Zirconia and Metal-based Single Crown Posterior Restorations.

Dental Prosthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758457
• Other study ID #: 222893
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2016
• Last updated: April 28, 2016
• Start date: January 2008
• Est. completion date: April 2015

Study information

• Verified date: April 2016
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 2015
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Crowns
• Dental Prosthesis
• Prosthodontics

Intervention

Device:
• dental crowns

Locations

Country	Name	City	State
Italy	Department of Biomedical and Neuromotor Sciences, Division of Prosthotontics and Maxilla-Facial Rehabilitation	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical complication rate	assessed by USPHS-criteria	5 years	No
Secondary	Survival rate	assessed by bleeding on probing	1, 3, 5 years	No
Secondary	Survival rate	pocket probing depth	1, 3, 5 years	No