Zirconia and Metal-based Single Crown Posterior Restorations.

Phase 4

Completed

• Conditions: Prosthodontics; Dental Prosthesis; Dental Crowns
• Interventions: Device: dental crowns

• Registration Number: NCT02758457
• Lead Sponsor: University of Bologna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2013-01
• Study Completion: 2015-04
• Status Verified: 2016-04
• Study First Submitted: 2016-04-23
• Study First Submitted QC: 2016-04-28
• Last Update Submitted: 2016-04-28
• Study First Posted: 2016-05-02
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metal-based restorations	dental crowns	single crown with a metal framework and pressed ceramic
zirconia-based restorations	dental crowns	single crown with a zirconia framework and pressed ceramic

Primary Outcome Measures

Name	Time	Method
Technical complication rate	5 years	assessed by USPHS-criteria

Secondary Outcome Measures

Name	Time	Method
Survival rate	1, 3, 5 years	pocket probing depth

Trial Locations

Locations (1)

Department of Biomedical and Neuromotor Sciences, Division of Prosthotontics and Maxilla-Facial Rehabilitation; 🇮🇹 Bologna, Italy