERIMENTAL

dental crowns

Intervention Type: DEVICE

Interventions

dental crowns

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

carlo monaco

Dr. Carlo Monaco, DDS, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Bologna, , Italy

Countries

Italy

References

Monaco C, Llukacej A, Baldissara P, Arena A, Scotti R. Zirconia-based versus metal-based single crowns veneered with overpressing ceramic for restoration of posterior endodontically treated teeth: 5-year results of a randomized controlled clinical study. J Dent. 2017 Oct;65:56-63. doi: 10.1016/j.jdent.2017.07.004. Epub 2017 Jul 21.

Reference Type: DERIVED

PMID: 28736293 (View on PubMed)

Other Identifiers

222893

Identifier Type: -

Identifier Source: org_study_id