Clinical Performance of All-ceramic Posterior Crowns. A Randomized, Prospective Clinical.
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 11, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedSeptember 8, 2021
September 1, 2021
3 years
February 11, 2020
September 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
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.
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.
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.
60 month
Secondary Outcomes (4)
Patient questionnaire
12 month
Patient questionnaire
24 month
Patient questionnaire
36 month
Patient questionnaire
60 month
Study Arms (3)
Glass-ceramic
ACTIVE COMPARATOR30 dental crowns of lithium-disilicate glass-ceramic
Zirconia
ACTIVE COMPARATOR30 dental crowns of high translucent zirconia
Zirconia with mini-veneer
ACTIVE COMPARATOR30 dental crowns of high translucent zirconia with a mini-veneer of porcelain
Interventions
Type: monolithic lithium-disilicate glass ceramic
Type: high translucent zirconia with a mini-veneer of porcelain
Eligibility Criteria
You may qualify if:
- need of one or more dental crowns in the posterior dentition, premolars and molars
You may not qualify if:
- high caries activity/risk for caries and/or advanced periodontal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Malmö Universitylead
Study Sites (1)
Malmö University
Malmo, Sweden
Related Publications (4)
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.
PMID: 25580846BACKGROUNDLE 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.
PMID: 31105161BACKGROUNDLarsson 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.
PMID: 24392475BACKGROUNDJohansson 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.
PMID: 23865549BACKGROUND
Study Officials
- STUDY CHAIR
Christel Larsson, PhD
Malmö University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicipal investigator
Study Record Dates
First Submitted
February 11, 2020
First Posted
February 17, 2020
Study Start
February 1, 2017
Primary Completion
February 1, 2020
Study Completion
September 1, 2021
Last Updated
September 8, 2021
Record last verified: 2021-09