Dental Prosthesis FailureNCT04272112
Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical.
A study testing IPS e.max CAD, Ivoclar Vivadent, BruxZir, Glidewell and BruxZir*, Glidewell in people with Dental Prosthesis Failure, run by Malmö University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Prosthesis Failure
- What is being tested?
- IPS e.max CAD, Ivoclar Vivadent, BruxZir, Glidewell and BruxZir*, Glidewell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2017to 1 Jul 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- need of one or more dental crowns in the posterior dentition, premolars and molars
Who cannot join
- high caries activity/risk for caries and/or advanced periodontal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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
- Conditions
- Dental Prosthesis Failure
- Being tested
- IPS e.max CAD, Ivoclar Vivadent, BruxZir, Glidewell, BruxZir*, Glidewell
- Keywords
- all ceramic, zirconia, crown, clinal trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPS e.max CAD, Ivoclar VivadentCombination product
Type: monolithic lithium-disilicate glass ceramic
BruxZir, GlidewellCombination product
Type: high translucent zirconia
BruxZir*, GlidewellCombination product
Type: high translucent zirconia with a mini-veneer of porcelain
| Study group | Role | What they receive |
|---|---|---|
| Glass-ceramic | Active comparator | 30 dental crowns of lithium-disilicate glass-ceramic Receives: Combination Product: BruxZir, Glidewell; Combination Product: BruxZir*, Glidewell |
| Zirconia | Active comparator | 30 dental crowns of high translucent zirconia Receives: Combination Product: IPS e.max CAD, Ivoclar Vivadent; Combination Product: BruxZir*, Glidewell |
| Zirconia with mini-veneer | Active comparator | 30 dental crowns of high translucent zirconia with a mini-veneer of porcelain Receives: Combination Product: IPS e.max CAD, Ivoclar Vivadent; Combination Product: BruxZir, Glidewell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical perfomance
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.
Measured: 12 month
Clinical perfomance
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.
Measured: 24 month
Clinical perfomance
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.
Measured: 36 month
Clinical perfomance
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.
Measured: 60 month
Clinical performance
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.
Measured: 120 months
Secondary outcomes (4)
Patient questionnaire
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').
Measured: 12 month
Patient questionnaire
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').
Measured: 24 month
Patient questionnaire
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').
Measured: 36 month
Patient questionnaire
Self-reported satisfaction with their treatment from 0 ('not satisfied at all') to 10 ('completely satisfied').
Measured: 60 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start1 Feb 2017
- Primary completion1 Feb 2026
- Study completion1 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental Prosthesis FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minh Le, Malmö University
- Investigators
- Christel Larsson, PhD, Study chair, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272112
- Sponsor's protocol ID
- NN1401
- Status last verified
- Oct 2026
- First submitted
- 11 Feb 2020
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25580846LE 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.
PubMed 31105161Larsson 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.
PubMed 24392475Johansson 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.
PubMed 23865549
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04272112
- Acronym / sponsor ID
- NN1401
- Conditions
- Dental Prosthesis Failure
- Keywords
- all ceramic, zirconia, crown, clinal trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Jul 2032 (estimated)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glass-ceramic | Active comparator | Combination Product: BruxZir, Glidewell, Combination Product: BruxZir*, Glidewell30 dental crowns of lithium-disilicate glass-ceramic |
| Zirconia | Active comparator | Combination Product: IPS e.max CAD, Ivoclar Vivadent, Combination Product: BruxZir*, Glidewell30 dental crowns of high translucent zirconia |
| Zirconia with mini-veneer | Active comparator | Combination Product: IPS e.max CAD, Ivoclar Vivadent, Combination Product: BruxZir, Glidewell30 dental crowns of high translucent zirconia with a mini-veneer of porcelain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- need of one or more dental crowns in the posterior dentition, premolars and molars
Key exclusion criteria (1 listed)
- high caries activity/risk for caries and/or advanced periodontal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPS e.max CAD, Ivoclar VivadentType: monolithic lithium-disilicate glass ceramic | Combination product | Zirconia, Zirconia with mini-veneer |
| BruxZir, GlidewellType: high translucent zirconia | Combination product | Glass-ceramic, Zirconia with mini-veneer |
| BruxZir*, GlidewellType: high translucent zirconia with a mini-veneer of porcelain | Combination product | Glass-ceramic, Zirconia |
Primary outcome
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.
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.
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.
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.
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.
4 secondary outcomes
Patient questionnaire
Time frame: 12 month
Patient questionnaire
Time frame: 24 month
Patient questionnaire
Time frame: 36 month
Patient questionnaire
Time frame: 60 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 25580846Le 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.
- Background: PubMed 31105161LE 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.
- Background: PubMed 24392475Larsson 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.
- Background: PubMed 23865549Johansson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christel Larsson, PhD study chair
Malmö University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPS e.max CAD, Ivoclar Vivadent, BruxZir, Glidewell and BruxZir*, Glidewell in people with Dental Prosthesis Failure, run by Malmö University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical perfomance (time frame: 12 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04272112, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.