Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical.

Not Applicable

Completed

• Conditions: Dental Prosthesis Failure
• Interventions: Combination Product: BruxZir, Glidewell; Combination Product: IPS e.max CAD, Ivoclar Vivadent; Combination Product: BruxZir*, Glidewell

• Registration Number: NCT04272112
• Lead Sponsor: Malmö University

Brief Summary

This is a randomized, prospective clinical trial. The aim of the project is to assess the clinical performance of three types of tooth-supported crowns; monolithic high translucent colored zirconia, crowns of high-translucent colored zirconia with a mini-veneer buccally and crowns of lithium-disilicate glass-ceramic. Crowns will be placed on posterior teeth and evaluated from an esthetic and functional point of view, to identify if there are any differences between the materials.

Detailed Description

90 monolithic tooth-supported crowns are planned to be included in the study; 30 crowns of high translucent zirconia (BruxZir, Glidewell), 30 crowns of high translucent zirconia (BruxZir, Glidewell) with a mini-veneer of porcelain and 30 crowns of lithium-disilicate glass-ceramic (IPS e.max CAD, Ivoclar Vivadent AG, Schaan, Liechtenstein).

Patients with indications for single crowns will be recruited from three general dental clinics. Inclusion criteria for participating in this study are patients in need of crowns in the posterior dentition, premolars and molars. Exclusion criteria are patients with high caries activity/risk for caries and/or advanced periodontal disease. Patients who meet the criteria will be offered the opportunity to participate in the study. They will receive written information about the study design, clinical procedures and the materials and methods to be used. Patients who are interested will confirm their participation by a written consent. The patients will be offered an extended warranty for the crowns in case of failure.

The study has been approved by the Regional Ethical Board in Lund, Sweden

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2020-02-01
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-12
• Study First Posted: 2020-02-17
• Status Verified: 2021-09
• Study Completion: 2021-09-01
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glass-ceramic	BruxZir*, Glidewell	30 dental crowns of lithium-disilicate glass-ceramic
Zirconia	BruxZir*, Glidewell	30 dental crowns of high translucent zirconia
Glass-ceramic	BruxZir, Glidewell	30 dental crowns of lithium-disilicate glass-ceramic
Zirconia	IPS e.max CAD, Ivoclar Vivadent	30 dental crowns of high translucent zirconia
Zirconia with mini-veneer	IPS e.max CAD, Ivoclar Vivadent	30 dental crowns of high translucent zirconia with a mini-veneer of porcelain
Zirconia with mini-veneer	BruxZir, Glidewell	30 dental crowns of high translucent zirconia with a mini-veneer of porcelain

Primary Outcome Measures

Name	Time	Method
Clinical perfomance	60 month	To identify if there are any differences between the materials. The marginal integrity and surface will be rated as excellent, acceptable, retrievable or not acceptable according to a modified California Dental Association (CDA) quality assessment system.

Secondary Outcome Measures

Name	Time	Method
Patient questionnaire	60 month	Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').

Trial Locations

Locations (1)

Malmö University; 🇸🇪 Malmö, Sweden