Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical.
May 8, 2026 updated by: Minh Le, Malmö University
Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical Trial Comparing Glass-ceramic Crowns to Monolithic Translucent Zirconia Crowns With and Without a Semi-veneer
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.
Study Overview
Status
Active, not recruiting
Conditions
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 Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Malmö, Sweden
- Malmö University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion criteria:
- need of one or more dental crowns in the posterior dentition, premolars and molars
Exclusion criteria:
- high caries activity/risk for caries and/or advanced periodontal disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Glass-ceramic
30 dental crowns of lithium-disilicate glass-ceramic
|
Type: high translucent zirconia
Type: high translucent zirconia with a mini-veneer of porcelain
|
|
Active Comparator: Zirconia
30 dental crowns of high translucent zirconia
|
Type: high translucent zirconia with a mini-veneer of porcelain
Type: monolithic lithium-disilicate glass ceramic
|
|
Active Comparator: Zirconia with mini-veneer
30 dental crowns of high translucent zirconia with a mini-veneer of porcelain
|
Type: high translucent zirconia
Type: monolithic lithium-disilicate glass ceramic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical perfomance
Time Frame: 12 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.
|
12 month
|
|
Clinical perfomance
Time Frame: 24 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.
|
24 month
|
|
Clinical perfomance
Time Frame: 36 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.
|
36 month
|
|
Clinical perfomance
Time Frame: 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.
|
60 month
|
|
Clinical performance
Time Frame: 120 months
|
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.
|
120 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient questionnaire
Time Frame: 12 month
|
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').
|
12 month
|
|
Patient questionnaire
Time Frame: 24 month
|
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').
|
24 month
|
|
Patient questionnaire
Time Frame: 36 month
|
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').
|
36 month
|
|
Patient questionnaire
Time Frame: 60 month
|
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').
|
60 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Christel Larsson, PhD, Malmö University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Larsson C, Wennerberg A. The clinical success of zirconia-based crowns: a systematic review. Int J Prosthodont. 2014 Jan-Feb;27(1):33-43. doi: 10.11607/ijp.3647.
- Le M, Papia E, Larsson C. The clinical success of tooth- and implant-supported zirconia-based fixed dental prostheses. A systematic review. J Oral Rehabil. 2015 Jun;42(6):467-80. doi: 10.1111/joor.12272. Epub 2015 Jan 10.
- Johansson C, Kmet G, Rivera J, Larsson C, Vult Von Steyern P. Fracture strength of monolithic all-ceramic crowns made of high translucent yttrium oxide-stabilized zirconium dioxide compared to porcelain-veneered crowns and lithium disilicate crowns. Acta Odontol Scand. 2014 Feb;72(2):145-53. doi: 10.3109/00016357.2013.822098. Epub 2013 Jul 18.
- LE M, Larsson C, Papia E. Bond strength between MDP-based cement and translucent zirconia. Dent Mater J. 2019 Jun 1;38(3):480-489. doi: 10.4012/dmj.2018-194. Epub 2019 May 17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Actual)
February 1, 2020
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
February 11, 2020
First Submitted That Met QC Criteria
February 12, 2020
First Posted (Actual)
February 17, 2020
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
May 8, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN1401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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