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NCT Number: NCT04272112

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Dental Prosthesis Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malmö University

Malmö, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IPS e.max CAD, Ivoclar Vivadent

Combination Product

Type: monolithic lithium-disilicate glass ceramic

BruxZir, Glidewell

Combination Product

Type: high translucent zirconia

BruxZir*, Glidewell

Combination Product

Type: high translucent zirconia with a mini-veneer of porcelain

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Patient questionnaire

    Time frame: 12 month

    Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').

  2. Patient questionnaire

    Time frame: 24 month

    Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').

  3. Patient questionnaire

    Time frame: 36 month

    Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').

  4. Patient questionnaire

    Time frame: 60 month

    Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').

Sponsors and collaborators

Lead sponsor

Malmö University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2026
First posted
Feb 17, 2020
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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