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

Not Applicable

Completed

• Conditions: Three-unit Posterior Bridges
• Interventions: Device: Manually layered veneering; Device: CAD/CAM Veneering

• Registration Number: NCT02175329
• Lead Sponsor: Ivoclar Vivadent AG

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-26
• Status Verified: 2017-03
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
manually layered	Manually layered veneering	Manually layered veneering on CAD/CAM fabricated zirconia bridge framework
CAD/CAM veneering	CAD/CAM Veneering	CAD/CAM manufactured e.max CAD veneers on zirconia framework

Primary Outcome Measures

Name	Time	Method
Number of participants with clinical success	2 years	Clinical success is defined as more than 95% survival of the restoration after 2 years.

Secondary Outcome Measures

Name	Time	Method
Restoration quality	1 week, 1 year, 2 years, 3 years, 4 years, 5 years	Characterisation of the restorations according to United States Public Health Services (USPHS) criteria

Trial Locations

Locations (1)

Universität Zürich, Zentrum für Zahn-, Mund- und Kieferheilkunde; 🇨🇭 Zürich, Switzerland