Clinical Investigation on Zirconia-ceramic Three-unit Bridges With CAD-on Veneering

Three-unit Posterior Bridges Clinical Trial

Official title:

A Randomized Clinical Trial of 3-unit Posterior Zirconia-ceramic Fixed Dental Prosthesis (FDPs) Veneered With Layered and Milled (CAD-on) Veneering Ceramics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02175329
• Other study ID #: CAD-On
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2017
• Source: Ivoclar Vivadent AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

60 bridge frameworks are CAD/CAM manufactured from zirconia-ceramic; 30 bridges are veneered with CAD/CAM fabricated lithium disilicate ceramic, 30 bridges are manually layered. The goal is to compare clinical survival , biological or technical behaviour of the restorations.

Description:

Randomized prospective controlled clinical study with three-unit posterior bridges made of zirconia-ceramic to compare veneering with manually layering or CAD/CAM fabricated lithium disilicate ceramic veneers. The hypothesis is that there is no difference in clinical survival of the restorations and no difference in biological or technical behaviour.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• single missing posterior tooth with two adjacent posterior teeth

• no acute conservative or paradontal treatment need except for the teeth to be treated in the study

• sufficient oral hygiene

Exclusion Criteria:

• known allergies to components

• bruxism

• missing antagonist tooth

• pregnancy or lactation

• missing written consent

• patients which are not expected to be compliant

• severe systemic diseases

• untreated carious lesions

• untreated parodontitis

Related Conditions & MeSH terms

• Three-unit Posterior Bridges

Intervention

Device:
• CAD/CAM Veneering
CAD/CAM fabricated zirconia bridge framework is veneered with CAD/CAM fabricated lithium disilicate ceramic veneer
• Manually layered veneering

Locations

Country	Name	City	State
Switzerland	Universität Zürich, Zentrum für Zahn-, Mund- und Kieferheilkunde	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Ivoclar Vivadent AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with clinical success	Clinical success is defined as more than 95% survival of the restoration after 2 years.	2 years
Secondary	Restoration quality	Characterisation of the restorations according to United States Public Health Services (USPHS) criteria	1 week, 1 year, 2 years, 3 years, 4 years, 5 years